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1.  Looking inside the black box: results of a theory-based process evaluation exploring the results of a randomized controlled trial of printed educational messages to increase primary care physicians’ diabetic retinopathy referrals [Trial registration number ISRCTN72772651] 
Background
Theory-based process evaluations conducted alongside randomized controlled trials provide the opportunity to investigate hypothesized mechanisms of action of interventions, helping to build a cumulative knowledge base and to inform the interpretation of individual trial outcomes. Our objective was to identify the underlying causal mechanisms in a cluster randomized trial of the effectiveness of printed educational materials (PEMs) to increase referral for diabetic retinopathy screening. We hypothesized that the PEMs would increase physicians’ intention to refer patients for retinal screening by strengthening their attitude and subjective norm, but not their perceived behavioral control.
Methods
Design: A theory based process evaluation alongside the Ontario Printed Educational Material (OPEM) cluster randomized trial. Postal surveys based on the Theory of Planned Behavior were sent to a random sample of trial participants two months before and six months after they received the intervention. Setting: Family physicians in Ontario, Canada. Participants: 1,512 family physicians (252 per intervention group) from the OPEM trial were invited to participate, and 31.3% (473/1512) responded at time one and time two. The final sample comprised 437 family physicians fully completing questionnaires at both time points. Main outcome measures: Primary: behavioral intention related to referring patient for retinopathy screening; secondary: attitude, subjective norm, perceived behavioral control.
Results
At baseline, family physicians reported positive intention, attitude, subjective norm, and perceived behavioral control to advise patients about retinopathy screening suggesting limited opportunities for improvement in these constructs. There were no significant differences on intention, attitude, subjective norm, and perceived behavioral control following the intervention. Respondents also reported additional physician- and patient-related factors perceived to influence whether patients received retinopathy screening.
Conclusions
Lack of change in the primary and secondary theory-based outcomes provides an explanation for the lack of observed effect of the main OPEM trial. High baseline levels of intention to advise patients to attend retinopathy screening suggest that post-intentional and other factors may explain gaps in care. Process evaluations based on behavioral theory can provide replicable and generalizable insights to aid interpretation of randomized controlled trials of complex interventions to change health professional behavior.
Trial registration
ISRCTN72772651.
Electronic supplementary material
The online version of this article (doi:10.1186/1748-5908-9-86) contains supplementary material, which is available to authorized users.
doi:10.1186/1748-5908-9-86
PMCID: PMC4261878  PMID: 25098442
Process evaluation; Theory of planned behavior; Printed educational material; Healthcare professional behavior; Behavior change
2.  Printed educational messages aimed at family practitioners fail to increase retinal screening among their patients with diabetes: a pragmatic cluster randomized controlled trial [ISRCTN72772651] 
Background
Evidence of the effectiveness of printed educational messages in narrowing the gap between guideline recommendations and practice is contradictory. Failure to screen for retinopathy exposes primary care patients with diabetes to risk of eye complications. Screening is initiated by referral from family practitioners but adherence to guidelines is suboptimal. We aimed to evaluate the ability of printed educational messages aimed at family doctors to increase retinal screening of primary care patients with diabetes.
Methods
Design: Pragmatic 2×3 factorial cluster trial randomized by physician practice, involving 5,048 general practitioners (with 179,833 patients with diabetes). Setting: Ontario family practitioners. Interventions: Reminders (that retinal screening helps prevent diabetes-related vision loss and is covered by provincial health insurance for patients with diabetes) with prompts to encourage screening were mailed to each physician in conjunction with a widely-read professional newsletter. Alternative printed materials formats were an ‘outsert’ (short, directive message stapled to the outside of the newsletter), and/or a two-page, evidence-based article (‘insert’) and a pre-printed sticky note reminder for patients. Main outcome measure: A successful outcome was an eye examination (which includes retinal screening) provided to a patient with diabetes, not screened in the previous 12 months, within 90 days after visiting a family practitioner. Analysis accounted for clustering of doctors within practice groups.
Results
No intervention effect was detected (eye exam rates were 31.6% for patients of control physicians, 31.3% for the insert, 32.8% for the outsert, 32.3% for those who received both, and 31.2% for those who received both plus the patient reminder with the largest 95% confidence interval around any effect extending from −1.3% to 1.1%).
Conclusions
This large trial conclusively failed to demonstrate any impact of printed educational messages on screening uptake. Despite their low cost, printed educational messages should not be routinely used in attempting to close evidence-practice gaps relating to diabetic retinopathy screening.
Trial registration
ISRCTN72772651
Electronic supplementary material
The online version of this article (doi:10.1186/1748-5908-9-87) contains supplementary material, which is available to authorized users.
doi:10.1186/1748-5908-9-87
PMCID: PMC4261896  PMID: 25098587
4.  Supporting middle-cadre health care workers in Malawi: lessons learned during implementation of the PALM PLUS package 
BMC Health Services Research  2014;14(Suppl 1):S8.
Background
The government of Malawi is committed to the broad rollout of antiretroviral treatment in Malawi in the public health sector; however one of the primary challenges has been the shortage of trained health care workers. The Practical Approach to Lung Health Plus HIV/AIDS in Malawi (PALM PLUS) package is an innovative guideline and training intervention that supports primary care middle-cadre health care workers to provide front-line integrated primary care. The purpose of this paper is to describe the lessons learned in implementing the PALM PLUS package.
Methods
A clinical tool, based on algorithm- and symptom-based guidelines was adapted to the Malawian context. An accompanying training program based on educational outreach principles was developed and a cascade training approach was used for implementation of the PALM PLUS package in 30 health centres, targeting clinical officers, medical assistants, and nurses. Lessons learned were identified during program implementation through engagement with collaborating partners and program participants and review of program evaluation findings.
Results
Key lessons learned for successful program implementation of the PALM PLUS package include the importance of building networks for peer-based support, ensuring adequate training capacity, making linkages with continuing professional development accreditation and providing modest in-service training budgets. The main limiting factors to implementation were turnover of staff and desire for financial training allowances.
Conclusions
The PALM PLUS approach is a potential model for supporting mid-level health care workers to provide front-line integrated primary care in low and middle income countries, and may be useful for future task-shifting initiatives.
doi:10.1186/1472-6963-14-S1-S8
PMCID: PMC4108880  PMID: 25080192
training; educational outreach; task-shifting; continuing professional development; antiretroviral treatment; integrated primary care; nurses; clinical officers; medical assistants; health surveillance assistants; guideline; train-the-trainer; south-south collaboration; formation; sensibilisation; délégation de tâches; formation continue; soins primaires intégrés; personnel infirmier; personnel clinique; auxiliaires médicaux; adjoints à la surveillance sanitaire; lignes directrices; formation des formateurs; collaboration Sud-Sud
5.  Impact of a chronic disease self-management program on health care utilization in rural communities: a retrospective cohort study using linked administrative data 
Background
Internationally, chronic disease self-management programs (CDSMPs) have been widely promoted with the assumption that confident, knowledgeable patients practicing self-management behavior will experience improved health and utilize fewer healthcare resources. However, there is a paucity of published data supporting this claim and the majority of the evidence is based on self-report.
Methods
We used a retrospective cohort study using linked administrative health data. Data from 104 tele-CDSMP participants from 13 rural and remote communities in the province of Ontario, Canada were linked to administrative databases containing emergency department (ED) and physician visits and hospitalizations. Patterns of health care utilization prior to and after participation in the tele-CDSMP were compared. Poisson Generalized Estimating Equations regression was used to examine the impact of the tele-CDSMP on health care utilization after adjusting for covariates.
Results
There were no differences in patterns of health care utilization before and after participating in the tele-CDSMP. Among participants ≤ 66 years, however, there was a 34% increase in physician visits in the 12 months following the program (OR = 1.34, 95% CI 1.11-1.61) and a trend for decreased ED visits in those >66 years (OR = 0.59, 95% CI 0.33-1.06).
Conclusions
This is the first study to examine health care use following participation in the CDSMP in a Canadian population and to use administrative data to measure health care utilization. Similar to other studies that used self-report measures to evaluate health care use we found no differences in health care utilization before and after participation in the CDSMP. Future research needs to confirm our findings and examine the impact of the CDSMP on health care utilization in different age groups to help to determine whether these interventions are more effective with select population groups.
doi:10.1186/1472-6963-14-198
PMCID: PMC4036726  PMID: 24885135
6.  “My approach to this job is ... one person at a time” 
Canadian Family Physician  2014;60(3):258-266.
Abstract
Objective
To understand the usefulness of audit and feedback among family physicians and examine the barriers to using it to improve quality of care.
Design
Qualitative study using in-depth interviews.
Setting
Family physicians across Ontario participating in audit and feedback initiatives describing the proportion of patients meeting quality targets for chronic disease.
Participants
Purposive sampling was conducted to ensure variation in sex, years of experience, and baseline performance for quality metrics. All participants used electronic medical records and worked in multidisciplinary primary care practices.
Methods
Semistructured interviews were conducted with family physicians. The interview guide and initial coding framework were adjusted iteratively in keeping with the constant comparative method. Sampling continued until saturation was reached. Interviews were analyzed using the framework approach.
Main findings
Participants reported that the feedback increased their awareness of gaps between ideal and actual performance. This resulted mainly in efforts to “try harder” patient by patient. Key barriers to acting upon feedback in a systematic manner included a perceived discordance between population-level quality targets and patient-centred care, as well as competing priorities at both the patient and organizational levels. Although all participants had electronic medical records, participants reported a lack of quality improvement infrastructure in their practices.
Conclusion
Family physicians were not highly motivated to achieve evidence-based population-level quality targets for diabetes; many competing organizational and clinical goals took priority. Additional human resources might be needed to translate data in feedback reports into systematic changes that could lead to sustained improvements in quality of care.
PMCID: PMC3952764  PMID: 24627384
7.  Pressure ulcer multidisciplinary teams via telemedicine: a pragmatic cluster randomized stepped wedge trial in long term care 
Background
The study was conducted to determine the clinical and cost effectiveness of enhanced multi-disciplinary teams (EMDTs) vs. ‘usual care’ for the treatment of pressure ulcers in long term care (LTC) facilities in Ontario, Canada
Methods
We conducted a multi-method study: a pragmatic cluster randomized stepped-wedge trial, ethnographic observation and in-depth interviews, and an economic evaluation. Long term care facilities (clusters) were randomly allocated to start dates of the intervention. An advance practice nurse (APN) with expertise in skin and wound care visited intervention facilities to educate staff on pressure ulcer prevention and treatment, supported by an off-site hospital based expert multi-disciplinary wound care team via email, telephone, or video link as needed. The primary outcome was rate of reduction in pressure ulcer surface area (cm2/day) measured on before and after standard photographs by an assessor blinded to facility allocation. Secondary outcomes were time to healing, probability of healing, pressure ulcer incidence, pressure ulcer prevalence, wound pain, hospitalization, emergency department visits, utility, and cost.
Results
12 of 15 eligible LTC facilities were randomly selected to participate and randomized to start date of the intervention following the stepped wedge design. 137 residents with a total of 259 pressure ulcers (stage 2 or greater) were recruited over the 17 month study period. No statistically significant differences were found between control and intervention periods on any of the primary or secondary outcomes. The economic evaluation demonstrated a mean reduction in direct care costs of $650 per resident compared to ‘usual care’. The qualitative study suggested that onsite support by APN wound specialists was welcomed, and is responsible for reduced costs through discontinuation of expensive non evidence based treatments. Insufficient allocation of nursing home staff time to wound care may explain the lack of impact on healing.
Conclusion
Enhanced multi-disciplinary wound care teams were cost effective, with most benefit through cost reduction initiated by APNs, but did not improve the treatment of pressure ulcers in nursing homes. Policy makers should consider the potential yield of strengthening evidence based primary care within LTC facilities, through outreach by APNs.
Trial registration
ClinicalTrials.gov identifier NCT01232764
doi:10.1186/1472-6963-14-83
PMCID: PMC4104322  PMID: 24559218
Pressure ulcer; Long term care; Nursing home; Multi-disciplinary team; Chronic wound; Treatment
8.  Variability in research ethics review of cluster randomized trials: a scenario-based survey in three countries 
Trials  2014;15:48.
Background
Cluster randomized trials (CRTs) present unique ethical challenges. In the absence of a uniform standard for their ethical design and conduct, problems such as variability in procedures and requirements by different research ethics committees will persist. We aimed to assess the need for ethics guidelines for CRTs among research ethics chairs internationally, investigate variability in procedures for research ethics review of CRTs within and among countries, and elicit research ethics chairs’ perspectives on specific ethical issues in CRTs, including the identification of research subjects. The proper identification of research subjects is a necessary requirement in the research ethics review process, to help ensure, on the one hand, that subjects are protected from harm and exploitation, and on the other, that reviews of CRTs are completed efficiently.
Methods
A web-based survey with closed- and open-ended questions was administered to research ethics chairs in Canada, the United States, and the United Kingdom. The survey presented three scenarios of CRTs involving cluster-level, professional-level, and individual-level interventions. For each scenario, a series of questions was posed with respect to the type of review required (full, expedited, or no review) and the identification of research subjects at cluster and individual levels.
Results
A total of 189 (35%) of 542 chairs responded. Overall, 144 (84%, 95% CI 79 to 90%) agreed or strongly agreed that there is a need for ethics guidelines for CRTs and 158 (92%, 95% CI 88 to 96%) agreed or strongly agreed that research ethics committees could be better informed about distinct ethical issues surrounding CRTs. There was considerable variability among research ethics chairs with respect to the type of review required, as well as the identification of research subjects. The cluster-cluster and professional-cluster scenarios produced the most disagreement.
Conclusions
Research ethics committees identified a clear need for ethics guidelines for CRTs and education about distinct ethical issues in CRTs. There is disagreement among committees, even within the same countries, with respect to key questions in the ethics review of CRTs. This disagreement reflects variability of opinion and practices pointing toward possible gaps in knowledge, and supports the need for explicit guidelines for the ethical conduct and review of CRTs.
doi:10.1186/1745-6215-15-48
PMCID: PMC3925119  PMID: 24495542
Cluster randomized trials; Informed consent; Research ethics guidelines; Research ethics review; Web-based survey
9.  Effect of an Educational Toolkit on Quality of Care: A Pragmatic Cluster Randomized Trial 
PLoS Medicine  2014;11(2):e1001588.
In a pragmatic cluster-randomized trial, Baiju Shah and colleagues evaluated the effectiveness of printed educational materials for clinician education focusing on cardiovascular disease screening and risk reduction in people with diabetes.
Please see later in the article for the Editors' Summary
Background
Printed educational materials for clinician education are one of the most commonly used approaches for quality improvement. The objective of this pragmatic cluster randomized trial was to evaluate the effectiveness of an educational toolkit focusing on cardiovascular disease screening and risk reduction in people with diabetes.
Methods and Findings
All 933,789 people aged ≥40 years with diagnosed diabetes in Ontario, Canada were studied using population-level administrative databases, with additional clinical outcome data collected from a random sample of 1,592 high risk patients. Family practices were randomly assigned to receive the educational toolkit in June 2009 (intervention group) or May 2010 (control group). The primary outcome in the administrative data study, death or non-fatal myocardial infarction, occurred in 11,736 (2.5%) patients in the intervention group and 11,536 (2.5%) in the control group (p = 0.77). The primary outcome in the clinical data study, use of a statin, occurred in 700 (88.1%) patients in the intervention group and 725 (90.1%) in the control group (p = 0.26). Pre-specified secondary outcomes, including other clinical events, processes of care, and measures of risk factor control, were also not improved by the intervention. A limitation is the high baseline rate of statin prescribing in this population.
Conclusions
The educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Despite being relatively easy and inexpensive to implement, printed educational materials were not effective. The study highlights the need for a rigorous and scientifically based approach to the development, dissemination, and evaluation of quality improvement interventions.
Trial Registration
http://www.ClinicalTrials.gov NCT01411865 and NCT01026688
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Clinical practice guidelines help health care providers deliver the best care to patients by combining all the evidence on disease management into specific recommendations for care. However, the implementation of evidence-based guidelines is often far from perfect. Take the example of diabetes. This common chronic disease, which is characterized by high levels of sugar (glucose) in the blood, impairs the quality of life of patients and shortens life expectancy by increasing the risk of cardiovascular diseases (conditions that affect the heart and circulation) and other life-threatening conditions. Patients need complex care to manage the multiple risk factors (high blood sugar, high blood pressure, high levels of fat in the blood) that are associated with the long-term complications of diabetes, and they need to be regularly screened and treated for these complications. Clinical practice guidelines for diabetes provide recommendations on screening and diagnosis, drug treatment, and cardiovascular disease risk reduction, and on helping patients self-manage their disease. Unfortunately, the care delivered to patients with diabetes frequently fails to meet the standards laid down in these guidelines.
Why Was This Study Done?
How can guideline adherence and the quality of care provided to patients be improved? A common approach is to send printed educational materials to clinicians. For example, when the Canadian Diabetes Association (CDA) updated its clinical practice guidelines in 2008, it mailed educational toolkits that contained brochures and other printed materials targeting key themes from the guidelines to family physicians. In this pragmatic cluster randomized trial, the researchers investigate the effect of the CDA educational toolkit that targeted cardiovascular disease screening and treatment on the quality of care of people with diabetes. A pragmatic trial asks whether an intervention works under real-life conditions and whether it works in terms that matter to the patient; a cluster randomized trial randomly assigns groups of people to receive alternative interventions and compares outcomes in the differently treated “clusters.”
What Did the Researchers Do and Find?
The researchers randomly assigned family practices in Ontario, Canada to receive the educational toolkit in June 2009 (intervention group) or in May 2010 (control group). They examined outcomes between July 2009 and April 2010 in all patients with diabetes in Ontario aged over 40 years (933,789 people) using population-level administrative data. In Canada, administrative databases record the personal details of people registered with provincial health plans, information on hospital visits and prescriptions, and physician service claims for consultations, assessments, and diagnostic and therapeutic procedures. They also examined clinical outcome data from a random sample of 1,592 patients at high risk of cardiovascular complications. In the administrative data study, death or non-fatal heart attack (the primary outcome) occurred in about 11,500 patients in both the intervention and control group. In the clinical data study, the primary outcome―use of a statin to lower blood fat levels―occurred in about 700 patients in both study groups. Secondary outcomes, including other clinical events, processes of care, and measures of risk factor control were also not improved by the intervention. Indeed, in the administrative data study, some processes of care outcomes related to screening for heart disease were statistically significantly worse in the intervention group than in the control group, and in the clinical data study, fewer patients in the intervention group reached blood pressure targets than in the control group.
What Do These Findings Mean?
These findings suggest that the CDA cardiovascular diseases educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Indeed, the toolkit may have led to worsening in some secondary outcomes although, because numerous secondary outcomes were examined, this may be a chance finding. Limitations of the study include its length, which may have been too short to see an effect of the intervention on clinical outcomes, and the possibility of a ceiling effect—the control group in the clinical data study generally had good care, which left little room for improvement of the quality of care in the intervention group. Overall, however, these findings suggest that printed educational materials may not be an effective way to improve the quality of care for patients with diabetes and other complex conditions and highlight the need for a rigorous, scientific approach to the development, dissemination, and evaluation of quality improvement interventions.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001588.
The US National Diabetes Information Clearinghouse provides information about diabetes for patients, health care professionals, and the general public (in English and Spanish)
The UK National Health Service Choices website provides information (including some personal stories) for patients and carers about type 2 diabetes, the commonest form of diabetes
The Canadian Diabetes Association also provides information about diabetes for patients (including some personal stories about living with diabetes) and health care professionals; its latest clinical practice guidelines are available on its website
The UK National Institute for Health and Care Excellence provides general information about clinical guidelines and about health care quality standards in the UK
The US Agency for Healthcare Research and Quality aims to improve the quality, safety, efficiency, and effectiveness of health care for all Americans (information in English and Spanish); the US National Guideline Clearinghouse is a searchable database of clinical practice guidelines
The International Diabetes Federation provides information about diabetes for patients and health care professionals, along with international statistics on the burden of diabetes
doi:10.1371/journal.pmed.1001588
PMCID: PMC3913553  PMID: 24505216
10.  Training for health services and systems research in Sub-Saharan Africa - a case study at four East and Southern African Universities 
Background
The need to develop capacity for health services and systems research (HSSR) in low and middle income countries has been highlighted in a number of international forums. However, little is known about the level of HSSR training in Sub-Saharan Africa (SSA). We conducted an assessment at four major East and Southern African universities to describe: a) the numbers of HSSR PhD trainees at these institutions, b) existing HSSR curricula and mode of delivery, and c) motivating and challenging factors for PhD training, from the trainees’ experience.
Methods
PhD training program managers completed a pre-designed form about trainees enrolled since 2006. A desk review of existing health curricula was also conducted to identify HSSR modules being offered; and PhD trainees completed a self-administered questionnaire on motivating and challenging factors they may have experienced during their PhD training.
Results
Of the 640 PhD trainees enrolled in the health sciences since 2006, only 24 (3.8%) were in an HSSR field. None of the universities had a PhD training program focusing on HSSR. The 24 HSSR PhD trainees had trained in partnership with a university outside Africa. Top motivating factors for PhD training were: commitment of supervisors (67%), availability of scholarships (63%), and training attached to a research grant (25%). Top challenging factors were: procurement delays (44%), family commitments (38%), and poor Internet connection (35%).
Conclusion
The number of HSSR PhD trainees is at the moment too small to enable a rapid accumulation of the required critical mass of locally trained HSSR professionals to drive the much needed health systems strengthening and innovations in this region. Curricula for advanced HSSR training are absent, exposing a serious training gap for HSSR in this region.
doi:10.1186/1478-4491-11-68
PMCID: PMC3878024  PMID: 24365482
Health services and systems research; training; Sub-Saharan Africa
11.  Feedback GAP: pragmatic, cluster-randomized trial of goal setting and action plans to increase the effectiveness of audit and feedback interventions in primary care 
Background
Audit and feedback to physicians is a commonly used quality improvement strategy, but its optimal design is unknown. This trial tested the effects of a theory-informed worksheet to facilitate goal setting and action planning, appended to feedback reports on chronic disease management, compared to feedback reports provided without these worksheets.
Methods
A two-arm pragmatic cluster randomized trial was conducted, with allocation at the level of primary care clinics. Participants were family physicians who contributed data from their electronic medical records. The ‘usual feedback’ arm received feedback every six months for two years regarding the proportion of their patients meeting quality targets for diabetes and/or ischemic heart disease. The intervention arm received these same reports plus a worksheet designed to facilitate goal setting and action plan development in response to the feedback reports. Blood pressure (BP) and low-density lipoprotein cholesterol (LDL) values were compared after two years as the primary outcomes. Process outcomes measured the proportion of guideline-recommended actions (e.g., testing and prescribing) conducted within the appropriate timeframe. Intention-to-treat analysis was performed.
Results
Outcomes were similar across groups at baseline. Final analysis included 20 physicians from seven clinics and 1,832 patients in the intervention arm (15% loss to follow up) and 29 physicians from seven clinics and 2,223 patients in the usual feedback arm (10% loss to follow up). Ten of 20 physicians completed the worksheet at least once during the study. Mean BP was 128/72 in the feedback plus worksheet arm and 128/73 in the feedback alone arm, while LDL was 2.1 and 2.0, respectively. Thus, no significant differences were observed across groups in the primary outcomes, but mean haemoglobin A1c was lower in the feedback plus worksheet arm (7.2% versus 7.4%, p<0.001). Improvements in both arms were noted over time for one-half of the process outcomes.
Discussion
Appending a theory-informed goal setting and action planning worksheet to an externally produced audit and feedback intervention did not lead to improvements in patient outcomes. The results may be explained in part by passive dissemination of the worksheet leading to inadequate engagement with the intervention.
Trial registration
ClinicalTrials.gov NCT00996645
doi:10.1186/1748-5908-8-142
PMCID: PMC3878579  PMID: 24341511
13.  Disengaged: a qualitative study of communication and collaboration between physicians and other professions on general internal medicine wards 
Background
Poor interprofessional communication in hospital is deemed to cause significant patient harm. Although recognition of this issue is growing, protocols are being implemented to solve this problem without empirical research on the interprofessional communication interactions that directly underpin patient care. We report here the first large qualitative study of directly-observed talk amongst professions in general internal medicine wards, describing the content and usual conversation partners, with the aim of understanding the mechanisms by which current patterns of interprofessional communications may impact on patient care.
Methods
Qualitative study with 155 hours of data-collection, including observation and one-on-one shadowing, ethnographic and semi-structured interviews with physicians, nurses, and allied health professionals in the General Internal Medicine (GIM) wards of two urban teaching hospitals in Canada. Data were coded and analysed thematically with a focus on collaborative interactions between health professionals in both interprofessional and intraprofesional contexts.
Results
Physicians in GIM wards communicated with other professions mainly in structured rounds. Physicians’ communications were terse, consisting of reports, requests for information, or patient-related orders. Non-physician observations were often overlooked and interprofessional discussion was rare. Intraprofessional interactions among allied health professions, and between nursing, as well as interprofessional interactions between nursing and allied health were frequent and deliberative in character, but very few such discussions involved physicians, whose deliberative interactions were almost entirely with other physicians.
Conclusion
Without interprofessional problem identification and discussion, physician decisions take place in isolation. While this might be suited to protocol-driven care for patients whose conditions were simple and courses predictable, it may fail complex patients in GIM who often need tailored, interprofessional decisions on their care.
Interpersonal communication training to increase interprofessional deliberation may improve efficiency, patient-centredness and outcomes of care in hospitals. Also, electronic communications tools which reduce cognitive burden and facilitate the sharing of clinical observations and orders could help physicians to engage more in non-medical deliberation. Such interventions should take into account real-world power differentials between physicians and other health professions.
doi:10.1186/1472-6963-13-494
PMCID: PMC4222762  PMID: 24274052
Interprofessional collaboration; Ethnography; General internal medicine
14.  Implementing wait-time reductions under Ontario government benchmarks (Pay-for-Results): a Cluster Randomized Trial of the Effect of a Physician-Nurse Supplementary Triage Assistance team (MDRNSTAT) on emergency department patient wait times 
Background
Internationally, emergency departments are struggling with crowding and its associated morbidity, mortality, and decreased patient and health-care worker satisfaction. The objective was to evaluate the addition of a MDRNSTAT (Physician (MD)-Nurse (RN) Supplementary Team At Triage) on emergency department patient flow and quality of care.
Methods
Pragmatic cluster randomized trial. From 131 weekday shifts (8:00–14:30) during a 26-week period, we randomized 65 days (3173 visits) to the intervention cluster with a MDRNSTAT presence, and 66 days (3163 visits) to the nurse-only triage control cluster. The primary outcome was emergency department length-of-stay (EDLOS) for patients managed and discharged only by the emergency department. Secondary outcomes included EDLOS for patients initially seen by the emergency department, and subsequently consulted and admitted, patients reaching government-mandated thresholds, time to initial physician assessment, left-without being seen rate, time to investigation, and measurement of harm.
Results
The intervention’s median EDLOS for discharged, non-consulted, high acuity patients was 4:05 [95th% CI: 3:58 to 4:15] versus 4:29 [95th% CI: 4:19–4:38] during comparator shifts. The intervention’s median EDLOS for discharged, non-consulted, low acuity patients was 1:55 [95th% CI: 1:48 to 2:05] versus 2:08 [95th% CI: 2:02–2:14]. The intervention’s median physician initial assessment time was 0:55 [95th% CI: 0:53 to 0:58] versus 1:21 [95th% CI: 1:18 to 1:25]. The intervention’s left-without-being-seen rate was 1.5% versus 2.2% for the control (p = 0.06). The MDRNSTAT subgroup analysis resulted in significant decreases in median EDLOS for discharged, non-consulted high (4:01 [95th% CI: 3:43–4:16]) and low acuity patients (1:10 95th% CI: 0:58–1:19]), as well as physician initial assessment time (0:25 [95th% CI: 0:23–0:26]). No patients returned to the emergency department after being discharged by the MDRNSTAT at triage.
Conclusions
The intervention reduced delays and left-without-being-seen rate without increased return visits or jeopardizing urgent care of severely ill patients.
Trial registration number
NCT00991471 ClinicalTrials.gov
doi:10.1186/1471-227X-13-17
PMCID: PMC4225765  PMID: 24207160
15.  Implementation of national guidelines, incorporated within structured diabetes and hypertension records at primary level care in Cape Town, South Africa: a randomised controlled trial 
Global Health Action  2013;6:10.3402/gha.v6i0.20796.
Background and objectives
Many clinical management guidelines for chronic diseases have been published, but they have not been put into practice by busy clinicians at primary care levels. This study evaluates the implementation of national guidelines incorporated within a structured diabetes and hypertension clinical record (SR) in Cape Town in a randomised controlled trial (RCT).
Methods
Eighteen public sector community health centres (CHC) were randomly selected and allocated as intervention or control CHC. At each clinic, 25 patients with diabetes and 35 patients with hypertension were enrolled at baseline. Questionnaires were completed, blood samples were collected, blood pressure (BP) and anthropometric measures were taken and patient records were audited. SR with clinical guideline prompts were introduced at the intervention clinics after training doctors in their use and suggestions to incorporate them in regular patient records. Contact was maintained during the year of intervention with the clinic staff. A follow-up survey was conducted 1 year later to assess BP and HbA1c, and the patient records were examined to ascertain the extent of use of the SR in the intervention clinics. In-depth interviews were conducted with doctors and nurses to record their response to the intervention.
Results
The intervention evaluated in this RCT had no impact on either diabetes or hypertension control. In the intervention clinics, less than 60% of the patient folders contained the SR and when present was seldom used. Although the staff were well disposed to the research team, their workload prohibited them from undertaking a true evaluation of the SR, and overall they did not perceive the SR as supporting their current process of patient care.
Conclusions
No benefit to diabetes of hypertension care by introducing and availability of the staff in the use of the SR was shown in this RCT. The process measures suggest that the SR was not widely used by the healthcare provided in the primary care clinics.
doi:10.3402/gha.v6i0.20796
PMCID: PMC3784670  PMID: 24070181
implementation; clinical guidelines; diabetes; hypertension; primary care
16.  Managing executive dysfunction following acquired brain injury and stroke using an ecologically valid rehabilitation approach: a study protocol for a randomized, controlled trial 
Trials  2013;14:306.
Background
We have been investigating an ecologically valid strategy-training approach to enable adults with executive dysfunction to attain everyday life goals. Here, we report the protocol of a randomized controlled trial of the effects of this training compared to conventional therapy in a sample of community-dwelling adults with acquired brain injury and/or stroke.
Methods/design
We will recruit 100 community-dwelling survivors at least six months post-acquired brain injury or stroke who report executive dysfunction during a telephone interview, confirmed in pre-training testing. Following pre-training testing, participants will be randomized to the ecologically valid strategy training or conventional therapy and receive two one-hour sessions for eight weeks (maximum of 15 hours of therapy). Post-testing will occur immediately following the training and three months later. The primary outcome is self-reported change in performance on everyday life activities measured using the Canadian Occupational Performance Measure, a standardized, semi-structured interview. Secondary outcomes are objective measurement of performance change from videotapes of treatment session, Performance Quality Rating Scale; executive dysfunction symptoms, Behavioural Rating Inventory of Executive Function – Adult; participation in everyday life, Mayo-Portland Adaptability Inventory Participation Index; and ability to solve novel problems, Instrumental Activities of Daily Living Profile.
Discussion
This study is of a novel approach to promoting improvements in attainment of everyday life goals through managing executive dysfunction using an ecologically valid strategy training approach, the Cognitive Orientation to daily Occupational Performance. This study compares the efficacy of this approach with that of conventional therapy. The approach has the potential to be a valuable treatment for people with chronic acquired brain injury and/or stroke.
Trial registration
clinicaltrials.gov, Trial Identification Number: NCT01414348
doi:10.1186/1745-6215-14-306
PMCID: PMC3849520  PMID: 24053695
Cognitive orientation to daily occupational performance; Executive dysfunction; Occupational therapy; Rehabilitation; Strategy-training; Stroke; Traumatic brain injury
17.  Making clinical trials more relevant: improving and validating the PRECIS tool for matching trial design decisions to trial purpose 
Trials  2013;14:115.
Background
If you want to know which of two or more healthcare interventions is most effective, the randomised controlled trial is the design of choice. Randomisation, however, does not itself promote the applicability of the results to situations other than the one in which the trial was done. A tool published in 2009, PRECIS (PRagmatic Explanatory Continuum Indicator Summaries) aimed to help trialists design trials that produced results matched to the aim of the trial, be that supporting clinical decision-making, or increasing knowledge of how an intervention works. Though generally positive, groups evaluating the tool have also found weaknesses, mainly that its inter-rater reliability is not clear, that it needs a scoring system and that some new domains might be needed. The aim of the study is to: Produce an improved and validated version of the PRECIS tool. Use this tool to compare the internal validity of, and effect estimates from, a set of explanatory and pragmatic trials matched by intervention.
Methods
The study has four phases. Phase 1 involves brainstorming and a two-round Delphi survey of authors who cited PRECIS. In Phase 2, the Delphi results will then be discussed and alternative versions of PRECIS-2 developed and user-tested by experienced trialists. Phase 3 will evaluate the validity and reliability of the most promising PRECIS-2 candidate using a sample of 15 to 20 trials rated by 15 international trialists. We will assess inter-rater reliability, and raters’ subjective global ratings of pragmatism compared to PRECIS-2 to assess convergent and face validity. Phase 4, to determine if pragmatic trials sacrifice internal validity in order to achieve applicability, will compare the internal validity and effect estimates of matched explanatory and pragmatic trials of the same intervention, condition and participants. Effect sizes for the trials will then be compared in a meta-regression. The Cochrane Risk of Bias scores will be compared with the PRECIS-2 scores of pragmatism.
Discussion
We have concrete suggestions for improving PRECIS and a growing list of enthusiastic individuals interested in contributing to this work. By early 2014 we expect to have a validated PRECIS-2.
doi:10.1186/1745-6215-14-115
PMCID: PMC3748822  PMID: 23782862
Pragmatic; Explanatory; Clinical trials; Trial design; Applicability
18.  Researchers’ perceptions of ethical challenges in cluster randomized trials: a qualitative analysis 
Trials  2013;14:1.
Background
Cluster randomized trials (CRTs) pose ethical challenges for investigators and ethics committees. This study describes the views and experiences of CRT researchers with respect to: (1) ethical challenges in CRTs; (2) the ethics review process for CRTs; and (3) the need for comprehensive ethics guidelines for CRTs.
Methods
Descriptive qualitative analysis of interviews conducted with a purposive sample of 20 experienced CRT researchers.
Results
Informants expressed concern over the potential for bias that may result from requirements to obtain informed consent from research participants in CRTs. Informants suggested that the need for informed consent ought to be related to the type of intervention under study in a CRT. Informants rarely expressed concern regarding risks to research participants in CRTs, other than risks to privacy. Important issues identified in the research ethics literature, including fair subject selection and other justice issues, were not mentioned by informants. The ethics review process has had positive and negative impacts on CRT conduct. Informants stated that variability in ethics review between jurisdictions, and increasingly stringent ethics review in recent years, have hampered their ability to conduct CRTs. Many informants said that comprehensive ethics guidelines for CRTs would be helpful to researchers and research ethics committees.
Conclusions
Informants identified key ethical challenges in the conduct of CRTs, specifically relating to identifying subjects, seeking informed consent, and the use of gatekeepers. These data have since been used to identify topics for in-depth ethical analysis and to guide the development of comprehensive ethics guidelines for CRTs.
doi:10.1186/1745-6215-14-1
PMCID: PMC3561139  PMID: 23286245
Cluster randomized trials; Research ethics; Informed consent; Clinical trials; Bioethics; Knowledge translation; Quality improvement; Implementation research
19.  Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial 
BMC Family Practice  2012;13:126.
Background
Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life.
Methods
Trial design: Pragmatic cluster randomized controlled trial
Participants: Type 2 diabetic patients attending 45 public sector community health centres in Cape Town
Interventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room.
Objective: To evaluate the effectiveness of the group diabetes education programme
Outcomes: Primary outcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. Secondary outcomes: self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of life
Randomisation: Computer generated random numbers
Blinding: Patients, health promoters and research assistants could not be blinded to the health centre’s allocation
Numbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570.
Discussion
The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely.
Trial register
Pan African Clinical Trial Registry PACTR201205000380384
doi:10.1186/1471-2296-13-126
PMCID: PMC3560091  PMID: 23265076
Diabetes; Group education; Health education; Motivational interviewing; Mid-level health workers; South Africa; Primary care
20.  Interprofessional communication with hospitalist and consultant physicians in general internal medicine: a qualitative study 
Background
Studies in General Internal Medicine [GIM] settings have shown that optimizing interprofessional communication is important, yet complex and challenging. While the physician is integral to interprofessional work in GIM there are often communication barriers in place that impact perceptions and experiences with the quality and quantity of their communication with other team members. This study aims to understand how team members’ perceptions and experiences with the communication styles and strategies of either hospitalist or consultant physicians in their units influence the quality and effectiveness of interprofessional relations and work.
Methods
A multiple case study methodology was used. Thirty-one semi-structured interviews were conducted with physicians, nurses and other health care providers [e.g. physiotherapist, social worker, etc.] working across 5 interprofessional GIM programs. Questions explored participants’ experiences with communication with all other health care providers in their units, probing for barriers and enablers to effective interprofessional work, as well as the use of communication tools or strategies. Observations in GIM wards were also conducted.
Results
Three main themes emerged from the data: [1] availability for interprofessional communication, [2] relationship-building for effective communication, and [3] physician vs. team-based approaches. Findings suggest a significant contrast in participants’ experiences with the quantity and quality of interprofessional relationships and work when comparing the communication styles and strategies of hospitalist and consultant physicians. Hospitalist staffed GIM units were believed to have more frequent and higher caliber interprofessional communication and collaboration, resulting in more positive experiences among all health care providers in a given unit.
Conclusions
This study helps to improve our understanding of the collaborative environment in GIM, comparing the communication styles and strategies of hospitalist and consultant physicians, as well as the experiences of providers working with them. The implications of this research are globally important for understanding how to create opportunities for physicians and their colleagues to meaningfully and consistently participate in interprofessional communication which has been shown to improve patient, provider, and organizational outcomes.
doi:10.1186/1472-6963-12-437
PMCID: PMC3520700  PMID: 23198855
Interprofessional care; General internal medicine; Teamwork; Collaboration; Communication
21.  Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster-randomised trial 
Lancet  2012;380(9845):889-898.
Summary
Background
Robust evidence of the effectiveness of task shifting of antiretroviral therapy (ART) from doctors to other health workers is scarce. We aimed to assess the effects on mortality, viral suppression, and other health outcomes and quality indicators of the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) programme, which provides educational outreach training of nurses to initiate and represcribe ART, and to decentralise care.
Methods
We undertook a pragmatic, parallel, cluster-randomised trial in South Africa between Jan 28, 2008, and June 30, 2010. We randomly assigned 31 primary-care ART clinics to implement the STRETCH programme (intervention group) or to continue with standard care (control group). The ratio of randomisation depended on how many clinics were in each of nine strata. Two cohorts were enrolled: eligible patients in cohort 1 were adults (aged ≥16 years) with CD4 counts of 350 cells per μL or less who were not receiving ART; those in cohort 2 were adults who had already received ART for at least 6 months and were being treated at enrolment. The primary outcome in cohort 1 was time to death (superiority analysis). The primary outcome in cohort 2 was the proportion with undetectable viral loads (<400 copies per mL) 12 months after enrolment (equivalence analysis, prespecified difference <6%). Patients and clinicians could not be masked to group assignment. The interim analysis was blind, but data analysts were not masked after the database was locked for final analysis. Analyses were done by intention to treat. This trial is registered, number ISRCTN46836853.
Findings
5390 patients in cohort 1 and 3029 in cohort 2 were in the intervention group, and 3862 in cohort 1 and 3202 in cohort 2 were in the control group. Median follow-up was 16·3 months (IQR 12·2–18·0) in cohort 1 and 18·0 months (18·0–18·0) in cohort 2. In cohort 1, 997 (20%) of 4943 patients analysed in the intervention group and 747 (19%) of 3862 in the control group with known vital status at the end of the trial had died. Time to death did not differ (hazard ratio [HR] 0·94, 95% CI 0·76–1·15). In a preplanned subgroup analysis of patients with baseline CD4 counts of 201–350 cells per μL, mortality was slightly lower in the intervention group than in the control group (0·73, 0·54–1.00; p=0·052), but it did not differ between groups in patients with baseline CD4 of 200 cells per μL or less (0·94, 0·76–1·15; p=0·577). In cohort 2, viral load suppression 12 months after enrolment was equivalent in intervention (2156 [71%] of 3029 patients) and control groups (2230 [70%] of 3202; risk difference 1·1%, 95% CI −2·4 to 4·6).
Interpretation
Expansion of primary-care nurses' roles to include ART initiation and represcription can be done safely, and improve health outcomes and quality of care, but might not reduce time to ART or mortality.
Funding
UK Medical Research Council, Development Cooperation Ireland, and Canadian International Development Agency.
doi:10.1016/S0140-6736(12)60730-2
PMCID: PMC3442223  PMID: 22901955
22.  Allocation techniques for balance at baseline in cluster randomized trials: a methodological review 
Trials  2012;13:120.
Reviews have repeatedly noted important methodological issues in the conduct and reporting of cluster randomized controlled trials (C-RCTs). These reviews usually focus on whether the intracluster correlation was explicitly considered in the design and analysis of the C-RCT. However, another important aspect requiring special attention in C-RCTs is the risk for imbalance of covariates at baseline. Imbalance of important covariates at baseline decreases statistical power and precision of the results. Imbalance also reduces face validity and credibility of the trial results. The risk of imbalance is elevated in C-RCTs compared to trials randomizing individuals because of the difficulties in recruiting clusters and the nested nature of correlated patient-level data. A variety of restricted randomization methods have been proposed as way to minimize risk of imbalance. However, there is little guidance regarding how to best restrict randomization for any given C-RCT. The advantages and limitations of different allocation techniques, including stratification, matching, minimization, and covariate-constrained randomization are reviewed as they pertain to C-RCTs to provide investigators with guidance for choosing the best allocation technique for their trial.
doi:10.1186/1745-6215-13-120
PMCID: PMC3503622  PMID: 22853820
Cluster-randomized trials; Balanced allocation; Restricted randomization
23.  What is the role and authority of gatekeepers in cluster randomized trials in health research? 
Trials  2012;13:116.
This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the sixth of the questions posed, namely, what is the role and authority of gatekeepers in CRTs in health research? ‘Gatekeepers’ are individuals or bodies that represent the interests of cluster members, clusters, or organizations. The need for gatekeepers arose in response to the difficulties in obtaining informed consent because of cluster randomization, cluster-level interventions, and cluster size. In this paper, we call for a more restrictive understanding of the role and authority of gatekeepers.
Previous papers in this series have provided solutions to the challenges posed by informed consent in CRTs without the need to invoke gatekeepers. We considered that consent to randomization is not required when cluster members are approached for consent at the earliest opportunity and before any study interventions or data-collection procedures have started. Further, when cluster-level interventions or cluster size means that obtaining informed consent is not possible, a waiver of consent may be appropriate. In this paper, we suggest that the role of gatekeepers in protecting individual interests in CRTs should be limited. Generally, gatekeepers do not have the authority to provide proxy consent for cluster members. When a municipality or other community has a legitimate political authority that is empowered to make such decisions, cluster permission may be appropriate; however, gatekeepers may usefully protect cluster interests in other ways. Cluster consultation may ensure that the CRT addresses local health needs, and is conducted in accord with local values and customs. Gatekeepers may also play an important role in protecting the interests of organizations, such as hospitals, nursing homes, general practices, and schools. In these settings, permission to access the organization relies on resource implications and adherence to institutional policies.
doi:10.1186/1745-6215-13-116
PMCID: PMC3443001  PMID: 22834691
24.  Implementing nurse-initiated and managed antiretroviral treatment (NIMART) in South Africa: a qualitative process evaluation of the STRETCH trial 
Background
Task-shifting is promoted widely as a mechanism for expanding antiretroviral treatment (ART) access. However, the evidence for nurse-initiated and managed ART (NIMART) in Africa is limited, and little is known about the key barriers and enablers to implementing NIMART programmes on a large scale. The STRETCH (Streamlining Tasks and Roles to Expand Treatment and Care for HIV) programme was a complex educational and organisational intervention implemented in the Free State Province of South Africa to enable nurses providing primary HIV/AIDS care to expand their roles and include aspects of care and treatment usually provided by physicians. STRETCH used a phased implementation approach and ART treatment guidelines tailored specifically to nurses. The effects of STRETCH on pre-ART mortality, ART provision, and the quality of HIV/ART care were evaluated through a randomised controlled trial. This study was conducted alongside the trial to develop a contextualised understanding of factors affecting the implementation of the programme.
Methods
This study was a qualitative process evaluation using in-depth interviews and focus group discussions with patients, health workers, health managers, and other key informants as well as observation in clinics. Research questions focused on perceptions of STRETCH, changes in health provider roles, attitudes and patient relationships, and impact of the implementation context on trial outcomes. Data were analysed collaboratively by the research team using thematic analysis.
Results
NIMART appears to be highly acceptable among nurses, patients, and physicians. Managers and nurses expressed confidence in their ability to deliver ART successfully. This confidence developed slowly and unevenly, through a phased and well-supported approach that guided nurses through training, re-prescription, and initiation. The research also shows that NIMART changes the working and referral relationships between health staff, demands significant training and support, and faces workload and capacity constraints, and logistical and infrastructural challenges.
Conclusions
Large-scale NIMART appears to be feasible and acceptable in the primary level public sector health services in South Africa. Successful implementation requires a comprehensive approach with: an incremental and well supported approach to implementation; clinical guidelines tailored to nurses; and significant health services reorganisation to accommodate the knock-on effects of shifts in practice.
Trial registration
ISRCTN46836853
doi:10.1186/1748-5908-7-66
PMCID: PMC3464669  PMID: 22800379
Antiretroviral treatment; NIMART; South Africa; Primary healthcare; Nurse training; Process evaluation; PALSA PLUS
25.  Delayed educational reminders for long-term medication adherence in ST-elevation myocardial infarction (DERLA-STEMI): Protocol for a pragmatic, cluster-randomized controlled trial 
Background
Despite evidence-based recommendations supporting long-term use of cardiac medications in patients post ST-elevation myocardial infarction, adherence is known to decline over time. Discontinuation of cardiac medications in such patients is associated with increased mortality.
Methods/design
This is a pragmatic, cluster-randomized controlled trial with blinded outcome assessment and embedded qualitative process evaluation. Patients from one health region in Ontario, Canada who undergo a coronary angiogram during their admission for ST-elevation myocardial infarction and who survive their initial hospitalization will be included. Allocation of eligible patients to intervention or usual care will take place within one week after the angiogram using a computer-generated random sequence. To avoid treatment contamination, patients treated by the same family physician will be allocated to the same study arm. The intervention consists of recurrent, personalized, paper-based educational messages and reminders sent via post on behalf of the interventional cardiologist to the patient, family physician, and pharmacist urging long-term adherence to secondary prevention medications. The primary outcome is the proportion of patients who report in a phone interview taking all relevant classes of cardiac medications at twelve months. Secondary outcomes to be measured at three and twelve months include proportions of patients who report: actively taking each cardiac medication class of interest (item-by-item); stopping medications due to side effects; taking one or two or three medication classes concurrently; a perfect Morisky Medication Adherence Score for cardiac medication compliance; and having a discussion with their family physician about long-term adherence to cardiac medications. Self-reported measures of adherence will be validated using administrative data for prescriptions filled.
Discussion
This intervention is designed to be easily generalizable. If effective, it could be implemented broadly. If it does not change medication utilization, the process evaluation will offer insights regarding how such an intervention could be optimized in future.
Trial registration
Clinicaltrials.gov NCT01325116
doi:10.1186/1748-5908-7-54
PMCID: PMC3536678  PMID: 22682691
Randomized trial; Medication adherence; Reminders

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