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

NCT05026853 | Completed Results

• 2 other identifiers: HUM00149448K24AR063120
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatic Diseases

Keywords

Health-related quality of life; PROMIS

Outcome Measures

Primary Outcomes (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)

  Documentation in EMR notes will be categorized as either 'yes' or 'no' and identified through EMR data pulls. Percent of appointments is shown by the count (and percentage) of participants for whom PROMIS scores were documented in the EMR for their appointment.

  Up to 3 months

Secondary Outcomes (3)

• 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

• Quality of Patient-provider Communication

  Up to 2 weeks

• Change in Score of the Most Bothersome PROMIS Domain

  Baseline, 3 months

Study Arms (2)

PRO Integration into Clinical Practice

EXPERIMENTAL

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

Behavioral: PRO Integration into Clinical Practice

Usual Care

NO INTERVENTION

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

Interventions

PRO Integration into Clinical Practice BEHAVIORAL

HCPs will document their discussion and recommendations/referrals in MiChart (Epic EMR)

PRO Integration into Clinical Practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Non-English speakers
• under 18 years of age
• Rheumatology health care providers, including clinicians and advanced practice providers at Michigan Medicine who are currently treating rheumatology patients

Sponsors & Collaborators

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

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Gedert R, Ochocki D, Kortam N, Huang S, Nagaraja V, Chakrabarti K, Ford J, Garber M, Lee J, Ognenovski V, Roofeh D, Cella D, Khanna D. A pilot trial of integrating the Patient-Reported Outcome Measurement Information System (PROMIS(R)) into rheumatology care. Clin Exp Rheumatol. 2025 Jan;43(1):112-118. doi: 10.55563/clinexprheumatol/fp914f. Epub 2024 Oct 25.

  PMID: 39480493 DERIVED

MeSH Terms

Conditions

Rheumatic Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Dinesh Khanna
• Organization: University of Michigan

khannad@med.umich.edu

734-763-7182

Study Officials

• Dinesh Khanna, MD, MSc

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Frederick G L Huetwell Professor of Rheumatology and Professor of Internal Medicine

Model Details: There will be two arms (1: 1 randomization) of the trial to assess PRO integration into care

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: August 30, 2021
• Study Start: September 14, 2021
• Primary Completion: February 27, 2023
• Study Completion: May 26, 2023
• Last Updated: April 30, 2024
• Results First Posted: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)