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

Rheumatic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05026853
• Other study ID #: HUM00149448
• Secondary ID: K24AR063120
• Status: Completed
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: May 26, 2023

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 26, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• Rheumatic Diseases

Intervention

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

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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