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Rheumatic DiseasesNCT05026853

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

A study testing PRO Integration into Clinical Practice in people with Rheumatic Diseases, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatic Diseases
What is being tested?
PRO Integration into Clinical Practice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited States
Study dates
14 Sep 2021to 26 May 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
  • Rheumatology health care providers, including clinicians and advanced practice providers at Michigan Medicine who are currently treating rheumatology patients

Who cannot join

  • Non-English speakers
  • under 18 years of age
  • Those not meeting the inclusion criteria

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Michigan

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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

Being tested
PRO Integration into Clinical Practice
Keywords
Health-related quality of life, PROMIS
Medical subject headings
Rheumatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRO Integration into Clinical PracticeBehavioural

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

Study groups in NCT05026853
Study groupRoleWhat they receive
PRO Integration into Clinical PracticeExperimentalPRO scores will be shared with patients and healthcare providers (HCPs) via an emailed report card
Receives: Behavioral: PRO Integration into Clinical Practice
Usual CareNo interventionPatients and HCPs will not receive an emailed PROMIS score report. PROMIS scores, however, will be available in the EMR as usual.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 3 months

Secondary outcomes (3)

  1. 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.

    Measured: Up to 3 months

  2. 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.

    Measured: Up to 2 weeks

  3. 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.

    Measured: Baseline, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2021
  2. Study start14 Sep 2021
  3. Primary completion27 Feb 2023
  4. Study completion26 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
There will be two arms (1: 1 randomization) of the trial to assess PRO integration into care
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05026853
Sponsor's protocol ID
HUM00149448
Other IDs
K24AR063120
Status last verified
Apr 2024
First submitted
24 Aug 2021
Last updated
30 Apr 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39480493

Questions about this trial

What is this clinical trial studying?

A study testing PRO Integration into Clinical Practice in people with Rheumatic Diseases, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05026853, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.

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