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Partnership in Resilience for Medication Safety (PROMIS)

Partnership in Resilience for Medication Safety

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05880368
Acronym
PROMIS
Enrollment
405
Registered
2023-05-30
Start date
2023-06-26
Completion date
2025-07-30
Last updated
2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Activation, Patient Empowerment, Patient Engagement

Keywords

Medication safety, Primary care

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.

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.

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).

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Stepped wedge with a parallel control arm

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Medication use and self-efficacyWithin 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

MeasureTime frameDescription
Medication regimen problemsWithin 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026