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1.  The role of evidence and context for implementing a multimodal intervention to increase HIV testing 
Background
Increasing the use of routine preventive care such as HIV testing is important, yet implementation of such evidence-based clinical care is complex. The Promoting Action on Research Implementation in Health Services (PARiHS) model for implementation posits that implementation will be most successful when the evidence, context, and facilitation strategies are strong for the clinical practice. We evaluated the relative importance of perceived evidence, context, and facilitation of HIV testing during the implementation of a multimodal intervention in US Department of Veterans Affairs primary care clinics.
Methods
A multimodal intervention including clinical reminders (CRs), academic detailing—providing education sessions for providers—and social marketing to improve HIV testing was implemented in 15 VA primary care clinics in three regions. We conducted qualitative formative and process evaluations using semi-structured interviews with HIV lead clinicians, primary care lead clinicians, nurse managers, and social workers. Interviews were analyzed thematically to identify barriers and facilitators to implementation of HIV testing and how these were addressed by the intervention. Sites were then rated high, medium, or low on the dimensions of perceived evidence and the context for testing. We then assessed the relationship of these ratings to improvements in HIV testing rates found in earlier quantitative analyses.
Results
Sites that showed greatest improvements in HIV testing rates also rated high on evidence and context. Conversely, sites that demonstrated the poorest improvements in testing rates rated low on both dimensions. Perceptions of evidence and several contextual aspects resulted in both barriers and facilitators to implementing testing. Evidence barriers included provider perceptions of evidence for routine testing as irrelevant to their population. Contextual barriers included clinical reminder overload, insufficient resources, onerous consent processes, stigma, provider discomfort, and concerns about linking individuals who test positive to HIV treatment. While most barriers were ameliorated by the intervention, HIV stigma in particular regions and concerns about linkage to care persisted.
Conclusions
Interventions to implement evidence-based practices such as HIV testing can be successful when utilizing proven quality improvement techniques. However, it is critical to address providers’ perceptions of evidence and consider aspects of the local context in order to fully implement new routine clinical practices such as HIV testing.
doi:10.1186/s13012-015-0214-4
PMCID: PMC4333886
HIV/AIDS; Health promotion/prevention; Qualitative research; Technology adoption/diffusion; Primary care; Implementation
2.  A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project 
Background
Identifying, developing, and testing implementation strategies are important goals of implementation science. However, these efforts have been complicated by the use of inconsistent language and inadequate descriptions of implementation strategies in the literature. The Expert Recommendations for Implementing Change (ERIC) study aimed to refine a published compilation of implementation strategy terms and definitions by systematically gathering input from a wide range of stakeholders with expertise in implementation science and clinical practice.
Methods
Purposive sampling was used to recruit a panel of experts in implementation and clinical practice who engaged in three rounds of a modified Delphi process to generate consensus on implementation strategies and definitions. The first and second rounds involved Web-based surveys soliciting comments on implementation strategy terms and definitions. After each round, iterative refinements were made based upon participant feedback. The third round involved a live polling and consensus process via a Web-based platform and conference call.
Results
Participants identified substantial concerns with 31% of the terms and/or definitions and suggested five additional strategies. Seventy-five percent of definitions from the originally published compilation of strategies were retained after voting. Ultimately, the expert panel reached consensus on a final compilation of 73 implementation strategies.
Conclusions
This research advances the field by improving the conceptual clarity, relevance, and comprehensiveness of implementation strategies that can be used in isolation or combination in implementation research and practice. Future phases of ERIC will focus on developing conceptually distinct categories of strategies as well as ratings for each strategy’s importance and feasibility. Next, the expert panel will recommend multifaceted strategies for hypothetical yet real-world scenarios that vary by sites’ endorsement of evidence-based programs and practices and the strength of contextual supports that surround the effort.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-015-0209-1) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-015-0209-1
PMCID: PMC4328074
Implementation research; Implementation strategies; Knowledge translation strategies; Mental health; US Department of Veterans Affairs
3.  Developing a checklist for guideline implementation planning: review and synthesis of guideline development and implementation advice 
Background
Developers, users and others have requested or advocated for guidance on how to plan for, and implement guidelines concurrent to their development given that existing resources are lacking such information. The purpose of this research was to develop a guideline implementation planning checklist.
Methods
Documents that described or evaluated the processes of planning or undertaking implementation were identified in several publications that had systematically identified such resources, and by searching medical literature databases (MEDLINE, EMBASE). Data that described implementation planning; how to develop guideline versions or tools that would support user implementation; and options and mechanisms for disseminating or implementing guidelines were independently extracted from eligible documents by the principal investigator and a trained research assistant. Data were integrated to create a unique list of guideline implementation planning processes and considerations.
Results
Thirty-five documents were eligible. Of these, 16 (45.7%) provided sparse information on implementation planning, 25 (71.4%) mentioned different versions or tools for implementation, and 30 (85.7%) listed options for dissemination or implementation. None provided instructions for operationalizing implementation strategies. Data were integrated into a multi-item Guideline Implementation Planning Checklist including considerations for implementation planning (12), development of implementation tools (8), types of implementation tools (12), and options for dissemination (11) and implementation (12).
Conclusions
Developers or users can apply the Guideline Implementation Planning Checklist to prepare for and/or undertake guideline implementation. Further development of the checklist is warranted to elaborate on all components. In ongoing research, we will consult with the international guideline community to do so. At the same time, guideline implementation is complex, so developers and users would benefit from training, and by including knowledge translation experts and brokers on implementation planning committees.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-015-0205-5) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-015-0205-5
PMCID: PMC4329197
Guidelines; Implementation
4.  Understanding feedback report uptake: process evaluation findings from a 13-month feedback intervention in long-term care settings 
Background
Long-term care settings provide care to a large proportion of predominantly older, highly disabled adults across the United States and Canada. Managing and improving quality of care is challenging, in part because staffing is highly dependent on relatively non-professional health care aides and resources are limited. Feedback interventions in these settings are relatively rare, and there has been little published information about the process of feedback intervention. Our objectives were to describe the key components of uptake of the feedback reports, as well as other indicators of participant response to the intervention.
Methods
We conducted this project in nine long-term care units in four facilities in Edmonton, Canada. We used mixed methods, including observations during a 13-month feedback report intervention with nine post-feedback survey cycles, to conduct a process evaluation of a feedback report intervention in these units. We included all facility-based direct care providers (staff) in the feedback report distribution and survey administration. We conducted descriptive analyses of the data from observations and surveys, presenting this in tabular and graphic form. We constructed a short scale to measure uptake of the feedback reports. Our analysis evaluated feedback report uptake by provider type over the 13 months of the intervention.
Results
We received a total of 1,080 survey responses over the period of the intervention, which varied by type of provider, facility, and survey month. Total number of reports distributed ranged from 103 in cycle 12 to 229 in cycle 3, although the method of delivery varied widely across the period, from 12% to 65% delivered directly to individuals and 15% to 84% left for later distribution. The key elements of feedback uptake, including receiving, reading, understanding, discussing, and reporting a perception that the reports were useful, varied by survey cycle and provider type, as well as by facility. Uptake, as we measured it, was consistently high overall, but varied widely by provider type and time period.
Conclusions
We report detailed process data describing the aspects of uptake of a feedback report during an intensive, longitudinal feedback intervention in long-term care facilities. Uptake is a complex process for which we used multiple measures. We demonstrate the feasibility of conducting a complex longitudinal feedback intervention in relatively resource-poor long-term care facilities to a wider range of provider types than have been included in prior feedback interventions.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-015-0208-2) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-015-0208-2
PMCID: PMC4331147
Feedback intervention; Long-term care; Quality improvement; Process evaluation
5.  Fast tracking the design of theory-based KT interventions through a consensus process 
Background
Despite available evidence for optimal management of spinal pain, poor adherence to guidelines and wide variations in healthcare services persist. One of the objectives of the Canadian Chiropractic Guideline Initiative is to develop and evaluate targeted theory- and evidence-informed interventions to improve the management of non-specific neck pain by chiropractors. In order to systematically develop a knowledge translation (KT) intervention underpinned by the Theoretical Domains Framework (TDF), we explored the factors perceived to influence the use of multimodal care to manage non-specific neck pain, and mapped behaviour change techniques to key theoretical domains.
Methods
Individual telephone interviews exploring beliefs about managing neck pain were conducted with a purposive sample of 13 chiropractors. The interview guide was based upon the TDF. Interviews were digitally recorded, transcribed verbatim and analysed by two independent assessors using thematic content analysis. A 15-member expert panel formally met to design a KT intervention.
Results
Nine TDF domains were identified as likely relevant. Key beliefs (and relevant domains of the TDF) included the following: influence of formal training, colleagues and patients on clinicians (Social Influences); availability of educational material (Environmental Context and Resources); and better clinical outcomes reinforcing the use of multimodal care (Reinforcement). Facilitating factors considered important included better communication (Skills); audits of patients’ treatment-related outcomes (Behavioural Regulation); awareness and agreement with guidelines (Knowledge); and tailoring of multimodal care (Memory, Attention and Decision Processes). Clinicians conveyed conflicting beliefs about perceived threats to professional autonomy (Social/Professional Role and Identity) and speed of recovery from either applying or ignoring the practice recommendations (Beliefs about Consequences). The expert panel mapped behaviour change techniques to key theoretical domains and identified relevant KT strategies and modes of delivery to increase the use of multimodal care among chiropractors.
Conclusions
A multifaceted KT educational intervention targeting chiropractors’ management of neck pain was developed. The KT intervention consisted of an online education webinar series, clinical vignettes and a video underpinned by the Brief Action Planning model. The intervention was designed to reflect key theoretical domains, behaviour change techniques and intervention components. The effectiveness of the proposed intervention remains to be tested.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-015-0213-5) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-015-0213-5
PMCID: PMC4330935
Theoretical domains framework; Knowledge translation; Interviews; Content analysis; Intervention design; Multifaceted intervention; Chiropractic; Neck pain; Self-management
6.  Implementation of a cystic fibrosis lung transplant referral patient decision aid in routine clinical practice: an observational study 
Background
The decision to have lung transplantation as treatment for end-stage lung disease from cystic fibrosis (CF) has benefits and serious risks. Although patient decision aids are effective interventions for helping patients reach a quality decision, little is known about implementing them in clinical practice. Our study evaluated a sustainable approach for implementing a patient decision aid for adults with CF considering referral for lung transplantation.
Methods
A prospective pragmatic observational study was guided by the Knowledge-to-Action Framework. Healthcare professionals in all 23 Canadian CF clinics were eligible. We surveyed participants regarding perceived barriers and facilitators to patient decision aid use. Interventions tailored to address modifiable identified barriers included training, access to decision aids, and conference calls. The primary outcome was >80% use of the decision aid in year 2.
Results
Of 23 adult CF clinics, 18 participated (78.2%) and 13 had healthcare professionals attend training. Baseline barriers were healthcare professionals’ inadequate knowledge for supporting patients making decisions (55%), clarifying patients’ values for outcomes of options (58%), and helping patients handle conflicting views of others (71%). Other barriers were lack of time (52%) and needing to change how transplantation is discussed (42%). Baseline facilitators were healthcare professionals feeling comfortable discussing bad transplantation outcomes (74%), agreeing the decision aid would be easy to experiment with (71%) and use in the CF clinic (87%), and agreeing that using the decision aid would not require reorganization of the CF clinic (90%). After implementing the decision aid with interventions tailored to the barriers, decision aid use increased from 29% at baseline to 85% during year 1 and 92% in year 2 (p < 0.001). Compared to baseline, more healthcare professionals at the end of the study were confident in supporting decision-making (p = 0.03) but continued to feel inadequate ability with supporting patients to handle conflicting views (p = 0.01).
Conclusion
Most Canadian CF clinics agreed to participate in the study. Interventions were used to target identified modifiable barriers to using the patient decision aid in routine CF clinical practice. CF clinics reported using it with almost all patients in the second year.
doi:10.1186/s13012-015-0206-4
PMCID: PMC4322562
Implementation; Cystic fibrosis; Patient decision aid; Lung transplantation; Decision support; Barriers
7.  Improving allied health professionals’ research implementation behaviours for children with cerebral palsy: protocol for a before-after study 
Background
Cerebral palsy is a permanent disorder of posture and movement caused by disturbances in the developing brain. It affects approximately 1 in every 500 children in developed countries and is the most common form of childhood physical disability. People with cerebral palsy may also have problems with speech, vision and hearing, intellectual difficulties and epilepsy. Health and therapy services are frequently required throughout life, and this care should be effective and evidence informed; however, accessing and adopting new research findings into day-to-day clinical practice is often delayed.
Methods/Design
This 3-year study employs a before and after design to evaluate if a multi-strategy intervention can improve research implementation among allied health professionals (AHPs) who work with children and young people with cerebral palsy and to establish if children’s health outcomes can be improved by routine clinical assessment. The intervention comprises (1) knowledge brokering with AHPs, (2) access to an online research evidence library, (3) provision of negotiated evidence-based training and education, and (4) routine use of evidence-based measures with children and young people aged 3–18 years with cerebral palsy. The study is being implemented in four organisations, with a fifth organisation acting as a comparison site, across four Australian states. Effectiveness will be assessed using questionnaires completed by AHPs at baseline, 6, 12 and 24 months, and by monitoring the extent of use of evidence-based measures. Children’s health outcomes will be evaluated by longitudinal analyses.
Discussion
Government, policy makers and service providers all seek evidence-based information to support decision-making about how to distribute scarce resources, and families are seeking information to support intervention choices. This study will provide knowledge about what constitutes an efficient, evidence-informed service and which allied health interventions are implemented for children with cerebral palsy.
Trial registration
Trial is not a controlled healthcare intervention and is not registered.
doi:10.1186/s13012-014-0202-0
PMCID: PMC4328993
Cerebral palsy; Knowledge translation; Evidence-based practice; Surveillance; Assessment; Child
8.  A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol 
Background
Opportunistic recruitment is a highly laborious and time-consuming process that is currently performed manually, increasing the workload of already busy practitioners and resulting in many studies failing to achieve their recruitment targets. The Translational Medicine and Patient Safety in Europe (TRANSFoRm) platform enables automated recruitment, data collection and follow-up of patients, potentially improving the efficiency, time and costs of clinical research. This study aims to assess the effectiveness of TRANSFoRm in improving patient recruitment and follow-up in primary care trials.
Methods/design
This multi-centre, parallel-arm cluster randomised controlled trial will compare TRANSFoRm-supported with standard opportunistic recruitment. Participants will be general practitioners and patients with gastro-oesophageal reflux disease from 40 primary care centres in five European countries. Randomisation will take place at the care centre level. The intervention arm will use the TRANSFoRm tools for recruitment, baseline data collection and follow-up. The control arm will use web-based case report forms and paper self-completed questionnaires. The primary outcome will be the proportion of eligible patients successfully recruited at the end of the 16-week recruitment period. Secondary outcomes will include the proportion of recruited patients with complete baseline and follow-up data and the proportion of participants withdrawn or lost to follow-up. The study will also include an economic evaluation and measures of technology acceptance and user experience.
Discussion
The study should shed light on the use of eHealth to improve the effectiveness of recruitment and follow-up in primary care research and provide an evidence base for future eHealth-supported recruitment initiatives. Reporting of results is expected in October 2015.
Trial registration
EudraCT: 2014-001314-25
doi:10.1186/s13012-015-0207-3
PMCID: PMC4318251  PMID: 25648301
9.  The evaluation of a tailored intervention to improve the management of suspected viral encephalitis: protocol for a cluster randomised controlled trial 
Background
Viral encephalitis is a devastating condition for which delayed treatment is associated with increased morbidity and mortality. Clinical audits indicate substantial scope for improved detection and treatment. Improvement strategies should ideally be tailored according to identified needs and barriers to change. The aim of the study is to evaluate the effectiveness and cost-effectiveness of a tailored intervention to improve the secondary care management of suspected encephalitis.
Methods/Design
The study is a two-arm cluster randomised controlled trial with allocation by postgraduate deanery. Participants were identified from 24 hospitals nested within 12 postgraduate deaneries in the United Kingdom (UK). We developed a multifaceted intervention package including core and flexible components with embedded behaviour change techniques selected on the basis of identified needs and barriers to change. The primary outcome will be a composite of the proportion of patients with suspected encephalitis receiving timely and appropriate diagnostic lumbar puncture within 12 h of hospital admission and aciclovir treatment within 6 h. We will gather outcome data pre-intervention and up to 12 months post-intervention from patient records. Statistical analysis at the cluster level will be blind to allocation. An economic evaluation will estimate intervention cost-effectiveness from the health service perspective.
Trial registration
Controlled Trials: ISRCTN06886935.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0201-1) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-014-0201-1
PMCID: PMC4314797  PMID: 25623603
Encephalitis; Cluster randomised controlled trial; Guideline implementation; Protocol
10.  Study protocol: transforming outcomes for patients through medical home evaluation and redesign: a cluster randomized controlled trial to test high value elements for patient-centered medical homes versus quality improvement 
Background
Health care in the United States is in the midst of a near perfect storm: strong cost pressures, dramatic redesign efforts like patient-centered medical homes and accountable care organizations, and a broad series of payment and eligibility reforms. To date, alternative models of care intended to reduce costs and improve outcomes have shown mixed effects in the U.S., in part due to the difficulty of performing rigorous evaluation studies that control for the broader transformation while avoiding other biases, such as organizational or clinic effect on individual patient outcomes. Our objective is to test whether clinics assigned to achieve high value elements (HVEs) of practice redesign are more likely than controls to achieve improvements in patient health and satisfaction with care and reduction in costs.
Methods/Design
To prepare, we interview stakeholders, align with health reform, and propose a pilot. Participants are primary care clinics engaged in reform. Study protocol requires that both arms receive monthly practice facilitation, IT-based milestone reporting, and small financial incentives based on self-determined quality improvement (QI) goals; intervention receives additional prompting to choose HVEs. Design is a cluster randomized controlled trial over 1 year with pre- and post-washout periods. Outcomes are unplanned utilization and costs, patient experience of care, quality, and team performance. Analysis is a multivariate difference-in-difference with adjustments for patient risk, intraclinic correlation, and other confounders.
Discussion
The TOPMED study is a cluster randomized controlled trial focused on learning how primary care practices can transform within health reform guidelines to achieve outcomes related to the Triple Aim.
Trial registration
ClinicalTrials.gov registration: NCT02106221.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-015-0204-6) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-015-0204-6
PMCID: PMC4307890  PMID: 25609501
11.  Computer-supported feedback message tailoring: theory-informed adaptation of clinical audit and feedback for learning and behavior change 
Background
Evidence shows that clinical audit and feedback can significantly improve compliance with desired practice, but it is unclear when and how it is effective. Audit and feedback is likely to be more effective when feedback messages can influence barriers to behavior change, but barriers to change differ across individual health-care providers, stemming from differences in providers’ individual characteristics.
Discussion
The purpose of this article is to invite debate and direct research attention towards a novel audit and feedback component that could enable interventions to adapt to barriers to behavior change for individual health-care providers: computer-supported tailoring of feedback messages. We argue that, by leveraging available clinical data, theory-informed knowledge about behavior change, and the knowledge of clinical supervisors or peers who deliver feedback messages, a software application that supports feedback message tailoring could improve feedback message relevance for barriers to behavior change, thereby increasing the effectiveness of audit and feedback interventions. We describe a prototype system that supports the provision of tailored feedback messages by generating a menu of graphical and textual messages with associated descriptions of targeted barriers to behavior change. Supervisors could use the menu to select messages based on their awareness of each feedback recipient’s specific barriers to behavior change. We anticipate that such a system, if designed appropriately, could guide supervisors towards giving more effective feedback for health-care providers.
Summary
A foundation of evidence and knowledge in related health research domains supports the development of feedback message tailoring systems for clinical audit and feedback. Creating and evaluating computer-supported feedback tailoring tools is a promising approach to improving the effectiveness of clinical audit and feedback.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0203-z) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-014-0203-z
PMCID: PMC4320482  PMID: 25603806
12.  Leadership and organizational change for implementation (LOCI): a randomized mixed method pilot study of a leadership and organization development intervention for evidence-based practice implementation 
Background
Leadership is important in the implementation of innovation in business, health, and allied health care settings. Yet there is a need for empirically validated organizational interventions for coordinated leadership and organizational development strategies to facilitate effective evidence-based practice (EBP) implementation. This paper describes the initial feasibility, acceptability, and perceived utility of the Leadership and Organizational Change for Implementation (LOCI) intervention. A transdisciplinary team of investigators and community stakeholders worked together to develop and test a leadership and organizational strategy to promote effective leadership for implementing EBPs.
Methods
Participants were 12 mental health service team leaders and their staff (n = 100) from three different agencies that provide mental health services to children and families in California, USA. Supervisors were randomly assigned to the 6-month LOCI intervention or to a two-session leadership webinar control condition provided by a well-known leadership training organization. We utilized mixed methods with quantitative surveys and qualitative data collected via surveys and a focus group with LOCI trainees.
Results
Quantitative and qualitative analyses support the LOCI training and organizational strategy intervention in regard to feasibility, acceptability, and perceived utility, as well as impact on leader and supervisee-rated outcomes.
Conclusions
The LOCI leadership and organizational change for implementation intervention is a feasible and acceptable strategy that has utility to improve staff-rated leadership for EBP implementation. Further studies are needed to conduct rigorous tests of the proximal and distal impacts of LOCI on leader behaviors, implementation leadership, organizational context, and implementation outcomes. The results of this study suggest that LOCI may be a viable strategy to support organizations in preparing for the implementation and sustainment of EBP.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0192-y) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-014-0192-y
PMCID: PMC4310135  PMID: 25592163
Leadership; Organization; Evidence-based practice; Organizational development; Organizational culture; Organizational climate
13.  Protocol for the evaluation of a quality-based pay for performance scheme in Liberia 
Background
Improving the quality of care at hospitals is a key next step in rebuilding Liberia’s health system. In order to improve the efficiency, effectiveness, and quality of care at the secondary hospital level, the country is developing a system to upgrade health worker skills and competencies, and shifting towards improved provider accountability for results, including a Graduate Medical Residency Program (GMRP) and provider accountability for improvements in quality through performance-based financing (PBF) at the hospital level.
Methods/design
This document outlines the protocol for the impact evaluation of the hospital improvement program. The evaluation will provide an estimate of the impact of the project and investigate the mechanism for success in a way that can provide general lessons about the quality of health care in low-income countries. The evaluation aims 1) to provide the best possible estimate of program impact and 2) to quantitatively describe the changes that took place within facilities as a result of the program. In particular, the impact evaluation focuses on the changes in human resources within the hospitals. As such, we use a three-period intensive evaluation of treated and matched comparison hospitals to see how services change in treated hospitals as well as a continuous data collection effort to track the activities of individual health workers within treated hospitals.
Discussion
We are particularly interested in understanding how facilities met quality targets. Did they bring in new health workers with higher qualifications? Did they improve the knowledge or competence of their existing staff? Did they improve the availability of medicines and equipment so that the capacities of existing health workers were improved? Did they address the motivation of health workers so that individuals with the same competence and capacity were able to provide higher quality? And, if they did improve quality, did patients notice?
doi:10.1186/s13012-014-0194-9
PMCID: PMC4297421  PMID: 25582091
Liberia; Impact evaluation; Performance-based financing; Results-based financing; Pay for performance; Health-care quality
14.  Who does it first? The uptake of medical innovations in the performance of thrombolysis on ischemic stroke patients in Germany: a study based on hospital quality data 
Background
Since 2000, systemic thrombolysis has been the only approved curative and causal treatment for acute ischemic stroke. In 2009, the guidelines of the German Society for Neurology were updated and the therapeutic window for performing thrombolysis was extended. The implementation of new therapies is influenced by many factors. We analyzed the factors at the organizational level that influence the implementation of thrombolysis in stroke patients.
Methods
The data published by the majority of German hospitals in their structured quality reports was assessed. We calculated a regression model in order to measure the influence of hospital/department-level characteristics (e.g., teaching status, ownership, location, and number of hospital beds) on the implementation of thrombolysis in 2006 (this is the earliest point in time that can be analyzed on this data basis). In order to measure the effect of the guideline update in 2009 on the thrombolysis rate (TR) change between 2008 and 2010, we performed a Wilcoxon signed-rank test and utilized a regression model.
Results
In 2006, 61.5% of a total of 286 neurology departments performed systemic thrombolysis to treat ischemic strokes. The influencing factors for the use of systemic thrombolysis in 2006 were the existence of a stroke unit (+) and a hospital size of between 500 and 1,000 beds (−). A significant increase of the mean departmental TR (thrombolysis rate) from 6.7% to 9.2% between 2008 and 2010 was observed after the guideline update in 2009. For the departments performing thrombolysis in 2008 and 2010, our analysis could not show any additional influencing factors on a structural level that would explain the TR rise during the period 2008–2010.
Conclusions
Because ischemic stroke patients benefit from systemic thrombolysis, it is necessary to examine possible barriers at the organizational level that hinder the implementation. Our data shows that, organizational factors have an influence on the implementation of thrombolysis. However, the recent guideline update resulted in a TR rise that occurred at all hospitals, regardless of the measured structural conditions, as our analysis could not identify any structural factors that might have influenced the TR after the guideline update.
doi:10.1186/s13012-014-0196-7
PMCID: PMC4300164  PMID: 25582164
Ischemic stroke; Thrombolysis; Guideline; Implementation; Neurology
15.  Effects of a demand-led evidence briefing service on the uptake and use of research evidence by commissioners of health services: protocol for a controlled before and after study 
Background
Clinical Commissioning Groups (CCGs) are mandated to use research evidence effectively to ensure optimum use of resources by the National Health Service (NHS), both in accelerating innovation and in stopping the use of less effective practices and models of service delivery. We intend to evaluate whether access to a demand-led evidence service improves uptake and use of research evidence by NHS commissioners compared with less intensive and less targeted alternatives.
Methods/design
This is a controlled before and after study involving CCGs in the North of England. Participating CCGs will receive one of three interventions to support the use of research evidence in their decision-making: 1) consulting plus responsive push of tailored evidence; 2) consulting plus an unsolicited push of non-tailored evidence; or 3) standard service unsolicited push of non-tailored evidence. Our primary outcome will be changed at 12 months from baseline of a CCGs ability to acquire, assess, adapt and apply research evidence to support decision-making. Secondary outcomes will measure individual clinical leads and managers’ intentions to use research evidence in decision making. Documentary evidence of the use of the outputs of the service will be sought. A process evaluation will evaluate the nature and success of the interactions both within the sites and between commissioners and researchers delivering the service.
Discussion
The proposed research will generate new knowledge of direct relevance and value to the NHS. The findings will help to clarify which elements of the service are of value in promoting the use of research evidence. Those involved in NHS commissioning will be able to use the results to inform how best to build the infrastructure they need to acquire, assess, adapt and apply research evidence to support decision-making and to fulfil their statutory duties under the Health and Social Care Act.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0199-4) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-014-0199-4
PMCID: PMC4296534  PMID: 25572116
16.  Development and preliminary evaluation of a rehabilitation consult for survivors of head and neck cancer: an intervention mapping protocol 
Background
Evidence suggests that rehabilitation interventions can improve function and quality of life in survivors of head and neck cancer (HNC), but there is a lack of coordinated, integrated services, and those offered are inconsistent. To address these gaps, we will develop and conduct preliminary evaluation of a rehabilitation consult, built on the theoretical foundations of goal setting and self-management, and composed of a brief functional evaluation, a resource compendium, and collaborative goal-setting and action planning processes.
Methods/design
The development of the rehabilitation consult will be guided by intervention mapping, which consists of six steps: 1. Needs assessment; 2. Definition of program objectives; 3. Selection of theory-based intervention methods; 4. Production and pretesting; 5. Adoption, implementation and sustainability planning; 6. Process and effect evaluation. Within the intervention mapping framework, an iterative process of constructing drafts and mini-evaluations with consumers and experts will be used, modifying the rehabilitation consult intervention until a version suitable for formal evaluation is established. The rehabilitation consult will then be evaluated using a prospective, mixed method, single group design with 30 survivors of head and neck cancer. Outcomes will be assessed pre- and post-intervention and at 6-month follow-up.
Discussion
Survivors of head and neck cancer have among the most complex rehabilitation needs of all cancer patients. The rehabilitation consult is expected to improve knowledge and uptake of rehabilitation resources and strategies in survivors of head and neck cancer and thereby improve long-term function and quality of life. If the rehabilitation consult is effective in cancer patients with such high and diverse needs, this project will produce a toolkit that will be adaptable for other types of cancer in other jurisdictions.
doi:10.1186/s13012-014-0191-z
PMCID: PMC4297361  PMID: 25571966
Head and neck cancer; Rehabilitation; Intervention mapping; Protocol; Self-management; Goal setting
17.  Implementation science in cancer prevention and control: a decade of grant funding by the National Cancer Institute and future directions 
Background
The National Cancer Institute (NCI) has supported implementation science for over a decade. We explore the application of implementation science across the cancer control continuum, including prevention, screening, treatment, and survivorship.
Methods
We reviewed funding trends of implementation science grants funded by the NCI between 2000 and 2012. We assessed study characteristics including cancer topic, position on the T2–T4 translational continuum, intended use of frameworks, study design, settings, methods, and replication and cost considerations.
Results
We identified 67 NCI grant awards having an implementation science focus. R01 was the most common mechanism, and the total number of all awards increased from four in 2003 to 15 in 2012. Prevention grants were most frequent (49.3%) and cancer treatment least common (4.5%). Diffusion of Innovations and Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) were the most widely reported frameworks, but it is unclear how implementation science models informed planned study measures. Most grants (69%) included mixed methods, and half reported replication and cost considerations (49.3%).
Conclusions
Implementation science in cancer research is active and diverse but could be enhanced by greater focus on measures development, assessment of how conceptual frameworks and their constructs lead to improved dissemination and implementation outcomes, and harmonization of measures that are valid, reliable, and practical across multiple settings.
doi:10.1186/s13012-014-0200-2
PMCID: PMC4296529  PMID: 25567702
Grants; Review; Implementation science; Study characteristics
18.  Improving the implementation of perioperative safety guidelines using a multifaceted intervention approach: protocol of the IMPROVE study, a stepped wedge cluster randomized trial 
Background
This study is initiated to evaluate the effects, costs, and feasibility at the hospital and patient level of an evidence-based strategy to improve the use of Dutch perioperative safety guidelines. Based on current knowledge, expert opinions and expertise of the project team, a multifaceted implementation strategy has been developed.
Methods/design
This is a stepped wedge cluster randomized trial including nine representative hospitals across The Netherlands. Hospitals are stratified into three groups according to hospital type and geographical location and randomized in terms of the period for receipt of the intervention. All adult surgical patients meeting the inclusion criteria are assessed for patient outcomes. The implementation strategy includes education, audit and feedback, organizational interventions (e.g., local embedding of the guidelines), team-directed interventions (e.g., multi-professional team training), reminders, as well as patient-mediated interventions (e.g., patient safety cards). To tailor the implementation activities, we developed a questionnaire to identify barriers for effective guideline adherence, based on (a) a theoretical framework for classifying barriers and facilitators, (b) an instrument for measuring determinants of innovations, and (c) 19 semi-structured interviews with perioperative key professionals. Primary outcome is guideline adherence measured at the hospital (i.e., cluster) and patient levels by a set of perioperative Patient Safety Indicators (PSIs), which was developed parallel to the perioperative guidelines. Secondary outcomes at the patient level are in-hospital complications, postoperative wound infections and mortality, length of hospital stay, and unscheduled transfer to the intensive care unit, non-elective readmission to the hospital and unplanned reoperation, all within 30 days after the initial surgery. Also, patient safety culture and team climate will be studied as potential determinants. Finally, a process evaluation is conducted to identify the compliance with the implementation strategy, as well as an economic evaluation to assess the costs. Data sources are registered clinical data and surveys. There is no form of blinding.
Discussion
The perioperative setting is an unexplored area with respect to implementation issues. This study is expected to yield important new evidence about the effects of a multifaceted approach on guideline adherence in the perioperative care setting.
Trial registration
Dutch trial registry: NTR3568
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0198-5) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-014-0198-5
PMCID: PMC4296536  PMID: 25567584
Guideline adherence; Health-care quality indicators; Implementation; Multifaceted approach; Patient safety; Perioperative care; Stepped wedge design
19.  Accuracy of using automated methods for detecting adverse events from electronic health record data: a research protocol 
Background
Adverse events are associated with significant morbidity, mortality and cost in hospitalized patients. Measuring adverse events is necessary for quality improvement, but current detection methods are inaccurate, untimely and expensive. The advent of electronic health records and the development of automated methods for encoding and classifying electronic narrative data, such as natural language processing, offer an opportunity to identify potentially better methods. The objective of this study is to determine the accuracy of using automated methods for detecting three highly prevalent adverse events: a) hospital-acquired pneumonia, b) catheter-associated bloodstream infections, and c) in-hospital falls.
Methods/design
This validation study will be conducted at two large Canadian academic health centres: the McGill University Health Centre (MUHC) and The Ottawa Hospital (TOH). The study population consists of all medical, surgical and intensive care unit patients admitted to these centres between 2008 and 2014. An automated detection algorithm will be developed and validated for each of the three adverse events using electronic data extracted from multiple clinical databases. A random sample of MUHC patients will be used to develop the automated detection algorithms (cohort 1, development set). The accuracy of these algorithms will be assessed using chart review as the reference standard. Then, receiver operating characteristic curves will be used to identify optimal cut points for each of the data sources. Multivariate logistic regression and the areas under curve (AUC) will be used to identify the optimal combination of data sources that maximize the accuracy of adverse event detection. The most accurate algorithms will then be validated on a second random sample of MUHC patients (cohort 1, validation set), and accuracy will be measured using chart review as the reference standard. The most accurate algorithms validated at the MUHC will then be applied to TOH data (cohort 2), and their accuracy will be assessed using a reference standard assessment of the medical chart.
Discussion
There is a need for more accurate, timely and efficient measures of adverse events in acute care hospitals. This is a critical requirement for evaluating the effectiveness of preventive interventions and for tracking progress in patient safety through time.
doi:10.1186/s13012-014-0197-6
PMCID: PMC4296680  PMID: 25567422
Adverse events; Electronic health record; Acute care hospital; Automated detection; Natural language processing; Patient safety; Data warehouse
20.  Economic evaluation of the practical approach to lung health and informal provider interventions for improving the detection of tuberculosis and chronic airways disease at primary care level in Malawi: study protocol for cost-effectiveness analysis 
Background
Chronic airway diseases pose a big challenge to health systems in most developing countries, particularly in Sub-Saharan Africa. A diagnosis for people with chronic or persistent cough is usually delayed because of individual and health system barriers. However, delayed diagnosis and treatment facilitates further transmission, severity of disease with complications and mortality. The objective of this study is to assess the cost-effectiveness of the practical approach to lung health strategy, a patient-centred approach for diagnosis and treatment of common respiratory illnesses in primary healthcare settings, as a means of strengthening health systems to improve the quality of management of respiratory diseases.
Methods/design
Economic evaluation nested in a cluster randomised controlled trial with three arms will be performed. Measures of effectiveness and costs for all arms of the study will be obtained from the cluster randomised controlled clinical trial. The main outcome measures are a combined rate of major respiratory diseases milestones and process indicators extracted from the practical approach to lung health strategy. For analysis, descriptive as well as regression techniques will be used. A cost-effectiveness analysis will be performed according to intention-to-treat principle and from a societal perspective. Cost-effectiveness ratios will be calculated using bootstrapping techniques.
Discussion
We hope to demonstrate the cost-effectiveness of the practical approach to lung health and informal healthcare providers, see an improvement in patients’ quality of life, achieve a reduction in the duration and occurrence of episodes and the chronicity of respiratory diseases, and are able to report a decrease in the social cost. If the practical approach to lung health and informal healthcare provider’s interventions are cost-effective, they could be scaled up to all primary healthcare centres.
Trial registration
PACTR: PACTR201411000910192
doi:10.1186/s13012-014-0195-8
PMCID: PMC4302070  PMID: 25567289
21.  The Society for Implementation Research Collaboration Instrument Review Project: A methodology to promote rigorous evaluation 
Background
Identification of psychometrically strong instruments for the field of implementation science is a high priority underscored in a recent National Institutes of Health working meeting (October 2013). Existing instrument reviews are limited in scope, methods, and findings. The Society for Implementation Research Collaboration Instrument Review Project’s objectives address these limitations by identifying and applying a unique methodology to conduct a systematic and comprehensive review of quantitative instruments assessing constructs delineated in two of the field’s most widely used frameworks, adopt a systematic search process (using standard search strings), and engage an international team of experts to assess the full range of psychometric criteria (reliability, construct and criterion validity). Although this work focuses on implementation of psychosocial interventions in mental health and health-care settings, the methodology and results will likely be useful across a broad spectrum of settings. This effort has culminated in a centralized online open-access repository of instruments depicting graphical head-to-head comparisons of their psychometric properties. This article describes the methodology and preliminary outcomes.
Methods
The seven stages of the review, synthesis, and evaluation methodology include (1) setting the scope for the review, (2) identifying frameworks to organize and complete the review, (3) generating a search protocol for the literature review of constructs, (4) literature review of specific instruments, (5) development of an evidence-based assessment rating criteria, (6) data extraction and rating instrument quality by a task force of implementation experts to inform knowledge synthesis, and (7) the creation of a website repository.
Results
To date, this multi-faceted and collaborative search and synthesis methodology has identified over 420 instruments related to 34 constructs (total 48 including subconstructs) that are relevant to implementation science. Despite numerous constructs having greater than 20 available instruments, which implies saturation, preliminary results suggest that few instruments stem from gold standard development procedures. We anticipate identifying few high-quality, psychometrically sound instruments once our evidence-based assessment rating criteria have been applied.
Conclusions
The results of this methodology may enhance the rigor of implementation science evaluations by systematically facilitating access to psychometrically validated instruments and identifying where further instrument development is needed.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0193-x) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-014-0193-x
PMCID: PMC4308900  PMID: 25567126
Implementation; Dissemination; Instruments; Evidence-based assessment; Psychometrics
22.  Evaluating the effect of a web-based quality improvement system with feedback and outreach visits on guideline concordance in the field of cardiac rehabilitation: rationale and study protocol 
Background
Implementation of clinical practice guidelines into daily care is hampered by a variety of barriers related to professional knowledge and collaboration in teams and organizations. To improve guideline concordance by changing the clinical decision-making behavior of professionals, computerized decision support (CDS) has been shown to be one of the most effective instruments. However, to address barriers at the organizational level, additional interventions are needed. Continuous monitoring and systematic improvement of quality are increasingly used to achieve change at this level in complex health care systems. The study aims to assess the effectiveness of a web-based quality improvement (QI) system with indicator-based performance feedback and educational outreach visits to overcome organizational barriers for guideline concordance in multidisciplinary teams in the field of cardiac rehabilitation (CR).
Methods
A multicenter cluster-randomized trial with a balanced incomplete block design will be conducted in 18 Dutch CR clinics using an electronic patient record with CDS at the point of care. The intervention consists of (i) periodic performance feedback on quality indicators for CR and (ii) educational outreach visits to support local multidisciplinary QI teams focussing on systematically improving the care they provide. The intervention is supported by a web-based system which provides an overview of the feedback and facilitates development and monitoring of local QI plans. The primary outcome will be concordance to national CR guidelines with respect to the CR needs assessment and therapy indication procedure. Secondary outcomes are changes in performance of CR clinics as measured by structure, process and outcome indicators, and changes in practice variation on these indicators. We will also conduct a qualitative process evaluation (concept-mapping methodology) to assess experiences from participating CR clinics and to gain insight into factors which influence the implementation of the intervention.
Discussion
To our knowledge, this will be the first study to evaluate the effect of providing performance feedback with a web-based system that incorporates underlying QI concepts. The results may contribute to improving CR in the Netherlands, increasing knowledge on facilitators of guideline implementation in multidisciplinary health care teams and identifying success factors of multifaceted feedback interventions.
Trial registration
NTR3251.
doi:10.1186/s13012-014-0131-y
PMCID: PMC4298976  PMID: 25551791
Quality improvement; Quality indicators; Health care; Cardiac rehabilitation; Guideline adherence
23.  Use of action planning to increase provision of smoking cessation care by general practitioners: role of plan specificity and enactment 
Background
Strategies are needed to help general practitioners (GPs) promote smoking cessation as recommended by guidelines. This study examines whether the quality of action planning among GPs improves their provision of smoking cessation care.
Methods
The effectiveness of a 1-h training programme was examined in a cluster randomised controlled trial in which 49 GPs participated. GPs who followed the training (intervention group; n = 25) formulated action plans related to i) enquiring about smoking, ii) advising to quit smoking, and iii) arranging follow-up for smokers motivated to quit. GPs also formulated a coping plan for encountering smokers not motivated to quit. The quality of these plans (plan specificity) was rated and, 6 weeks after the training, GPs reported on the performance of these plans (plan enactment). Multilevel regression analyses were used to examine the effects of plan specificity and plan enactment on patient-reported smoking cessation activities of the GPs in the intervention group (n = 1,632 patients) compared with the control group (n = 1,769 patients).
Results
Compared to the control group, GPs who formulated a highly specific action plan during the training asked their patients about smoking more often after the training compared to prior to the training (OR 2.11, 95% CI 1.51–2.95). GPs were most likely to have asked patients about smoking after the training compared to prior to the training when they had enacted a highly specific formulated action plan (OR 3.08, 95% CI 2.04–4.64). The effects of GP plan specificity and plan enactment on asking patient about smoking were most prominent among GPs who, at baseline, intended to provide smoking cessation care.
Conclusions
A highly specific action plan formulated by a GP on when, how, and by whom patients will be asked about smoking had a positive effect on GPs’ asking patients about smoking, especially when these professionals also reported to have enacted this plan. This effect was most prominent among GPs who intended to provide smoking cessation care prior to the intervention. Training in devising personalised coping plans is recommended to further increase GPs’ provision of advice to quit smoking and arranging follow-up support to quit smoking.
doi:10.1186/s13012-014-0180-2
PMCID: PMC4299546  PMID: 25547978
General practise; Smoking cessation care; Implementation; Action planning
24.  Local politico-administrative perspectives on quality improvement based on national registry data in Sweden: a qualitative study using the Consolidated Framework for Implementation Research 
Background
Through a national policy agreement, over 167 million Euros will be invested in the Swedish National Quality Registries (NQRs) between 2012 and 2016. One of the policy agreement’s intentions is to increase the use of NQR data for quality improvement (QI). However, the evidence is fragmented as to how the use of medical registries and the like lead to quality improvement, and little is known about non-clinical use. The aim was therefore to investigate the perspectives of Swedish politicians and administrators on quality improvement based on national registry data.
Methods
Politicians and administrators from four county councils were interviewed. A qualitative content analysis guided by the Consolidated Framework for Implementation Research (CFIR) was performed.
Results
The politicians’ and administrators’ perspectives on the use of NQR data for quality improvement were mainly assigned to three of the five CFIR domains. In the domain of intervention characteristics, data reliability and access in reasonable time were not considered entirely satisfactory, making it difficult for the politico-administrative leaderships to initiate, monitor, and support timely QI efforts. Still, politicians and administrators trusted the idea of using the NQRs as a base for quality improvement. In the domain of inner setting, the organizational structures were not sufficiently developed to utilize the advantages of the NQRs, and readiness for implementation appeared to be inadequate for two reasons. Firstly, the resources for data analysis and quality improvement were not considered sufficient at politico-administrative or clinical level. Secondly, deficiencies in leadership engagement at multiple levels were described and there was a lack of consensus on the politicians’ role and level of involvement. Regarding the domain of outer setting, there was a lack of communication and cooperation between the county councils and the national NQR organizations.
Conclusions
The Swedish experiences show that a government-supported national system of well-funded, well-managed, and reputable national quality registries needs favorable local politico-administrative conditions to be used for quality improvement; such conditions are not yet in place according to local politicians and administrators.
doi:10.1186/s13012-014-0189-6
PMCID: PMC4307376  PMID: 25544124
Quality registry; Clinical database; Clinical registry; Implementation; Quality improvement; Consolidated Framework for Implementation Research

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