Kurt Kroenke1,2,3, Tasneem L Talib4, Timothy E Stump5, Jacob Kean6, David A Haggstrom7,4,8, Paige DeChant4, Kittie R Lake4, Madison Stout4, Patrick O Monahan5. 1. Division of General Internal Medicine and Geriatrics, Indiana University School of Medicine, Indianapolis, IN, USA. kkroenke@regenstrief.org. 2. Regenstrief Institute, Indianapolis, IN, USA. kkroenke@regenstrief.org. 3. Veterans Affairs Health Services Research and Development Center for Health Information and Communication, Indianapolis, IN, USA. kkroenke@regenstrief.org. 4. Regenstrief Institute, Indianapolis, IN, USA. 5. Department of Biostatistics, Fairbanks School of Public Health, Indianapolis, IN, USA. 6. University of Utah School of Medicine, Salt Lake City, UT, USA. 7. Division of General Internal Medicine and Geriatrics, Indiana University School of Medicine, Indianapolis, IN, USA. 8. Veterans Affairs Health Services Research and Development Center for Health Information and Communication, Indianapolis, IN, USA.
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.
RCT Entities:
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.
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