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Randomized Controlled Trial Multicenter Study
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, and Patrick O Monahan.
- Division of General Internal Medicine and Geriatrics, Indiana University School of Medicine, Indianapolis, IN, USA. kkroenke@regenstrief.org.
- J Gen Intern Med. 2018 Aug 1; 33 (8): 1245-1252.
BackgroundSymptoms 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.ObjectiveTo assess the effectiveness of providing PROMIS (Patient-Reported Outcome Measure Information System) symptom scores to clinicians on symptom outcomes.DesignRandomized clinical trial conducted from March 2015 through May 2016 in general internal medicine and family practice clinics in an academic healthcare system.ParticipantsPrimary care patients who screened positive for at least one SPADE symptom.InterventionsAfter 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 MeasuresThe 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 ResultsMost 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.ConclusionsSimple 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 Registrationclinicaltrials.gov identifier: NCT02383862.
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