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Completed

NCT Number: NCT05880368

Partnership in Resilience for Medication Safety (PROMIS)

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John Peter Smith Health, Fort Worth, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Medication use and self-efficacy

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

    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.

Secondary outcomes

  1. Medication regimen problems

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

    The number of medication regimen problems identified by the provider during the visit, using a medication review form, with higher number of problems indicating higher risks for medication regimen problems. Different types of regimen problems, such as unintentional duplication, will be countered and added.

Sponsors and collaborators

Lead sponsor

The University of Texas at Arlington

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Partnership in Resilience for Medication Safety

Acronym: PROMIS

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
May 30, 2023
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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