Partnership in Resilience for Medication Safety (PROMIS)

Patient Engagement Clinical Trial

— PROMIS  

Official title:

Partnership in Resilience for Medication Safety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05880368
• Other study ID #: 2019-0439
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2023
• Est. completion date: September 29, 2025

Study information

• Verified date: July 2023
• Source: The University of Texas at Arlington
• Contact: Yan Xiao, PhD
• Phone: 872-379-9378
• Email: yan.xiao[@]uta.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 29, 2025
• Est. primary completion date: September 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Activation
• Patient Empowerment
• Patient Engagement

Intervention

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).

Locations

Country	Name	City	State
United States	John Peter Smith Health	Fort Worth	Texas
United States	Texas Health Care	Fort Worth	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas at Arlington	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Within 4 hours after primary care visit (one time assessment)