Incorporating PROMIS Symptom Measures into Primary Care Practice—a Randomized Clinical Trial

  • Kurt Kroenke
  • Tasneem L. Talib
  • Timothy E. Stump
  • Jacob Kean
  • David A. Haggstrom
  • Paige DeChant
  • Kittie R. Lake
  • Madison Stout
  • Patrick O. Monahan
Original Research

Abstract

Background

Symptoms account for more than 400 million clinic visits annually in the USA. The SPADE symptoms (sleep, pain, anxiety, depression, and low energy/fatigue) are particularly prevalent and undertreated.

Objective

To assess the effectiveness of providing PROMIS (Patient-Reported Outcome Measure Information System) symptom scores to clinicians on symptom outcomes.

Design

Randomized clinical trial conducted from March 2015 through May 2016 in general internal medicine and family practice clinics in an academic healthcare system.

Participants

Primary care patients who screened positive for at least one SPADE symptom.

Interventions

After completing the PROMIS symptom measures electronically immediately prior to their visit, the 300 study participants were randomized to a feedback group in which their clinician received a visual display of symptom scores or a control group in which scores were not provided to clinicians.

Main Measures

The primary outcome was the 3-month change in composite SPADE score. Secondary outcomes were individual symptom scores, symptom documentation in the clinic note, symptom-specific clinician actions, and patient satisfaction.

Key Results

Most patients (84%) had multiple clinically significant (T-score ≥ 55) SPADE symptoms. Both groups demonstrated moderate symptom improvement with a non-significant trend favoring the feedback compared to control group (between-group difference in composite T-score improvement, 1.1; P = 0.17). Symptoms present at baseline resolved at 3-month follow-up only one third of the time, and patients frequently still desired treatment. Except for pain, clinically significant symptoms were documented less than half the time. Neither symptom documentation, symptom-specific clinician actions, nor patient satisfaction differed between treatment arms. Predictors of greater symptom improvement included female sex, black race, fewer medical conditions, and receiving care in a family medicine clinic.

Conclusions

Simple feedback of symptom scores to primary care clinicians in the absence of additional systems support or incentives is not superior to usual care in improving symptom outcomes.

Trial Registration

clinicaltrials.gov identifier: NCT02383862.

KEY WORDS

patient-reported outcomes symptoms primary care feedback clinical trial 

Notes

Authors’ Contributions

There are no contributors who do not meet the criteria for authorship.

Compliance with Ethical Standards

Conflicts of Interest

The authors declare that they do not have a conflict of interest.

Prior Presentations

Part of this work was presented at the Health Measures User Conference, September 27, 2017, in Chicago, Illinois.

Supplementary material

11606_2018_4391_MOESM1_ESM.docx (18 kb)
ESM 1 (DOCX 17 kb)

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Copyright information

© Society of General Internal Medicine 2018

Authors and Affiliations

  • Kurt Kroenke
    • 1
    • 2
    • 3
  • Tasneem L. Talib
    • 2
  • Timothy E. Stump
    • 4
  • Jacob Kean
    • 5
  • David A. Haggstrom
    • 1
    • 2
    • 3
  • Paige DeChant
    • 2
  • Kittie R. Lake
    • 2
  • Madison Stout
    • 2
  • Patrick O. Monahan
    • 4
  1. 1.Division of General Internal Medicine and GeriatricsIndiana University School of MedicineIndianapolisUSA
  2. 2.Regenstrief InstituteIndianapolisUSA
  3. 3.Veterans Affairs Health Services Research and Development Center for Health Information and CommunicationIndianapolisUSA
  4. 4.Department of BiostatisticsFairbanks School of Public HealthIndianapolisUSA
  5. 5.University of Utah School of MedicineSalt Lake CityUSA

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