Partnership in Resilience for Medication Safety (PROMIS)

NCT ID: NCT05880368

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 405 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-26
• Study Completion Date: 2025-07-30

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.

Conditions

Patient Engagement; Patient Empowerment; Patient Activation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Patient partnership tool

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

Group Type: EXPERIMENTAL

Patient partnership tools

Intervention Type: OTHER

The intervention consists of two patient partnership tools: (1) a one-page 'visit prep guide' given to relevant patients by clinic staff before seeing the primary care 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. The interventions will be included in the workflow of the clinics during the intervention periods (i.e., clinics either do not use the intervention or use them for all relevant patients depending on study period).

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Patient partnership tools

The intervention consists of two patient partnership tools: (1) a one-page 'visit prep guide' given to relevant patients by clinic staff before seeing the primary care 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. The interventions will be included in the workflow of the clinics during the intervention periods (i.e., clinics either do not use the intervention or use them for all relevant patients depending on study period).

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

The University of Texas at Arlington

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Xiao, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Arlington

Locations

Texas Health Care

Fort Worth, Texas, United States

John Peter Smith Health

Fort Worth, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20650594 (View on PubMed)

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

Reference Type: BACKGROUND

Xiao Y, Fulda KG, Young RA, Hendrix ZN, Daniel KM, Chen KY, Zhou Y, Roye JL, Kosmari L, Wilson J, Espinoza AM, Sutcliffe KM, Pitts SI, Arbaje AI, Chui MA, Blair S, Sloan D, Jackson M, Gurses AP. Patient Partnership Tools to Support Medication Safety in Community-Dwelling Older Adults: Protocol for a Nonrandomized Stepped Wedge Clinical Trial. JMIR Res Protoc. 2024 Apr 29;13:e57878. doi: 10.2196/57878.

Reference Type: DERIVED

PMID: 38684080 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form: Patient engagement survey consent form

View Document

Document Type: Informed Consent Form: Provider consent form

View Document

Other Identifiers

2019-0439

Identifier Type: -

Identifier Source: org_study_id