JMIR Publications

ABSTRACT

Background:

Preventable harms from medications are significant threats to patient safety in community settings, especially among ambulatory older adults on multiple prescription medications. Patients may partner with primary care professionals by taking on active roles in decisions, learning the basics of medication self-management, and working with community resources.

Objective:

We aim to assess the impact of a set of patient partnership tools that redesign primary care encounters to encourage and empower patients to make more effective use of those encounters to improve medication safety.

Methods:

The study is a non-randomized, cross-sectional stepped wedge cluster-controlled trial with one private family medicine clinic and two public safety-net primary care clinics each composing their own cluster. There are two intervention sequences with one cluster per sequence and one control sequence with one cluster. Cross-sectional surveys will be taken immediately at the conclusion of visits to the clinics during 6 time periods of 6 weeks each, with a transition period of no data collection during intervention implementation. The numbers of visits to be surveyed will vary by period and cluster. We plan to recruit patients and professionals for surveys during 405 visits. In the experimental periods, visits will be conducted with two partnership tools and associated clinic process changes: 1) a one-page visit preparation guide given to relevant patients by clinic staff before seeing the provider, with the intention to improve communication and shared decision-making; and (2) a library of short educational videos that clinic staff encourage patients to watch on medication safety. In the control periods, visits will be conducted with usual care. The primary outcome will be patients’ self-efficacy in medication use. The secondary outcomes are medication related issues such as duplicate therapies identified by primary care providers and assessment of collaborative work during visit.

Results:

The study was funded in September 2019. Data collection started in April 2023. As of February 15, 2024, we enrolled 405 patients.

Conclusions:

This study will assess the impact of patient partnership tools and associated process changes in primary care on medication use self-efficacy and medication-related issues. The study is powered to identify types of patients who may benefit most from patient engagement tools in primary care visits. Clinical Trial: This study was registered with ClinicalTrials.gov (NCT05880368) on May 26, 2023