Patient Partnership Tools for Patient Engagement

(PROMIS Trial)

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

405 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment PROMIS?

The Patient-Reported Outcomes Measurement Information System (PROMIS) is a tool that helps measure important health outcomes from the patient's perspective, including physical, mental, and social health. It is widely used in clinical and research settings to improve patient care and decision-making, suggesting its effectiveness in enhancing patient engagement and satisfaction. ^{1 2 3 4 5}

What safety data exists for the treatment evaluated under different names, including PROMIS?

The Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium has developed guidance to improve safety reporting by incorporating patient perspectives on adverse events. This guidance aims to ensure patient voices are included in safety data collection, which can help better define the safety profile of treatments, including those evaluated under systems like PROMIS. ^{6 7 8 9 10}

How does this treatment differ from other treatments for patient engagement?

This treatment is unique because it focuses on creating active partnerships between patients, families, and health professionals to improve healthcare delivery, rather than just treating a medical condition. It emphasizes the role of patients as partners in the healthcare system, which is a relatively new approach compared to traditional methods. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Research Team

Yan Xiao, PhD

Principal Investigator

University of Texas at Arlington

Eligibility Criteria

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 50 years old or older.

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

I am taking 5 or more medications.

Exclusion Criteria

I do not speak English or Spanish.

I have difficulty making decisions due to my health condition.

Non-consenting

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Does Patient-Reported Outcome Measures Use at New Foot and Ankle Patient Clinic Visits Improve Patient Activation, Experience, and Satisfaction? [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Advantages and Design of PROMIS Questionnaires. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The experiences of professionals with using information from patient-reported outcome measures to improve the quality of healthcare: a systematic review of qualitative research. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Pearls and pitfalls of PROMIS clinically significant outcomes in orthopaedic surgery. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Beyond methods to applied research: Realizing the vision of PROMIS®. [2019]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Neurosurgery outcomes and complications in a monocentric 7-year patient registry. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the design and operation of multi-center clinical trials: a qualitative research study. [2023]

9. United States 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. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Score equivalence of paper-, tablet-, and interactive voice response system-based versions of PROMIS, PRO-CTCAE, and numerical rating scales among cancer patients. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Patient engagement study to identify and improve surgical experience. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Towards conceptualizing patients as partners in health systems: a systematic review and descriptive synthesis. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Implementing a pragmatic framework for authentic patient-researcher partnerships in clinical research. [2022]

14. Canada pubmed.ncbi.nlm.nih.gov

Patient Partners Respond to High-Level Findings on the Connectedness of Health and Social Services across Canada. [2023]

15. Belgium pubmed.ncbi.nlm.nih.gov

[Patient partner approach into question]. [2019]