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

Primary Purpose

Rheumatic Diseases

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PRO Integration into Clinical Practice

About this trial

This is an interventional health services research trial for Rheumatic Diseases focused on measuring Health-related quality of life, PROMIS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PRO Integration into Clinical Practice

Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Quality of patient-provider communication

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)

Change in score of the most bothersome PROMIS domain

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

Full Information

NCT ID

NCT05026853

First Posted

August 24, 2021

Last Updated

August 4, 2023

Sponsor

University of Michigan

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

1. Study Identification

Unique Protocol Identification Number

NCT05026853

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

September 14, 2021 (Actual)

Primary Completion Date

February 27, 2023 (Actual)

Study Completion Date

May 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatic Diseases

Keywords

Health-related quality of life, PROMIS

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PRO Integration into Clinical Practice

Arm Type

Experimental

Arm Description

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

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

PRO Integration into Clinical Practice

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

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

Time Frame

Up to 3 months

Secondary Outcome Measure Information:

Title

Percent of appointments at which referrals/recommendations related to PROMIS scores are documented in the EMR note by the participating HCP

Description

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

Time Frame

Up to 3 months

Title

Quality of patient-provider communication

Description

Time Frame

Up to 2 weeks

Title

Change in score of the most bothersome PROMIS domain

Description

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

Time Frame

Baseline, 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dinesh Khanna, MD, MSc

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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