Partnership in Resilience for Medication Safety (PROMIS)

Sponsor
The University of Texas at Arlington (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05880368
Collaborator
Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
500
2
27.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Patient partnership tools
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Stepped wedge with a parallel control armStepped wedge with a parallel control arm
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Partnership in Resilience for Medication Safety
Anticipated Study Start Date :
Jun 26, 2023
Anticipated Primary Completion Date :
Sep 29, 2024
Anticipated Study Completion Date :
Sep 29, 2025

Arms and Interventions

Arm Intervention/Treatment
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
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).

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

  1. Medication use and self-efficacy [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 Outcome Measures

  1. Medication regimen problems [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
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:
  • Non-English and non-Spanish speaking

  • Impaired decision making capacity

  • Non-consenting

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Yan Xiao, PhD, University of Texas at Arlington

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
The University of Texas at Arlington
ClinicalTrials.gov Identifier:
NCT05880368
Other Study ID Numbers:
  • 2019-0439
First Posted:
May 30, 2023
Last Update Posted:
May 30, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The University of Texas at Arlington

Study Results

No Results Posted as of May 30, 2023