Partnership in Resilience for Medication Safety (PROMIS)

NCT05880368 | Completed DMC

• 1 other identifier: 2019-0439
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 2

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.

Conditions

Patient Engagement; Patient Empowerment; Patient Activation

Keywords

Medication safety; Primary care

Outcome Measures

Primary Outcomes (1)

• Medication use and self-efficacy

  Medication use and self-efficacy, which is a validated 8-item, 4-point Likert scale survey with a score range of 8-32 and higher indicating higher self-efficacy. The items are: (1) It is easy for me to take my medicine on time, (2) It is easy to remember to take all my medicines, (3) It is easy for me to set a schedule to take my medicines each day, (4) It is easy for me to take my medicines each day, (5) It is easy for me to ask my pharmacist questions about my medicine, (6) It is easy for me to understand my pharmacist's instructions for my medicine, (7) It is easy for me to understand instructions on medicine bottles, (8) It is easy for me to get all the information I need about my medicine.

  Within 4 hours after primary care visit (one time assessment)

Secondary Outcomes (1)

• Medication regimen problems

  Within 4 hours after primary care visit (one time assessment)

Study Arms (2)

Patient partnership tool

EXPERIMENTAL

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

Other: Patient partnership tools

Control

NO INTERVENTION

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

Interventions

Patient partnership tools 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).

Patient partnership tool

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas at Arlington: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (2)

Texas Health Care

Fort Worth, Texas, 76104, United States

Location

John Peter Smith Health

Fort Worth, Texas, 96104, United States

Location

Related Publications (3)

• 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.

  PMID: 20650594 BACKGROUND

• 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

  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.

  PMID: 38684080 DERIVED

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Yan Xiao, PhD

  University of Texas at Arlington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped wedge with a parallel control arm

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 30, 2023
• Study Start: June 26, 2023
• Primary Completion: December 31, 2023
• Study Completion: July 30, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)