Partnership in Resilience for Medication Safety (PROMIS)

The University of Texas System (UT)

Status: Completed

Conditions: Patient Activation; Patient Empowerment; Patient Engagement

Treatments: Other: Patient partnership tools

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05880368

2019-0439

Details and patient eligibility

About

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.

Full 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.

Enrollment: 405 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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405 participants in 2 patient groups

Patient partnership tool

Experimental group

Description:

Study participants as patients visiting primary care providers in the clinics using the study patient engagement tools aimed to reduce preventable adverse drug events.

Treatment:

Other: Patient partnership tools

Control

No Intervention group

Description:

Study participants as patients visiting primary care providers in the clinics without the study patient engagement tools.