NCT04022850: De-imFAR

De-implementation of Low-value Pharmacological Prescriptions

Completed NA Last updated 11 February 2025

What this trial tests

NA trial testing A non-reflective decision assistance strategy in Inappropriate Prescribing in 348 participants. Completed in 5 May 2024.

Timeline

5 May 2022

Primary endpoint
5 May 2024

5 May 2024

Quick facts

Lead sponsor	Basque Health Service
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	health services research
Enrollment	348
Start date	5 May 2022
Primary completion	5 May 2024
Estimated completion	5 May 2024
Sites	1 location across Spain

Drugs / interventions tested

• A non-reflective decision assistance strategy
• A both reflective and non-reflective decision information strategy
• A reflective decision structure strategy

Conditions studied

• Inappropriate Prescribing — all drugs for Inappropriate Prescribing →
• Implementation Science — all drugs for Implementation Science →
• Behavioral Sciences — all drugs for Behavioral Sciences →

Sponsor

Basque Health Service — full company profile →

Who can join

Eligibility, any sex, with Inappropriate Prescribing or Implementation Science. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Addressing low-value pharmacological prescribing in primary prevention of CVD through a structured evidence-based and theory-informed process for the design and testing of de-implementation strategies: the DE-imFAR study.
   Sanchez A, Pijoan JI, Pablo S, Mediavilla M, et al · · 2020 · cited 4× · PMID 31969175 · DOI 10.1186/s13012-020-0966-3
2. De-imFAR phase II project: a study protocol for a cluster randomised implementation trial to evaluate the effectiveness of de-implementation strategies to reduce low-value statin prescribing in the primary prevention of cardiovascular disease.
   Sanchez A, Pijoan JI, Sainz de Rozas R, Lekue I, et al · · 2024 · cited 1× · PMID 38631840 · DOI 10.1136/bmjopen-2023-078692
3. Applying the behavior change wheel to design de-implementation strategies to reduce low-value statin prescription in primary prevention of cardiovascular disease in primary care.
   Sanchez A, Elizondo-Alzola U, Pijoan JI, Mediavilla MM, et al · · 2022 · cited 1× · PMID 36314033 · DOI 10.3389/fmed.2022.967887
4. Comparative effectiveness of non-reflective and reflective strategies to favor de-implementation of low-value prescribing for the primary prevention of cardiovascular disease in primary care: the DE-imFAR cluster randomized implementation trial.
   Sanchez A, Pijoan JI, Sainz de Rozas R, Lekue I, et al · · 2026 · PMID 42174713 · DOI 10.1186/s43058-026-00968-1
5. 100th EGPRN Meeting, 8–11 May 2025, Gothenburg – Sweden
   · 2025
6. Mapping De-Implementation Strategies To Identified Determinants of Low-Value Statin Prescription for Primary CVD Prevention in Primary Care
   Sanchez A, Elizondo-Alzola U, Pijoan JI, Mediavilla MM, et al · · 2021 · DOI 10.21203/rs.3.rs-1067650/v1