CClinicalTrials.gg
CompletedNCT05880368PROMISUpdated Sep 17, 2025

Partnership in Resilience for Medication Safety (PROMIS)

An interventional study of Patient partnership tools in Patient Engagement, Patient Empowerment and Patient Activation, sponsored by The University of Texas at Arlington. Completed at 2 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-09-17.

Sponsored by The University of Texas at Arlington · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
405
Allocation
Non-randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Patient Engagement
  • Patient Empowerment
  • Patient Activation

Browse trials for

Keywords

  • Medication safety
  • Primary care
03

In context

Patient Participation

127 studies on the registry are indexed under Patient Participation; 64 are open to participants now.

This study's enrollment of 405 is above the median of 138 across 105 interventional studies indexed under Patient Participation.

Browse Patient Participation studies →

Lead sponsor

The University of Texas at Arlington is the lead sponsor of 37 studies on the registry; 11 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Non-English and non-Spanish speaking
  • Impaired decision making capacity
  • Non-consenting
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
405 participants (actual)

Study arms

  • Experimental
    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.

    Other: Patient partnership tools

  • No intervention
    Control

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

Interventions

  • OtherPatient 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).

06

What researchers measure

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.

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

Secondary outcomes

  1. Medication regimen problems

    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.

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

07

Study locations

2 sites
  • Texas Health Care
    Fort Worth, Texas 76104, United States
  • John Peter Smith Health
    Fort Worth, Texas 96104, United States
08

References and documents

Publications

  • 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. PubMed 20650594 ↗
  • 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
  • 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. PubMed 38684080 ↗

Study documents

  • Informed consent form · May 10, 2023
  • Informed consent form · May 10, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Individual participant data will not be shared to protect patient privacy.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05880368
Lead sponsor
The University of Texas at Arlington
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
Responsible party
Sponsor
First posted
May 30, 2023
Start date
Jun 26, 2023
Primary completion
Dec 31, 2023
Completion
Jul 30, 2025
Last update
Sep 17, 2025

Study contacts

Yan Xiao, PhD
principal investigator · University of Texas at Arlington

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion