Randomized controlled trials in de-implementation research: a systematic scoping review

Abstract

Background Healthcare costs are rising, and a substantial proportion of medical care is of little value. De-implementation of low-value practices is important for improving overall health outcomes and reducing costs. We aimed to identify and synthesize randomized controlled trials (RCTs) on de-implementation interventions and to provide guidance to improve future research. Methods MEDLINE and Scopus up to May 24, 2021, for individual and cluster RCTs comparing de-implementation interventions to usual care, another intervention, or placebo. We applied independent duplicate assessment of eligibility, study characteristics, outcomes, intervention categories, implementation theories, and risk of bias. Results Of the 227 eligible trials, 145 (64%) were cluster randomized trials (median 24 clusters; median follow-up time 305 days), and 82 (36%) were individually randomized trials (median follow-up time 274 days). Of the trials, 118 (52%) were published after 2010, 149 (66%) were conducted in a primary care setting, 163 (72%) aimed to reduce the use of drug treatment, 194 (85%) measured the total volume of care, and 64 (28%) low-value care use as outcomes. Of the trials, 48 (21%) described a theoretical basis for the intervention, and 40 (18%) had the study tailored by context-specific factors. Of the de-implementation interventions, 193 (85%) were targeted at physicians, 115 (51%) tested educational sessions, and 152 (67%) multicomponent interventions. Missing data led to high risk of bias in 137 (60%) trials, followed by baseline imbalances in 99 (44%), and deficiencies in allocation concealment in 56 (25%). Conclusions De-implementation trials were mainly conducted in primary care and typically aimed to reduce low-value drug treatments. Limitations of current de-implementation research may have led to unreliable effect estimates and decreased clinical applicability of studied de-implementation strategies. We identified potential research gaps, including de-implementation in secondary and tertiary care settings, and interventions targeted at other than physicians. Future trials could be improved by favoring simpler intervention designs, better control of potential confounders, larger number of clusters in cluster trials, considering context-specific factors when planning the intervention (tailoring), and using a theoretical basis in intervention design. Registration OSF Open Science Framework hk4b2

Challenges and Opportunities for Reducing Low-value Care; A Response to Recent Commentaries

“…Zadro et al 9 emphasize the need for a review on effective interventions. Although there are several reviews on the effect of de-implementation interventions, [10][11][12][13] none of these reviews provide a clear guidance on the type of intervention for a certain low-value care practice or context. We need especially more evidence on how to develop and evaluate interventions, and moreover preserve results and spread effective de-implementation interventions.…”

Methodological progress note: De‐implementation of low‐value care

“…Table 1 introduced examples of specific barriers and how they could be addressed. Below we discuss in more detail several effective strategies for de‐implementation that are commonly used in the hospital setting 1,5–10 …”

“…Randomized controlled trials and quasi‐experimental studies are needed to test multilevel strategies for de‐implementation, ideally incorporating mixed methods approaches to understand any differences across clinical contexts and patient populations. Structured evaluation of initiatives will lead to refinements in current approaches, evidence about which strategies are most effective in different settings, as well as a better understanding of how to sustain de‐implementation 7 . Understanding and continuing to develop effective methods for de‐implementation will further the provision of evidence‐based, high‐value patient care.…”

“…Structured evaluation of initiatives will lead to refinements in current approaches, evidence about which strategies are most effective in different settings, as well as a better understanding of how to sustain de-implementation. 7 Understanding and continuing to develop effective methods for de-implementation will further the provision of evidence-based, high-value patient care.…”

“…Identifying the barriers and facilitators to the de‐implementation of the particular low‐value service in that specific healthcare context leads to the fifth factor—selection of the most appropriate multilevel strategies to achieve successful practice change. Select barriers to de‐implementation and strategies to address them are shown in Table 1 1,5–10 …”