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1.  Stakeholders’ contributions to tailored implementation programs: an observational study of group interview methods 
Background
Tailored strategies to implement evidence-based practice can be generated in several ways. In this study, we explored the usefulness of group interviews for generating these strategies, focused on improving healthcare for patients with chronic diseases.
Methods
Participants included at least four categories of stakeholders (researchers, quality officers, health professionals, and external stakeholders) in five countries. Interviews comprised brainstorming followed by a structured interview and focused on different chronic conditions in each country. We compared the numbers and types of strategies between stakeholder categories and between interview phases. We also determined which strategies were actually used in tailored intervention programs.
Results
In total, 127 individuals participated in 25 group interviews across five countries. Brainstorming generated 8 to 120 strategies per group; structured interviews added 0 to 55 strategies. Healthcare professionals and researchers provided the largest numbers of strategies. The type of strategies for improving healthcare practice did not differ systematically between stakeholder groups in four of the five countries. In three out of five countries, all components of the chosen intervention programs were mentioned by the group of researchers.
Conclusions
Group interviews with different stakeholder categories produced many strategies for tailored implementation of evidence-based practice, of which the content was largely similar across stakeholder categories.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0185-x) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-014-0185-x
PMCID: PMC4268850  PMID: 25479618
Group interview methods; Methodology/methods; Chronic illness care; Implementation science; Evidence-based practice
2.  Effectiveness of Improvement Plans in Primary Care Practice Accreditation: A Clustered Randomized Trial 
PLoS ONE  2014;9(12):e114045.
Background
Accreditation of healthcare organizations is a widely used method to assess and improve quality of healthcare. Our aim was to determine the effectiveness of improvement plans in practice accreditation of primary care practices, focusing on cardiovascular risk management (CVRM).
Method
A two-arm cluster randomized controlled trial with a block design was conducted with measurements at baseline and follow-up. Primary care practices allocated to the intervention group (n = 22) were instructed to focus improvement plans during the intervention period on CVRM, while practices in the control group (n = 23) could focus on any domain except on CVRM and diabetes mellitus. Primary outcomes were systolic blood pressure <140 mmHg, LDL cholesterol <2.5 mmol/l and prescription of antiplatelet drugs. Secondary outcomes were 17 indicators of CVRM and physician's perceived goal attainment for the chosen improvement project.
Results
No effect was found on the primary outcomes. Blood pressure targets were reached in 39.8% of patients in the intervention and 38.7% of patients in the control group; cholesterol target levels were reached in 44.5% and 49.0% respectively; antiplatelet drugs were prescribed in 82.7% in both groups. Six secondary outcomes improved: smoking status, exercise control, diet control, registration of alcohol intake, measurement of waist circumference, and fasting glucose. Participants' perceived goal attainment was high in both arms: mean scores of 7.9 and 8.2 on the 10-point scale.
Conclusions
The focus of improvement plans on CVRM in the practice accreditation program led to some improvements of CVRM, but not on the primary outcomes.
ClinicalTrials.gov NCT00791362
doi:10.1371/journal.pone.0114045
PMCID: PMC4252098  PMID: 25463149
3.  Evaluation of a health systems knowledge translation network for Africa (KTNET): a study protocol 
Background
Despite the increasing investment in health-related research in Sub-Saharan Africa, a large gulf remains between what is known and what is practiced in health systems. Knowledge translation programs aim to ensure that a wide range of stakeholders are aware of and use research evidence to inform their health and health-care decision-making. The purpose of this study is to provide insight into the impacts on capacity building for knowledge translation and knowledge translation activities by a coalition of eight research groups in Africa.
Methods/design
We will use a mixed methods approach. Key informant interviews and document reviews will be employed to evaluate changes in knowledge translation capacity and to evaluate the effects of knowledge translation on potential users of research. Quarterly teleconferences will be done to evaluate the impacts of knowledge translation activities on users of research. Using website tracking, we will be able to explore the influence of knowledge translation networking and dynamics of the knowledge translation network.
Discussion
We have adopted the dynamic knowledge transfer model and the Landry framework to come up with a framework for this study so as to explore the capacity of producers and users of research to generate, disseminate, and use research findings, while highlighting their strengths and weaknesses. This information will be useful for guiding implementers that seek to build capacity on knowledge translation so as to promote the utilization of research findings for informing programs, practice, and policy.
doi:10.1186/s13012-014-0170-4
PMCID: PMC4274690  PMID: 25423876
Health systems; Knowledge translation; Evidence-based practice; Africa
4.  The role of skin self-examination at the Swiss skin cancer day 
Background
The rising incidence of melanoma – Switzerland has the highest incidence in Europe - is a major public health challenge. Swiss dermatologist introduced the “Swiss Skin Cancer Day” (SSCD) in 2006, which provides skin cancer screening at no costs. The aim of the study was to describe the participating subjects and their motivation and investigate factors influencing the probability of a clinical diagnosis of skin malignancy.
Methods
150 dermatologists were involved in the SSCD in May 2012. Dermatologists were not remunerated. Participants had the opportunity to show a single skin lesion to a dermatologist at no cost. A questionnaire for each participating subject collected data about subjects’ age, sex, risk factors and reason for encounter; furthermore the dermatologist noted down clinical diagnosis and further management. We used descriptive statistics to report characteristics of participants and skin lesions. We built two multiple logistic regression models, one regarding the clinical diagnosis of skin malignancy and one regarding the further management.
Results
5266 subjects (55.6% female) were assessed; in 308 (5.8%) participants a clinical diagnosis of skin malignancy was found. In 1732 participants (32.9%) a clinical follow up or an excision was recommended. In the multiple logistic regression model age, sex, skin phototype and the reason for participation at the SSCD were found as significant risk factors regarding the clinical diagnosis of skin malignancy. Participants with skin cancer risk factors were more likely to get a clinical follow up recommended even if the clinical diagnosis was benign.
Conclusion
A self-perceived suspicious lesion was the strongest predictor for a clinical diagnosis of skin malignancy at the SSCD. This suggests that skin self-examination might also work in general population. Future research should focus on better access to a specialist in case a suspicious skin lesion was discovered. Safety and quality of the SSCD should be further investigated, especially concerning the discrepancy between the low number of malignant lesions and the high quantity of participants where further clinical examinations or interventions were recommended.
Electronic supplementary material
The online version of this article (doi:10.1186/s12913-014-0581-6) contains supplementary material, which is available to authorized users.
doi:10.1186/s12913-014-0581-6
PMCID: PMC4237758  PMID: 25408258
Skin cancer; Prevention; Skin self-examination; Swiss skin cancer day
5.  Effect of accreditation on the quality of chronic disease management: a comparative observational study 
BMC Family Practice  2014;15(1):179.
Background
Practice accreditation is widely used to assess and improve quality of healthcare providers. Little is known about its effectiveness, particularly in primary care. In this study we examined the effect of accreditation on quality of care regarding diabetes, chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD).
Methods
A comparative observational study with two cohorts was performed. We included 138 Dutch family practices that participated in the national accreditation program for primary care. A first cohort of 69 practices was measured at start and completion of a 3-year accreditation program. A second cohort of 69 practices was included and measured simultaneously with the final measurement of the first cohort. In separate multilevel regression analyses, we compared both within-group changes in the first cohort and between-groups differences at follow-up (first cohort) and start (second cohort). Outcome measures consisted of 24 systematically developed indicators of quality of care in targeted chronic diseases.
Results
In the within-group comparison, we found improvements on 6 indicators related to diabetes (feet examination, cholesterol measurement, lipid lowering medication prescription) and COPD (spirometry performance, stop smoking advice). In the between-groups comparison we found that first cohort practices performed better on 4 indicators related to diabetes (cholesterol outcome) and CVD (blood pressure outcome, smoke status registration, glucose measurement).
Conclusions
Improvements of the quality of primary care for patients with chronic diseases were found, but few could be attributed to the accreditation program. Further development of accreditation is needed to enhance its effectiveness on chronic disease management.
doi:10.1186/s12875-014-0179-4
PMCID: PMC4224756  PMID: 25366033
Accreditation; Chronic disease; Primary health care; Quality improvement
6.  Improving patient care for attention deficit hyperactivity disorder in children by organizational redesign (Tornado program) and enhanced collaboration between psychiatry and general practice: a controlled before and after study 
Background
Implementation of clinical guidelines for diagnosis and treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents is a challenge in practice due to insufficient availability of mental health specialists and lack of effective cooperation with primary care physicians. The Tornado program aims to reduce time between referral and start of treatment in eligible patients. This study aims to assess the effectiveness and efficiency of this program.
Methods/design
This is a non-randomized controlled before-after study involving 90 outpatients (6–18 years old) suspected of uncomplicated ADHD, which were recruited by ten mental health teams. The Tornado program, provided by three teams, combines accelerated-track diagnosis and treatment planning. This is followed by psychoeducation at a mental health center and pharmacological treatment by primary care physicians, who received an online e-learning module for this purpose. The control group consists of patients of seven other teams, who receive care as usual. Primary outcome is the patients’ time between referral to the mental health or pediatric center and start of treatment. Secondary outcomes include severity of ADHD symptoms; functional status; health-related quality of life; treatment adherence; indicators of diagnostic procedures and treatments; patient, parent, and professional experiences and satisfaction with care; and an economic evaluation. The study is powered to detect a difference of 36 days.
Discussion
This study will provide insight into the effectiveness and efficiency of the Tornado program, an accelerated-track program in mental healthcare.
Trial registration
Netherlands Trial Register NTR2505. Trial status: active data collection.
doi:10.1186/s13012-014-0155-3
PMCID: PMC4219050  PMID: 25359002
ADHD in children and adolescents; ADHD in child and adolescent psychiatry; ADHD in primary care; Implementation science; Organizational redesign
7.  Emerging trends in diabetes care practice and policy in The Netherlands: a key informants study 
BMC Research Notes  2014;7(1):693.
Background
Effective self-management is viewed as the cornerstone of diabetes care. Many interventions and policies are available to support self-management, but challenges remain regarding reaching specific subgroups and effectively changing lifestyles. Here, our aim was to identify emerging policies and practices regarding diabetes care in The Netherlands.
Methods
Study with a purposeful sample of key informants, covering a range of stakeholders. They were individually interviewed, using a flexible and semi-structured approach. A thematic analysis was done, guided by an international framework, which resulted in 28 themes.
Results
After a decade of investing in diabetes care in The Netherlands, stakeholders seem to have shifted their focus towards a view that effective self-management is expected in most people. The expectation is that individuals’ personal networks, community organizations and emerging information technologies will facilitate this. If support of self-management is required, this has to be provided by local coalitions of health and social care organizations, with involvement of municipalities. Poor reach in specific subgroups of the population, such as economically deprived people, is recognized but has not led to targeted policies.
Conclusions
The role of healthcare providers in supporting patients’ self-management in diabetes care seems to be changing in The Netherlands.
doi:10.1186/1756-0500-7-693
PMCID: PMC4195957  PMID: 25286928
Diabetes care; Self-management; Health policy; The Netherlands
8.  Identifying determinants of care for tailoring implementation in chronic diseases: an evaluation of different methods 
Background
The tailoring of implementation interventions includes the identification of the determinants of, or barriers to, healthcare practice. Different methods for identifying determinants have been used in implementation projects, but which methods are most appropriate to use is unknown.
Methods
The study was undertaken in five European countries, recommendations for a different chronic condition being addressed in each country: Germany (polypharmacy in multimorbid patients); the Netherlands (cardiovascular risk management); Norway (depression in the elderly); Poland (chronic obstructive pulmonary disease—COPD); and the United Kingdom (UK) (obesity). Using samples of professionals and patients in each country, three methods were compared directly: brainstorming amongst health professionals, interviews of health professionals, and interviews of patients. The additional value of discussion structured through reference to a checklist of determinants in addition to brainstorming, and determinants identified by open questions in a questionnaire survey, were investigated separately. The questionnaire, which included closed questions derived from a checklist of determinants, was administered to samples of health professionals in each country. Determinants were classified according to whether it was likely that they would inform the design of an implementation intervention (defined as plausibly important determinants).
Results
A total of 601 determinants judged to be plausibly important were identified. An additional 609 determinants were judged to be unlikely to inform an implementation intervention, and were classified as not plausibly important. Brainstorming identified 194 of the plausibly important determinants, health professional interviews 152, patient interviews 63, and open questions 48. Structured group discussion identified 144 plausibly important determinants in addition to those already identified by brainstorming.
Conclusions
Systematic methods can lead to the identification of large numbers of determinants. Tailoring will usually include a process to decide, from all the determinants that are identified, those to be addressed by implementation interventions. There is no best buy of methods to identify determinants, and a combination should be used, depending on the topic and setting. Brainstorming is a simple, low cost method that could be relevant to many tailored implementation projects.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0102-3) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-014-0102-3
PMCID: PMC4243773  PMID: 25112492
Chronic disease; Guideline adherence; Quality assurance; Healthcare
9.  Medication Incidents Related to Automated Dose Dispensing in Community Pharmacies and Hospitals - A Reporting System Study 
PLoS ONE  2014;9(7):e101686.
Introduction
Automated dose dispensing (ADD) is being introduced in several countries and the use of this technology is expected to increase as a growing number of elderly people need to manage their medication at home. ADD aims to improve medication safety and treatment adherence, but it may introduce new safety issues. This descriptive study provides insight into the nature and consequences of medication incidents related to ADD, as reported by healthcare professionals in community pharmacies and hospitals.
Methods
The medication incidents that were submitted to the Dutch Central Medication incidents Registration (CMR) reporting system were selected and characterized independently by two researchers.
Main Outcome Measures
Person discovering the incident, phase of the medication process in which the incident occurred, immediate cause of the incident, nature of incident from the healthcare provider's perspective, nature of incident from the patient's perspective, and consequent harm to the patient caused by the incident.
Results
From January 2012 to February 2013 the CMR received 15,113 incidents: 3,685 (24.4%) incidents from community pharmacies and 11,428 (75.6%) incidents from hospitals. Eventually 1 of 50 reported incidents (268/15,113 = 1.8%) were related to ADD; in community pharmacies more incidents (227/3,685 = 6.2%) were related to ADD than in hospitals (41/11,428 = 0.4%). The immediate cause of an incident was often a change in the patient's medicine regimen or relocation. Most reported incidents occurred in two phases: entering the prescription into the pharmacy information system and filling the ADD bag.
Conclusion
A proportion of incidents was related to ADD and is reported regularly, especially by community pharmacies. In two phases, entering the prescription into the pharmacy information system and filling the ADD bag, most incidents occurred. A change in the patient's medicine regimen or relocation was the immediate causes of an incident.
doi:10.1371/journal.pone.0101686
PMCID: PMC4109935  PMID: 25058321
10.  Sepsis survivors monitoring and coordination in outpatient health care (SMOOTH): study protocol for a randomized controlled trial 
Trials  2014;15:283.
Background
Sepsis sequelae include critical illness polyneuropathy, myopathy, wasting, neurocognitive deficits, post-traumatic stress disorder, depression and chronic pain. Little is known howlong-term sequelae following hospital discharge are treated. The aim of our study is to determine the effect of a primary care-based, long-term program on health-related quality of life in sepsis survivors.
Methods/Design
In a two-armed randomized multicenter interventional study, patients after sepsis (n = 290) will be assessed at 6, 12 and 24 months. Patients are eligible if severe sepsis or septic shock (ICD-10), at least two criteria of systemic inflammatory response syndrome (SIRS), at least one organ dysfunction and sufficient cognitive capacity are present. The intervention comprises 1) discharge management, 2) training of general practitioners and patients in evidence-based care for sepsis sequelae and 3) telephone monitoring of patients. At six months, we expect an improved primary outcome (health-related quality of life/SF-36) and improved secondary outcomes such as costs, mortality, clinical-, psycho-social- and process-of-care measures in the intervention group compared to the control group.
Discussion
This study evaluates a primary care-based, long-term program for patients after severe sepsis. Study results may add evidence for improved sepsis care management. General practitioners may contribute efficiently to sepsis aftercare.
Trial registration
U1111-1119-6345. DRKS00000741, CCT-NAPN-20875 (25 February 2011).
doi:10.1186/1745-6215-15-283
PMCID: PMC4226940  PMID: 25015838
Severe sepsis; Sequelae; Critical illness; Primary health care; Aftercare
11.  Tailored Implementation of Evidence-Based Practice for Patients with Chronic Diseases 
PLoS ONE  2014;9(7):e101981.
Background
When designing interventions and policies to implement evidence based healthcare, tailoring strategies to the targeted individuals and organizations has been recommended. We aimed to gather insights into the ideas of a variety of people for implementing evidence-based practice for patients with chronic diseases, which were generated in five European countries.
Methods
A qualitative study in five countries (Germany, Netherlands, Norway, Poland, United Kingdom) was done, involving overall 115 individuals. A purposeful sample of four categories of stakeholders (healthcare professionals, quality improvement officers, healthcare purchasers and authorities, and health researchers) was involved in group interviews in each of the countries to generate items for improving healthcare in different chronic conditions per country: chronic obstructive pulmonary disease, cardiovascular disease, depression in elderly people, multi-morbidity, obesity. A disease-specific standardized list of determinants of practice in these conditions provided the starting point for these groups. The content of the suggested items was categorized in a pre-defined framework of 7 domains and specific themes in the items were identified within each domain.
Results
The 115 individuals involved in the study generated 812 items, of which 586 addressed determinants of practice. These largely mapped onto three domains: individual health professional factors, patient factors, and professional interactions. Few items addressed guideline factors, incentives and resources, capacity of organizational change, or social, political and legal factors. The relative numbers of items in the different domains were largely similar across stakeholder categories within each of the countries. The analysis identified 29 specific themes in the suggested items across countries.
Conclusion
The type of suggestions for improving healthcare practice was largely similar across different stakeholder groups, mainly addressing healthcare professionals, patient factors and professional interactions. As this study is one of the first of its kind, it is important that more research is done on tailored implementation strategies.
doi:10.1371/journal.pone.0101981
PMCID: PMC4087017  PMID: 25003371
12.  Social networks of health care providers and patients in cardiovascular risk management: a study protocol 
Background
In recent years, preventive and clinical interventions for cardiovascular risk management have been implemented widely in primary care in the Netherlands. Although this has enhanced quality and outcomes of cardiovascular risk management, further improvement remains possible. In the planned observational study, we aim to examine the role of social networks of healthcare providers and patients in quality and outcomes of cardiovascular risk management.
Methods/Design
In a longitudinal observational study, data on social networks of approximately 300 primary care providers from 30 general practices and 900 cardiovascular patients will be collected twice, with a six month interval, using a mix of measures. Social networks are documented with specifically designed questionnaires for patients, relatives, and healthcare professionals. For each included patient, we will extract from medical records to gather data on clinical processes and cardiovascular risk predictors. Data on self-management and psychosocial outcomes of patients will be collected using questionnaires for patients. The analysis focuses on identifying network characteristics, which are associated with (changes in) cardiovascular risk management or self-management.
Discussion
This research will provide insight into the role of social networks of patients and providers in cardiovascular risk management in primary practice.
Trial registration
Nederlands Trial Register NTR4069.
doi:10.1186/1472-6963-14-265
PMCID: PMC4071149  PMID: 24942555
Social network analysis; Information sharing; Primary care; Cardiovascular disease
13.  Substitution of physicians by nurses in primary care: a systematic review and meta-analysis 
Background
In many countries, substitution of physicians by nurses has become common due to the shortage of physicians and the need for high-quality, affordable care, especially for chronic and multi-morbid patients. We examined the evidence on the clinical effectiveness and care costs of physician-nurse substitution in primary care.
Methods
We systematically searched OVID Medline and Embase, The Cochrane Library and CINAHL, up to August 2012; selected and critically appraised published randomised controlled trials (RCTs) that compared nurse-led care with care by primary care physicians on patient satisfaction, Quality of Life (QoL), hospital admission, mortality and costs of healthcare. We assessed the individual study risk of bias, calculated the study-specific and pooled relative risks (RR) or standardised mean differences (SMD); and performed fixed-effects meta-analyses.
Results
24 RCTs (38,974 participants) and 2 economic studies met the inclusion criteria. Pooled analyses showed higher overall scores of patient satisfaction with nurse-led care (SMD 0.18, 95% CI 0.13 to 0.23), in RCTs of single contact or urgent care, short (less than 6 months) follow-up episodes and in small trials (N ≤ 200). Nurse-led care was effective at reducing the overall risk of hospital admission (RR 0.76, 95% CI 0.64 to 0.91), mortality (RR 0.89, 95% CI 0.84 to 0.96), in RCTs of on-going or non-urgent care, longer (at least 12 months) follow-up episodes and in larger (N > 200) RCTs. Higher quality RCTs (with better allocation concealment and less attrition) showed higher rates of hospital admissions and mortality with nurse-led care albeit less or not significant. The results seemed more consistent across nurse practitioners than with registered or licensed nurses. The effects of nurse-led care on QoL and costs were difficult to interpret due to heterogeneous outcome reporting, valuation of resources and the small number of studies.
Conclusions
The available evidence continues to be limited by the quality of the research considered. Nurse-led care seems to have a positive effect on patient satisfaction, hospital admission and mortality. This important finding should be confirmed and the determinants of this effect should be assessed in further, larger and more methodically rigorous research.
doi:10.1186/1472-6963-14-214
PMCID: PMC4065389  PMID: 24884763
Systematic review; Meta-analysis; Physician-nurse substitution; Skill-mix; Health outcomes; Cost
14.  Patient reported outcome measures (PROMs) in primary care: an observational pilot study of seven generic instruments 
BMC Family Practice  2014;15:88.
Background
Patient reported outcome measures (PROMs) have been introduced in studies to assess healthcare performance. The development of PROMs for primary care poses specific challenges, including a preference for generic measures that can be used across diseases, including early phases or mild conditions. This pilot study aimed to explore the potential usefulness of seven generic measures for assessing health outcomes in primary care patients.
Methods
A total of 300 patients in three general practices were invited to participate in the study, shortly after their visit to the general practitioner. Patients received a written questionnaire, containing seven validated instruments, focused on patient empowerment (PAM-13 or EC-17), quality of life (EQ-5D or SF-12), mental health (GHQ-12), enablement (PEI) and perceived treatment effect (GPE). Furthermore, questions on non-specific symptoms and number of GP contacts were included. After 4 weeks patients received a second, identical, questionnaire. Response and missing items, total scores and dispersion, responsiveness, and associations between instruments and other measures were examined.
Results
A total of 124 patients completed the questionnaire at baseline, of whom 98 completed it both at baseline and 4 weeks later (response rate: 32.7%). The instruments had a full completion rate of 80% or higher. Differences between baseline and follow up were significant for the EQ-5D (p = 0.026), SF-12 PCS (p = 0.026) and the GPE (p = 0.006). A strong correlation (r ≥ 0.6) was found between the SF-12 MCS and GHQ-12, at both baseline measurement and after four weeks. Other observed associations between instruments were moderately strong. No strong correlations were found between instruments and non-specific symptoms or number of GP contacts.
Conclusions
The present study is among the first to explore the use of generic patient-reported outcome measures in primary care. It provides several leads for developing a generic PROM questionnaire in primary care as well as for potential limitations of such instruments.
doi:10.1186/1471-2296-15-88
PMCID: PMC4029823  PMID: 24884544
Patient-reported outcome measures; Primary care; General practice; Quality of life; Patient empowerment; Patient enablement
15.  Effectiveness of a quality management program in dental care practices 
BMC Oral Health  2014;14:41.
Background
Structured quality management is an important aspect for improving patient dental care outcomes, but reliable evidence to validate effects is lacking. We aimed to examine the effectiveness of a quality management program in primary dental care settings in Germany.
Methods
This was an exploratory study with a before-after-design. 45 dental care practices that had completed the European Practice Assessment (EPA) accreditation scheme twice (intervention group) were selected for the study. The mean interval between the before and after assessment was 36 months. The comparison group comprised of 56 dental practices that had undergone their first assessment simultaneously with follow-up assessment in the intervention group. Aggregated scores for five EPA domains: ‘infrastructure’, ‘information’, ‘finance’, ‘quality and safety’ and ‘people’ were calculated.
Results
In the intervention group, small non-significant improvements were found in the EPA domains. At follow-up, the intervention group had higher scores on EPA domains as compared with the comparison group (range of differences was 4.2 to 10.8 across domains). These differences were all significant in regression analyses, which controlled for relevant dental practice characteristics.
Conclusions
Dental care practices that implemented a quality management program had better organizational quality in contrast to a comparison group. This may reflect both improvements in the intervention group and a selection effect of dental practices volunteering for the first round of EPA practice assessment.
doi:10.1186/1472-6831-14-41
PMCID: PMC4012092  PMID: 24773764
Dental care; Oral health care; Quality of care; Quality improvement; Quality management
16.  Involving patients in detecting quality gaps in a fragmented healthcare system: development of a questionnaire for Patients' Experiences Across Health Care Sectors (PEACS) 
Objective
The purpose of this study was to develop and validate a generic questionnaire to evaluate experiences and reported outcomes in patients who receive treatment across a range of healthcare sectors.
Design
Mixed-methods design including focus groups, pretests and field test.
Setting
The patient questionnaire was developed in the context of a nationwide program in Germany aimed at quality improvements across the healthcare sectors.
Participants
For the field test, 589 questionnaires were distributed to patients via 47 general practices.
Main Measurements
Descriptive item analyzes non-responder analysis and factor analysis (PCA). Retest coefficients (r) calculated by correlation of sum scores of PCA factors. Quality gaps were assessed by the proportion of responders choosing a response category defined as indicating shortcomings in quality of care.
Results
The conceptual phase showed good content validity. Four hundred and seventy-four patients who received a range of treatment across a range of sectors were included (response rate: 80.5%). Data analysis confirmed the construct, oriented to the patient care journey with a focus on transitions between healthcare sectors. Quality gaps were assessed for the topics ‘Indication’, including shared-decision-making (6 items, 24.5–62.9%) and ‘Discharge and Transition’ (10 items; 20.7–48.2%). Retest coefficients ranged from r = 0.671 until r = 0.855 and indicated good reliability. Low ratios of item-non-response (0.8–9.3%) confirmed a high acceptance by patients.
Conclusions
The number of patients with complex healthcare needs is increasing. Initiatives to expand quality assurance across organizational borders and healthcare sectors are therefore urgently needed. A validated questionnaire (called PEACS 1.0) is available to measure patients' experiences across healthcare sectors with a focus on quality improvement.
doi:10.1093/intqhc/mzu044
PMCID: PMC4041096  PMID: 24758750
quality measurement; quality management; patient satisfaction; measurement of quality; patient-centered care; quality improvement
17.  GPs’ role security and therapeutic commitment in managing alcohol problems: a randomised controlled trial of a tailored improvement programme 
BMC Family Practice  2014;15:70.
Background
General practitioners with more positive role security and therapeutic commitment towards patients with hazardous or harmful alcohol consumption are more involved and manage more alcohol-related problems than others. In this study we evaluated the effects of our tailored multi-faceted improvement implementation programme on GPs’ role security and therapeutic commitment and, in addition, which professional related factors influenced the impact of the implementation programme.
Methods
In a cluster randomised controlled trial, 124 GPs from 82 Dutch general practices were randomised to either the intervention or control group. The tailored, multi-faceted programme included combined physician, organisation, and patient directed alcohol-specific implementation strategies to increase role security and therapeutic commitment in GPs. The control group was mailed the national guideline and patients received feedback letters. Questionnaires were completed before and 12 months after start of the programme. We performed linear multilevel regression analysis to evaluate effects of the implementation programme.
Results
Participating GPs were predominantly male (63%) and had received very low levels of alcohol related education before start of the study (0.4 h). The programme increased therapeutic commitment (p = 0.005; 95%-CI 0.13 – 0.73) but not role security (p = 0.58; 95%-CI −0.31 – 0.54). How important GPs thought it was to improve their care for problematic alcohol consumption, and the GPs’ reported proportion of patients asked about alcohol consumption at baseline, contributed to the effect of the programme on therapeutic commitment.
Conclusions
A tailored, multi-faceted programme aimed at improving GP management of patients with hazardous and harmful alcohol consumption improved GPs’ therapeutic commitment towards patients with alcohol-related problems, but failed to improve GPs’ role security. How important GPs thought it was to improve their care for problematic alcohol consumption, and the GPs’ reported proportion of patients asked about alcohol consumption at baseline, both increased the impact of the programme on therapeutic commitment. It might be worthwhile to monitor proceeding of role security and therapeutic commitment throughout the year after the implementation programme, to see whether the programme is effective on short term but faded out on the longer term.
Trial registration
ClinicalTrials.gov Identifier: NCT00298220
doi:10.1186/1471-2296-15-70
PMCID: PMC4021502  PMID: 24742032
Alcohol; Role security; Therapeutic commitment; Prevention; Primary healthcare; Implementation
18.  Evaluation of a practice team-supported exposure training for patients with panic disorder with or without agoraphobia in primary care - study protocol of a cluster randomised controlled superiority trial 
Trials  2014;15:112.
Background
Panic disorder and agoraphobia are debilitating and frequently comorbid anxiety disorders. A large number of patients with these conditions are treated by general practitioners in primary care. Cognitive behavioural exposure exercises have been shown to be effective in reducing anxiety symptoms. Practice team-based case management can improve clinical outcomes for patients with chronic diseases in primary care. The present study compares a practice team-supported, self-managed exposure programme for patients with panic disorder with or without agoraphobia in small general practices to usual care in terms of clinical efficacy and cost-effectiveness.
Methods/Design
This is a cluster randomised controlled superiority trial with a two-arm parallel group design. General practices represent the units of randomisation. General practitioners recruit adult patients with panic disorder with or without agoraphobia according to the International Classification of Diseases, version 10 (ICD-10). In the intervention group, patients receive cognitive behaviour therapy-oriented psychoeducation and instructions to self-managed exposure exercises in four manual-based appointments with the general practitioner. A trained health care assistant from the practice team delivers case management and is continuously monitoring symptoms and treatment progress in ten protocol-based telephone contacts with patients. In the control group, patients receive usual care from general practitioners. Outcomes are measured at baseline (T0), at follow-up after six months (T1), and at follow-up after twelve months (T2). The primary outcome is clinical severity of anxiety of patients as measured by the Beck Anxiety Inventory (BAI). To detect a standardised effect size of 0.35 at T1, 222 patients from 37 general practices are included in each group. Secondary outcomes include anxiety-related clinical parameters and health-economic costs.
Trial registration
Current Controlled Trials [http://ISCRTN64669297]
doi:10.1186/1745-6215-15-112
PMCID: PMC3983856  PMID: 24708672
Panic disorder; Agoraphobia; Case management; Primary health care; General practice
19.  Evaluation of a tailored implementation strategy to improve the management of patients with chronic obstructive pulmonary disease in primary care: a study protocol of a cluster randomized trial 
Trials  2014;15:109.
Background
Chronic obstructive pulmonary disease (COPD) remains a major health problem, strongly related to smoking. Despite the publication of practice guidelines on prevention and treatment, not all patients with the disease receive the recommended healthcare, particularly with regard to smoking cessation advice where applicable. We have developed a tailored implementation strategy for enhancing general practitioners’ adherence to the disease management guidelines. The primary aim of the study is to evaluate the effects of this tailored implementation intervention on general practitioners’ adherence to guidelines.
Methods/Design
A pragmatic two-arm cluster randomized trial has been planned to compare care following the implementation of tailored interventions of four recommendations in COPD patients against usual care. The study will involve 18 general practices (9 in the intervention group and 9 in the control group) in Poland, each with at least 80 identified (at the baseline) patients with diagnosed COPD. The nine control practices will provide usual care without any interventions. Tailored interventions to implement four recommendations will be delivered in the remaining nine practices. At follow-up after nine months, data will be collected for all 18 general practices. The primary outcome measure is physicians’ adherence to all four recommendations: brief anti-smoking advice, dyspnea assessment, care checklist utilization and demonstration to patients of correct inhaler use. This measurement will be based on data extracted from identified patients’ records. Additionally, we will survey and interview patients with chronic obstructive pulmonary disease about the process of care.
Discussion
The results of this trial will be directly applicable to primary care in Poland and add to the growing body of evidence on interventions to improve chronic illness care.
Trial registration
This trial has been registered with Clinical Trials Protocol Registration System. Trial number: NCT01893476.
doi:10.1186/1745-6215-15-109
PMCID: PMC4017831  PMID: 24708623
Chronic obstructive pulmonary disease; Implementation science; Primary health care
20.  The improving care in chronic obstructive lung disease study: CAROL improving processes of care and quality of life of COPD patients in primary care: study protocol for a randomized controlled trial 
Trials  2014;15:96.
Background
The Swiss health ministry launched a national quality program ‘QualiCCare’ in 2011 to improve health care for patients with COPD.
The aim of this study is to determine whether participation in the COPD quality initiative (‘QualiCCare’) improves adherence to recommended clinical processes and shows impact on patients’ COPD care and on the impact of COPD on a person's life.
Methods
CAROL is a cluster-randomized controlled trial with randomization on the general practioner (GP) level. Thirty GPs will be randomly assigned to equally sized intervention group or control group.
Each GP will approach consecutively and regardless of the reason for the current consultation, patients aged 45 years or older, with a smoking history of ≥ ten pack-years (PY). Patients with confirmed (by spirometric evaluation) COPD will be included in the study. GPs in the intervention group will receive ‘QualiCCare’ education, which addresses knowledge, decision-making and behavioural aspects as well as delivery of care according to COPD quality indicators and evidence-based key elements. In the control group, no educational intervention will be applied and COPD patients will be treated as usual. The study period is one year.
The primary outcome measure is an aggregated score of relevant clinical processes defining elements in the care of patients with COPD: smoking cessation counseling, influenza vaccination, motivation for physical activity, appropriate pharmacotherapy, patient education and collaborative care. Given a power of 90% and a significance level alpha of 5%, 15 GPs recruiting eight patients each will be necessary in both study arms. With an assumed dropout rate of 20%, 288 patients will need to be included.
Discussion
It is important to develop and implement interventions that add value to COPD care considering quality and efficiency. Care pathways modifying the knowledge and behavior of physicians have the potential for improving care by transferring knowledge to clinical practice.
Trial registration
ClinicalTrials.gov: NCT01921556
doi:10.1186/1745-6215-15-96
PMCID: PMC3986912  PMID: 24670200
21.  Tailored Implementation for Chronic Diseases (TICD): a protocol for process evaluation in cluster randomized controlled trials in five European countries 
Trials  2014;15:87.
Background
In the ‘Tailored Implementation for Chronic Diseases (TICD)’ project, five tailored implementation programs to improve healthcare delivery in different chronic conditions have been developed. These programs will be evaluated in distinct cluster-randomized controlled trials. This protocol describes the process evaluation across these trials, which aims to identify determinants of change in chronic illness care, to examine the validity of the tailoring methods that were applied, and to analyze the association of implementation activities and the effectiveness of the program.
Methods
A multilevel approach was used to develop five tailored implementation interventions. In order to guide the process evaluation in five distinct trials, the study protocols for the cluster randomized trials and the related process evaluations were developed simultaneously and iteratively.
Results
The process evaluation comprises three main components: a structured survey with health professionals in the trials, semi-structured interviews with a purposeful sample of this study population, and standardized documentation of organizational practice characteristics. Norway will only conduct the qualitative part of the analysis because the survey and documentation of practice characteristics are considered to be not feasible. The evaluation is guided by ‘logic models’ of the implementation programs: frameworks that specify the linkages between the strategies used, the determinants addressed by tailoring, and the anticipated outcomes. Standardization of measures across trials is sought to facilitate analysis of aggregated data from the trials.
Conclusions
This process evaluation will need to find a balance between standardization of methods across trials and the tailoring of measures to the specificities of each trial.
doi:10.1186/1745-6215-15-87
PMCID: PMC3994491  PMID: 24655439
process evaluation; tailored implementation intervention; chronic illness care
22.  Evaluation of a tailored intervention to improve management of overweight and obesity in primary care: study protocol of a cluster randomised controlled trial 
Trials  2014;15:82.
Background
In the UK around 22% of men and 24% of women are obese, and there are varying but worrying levels in other European countries. Obesity is a chronic condition that carries an important health risk. National guidelines, for use in England, on the management of people who are overweight or obese have been published by the National Institute for Health and Clinical Excellence (NICE, 2006). NICE recommendations for primary care teams are: determine the degree of overweight and obesity; assess lifestyle, comorbidities and willingness to change; offer multicomponent management of overweight and obesity; referral to external services when appropriate. This study investigates a tailored intervention to improve the implementation of these recommendations by primary care teams.
Methods/Design
The study is a cluster randomised controlled trial. Primary care teams will be recruited from the East Midlands of England, and randomised into two study arms: 1) the study group, in which primary care teams are offered a set of tailored interventions to help implement the NICE guidelines for overweight and obesity; or 2) the control group in which primary care teams continue to practice usual care. The primary outcome is the proportion of overweight or obese patients for whom the primary care team adheres to the NICE guidelines. Secondary outcomes include the proportion of patients with a record of lifestyle assessment, referral to external weight loss services, the proportion of obese patients who lose weight during the intervention period, and the mean weight change over the same period.
Discussion
Although often recommended, the methods of tailoring implementation interventions to account for the determinants of practice are not well developed. This study is part of a programme of studies seeking to develop the methods of tailored implementation.
Trial registration
Current Controlled Trials ISRCTN07457585. Registered 09/08/2013. Randomisation commenced 30/08/2013.
doi:10.1186/1745-6215-15-82
PMCID: PMC3973828  PMID: 24641767
Obesity; Overweight; Tailored implementation of chronic diseases; TICD; Primary care teams
23.  Social support systems as determinants of self-management and quality of life of people with diabetes across Europe: study protocol for an observational study 
Background
Long-term conditions pose major challenges for healthcare systems. Optimizing self-management of people with long-term conditions is an important strategy to improve quality of life, health outcomes, patient experiences in healthcare, and the sustainability of healthcare systems. Much research on self-management focuses on individual competencies, while the social systems of support that facilitate self-management are underexplored. The presented study aims to explore the role of social systems of support for self-management and quality of life, focusing on the social networks of people with diabetes and community organisations that serve them.
Methods
The protocol concerns a cross-sectional study in 18 geographic areas in six European countries, involving a total of 1800 individuals with diabetes and 900 representatives of community organisations. In each country, we include a deprived rural area, a deprived urban area, and an affluent urban area. Individuals are recruited through healthcare practices in the targeted areas. A patient questionnaire comprises measures for quality of life, self-management behaviours, social network and social support, as well as individual characteristics. A community organisations’ survey maps out interconnections between community and voluntary organisations that support patients with chronic illness and documents the scope of work of the different types of organisations. We first explore the structure of social networks of individuals and of community organisations. Then linkages between these social networks, self-management and quality of life will be examined, taking deprivation and other factors into account.
Discussion
This study will provide insight into determinants of self-management and quality of life in individuals with diabetes, focusing on the role of social networks and community organisations.
doi:10.1186/1477-7525-12-29
PMCID: PMC4021429  PMID: 24593668
Quality of life; Self-management; Chronic illness; Diabetes type 2; Social networks; Community organisations; Deprivation
24.  Implementing guidelines for depression on antidepressant prescribing in general practice: a quasi-experimental evaluation 
BMC Family Practice  2014;15:35.
Background
Internationally, guidelines for depression recommend a stepped care approach, implying that antidepressant medication should not be offered as a first step treatment to patients with sub-threshold or mild depression. In the Netherlands, antidepressant prescribing rates in general practice as a first treatment step are considered to be high. The aim of this study was to evaluate the implementation of guideline recommendations on antidepressant prescribing.
Methods
A quasi-experimental study with a non-equivalent naturalistic control group and three years follow-up was performed in the general practice setting in the Netherlands. General Practitioners (GPs) participated in a national Quality Improvement Collaborative (QIC), focusing on the implementation of a guideline based model for a stepped care approach to depression. The model consisted of self-help and psychological treatment options for patients with milder symptoms as an alternative to antidepressants in general practice. Changes in antidepressant prescription rates of GPs were documented for a three-year period and compared to those in a control group of GPs, selected from an ongoing national registration network.
Results
A decrease of 23.3% (49.4%-26.1%) in antidepressant prescription rates for newly diagnosed patients with depressive symptoms was found within the intervention group, whereas no difference occurred in the reference group (50.3%-52.6%). The decrease over time was significant, compared to the usual care group (OR 0.44, 95% CI: 0.21-0.92).
Conclusions
An implementation program using stepped care principles for the allocation of depression interventions resulted in reduced antidepressant prescription rates in general practice. GPs can change prescribing behaviour within the context of a QIC.
doi:10.1186/1471-2296-15-35
PMCID: PMC3996100  PMID: 24552140
General practice; Guidelines; Antidepressants; Implementation; Stepped care
25.  Physician Awareness of Knee and Hip Pain in the Context of Coronary Heart Disease Treatment 
The Scientific World Journal  2014;2014:494801.
Background. The benefit of physical activity for the prevention and treatment of cardiovascular disease (CVD) has been well documented. The aim of the present study was to determine the level of awareness among general practitioners (GPs) of knee and hip problems in patients with CVD or CVD risk. Design. Cross-sectional questionnaire survey. Setting and Subjects. Thirty-five Austrian GPs and 1,118 patients were included. The GPs completed an extraction form about the presence or absence of documented evidence of problems related to the knee and/or hip joint within the patient medical data. Patients, in turn, were asked to complete a questionnaire that included the Oxford Knee/Hip Score and the cardiovascular risk-chart established by the European Society of Cardiology. Results. In 748 patients' data from medical records and questionnaires were available. 40.9% of these patients suffered from serious knee pain and 32.1% from hip pain. However, in the medical records, in only 51.3% (knee) and 48.1% (hip) of these pain-patients the problems were documented. Conclusion. Joint disorders of the knee and hip problems are considerable barriers to effective physical activity and can therefore contribute to the development of CVD. Our data showed that GP awareness of such knee/hip disorders should be improved.
doi:10.1155/2014/494801
PMCID: PMC3932273  PMID: 24688391

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