Sleep Specialty Consultation: Improving Management of Sleep Disorders

Sleep Disorders Clinical Trial

Official title: Sleep Specialty Consultation: Improving Management of Sleep Disorders

Status Completed

Clinical Trial Summary

Sleep disorders are prevalent health problems that reduce quality of life, increase risks for medical disease, and enhance healthcare costs/utilization. Only a small proportion of these cases are diagnosed in primary care. Pilot data from this VA suggest that sleep disorders are not adequately managed in a primary care setting: 33% of veterans with an insomnia complaint had an undiagnosed primary sleep disorder (e.g., sleep apnea), and 50% of these patients were prescribed pharmacologic treatment for insomnia by their primary care providers.

Clinical Trial Description

Sleep disorders are prevalent health problems that reduce quality of life, increase risks for medical disease, and enhance healthcare costs/utilization. Only a small proportion of these cases are diagnosed in primary care. Pilot data from this VA suggest that sleep disorders are not adequately managed in a primary care setting: 33% of veterans with an insomnia complaint had an undiagnosed primary sleep disorder (e.g., sleep apnea), and 50% of these patients were prescribed pharmacologic treatment for insomnia by their primary care providers. This project tests the incremental benefits of adding a one-time sleep specialty consultation (SSC) to usual primary care for reducing sleep disturbance, diurnal dysfunction, quality of life concerns and health care utilization among veterans enrolled in the DVAMC Primary Care Clinics. The SSC will consist of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants' primary care providers. Study hypotheses predict that patients who receive an SSC with feedback to their primary care providers will show greater improvements in sleep, mood, quality of life, and patient satisfaction, as well as larger reductions in health care utilization than will those who receive usual care alone. This is a randomized, wait-list control, clinical intervention study of 300 veterans with sleep complaints. Eligibility criteria include: sleep complaint for > 1 month duration, Pittsburgh Sleep Quality Index score > 5; mental status score > 24 on Folstein MMSE, no unstable medical or psychiatric disorder, and approval of primary provider. The SSC intervention consists of a clinician-administered structured interview assessing sleep pathology, plus manualized feedback to patients and primary care providers. Participants are randomly assigned to SSC or Wait List Control (WLC) conditions. Measures of sleep, mood, quality of life, and patient satisfaction are obtained at enrollment and at 5- and 10-month follow-up. Computerized utilization data is obtained for the 10 months prior to and 10 months following enrollment. A series of multivariate and univariate statistical tests will be conducted.

Study findings should provide important new information about managing both the sleep problems and overall health care utilization patterns of patients with sleep complaints presenting in VA primary care settings. If SSC-evaluated patients show substantial reductions in their VA inpatient/outpatient utilization, this finding could have important cost-saving implications to the VA system. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorders

• NCT number: NCT00390572
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Completed
• Phase: N/A
• Start date: January 2007
• Completion date: December 2010