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

J Gen Intern Med. 2018 Aug;33(8):1245-1252. doi: 10.1007/s11606-018-4391-0. Epub 2018 Apr 5.


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: identifier: NCT02383862.

Keywords: clinical trial; feedback; patient-reported outcomes; primary care; symptoms.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anxiety / diagnosis
  • Anxiety / epidemiology
  • Depression / diagnosis
  • Depression / epidemiology
  • Fatigue / diagnosis
  • Fatigue / epidemiology
  • Female
  • Humans
  • Internal Medicine / methods*
  • Male
  • Middle Aged
  • Pain / diagnosis
  • Pain / epidemiology
  • Patient Reported Outcome Measures*
  • Patient Satisfaction
  • Primary Health Care / methods*
  • Prospective Studies
  • Sleep Wake Disorders / diagnosis
  • Sleep Wake Disorders / epidemiology

Associated data