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OpenTrials
Completed

NCT Number: NCT05026853

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRO Integration into Clinical Practice

Behavioral

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

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)

    Time frame: Up to 3 months

    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.

Secondary outcomes

  1. Percent of Appointments at Which Referrals/Recommendations Related to PROMIS Scores Are Documented in the EMR Note by the Participating HCP

    Time frame: Up to 3 months

    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.

  2. Quality of Patient-provider Communication

    Time frame: Up to 2 weeks

    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.

  3. Change in Score of the Most Bothersome PROMIS Domain

    Time frame: Baseline, 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2021
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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