Clinical trial NCT04022850: De-implementation of Low-value Pharmacological Prescriptions
Official title: De-implementation of Low-value Pharmacological Prescriptions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inappropriate Prescribing
Implementation Science
Behavioral Sciences
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
Collaborators: name: Health Department of the Basque Government
name: Carlos III Health Institute
name: European Union
First posted: 2019-07-17
Enrollment: 348
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: De-implementation strategies effectiveness: incidence of the PIP of statins
timeFrame: from baseline to 12 months and 24 months
measure: De-implementation strategies effectiveness: incidence of the provision of advice regarding healthy lifestyles promotion activities
timeFrame: from baseline to 12 months and 24 months
Secondary outcomes:
measure: Reach of recommendations for CVD primary prevention
timeFrame: 12 months
measure: De-implementation strategies secondary effectiveness: incidence of CVR (REGICOR)
timeFrame: from baseline to 12 months
measure: FP's adoption: degree to which the recommended CVD primary prevention clinical intervention is adopted by the FPs
timeFrame: 12 months
measure: Strategies implementation fidelity
timeFrame: 12 months
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Primary Care Research Unit of Bizkaia
state: Bizkaia
Study officials:
References:
citation: Sanchez A, Elizondo-Alzola U, Pijoan JI, Mediavilla MM, Pablo S, Sainz de Rozas R, Lekue I, Gonzalez-Larragan S, Llarena M, Larranaga O, Helfrich CD, Grandes G. 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. Front Med (Lausanne). 2022 Oct 13;9:967887. doi: 10.3389/fmed.2022.967887. eCollection 2022.
citation: Sanchez A, Pijoan JI, Pablo S, Mediavilla M, de Rozas RS, Lekue I, Gonzalez-Larragan S, Lantaron G, Argote J, Garcia-Alvarez A, Latorre PM, Helfrich CD, Grandes G. 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. Implement Sci. 2020 Jan 22;15(1):8. doi: 10.1186/s13012-020-0966-3.