Results Summary
What was the research about?
Sleep disorders, such as insomnia or breathing problems while sleeping, affect 50 to 70 million people in the United States. These sleep problems can affect patients’ overall health and day-to-day lives. Doctors who specialize in sleep problems usually treat patients at a sleep clinic.
In this study, the research team worked with patients and doctors to develop a new approach for care. The new approach included
- New ways to diagnose and manage sleep disorders using sleep monitors at home and at the sleep clinic
- A secure website for patients to see their own information, test results, and treatment plans
- Classes for patients to learn about sleep disorders
Under the new approach, patients could also get care for sleep disorders at their primary care doctor’s office. The team wanted to learn if the new approach improved patients’ care and health more than usual care.
What were the results?
Compared with usual care, the new approach didn’t improve how patients rated their
- Care
- Overall health
- Doctor’s communication
- Doctor’s use of technology, such as sleep monitors and websites, to help patients understand the sleep disorder
Compared with the website for usual care, patients rated the website for the new approach as more helpful in presenting information about care and tests.
The cost of treatment paid by patients was similar in the two approaches.
Who was in the study?
The study included 1,836 adults with a sleep disorder. Patients were receiving care from a sleep clinic in Santa Clara County, California. Among patients getting the new approach, 75 percent were white, 11 percent were Asian, and 3 percent were African American. The average age was 49, and 56 percent were men. Among patients receiving usual care, 67 percent were white, 16 percent were Asian, and 4 percent were African American. The average age was 51, and 57 percent were men.
What did the research team do?
The research team assigned patients to one of two groups by chance. The first group received the new approach for managing sleep disorders. The second group received usual care. This care included office visits, tests, and a limited amount of information about the sleep disorder and treatment through a website. Patients in both groups completed surveys at the start of the study and again one year later.
Patients, doctors, professional organizations, and members of medical device companies helped to develop the new approach and design the study.
What were the limits of the study?
Some doctors started using aspects of the new approach with patients in the usual care group, which could have affected the study results. Many of the patients who initially joined the study didn’t complete it. Results may have been different if these patients had completed the study. This study included patients with sleep disorders from a single sleep clinic in California. Results may be different for patients with other health problems or living in other places.
Future studies could take steps to make sure patients get either the new approach or usual care only.
How can people use the results?
Researchers can use these results to identify other ways to improve care for patients with sleep disorders.
Professional Abstract
Objective
To determine whether a patient-centered outcomes and coordinated-care management (PCCM) approach improves the care and health of patients with sleep disorders compared with the standard outpatient medical care approach
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 1,836 adult patients with a sleep disorder |
| Interventions/ Comparators |
|
| Outcomes |
Primary: healthcare provider clinical care performance, patient-reported health status Secondary: patient perceptions of provider communication, helpfulness of provider website, provider use of computers to aid patient understanding, patient out-of-pocket costs |
| Timeframe | 1-year follow-up for primary outcomes |
This randomized controlled trial compared the PCCM approach with usual care on provider clinical care performance and patient-reported health status among patients with a sleep disorder.
Researchers randomized 1,836 adults with a sleep disorder receiving care at a sleep clinic in Santa Clara County, California, to either the PCCM approach or usual care. In the PCCM approach, patients could go to an outpatient sleep clinic and a satellite sleep clinic that was set up in the primary care clinic area. Primary care providers monitored patients’ sleep-wake cycles and blood pressure using wristband monitoring devices. Through a web portal designed for the study, patients had access to information and resources about managing sleep disorders, home-based diagnostic tests, and clinical data. Patients also attended group classes, led by sleep clinicians, about treatment approaches for sleep disorders.
In usual care, patients only went to the outpatient sleep clinic. Sleep clinic providers took a patient medical history, performed a physical examination, discussed diagnostic and treatment plans, and scheduled follow-up visits. Patients had access to limited medical information through their provider’s website.
Among patients who received the PCCM approach, 75% were white, 11% were Asian, and 3% were African American. The average age was 49, and 56% were male. Among patients who received usual care, 67% were white, 16% were Asian, and 4% were African American. The average age was 51, and 57% were male.
All patients completed surveys at baseline and one year later. Surveys included questions related to primary and secondary outcomes.
Patients, patient support groups, healthcare providers, professional organizations, and medical device and pharmaceutical manufacturers participated in developing the PCCM approach and designing the study.
Results
Compared with usual care, the PCCM approach did not improve patient-reported health status or overall provider performance rating. The two approaches did not differ in patients’ perceptions of communication with their providers, assessments of the providers’ use of computers to aid patients’ understanding of their conditions, or out-of-pocket costs.
Patients rated the PCCM website as more helpful than the usual care website in providing information about care and tests (p=0.003).
Limitations
Providers in usual care adopted some features of the PCCM approach, possibly contributing to the lack of significant findings for the primary outcomes. Researchers excluded 38% of randomized patients who did not have data for a primary outcome from the analysis, resulting in possible selection bias and reduced precision. This study included only patients with sleep disorders at a single academic medical center. Findings may be different for populations with other medical conditions or living in other locations.
Conclusions and Relevance
The use of the new tests and technologies in the PCCM approach did not have a significant impact on patient-reported provider ratings and health status. However, patients felt satisfied with the information they received from the PCCM web portal.
Future Research Needs
Studies to further examine the comparative effectiveness of the PCCM approach may take measures to prevent patients in the comparison group from having exposure to the intervention.
Final Research Report
View this project's final research report.
Journal Citations
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 assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot 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 descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- Reviewers noted a significant rate of cross contamination in the study because providers in the control group used some of the features of the intervention. They suggested that future studies of this tool should be cluster randomized to avoid this contamination, and that this problem likely limited the generalizability of results. The researchers added these concerns to the study limitations.
- Reviewers expressed concern about the high rate of missing data in primary outcomes, which was about 38 percent of participants. Also, reviewers expressed concerns that the study did not appear to account for the missing data or discuss the potential for biased outcome measures in the study population. The researchers added to the report their initial expectations regarding recruitment and retention, indicating that they expected a high rate of non-completion. The researchers also stated that they planned to input the missing data in future analyses in order to test for the effect of the missing data.
- Reviewers expressed concern that the report focused too much on secondary and exploratory results related to group differences in patient ratings of the provider. The reviewers raised questions about these results because randomization was at the patient, not the provider level. Since the researchers did not randomize the providers, patient expectations or other patient characteristics may have differed by provider and therefore, may explain the difference in ratings. The researchers revised their conclusions and emphasized that the provider effects should be considered exploratory and in need of further research.