Professional Abstract

Objective

To determine whether providing patient-reported outcomes (PRO) data to primary care doctors improves five patient symptoms: sleep disturbance, pain, anxiety, depression, and fatigue

Study Design

Design Element	Description
Design	Randomized controlled trial
Population	300 adult patients with moderate to severe symptoms of sleep disturbance, pain, anxiety, depression, or fatigue
Interventions/ Comparators	Providing primary care doctors with visual displays of PRO symptom severity data in addition to usual care Standard primary care (usual care)
Outcomes	Primary: patient-reported improvement in severity of symptoms Secondary: patient discussion of symptoms with doctor, patient desire for treatment of symptoms, patient satisfaction with care for their symptoms, documentation of symptoms by doctors, clinical actions to diagnose and treat symptoms
Timeframe	3-month follow-up for primary outcome

The research team conducted a randomized controlled trial to see whether providing primary care doctors with a visual display of PRO data about the severity of patient symptoms improved patients’ sleep disturbance, pain, anxiety, depression, or fatigue.

Input from a patient advisory panel helped researchers develop the PRO data collection and results display. Primary care doctors helped identify patients to participate in the study.

The study included 300 patients from primary care clinics in one large urban area. About 70% of patients were female. Of the patients in the study, 49% of patients were African American, 45% were white, and 6% were from other races. Patients were 18 years and older and receiving care from a primary care doctor. The research team included patients in the study who reported moderate to severe symptoms of sleep disturbance, pain, anxiety, depression, or fatigue, indicated by a score of 4 or more on a scale from 0 to 10, with higher scores indicating worse symptoms, on a screening questionnaire.

The research team randomly assigned patients to either an intervention group or a control group. Patients in both groups completed a Patient-Reported Outcomes Measurement Information System (PROMIS^®) short form survey for each of the five symptoms before the start of their visits with their primary care doctors. When a doctor met with a patient in the intervention group, the doctor received a piece of paper with a visual display of the patient’s symptom severity. The display showed a graphic of the patient’s symptom severity scores and instructions for interpreting the scores. When a doctor met with a patient in the control group, the doctor did not receive the visual display. In this group, doctors provided usual care to patients.

Three months after the initial visit, 256 patients completed the PROMIS survey again. Patients also completed a survey measuring patient discussion of symptoms with doctors during visits, patient desire for treatment of symptoms, and patient satisfaction with care for their symptoms. The research team also reviewed patient medical records to see whether doctors documented patients’ symptoms and any resulting clinical actions.

The primary study outcome was symptom improvement, as measured by PROMIS. The research team compared the change in PROMIS survey scores between the intervention and control groups. The secondary study outcomes included patient discussion of symptoms with doctors during visits, patient desire for treatment of symptoms, patient satisfaction with care received for their symptoms, doctors’ documentation of patient-reported symptoms, and doctors’ actions to diagnose and treat symptoms.

Results

There was no difference in change in PROMIS survey scores between the intervention and control groups.

There was also no difference for any of the secondary study outcomes between the intervention and control groups.

Limitations

Some doctors saw patients from both intervention and control groups, which may have reduced the differences between the two groups. Patients may not have accurately remembered some secondary outcomes, such as discussion of symptoms during the visit, three months later when the researchers asked patients questions about these outcomes. Participants were from urban primary care clinics that provided care to underserved populations. The study may not be generalizable to other populations.

Conclusions and Relevance

The researchers found that the visual display of symptom severity in this study did not improve patient symptoms after a three-month follow-up. Other strategies, such as physician training in symptom management, extra time during visits, or resources to help patients self-manage their symptoms, may be necessary to improve patient symptoms.

Future Research Needs

Because displays had no effect on symptom outcomes in this study, future research could evaluate whether additional interventions used in combination with PRO displays have an effect on outcomes. These interventions could include testing a stepped-care approach, assessing patient preferences for treating symptoms, or prioritizing symptoms for sequential treatment.