Patient Partnership Tools for Patient Engagement

(PROMIS Trial)

No longer recruiting at 1 trial location

Overseen By Noah Hendrix, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas at Arlington

Disqualifiers: Non-English, Non-Spanish, Impaired decision making, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two tools to enhance communication between patients and doctors during medical visits. One tool is a short guide provided to patients before their appointment, and the other is a set of educational videos. The goal is to improve collaborative decision-making and reduce medication-related issues. The trial seeks participants who are 50 or older, live at home, speak English or Spanish, and take five or more medications. As an unphased trial, this study offers a unique opportunity to contribute to better patient-doctor communication and decision-making.

Do I have to stop taking my current medications for the trial?

The trial does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications since the trial focuses on communication and education tools.

What prior data suggests that these patient partnership tools are safe for use in clinics?

Research has shown that PROMIS is a tool used to understand patients' perceptions of their health, assessing factors like pain, fatigue, and overall well-being. Clinics commonly use PROMIS to gain a comprehensive view of patients' health.

No evidence suggests safety issues because PROMIS is neither a drug nor a medical device. It simply gathers information from patients about their health, and as a measurement tool, it has no reported side effects.

PROMIS is well-established and has been used in many clinical settings. It helps doctors better understand patients' experiences, potentially leading to improved care. Therefore, using PROMIS in this study should be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the patient partnership tool because it offers a fresh approach to preventing adverse drug events. Unlike traditional methods that rely heavily on medical professionals managing medication safety, this tool actively involves patients, empowering them to engage in their own care. By fostering a collaborative environment between patients and primary care providers, the tool aims to enhance communication and reduce preventable medication errors. This patient-centered approach is seen as a promising way to improve overall patient safety and outcomes.

What evidence suggests that these patient partnership tools are effective for improving patient engagement?

Research has shown that PROMIS is a system used to measure health directly from patients' perspectives, focusing on physical, mental, and social well-being. Studies indicate that it tracks health conditions by collecting feedback on patients' feelings and daily functioning. Many healthcare settings use this tool to better understand patient experiences. Although it doesn't treat conditions directly, PROMIS offers important insights that can lead to better healthcare decisions and outcomes. In this trial, participants in the "Patient partnership tool" arm will engage with patient engagement tools, while those in the "Control" arm will not use these tools. ^{1 2 4 6 7}

Who Is on the Research Team?

Yan Xiao, PhD

Principal Investigator

University of Texas at Arlington

Are You a Good Fit for This Trial?

The PROMIS trial is for people who live at home, are aged 50 or older, take five or more medications, and speak English or Spanish. It's not for those in nursing facilities, with impaired decision-making abilities, or who don't consent to participate.

Inclusion Criteria

I am taking 5 or more medications.

Community dwelling (e.g., not in skilled nursing facilities)

I am 50 years old or older.

Exclusion Criteria

Non-consenting

I do not speak English or Spanish.

I have difficulty making decisions due to my health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive patient partnership tools including a visit prep guide and educational videos to improve communication and shared decision-making

Duration not specified

1 visit (in-person)

Follow-up

Participants are monitored for medication use self-efficacy and medication regimen problems

4 hours after primary care visit

What Are the Treatments Tested in This Trial?

Interventions

• PROMIS

Trial Overview This study tests two tools designed to help patients engage better with their healthcare providers: a 'visit prep guide' to improve communication during appointments and educational videos aimed at empowering patients in managing their health.

How Is the Trial Designed?

Group I: Patient partnership tool Experimental Treatment 1 Intervention

Study participants as patients visiting primary care providers in the clinics using the study patient engagement tools aimed to reduce preventable adverse drug events.

Group II: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

The University of Texas at Arlington

Lead Sponsor

Trials

48

Recruited

7,300+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

A prospective patient registry for neurosurgical procedures, implemented in 2013, successfully captured data from 8226 patients across nearly 12,000 surgeries, highlighting its effectiveness in tracking complications over time.

The Clavien-Dindo grade (CDG) was validated as a reliable method for classifying complications, showing a clear correlation with patient outcomes such as performance status and length of hospital stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurosurgery outcomes and complications in a monocentric 7-year patient registry. Sarnthein, J., Staartjes, VE., Regli, L.[2022]

The PROSPER Consortium aims to enhance safety reporting in healthcare by integrating patient-reported outcomes (PROs) into the assessment of adverse events, recognizing the importance of the patient's perspective in understanding treatment effects.

Despite advancements in technology and increased focus on patient involvement, current safety reporting still heavily relies on healthcare professionals, which can lead to under-reporting and discrepancies between patient experiences and clinician perceptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance. Banerjee, AK., Okun, S., Edwards, IR., et al.[2022]

In a survey of 7,661 older patients who experienced adverse events (AEs) during hospitalization, 7% reported such events, and those who did not receive an apology were more likely to file complaints or seek legal advice.

The study highlighted that the manner in which AEs are disclosed, particularly the presence of apologies and formal communication, significantly influences patients' likelihood to complain or pursue legal action, emphasizing the importance of effective communication in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Drives Patients' Complaints About Adverse Events in Their Hospital Care? A Data Linkage Study of Australian Adults 45 Years and Older. Case, J., Walton, M., Harrison, R., et al.[2023]

Citations

1. commonfund.nih.gov commonfund.nih.gov/promis

Patient-Reported Outcomes Measurement Information ... PROMIS is a system for measuring patient-reported outcomes like pain and fatigue, using a computer adaptive testing system, and is publicly available.

2. healthmeasures.net healthmeasures.net/explore-measurement-systems/promis

PROMIS PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children.

3. mmshub.cms.gov mmshub.cms.gov/about-quality/types/proms/overview

Patient-Reported Outcome Measures Overview Patient-Reported Outcome Measures (PROMs) are tools that capture patient-reported outcomes (PROs), which are direct reports of health status, ...

4. patientiq.io patientiq.io/resources/blog/what-is-promis-a-guide-to-patient-reported-outcome-measures-in-clinical-practice

What Is PROMIS? A Guide to Patient-Reported Outcome ... PROMIS is Patient-Reported Outcomes Measurement Information System, a set of tools to measure physical, mental, and social health. PROMIS ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e23192

Patient Reported Outcome Measurement Information ... This study characterizes the use of the NIH-sponsored Patient Reported Outcomes Measurement Information System (PROMIS) in routine oncological care

6. promishealth.org promishealth.org/57461-2/

What is PROMIS? PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children.

7. hopkinsarthritis.org hopkinsarthritis.org/arthritis-research/patient-centered-outcomes-research/promis/

PROMIS – What is PROMIS PROMIS is a system for measuring patient-reported health status, measuring what patients can do and how they feel, and used in clinical studies.