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

Abstract

Background: De-implementation or abandonment of ineffective or low-value healthcare is becoming a priority research field globally due to the growing empirical evidence of the high prevalence of such care and its impact in terms of patient safety and social inefficiency. Little is known, however, about the factors, barriers, and facilitators involved or about interventions that are effective in promoting and accelerating the de-implementation of lowvalue healthcare. The De-imFAR study seeks to carry out a structured, evidence-based, and theory-informed process involving the main stakeholders (clinicians, managers, patients, and researchers) for the design, deployment, and assessment of de-implementation strategies for reducing low-value pharmacological prescribing. Methods: A phase I formative study using a systematic and comprehensive framework based on theory and evidence for the design of implementation strategies-specifically, the Behavior Change Wheel (BCW)-will be conducted to design and model de-implementation strategies to favor reductions in low-value pharmacological prescribing of statins in primary prevention of cardiovascular disease (CVD) by main stakeholders (clinicians, managers, patients, and researchers) in a collegiate way. Subsequently, a phase II comparative hybrid trial will be conducted to assess the feasibility and potential effectiveness of at least one active de-implementation strategy to reduce low-value pharmacological prescribing of statins in primary prevention of CVD compared to the usual procedures for dissemination of clinical practice guidelines ("what-not-to-do" recommendations). A mixed-methods evaluation will be used: quantitative for the results of the implementation at the professional level (e.g., adoption, reach and implementation or execution of the recommended clinical practice); and qualitative to determine the feasibility and perceived impact of the de-implementation strategies from the clinicians' perspective, and patients' experiences related to the clinical care received.

Strategies for de-implementation of low-value care—a scoping review

“…Studies investigating strategies to reduce LVC have been published in a broad range of journals, typically within specific clinical and medical care areas, from microbiological research on antimicrobial resistance to potentially inappropriate medication for the elderly [2]. Studies on strategies for de-implementation have also focused on specific LVC within fields such as nursing [25], low-value blood management techniques in primary hip and knee arthroplasty [26], pharmacological prescriptions [27], and cancer [28]. An exception is a systematic review of de-implementation strategies covering a wide range of clinical areas [29] that found promising results for clinical decision support and performance feedback, concluding that multicomponent strategies addressing both clinicians and patients had the greatest potential for reducing LVC.…”

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

“…Research is now needed however, to test whether these barrierspecific strategies for de-implementation identified in the present study are also effective in our context (17).…”

“…Therefore, though not innovative interventions or strategies, those identified are those that address the specific determinants identified by the protagonists. Research is now needed however, to test whether these barrier-specific strategies for de-implementation identified in the present study are also effective in our context ( 17 ).…”

“…This study aimed to report on the application of a systematic, comprehensive, theory-and evidence-informed framework to design potentially effective and feasible de-implementation strategies to favor the abandonment of low-value pharmacological prescribing in CVD primary prevention in low CVD risk patients ( 17 ). Specifically, guided by the TDF and the BCW frameworks ( 13 , 23 – 25 ), we have conducted a series of actions to identify determinants of low-value practices and behavioral objectives as areas for improvement, which have helped us to design, operationalize and prioritize various de-implementation strategies.…”

“…The DE-imFAR (from the Spanish for DE-implementation of low-value pharmacological prescriptions) study aims to carry out a structured, evidence-based and theory-informed process involving the main stakeholders (healthcare managers, professionals, patients, and researchers) for the design, deployment and evaluation of targeted de-implementation strategies for reducing low-value pharmacological prescribing ( 17 ). Specifically, the selected low-value practice is the prescription of statins in primary prevention of cardiovascular disease (CVD) in patients with low cardiovascular risk (CVR) (i.e., <10% CVR according to the REGICOR equation).…”