Clinical trial NCT05880368: Partnership in Resilience for Medication Safety (PROMIS)
Official title: Partnership in Resilience for Medication Safety
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Patient Engagement
Patient Empowerment
Patient Activation
Keywords: Medication safety
Primary care
Lead sponsor: The University of Texas at Arlington
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2023-05-30
Enrollment: 405
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stepped wedge with a parallel control arm
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The trial is to assess the impact of two patient partnership tools: (1) a one-page 'visit prep 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 series of short educational videos that clinic staff can encourage patients to watch.

Detailed description: Preventable patient harms from medications are significant threats to patient safety in ambulatory and community settings and contributed 700,000 emergency department visits each year. More than a third of community-dwelling 65 years or older adults take 5 or more prescription medications. In ambulatory and community settings, more so than in inpatient settings, medication safety is shaped by interactions among patient/caregivers and different professionals across locations. We developed a set of patient partnership tools to encourage and empower patients to make use of their office visits through setting expectations of information sharing, learning basics of medication self-management, and working with community pharmacy resources. The trial will be conducted at private and safety-net primary care clinics to assess the impact of the partnership tools: 1) a one-page 'visit prep 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 series of short educational videos that clinic staff can encourage patients to watch. A step-wedge design will be used, with medication use self-efficacy as the primary outcome, as measured by a validated tool. Secondary outcomes are issues identified by medication review.

Eligibility criteria: Inclusion Criteria:

* Community dwelling (e.g., not in skilled nursing facilities)
* Age 50 years or older
* Taking 5 or more medications
* English or Spanish speaking

Exclusion Criteria:

* Non-English and non-Spanish speaking
* Impaired decision making capacity
* Non-consenting

Primary outcomes:
measure: Medication use and self-efficacy
timeFrame: Within 4 hours after primary care visit (one time assessment)
Secondary outcomes:
measure: Medication regimen problems
timeFrame: Within 4 hours after primary care visit (one time assessment)
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Texas Health Care
state: Texas
city: Fort Worth
country: United States
facility: John Peter Smith Health
state: Texas
Study officials:
affiliation: University of Texas at Arlington
name: Yan Xiao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cameron KA, Ross EL, Clayman ML, Bergeron AR, Federman AD, Bailey SC, Davis TC, Wolf MS. Measuring patients' self-efficacy in understanding and using prescription medication. Patient Educ Couns. 2010 Sep;80(3):372-6. doi: 10.1016/j.pec.2010.06.029. Epub 2010 Jul 21.
citation: Brega AG, Barnard J, Mabachi NM, et al. AHRQ Health Literacy Universal Precautions Toolkit, Second Edition. Rockville, MD: AHRQ Publication No. 15-0023-EF;2015