conceptual illustration of interconnected lines

Symptoms account for more than 400 million clinic visits annually in the United States. However, in contrast to specific diseases, symptoms have received far less attention in research, training, and consequently, patient care. Five symptoms that warrant special attention are the SPADE pentad – sleep problems, pain, anxiety, depression, and energy/fatigue. These 5 symptoms are among the most prevalent, chronic, disabling, and under-treated symptoms in clinical practice. The purpose of this study is to determine if measuring and providing symptom scores to physicians affect patients’ symptom outcomes and physicians’ management of symptoms.

The purpose of this 2-year clinical trial is to determine, from both the patient and physician perspective, the usefulness of measuring the SPADE symptoms. Adults, 18 years of age or older, who receive care from a participating primary care doctor and have at least 1 of the 5 symptoms at a moderate level of severity, are eligible to participate. Just prior to seeing their primary care doctor, participants are asked to complete the PROMIS symptom questionnaire, a questionnaire that measures the extent to which patients experience problems with sleep, pain, anxiety, depression, and fatigue over the past 7 days. Upon completing the questionnaire, patients are randomly assigned to a feedback or a control group. A graph of patients’ symptom scores is given to physicians, prior to the encounter, for patients who are assigned to the feedback group. For patients assigned to the control group, physicians do not receive patients’ symptom scores. Three months after the initial baseline visit, participants complete the PROMIS questionnaire, in addition to questionnaires assessing symptoms, medical conditions, and satisfaction with care. Medical records are reviewed to determine the type and frequency of symptom documentation. A small sample of patients and physicians also are interviewed to explore their perceptions of the usefulness of completing symptom questionnaires.

A unique aspect of the partnership with the funding agency – Patient-Centered Outcomes Research Institute – is the involvement of patient study team members. This 3-patient panel has and continues to provide feedback to the research team in areas such as the development of qualitative interview scripts, interpretation of study results, and planning for disseminating of research findings.


To date, 301 participants have enrolled in the study. The study team is currently collecting 3 month follow up data from enrolled participants. To determine the effects of feedback on patients’ symptoms, group differences in the change between baseline and 3-month PROMIS scores will be assessed. The medical records also will be reviewed to ascertain differences in symptom documentation between patients assigned to the feedback and the control group. Analysis of data will begin in the summer of 2016.

The qualitative interviews are currently in progress. Seven patients have been interviewed, providing their opinions about the utility of using symptom questionnaires in primary care clinics. Additional patients will be interviewed in the summer of 2016. The script for the qualitative interviews with physicians has been developed. Physicians will be interviewed beginning in the fall of 2016.

Regenstrief Center

  • Center for Health Services Research

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