An interventional study of A non-reflective decision assistance strategy and A both reflective and non-reflective decision information strategy in Inappropriate Prescribing, Implementation Science and Behavioral Sciences, sponsored by Basque Health Service. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by Basque Health Service · Not applicable, Interventional, and Health services research
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
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.
Eligibility for professionals:
Eligibility for patients:
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
Behavioral: 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)
Behavioral: A non-reflective decision assistance strategy · Behavioral: 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)
Behavioral: A non-reflective decision assistance strategy · Behavioral: A both reflective and non-reflective decision information strategy · Behavioral: A reflective decision structure strategy
A strategy based on providing evidence-based information communication technology tools to help and guide decision-making: pop-up reminders and alerts with associated messages incorporated into the REGICOR CVR calculator in OSABIDE (Osakidetza's EHR system) and within the prescription pathway in PRESBIDE (the electronic drug prescribing component).
This strategy consists of a corporate campaign entitled "Stopping Low-Value Prescribing" run by the organization (Osakidetza- Basque Health Service) that provides FPs with the evidence-based Clinical Practice Guidelines for the primary prevention of CVD in low-risk patients.
The strategy involves the sending of regular audit/feedback reports with practice- and organizational-level performance indicators regarding PIP of statins and healthy lifestyle promotion to prompt reflection about their own care practice, provided along with intention formation and goal-setting-focused messages.
De-implementation strategies effectiveness: incidence of the PIP of statins
Change in the incidence of the PIP of statins recorded in the EHR in the target population.
Time frame: from baseline to 12 months and 24 months
De-implementation strategies effectiveness: incidence of the provision of advice regarding healthy lifestyles promotion activities
Change in the incidence of the provision of advice regarding healthy lifestyles promotion activities recorded in the EHR in the target population.
Time frame: from baseline to 12 months and 24 months
Reach of recommendations for CVD primary prevention
Absolute number and percentage of patients in the target population who received the recommended CVD primary prevention clinical intervention.
Time frame: 12 months
De-implementation strategies secondary effectiveness: incidence of CVR (REGICOR)
Change in the incidence of CVR (REGICOR) recorded in the EHR in the target population.
Time frame: from baseline to 12 months
FP's adoption: degree to which the recommended CVD primary prevention clinical intervention is adopted by the FPs
Percentage of FPs who reduce PIP of statins and/or increase health promotion activities recorded in the EHR in the target population.
Time frame: 12 months
Strategies implementation fidelity
Process indicators of the delivery of and exposure to the de-implementation strategies (percentage of FPs exposed to the strategies compared)
Time frame: 12 months
Plan to share: Yes — Individual participant data will be shared that underlie results reported in the publication, after deidentification
Supporting information: Study protocol
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Basque Health Service