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

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

Study Overview

• Status: Completed
• Conditions: Rheumatic Diseases
• Intervention / Treatment: Behavioral: PRO Integration into Clinical Practice

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Appointments at Which Referrals/Recommendations Related to PROMIS Scores Are Documented in the EMR Note by the Participating HCP	Documentation in EMR notes will be either 'yes' or 'no' and identified through EMR data pulls. Percent of appointments is shown by the count (and percentage) of participants for whom referrals were documented in the EMR.	Up to 3 months
Quality of Patient-provider Communication	Patient-provider communication is measured using the Interpersonal Processes of Care (IPC) Survey (29 items), which measures 7 subscales. For the subscales "elicited concerns/responded", "explained results/medications", "patient-centered decision making", and "compassionate, respectful" a higher score is better. For the subscales "hurried communication", "discrimination", and "disrespectful office staff" a lower score is better. (score for each subscale ranges from 1-5; + indicates a higher score is better, - indicates a lower score is better). Questions were not mandatory.	Up to 2 weeks
Change in Score of the Most Bothersome PROMIS Domain	Change in score of PROMIS domain deemed most bothersome by each subject at baseline. Pain intensity is reported as a scaled score of 0-10, where 0 is no pain and 10 is the worst pain possible. Physical function and sleep disturbance are reported as T-scores. The scores in PROMIS measures are computed to a T-score metric, where 50 represents the mean for US general population, and 10 is the standard deviation. A higher PROMIS T-score represents more of the concept being measured, except physical function where a lower T-score indicates increased impairment. With physical function, a higher score indicates greater function and with sleep disturbance, a lower score indicates less disturbance.	Baseline, 3 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Dinesh Khanna, MD, MSc, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Actual): February 27, 2023
• Study Completion (Actual): May 26, 2023

Study Registration Dates

• First Submitted: August 24, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Health-related quality of life; PROMIS
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: HUM00149448; K24AR063120 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No