De-implementation of Low-value Pharmacological Prescriptions (De-imFAR)

Basque Health Service

Status: Active, not recruiting

Conditions: Implementation Science; Inappropriate Prescribing; Behavioral Sciences

Treatments: Behavioral: A both reflective and non-reflective decision information strategy; Behavioral: A reflective decision structure strategy; Behavioral: A non-reflective decision assistance strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT04022850

PI21/00025 (Other Grant/Funding Number)

2021111024 (Other Grant/Funding Number)

RD16/0007/0002 (Other Grant/Funding Number)

RD21/0016/0003 (Other Grant/Funding Number)

2018111085

Details and patient eligibility

About

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.

Enrollment: 348 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Eligibility for professionals:

• FPs belonging to any of the 13 Integrated Healthcare Organizations of Osakidetza
• Non-zero annual incidence rate of PIP of statins at baseline (2021)
• A minimum cluster size of n ≥10 patients

Eligibility for patients:

• 40- to 74-year-old men and 45- to 74-year-old women
• No history of statin use
• LDL cholesterol levels between 70 and 189 mg/dL and/or TC between 200 and 289 mg/dL
• Without ischemic heart disease/CVD
• Estimated CVR REGICOR <7.5%
• Attend at least one appointment at the participating FPs' practices during the study period from May 2022 to May 2023, and followed until May 2024

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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348 participants in 3 patient groups

Non-reflective decision assistance strategy

Active Comparator group

Description:

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

Treatment:

Behavioral: A non-reflective decision assistance strategy

Reflective and non-reflective decision information strategy in addition to the previous arm

Experimental group

Description:

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)

Treatment:

Behavioral: A non-reflective decision assistance strategy

Behavioral: A both reflective and non-reflective decision information strategy

A reflective decision structure strategy in addition to the previous arm

Experimental group

Description:

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)

Treatment:

Behavioral: A non-reflective decision assistance strategy

Behavioral: A reflective decision structure strategy

Behavioral: A both reflective and non-reflective decision information strategy