Patient and family engagement interventions on patients' safety in primary care: a systematic review and meta-analysis

ImportanceEngaging patients and their families has been proposed and promoted as a key strategy for improving patient safety of health systems. However, little is known about the use of this approach in the primary care settings. ObjectiveThis systematic review and meta-analysis assessed the effectiveness of interventions promoting patient and family engagement for patient safety in primary care based on randomised controlled trials (RCTs). Data SourcesFive electronic databases (MEDLINE, CINAHL, Embase, Web of Science, and CENTRAL) were searched from inception to February 2023 with key words structured in four blocks (patient and family engagement; patient safety; primary care; randomised controlled trial). Study SelectionDefinition of patient safety included adverse events and non-recommended practices. Two independent study team members screened each record, with discrepancies resolved by consensus. Data Extraction and SynthesisReporting followed PRISMA standards and included risk of bias and level of certainty assessments. For studies reporting on similar safety outcomes, results were combined into meta-analyses using multi-level random-effects models in case of moderate/substantial heterogeneity (30%[≤]I{superscript 2}[≤]75%), and fixed-effect models when heterogeneity was low (I{superscript 2}[≤]30%). Main Outcome(s) and Measure(s)Expected primary study outcomes were adverse events, non-recommended medical practices, and medical errors. Interventions were considered of interest, if they prompted patients and/or families to take actions, focused on patient education about engagement, or had a significant patient engagement component if they were multifaceted interventions. Interventions were rated based on increasing degrees of patient/family engagement as "Inform about engagement", "Empower", and "Partner/Integrate". ResultsSixteen records were identified, among which eight completed RCTs. No intervention reached the highest engagement level. RCTs primarily targeted medication safety outcomes, with meta-analyses showing no significant effects on adverse drug events (OR=0.73, 95%CI [0.46,1.15]) and medication appropriateness using categorical (OR=0.97, 95%CI [0.73,1.17]) and continuous outcome variables (MD=0.56, 95%CI [-0.61, 1.72]). Overall risk of bias was low and the certainty of evidence ranged from moderate to high for most completed studies. Conclusion and RelevancePatient and family engagement strategies in primary care show inconclusive results based on extant randomised controlled evidence. They should delve into more comprehensive levels of engagement and address more diverse patient safety outcomes. Key pointsO_LIQuestion: Is there randomised controlled evidence supporting the use of patient and family engagement interventions in primary care patient safety? C_LIO_LIFindings: Randomised controlled interventions targeting patient safety through patient and family engagement are scarce in primary care, mostly focus on medication safety, and stay at low to intermediate levels of patient and family engagement. Although their combined effectiveness did not reach significance in meta-analyses, favourable results were reported for several patient safety outcomes. C_LIO_LIMeaning: Patient and family engagement interventions for patient safety in primary care show inconclusive results based on the randomised controlled evidence at hand, yet their scarcity and relatively low level of patient/family engagement underscores the need to further test and refine such approaches in all patient safety domains. C_LI