Patient-Reported Outcomes Measurement Information System Integration Into Rheumatology Clinical Practice

Sponsor
University of Michigan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05026853
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
500
1
2
52.6
9.5

Study Details

Study Description

Brief Summary

This study will examine the impact of providing patient-reported outcomes measurement information system (PROMIS) scores to patients before appointments with their healthcare provider.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: PRO Integration into Clinical Practice
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
There will be two arms (1: 1 randomization) of the trial to assess PRO integration into careThere will be two arms (1: 1 randomization) of the trial to assess PRO integration into care
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Patient-Reported Outcomes Measurement Information System Integration Into Rheumatology Clinical Practice
Actual Study Start Date :
Sep 14, 2021
Anticipated Primary Completion Date :
Feb 1, 2026
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: PRO Integration into Clinical Practice

PRO scores will be shared with patients and healthcare providers (HCPs) via an emailed report card

Behavioral: PRO Integration into Clinical Practice
HCPs will document their discussion and recommendations/referrals in MiChart (Epic EMR)

No Intervention: Usual Care

Patients and HCPs will not receive an emailed PROMIS score report. PROMIS scores, however, will be available in the EMR as usual.

Outcome Measures

Primary Outcome Measures

  1. Percent of appointments at which Patient-Reported Outcomes Measurement Information System (PROMIS) scores are documented in the electronic medical record (EMR) note by the participating health care provider (HCP) [Up to 3 months]

    Documentation in EMR notes will be categorized as either 'yes' or 'no' and identified through EMR data pulls.

Secondary Outcome Measures

  1. Percent of appointments at which referrals/recommendations related to PROMIS scores are documented in the EMR note by the participating HCP [Up to 3 months]

    Documentation in EMR notes will be either 'yes' or 'no' and identified through EMR data pulls.

  2. Quality of patient-provider communication [Up to 2 weeks]

    Patient-provider communication is measured using the Interpersonal Processes of Care (IPC) Survey (29 items), which measures 7 subscales: hurried communication, elicited concerns/responded, explained results/medications, patient-centered decision making, compassion, discrimination, and disrespectful office staff (score for each subscale ranges from 1-5; a higher score indicates better IPC)

  3. Change in score of the most bothersome PROMIS domain [Baseline, 3 months]

    Change in the z score of the most bothersome PROMIS domain at baseline .

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria for patients:
  • New and established patients seeking care at Michigan Medicine rheumatology clinics

  • Patients should have access to the patient portal in MiChart patient portal

  • Patients should have access to the internet at home to be able to complete the PROMIS PRO measures and study surveys online

  • Patients should have completed PROMIS pain, physical function, and sleep disturbance measures at least one day before their baseline appointment

  • At least one of the PROMIS PRO scores should be in the concerning zone (pain intensity ≥ 5, physical function ≤ 40, or sleep disturbance ≥ 60).

Exclusion Criteria:
  • Non-English speakers

  • under 18 years of age

Inclusion Criteria for providers:
  • Rheumatology health care providers, including clinicians and advanced practice providers at Michigan Medicine who are currently treating rheumatology patients
Exclusion Criteria:
  • Those not meeting the inclusion criteria

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Michigan Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Principal Investigator: Dinesh Khanna, MD, MSc, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dinesh Khanna, MD, MS, Frederick G L Huetwell Professor of Rheumatology and Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier:
NCT05026853
Other Study ID Numbers:
  • HUM00149448
  • K24AR063120
First Posted:
Aug 30, 2021
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
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 Dinesh Khanna, MD, MS, Frederick G L Huetwell Professor of Rheumatology and Professor of Internal Medicine, University of Michigan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2022