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

Background Engaging patients and their families in patient safety has been proposed and promoted as key strategy in recent decades. However, little is known about the translation of such an approach in Primary Care. We aimed to estimate the effectiveness of interventions focussing on patient and family engagement for patient safety in primary care based on the published randomized controlled evidence. Methods Following a published protocol, electronic databases (MEDLINE, CINAHL, Embase, Web of Science, and CENTRAL) were searched for eligible studies from inception to February 2023 using tailored searches structured in three blocks (patient and family engagement, patient safety, and primary care). Following piloting of the eligibility criteria, duplicate independent title/abstract screening was undertaken in Rayyan. R was used to conduct mixed-effects multi-level meta-analyses and explore heterogeneity. Cochrane Risk of Bias 2 was used for assessing risk of bias and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) framework was used to appraise the level of certainty. Reporting followed PRISMA standards. Results Twelve interventions were identified in the 16 records included in this review. Of these, six completed randomized-controlled trials (RCTs) were included in the meta-analyses. The interventions spanned the “Inform about Engagement” and “Empower” levels of patient and family engagement, without reaching the highest level of “Partner/Integrate.” Except for one, all reported outcomes centred on various aspects of medication safety. None of the three meta-analyses aggregating evidence on adverse drug events (Log OR=−0.32, 95%CI [−0.78, 0.14]), medication appropriateness assessed categorically (Log OR=−0.08, 95%CI [−0.32, 0.16]), and continuously (Log OR=0.56, 95%CI [−0.61, 1.72]) did not reveal significant effects. The overall risk of bias was low, and the certainty of evidence ranged from moderate to high for most completed studies, with the exception of on adverse drug events, where the certainty was rated as low. Conclusion RCTs investigating interventions related to patient and family engagement in primary care patient safety are limited and yield inconclusive results. Patient engagement strategies should delve into more comprehensive levels of patient and family engagement and address diverse patient safety outcomes. PROSPERO registration number: CRD42023397495 ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Protocols ### Funding Statement This study was funded by Technology and Compassion improving patient outcomes through data analytics and patients voice in Primary Care ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors.