Results Summary
What was the research about?
Sometimes patients don't tell their doctors about all of their symptoms. For example, they may not tell their doctors about having low energy or not sleeping well. These symptoms can be signs of a health problem. Knowing about symptoms can help doctors find ways to help patients feel better. Using patient-reported outcomes (PRO) surveys is one way for doctors to collect this information. These surveys ask how health problems and their treatments affect patients from the patients’ point of view. Filling out PRO surveys helps patients tell their doctors how they are feeling.
The research team wanted to know if giving doctors information from their patients about symptoms at the start of an office visit would lead to the patients feeling better. The team collected information from patients about their symptoms using PRO surveys. The surveys tracked five common symptoms: sleep problems, pain, anxiety, depression, and low energy.
What were the results?
Three months after the doctor visits, there was no difference in symptoms between patients whose doctors got survey information about patient symptoms and patients whose doctors didn’t get this information. There was no difference between the two groups in how much patients talked about their symptoms during doctors’ visits, how much patients wanted treatment for the symptoms, or how happy patients were with treatment for their symptoms. There was also no difference between the groups in how often doctors made notes about patients’ symptoms in the patients’ medical records or how much care patients got for their symptoms.
Who was in the study?
The research study included 300 adult patients. The patients got care at primary care clinics in Indianapolis, Indiana. The patients had medium to severe sleep problems, pain, anxiety, depression, or low energy. About 70 percent of patients were female. Forty-nine percent of patients were African American, 45 percent were white, and 6 percent were from other races.
What did the research team do?
Patients took PRO surveys before seeing their doctors. The research team then assigned patients to one of two groups by chance. In the first group, each patient’s doctor saw survey information about the patient’s symptoms at the start of the office visit. In the second group, each patient’s doctor did not see this information. The patients in both groups took the survey again three months after their doctor’s visit. At the same time, patients took another survey that asked if they had talked to their doctors about their symptoms, how much they wanted treatment for their symptoms, and how happy they were with treatment for their symptoms. The research team checked if doctors wrote the symptoms in patients’ medical records and any notes about what they did to help improve the symptoms.
The research team worked with a group of patients to help decide how to show doctors information from the PRO surveys. Doctors from the primary care clinics helped the research team enroll patients in the study.
What were the limits of the study?
Some of the doctors saw patients from both study groups. Seeing PRO survey information for patients in the first group could have caused these doctors to ask patients in the second group about their symptoms. This may have led to there being no differences in the results between groups. Also, some patients may not have remembered their doctor visits accurately when asked about them three months later. Also, 70 percent of patients in the study were female, 49 percent were African American, and all patients lived in one large city. The results may be different if the study included people from other backgrounds and locations.
How can people use the results?
Research teams can use the results to plan other studies to improve patient symptoms. For example, future studies could look at whether spending more time with patients during visits or training doctors to manage patient symptoms could improve patients’ health.
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 |
|
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.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer review process here.
In response to peer review, the PI made changes including
- Adding more detail about how missing data were handled in the study
- Editing the Abstract for clarity
- Removing discussion of patient and clinician study participants from the section engagement of patients and other stakeholders as study partners
- Expanding the discussion of potential limitations of the study