De-implementation of Low-value Pharmacological Prescriptions
- Conditions
- Inappropriate PrescribingImplementation ScienceBehavioral Sciences
- Interventions
- Behavioral: A non-reflective decision assistance strategyBehavioral: A both reflective and non-reflective decision information strategyBehavioral: A reflective decision structure strategy
- Registration Number
- NCT04022850
- Lead Sponsor
- Basque Health Service
- Brief Summary
The De-imFAR study is a two phase study that aims to carry out and test a structured, evidence-based and theory informed process involving the main stakeholders (managers, professionals, patients and researches) for the design, deployment, and evaluation of targeted de-implementation strategies for reducing potentially inappropriate prescribing (PIP). Specifically, the targeted low-value practice of the DE-imFAR study is the pharmacological prescription of statins in the primary prevention of cardiovascular disease (CVD) in low-risk patients. In order to prevent CVD, one of the leading causes of morbidity and death worldwide, there is general agreement on the indication of lipid-lowering treatment, mainly with statins, in patients with a cardiovascular risk (CVR) measurement greater than 10% over 10 years or in secondary prevention. Whereas, for primary prevention in patients with low CVR (\<10%), preventive activities should be focused on the promotion of healthy lifestyles through optimizing diet, increasing physical activity, and stopping smoking.
Aims
1. Phase I: To design and model in a collegiate way among the agents involved (professionals, patients, managers and researchers) de-implementation strategies to favour the reduction and / or abandonment of low-value prescription of lipid-lowering drugs in primary prevention of cardiovascular disease. This strategy will be designed using systematic, comprehensive frameworks based on theory and evidence for the design of implementation strategies - the Theoretical Domains Framework (TDF) and the Behavior Change Wheel (BCW), focused on addressing the main determinants (barriers and facilitators) of clinical practice of primary prevention of CVD and adapted to the specific context of primary care in Osakidetza-Basque Health System
2. Phase II: To evaluate the effectiveness and feasibility of several de-implementation strategies derived from the systematic process of identification of determinants and mapping of adapted intervention strategies with the TDF/BCW frameworks: a strategy based on providing evidence-based information communication technology tools to help and guide decision-making (a non-reflective decision assistance strategy); a decision information strategy based on the dissemination of the evidence concerning CVD primary prevention framed in a corporate campaign encouraging family physicians to move away from PIP (a both reflective and non-reflective decision information strategy) ; and a reflective decision structure strategy encouraging reflection on actual performance based on an audit/feedback system (A reflective decision structure strategy).
Hypothesis Professionals exposed to the de-implementation strategies derived from the systematic process of identification of determinants and mapping of adapted intervention strategies with the TDF/BCW frameworks, will be effective in reducing and/or abandoning the prescription of statins in primary prevention of CVD. Among the evaluated de-implementation strategies, those that encourage self-reflection on actual performance will obtain the largest effects as compared to non-reflective strategies.
Design Phase I formative research to design and model de-implementation strategies and Phase II effectiveness and feasibility evaluation through a cluster randomized implementation trial with an additional control group. Phase I formative research will include the following actions: Cross-sectional observational study of low value pharmacological prescription in the primary prevention of CVD; Literature review on the determinants of low value pharmacological prescription behaviour and effective intervention strategies; Qualitative study on the determinants of low value pharmacological prescription in primary prevention of CVD; Collegiate mapping of the de-implementation strategies; Selection of de-implementation strategies based in perceived effectiveness and feasibility. During Phase II, the evaluation of several de-implementation strategies produced through the phase I formative evaluation will be conducted. A mixed method evaluation will be used: quantitative for assessing the implementation results at the professional level and qualitative for assessing the feasibility and perceived impact of the de-implementation strategies from the family physicians' (FPs) perspective and the experience and satisfaction of patients concerning the clinical care received.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 348
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-reflective decision assistance strategy A non-reflective decision assistance strategy The decision support tools integrated in the electronic health record (EHR) for the non-reflective decision assistance strategy will be applied to all FPs from the 13 Integrated Healthcare Organizations (IHOs) of Osakidetza- Basque Health Service Reflective and non-reflective decision information strategy in addition to the previous arm A non-reflective decision assistance strategy At least 58 FPs from two IHOs (Barakaldo-Sestao and Ezkerraldea-Enkarterri-Cruces) will be randomly assigned to this experimental arm (decision assistance strategy + decision information strategy) Reflective and non-reflective decision information strategy in addition to the previous arm A both reflective and non-reflective decision information strategy At least 58 FPs from two IHOs (Barakaldo-Sestao and Ezkerraldea-Enkarterri-Cruces) will be randomly assigned to this experimental arm (decision assistance strategy + decision information strategy) A reflective decision structure strategy in addition to the previous arm A both reflective and non-reflective decision information strategy At least other 58 FPs from two IHOs (Barakaldo-Sestao and Ezkerraldea-Enkarterri-Cruces) will be randomly assigned to this experimental arm (decision assistance strategy + decision information strategy + decision structure strategy) A reflective decision structure strategy in addition to the previous arm A reflective decision structure strategy At least other 58 FPs from two IHOs (Barakaldo-Sestao and Ezkerraldea-Enkarterri-Cruces) will be randomly assigned to this experimental arm (decision assistance strategy + decision information strategy + decision structure strategy) A reflective decision structure strategy in addition to the previous arm A non-reflective decision assistance strategy At least other 58 FPs from two IHOs (Barakaldo-Sestao and Ezkerraldea-Enkarterri-Cruces) will be randomly assigned to this experimental arm (decision assistance strategy + decision information strategy + decision structure strategy)
- Primary Outcome Measures
Name Time Method De-implementation strategies effectiveness: incidence of the provision of advice regarding healthy lifestyles promotion activities from baseline to 12 months and 24 months Change in the incidence of the provision of advice regarding healthy lifestyles promotion activities recorded in the EHR in the target population.
De-implementation strategies effectiveness: incidence of the PIP of statins from baseline to 12 months and 24 months Change in the incidence of the PIP of statins recorded in the EHR in the target population.
- Secondary Outcome Measures
Name Time Method De-implementation strategies secondary effectiveness: incidence of CVR (REGICOR) from baseline to 12 months Change in the incidence of CVR (REGICOR) recorded in the EHR in the target population.
FP's adoption: degree to which the recommended CVD primary prevention clinical intervention is adopted by the FPs 12 months Percentage of FPs who reduce PIP of statins and/or increase health promotion activities recorded in the EHR in the target population.
Reach of recommendations for CVD primary prevention 12 months Absolute number and percentage of patients in the target population who received the recommended CVD primary prevention clinical intervention.
Strategies implementation fidelity 12 months Process indicators of the delivery of and exposure to the de-implementation strategies (percentage of FPs exposed to the strategies compared)
Trial Locations
- Locations (1)
Primary Care Research Unit of Bizkaia
🇪🇸Bilbao, Bizkaia, Spain