Sleep Specialty Consultation: Improving Management of Sleep Disorders

Brief Summary

Official Title: “Sleep Specialty Consultation: Improving Management of Sleep Disorders”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: July 2010

Detailed 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.

Interventions Used in this Clinical Trial

  • Procedure: Sleep specialty evaluation
    • The intervention (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´┐Ż primary care providers
  • Behavioral: Behavior treatment
    • Sleep specialty evaluation includes education about the specific sleep disorders and relevant treatment recommendations, including sleep hygiene
  • Procedure: Sleep specialty evaluation
    • The intervention (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´┐Ż primary care providers
  • Behavioral: Behavior treatment
    • Sleep specialty evaluation includes education about the specific sleep disorders and relevant treatment recommendations, including sleep hygiene

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Arm 1
    • Participants randomized to receive a one-time sleep consultation at beginning of study
  • Placebo Comparator: Arm 2
    • Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).

Outcome Measures for this Clinical Trial

Primary Measures

  • Sleep measures and health care utilization
    • Time Frame: 5 and 10 months after baseline
      Safety Issue?: No

Secondary Measures

  • sleepiness, fatigue, mood, quality of life, and satisfaction with medical care
    • Time Frame: 5 and 10 months after baseline
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • veteran seen at Durham VAMC for primary care;
  • must have had a sleep complaint for > 1 month;
  • not being treated by a sleep specialist for sleep complaint;
  • provide informed consent;
  • have concurrence for enrollment from their assigned MD PCP;
  • score >5 on the Pittsburgh Sleep Quality Index at time of screening

Exclusion Criteria

  • terminal illness;
  • acute or highly unstable Axis I psychiatric condition;
  • not mentally competent;
  • unstable living environment;
  • unstable medical or psychiatric condition;
  • established sleep disorder or currently under the care of one or more of our VAMC's sleep disorders specialists;
  • previous evaluation by sleep disorders specialist;
  • refuse to give informed consent

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Department of Veterans Affairs
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jack D. Edinger, PhD, Principal Investigator, Department of Veterans Affairs

Citations Reporting on Results

Olsen MK, Stechuchak KM, Edinger JD, Ulmer CS, Woolson RF. Move over LOCF: principled methods for handling missing data in sleep disorder trials. Sleep Med. 2012 Feb;13(2):123-32. doi: 10.1016/j.sleep.2011.09.007. Epub 2011 Dec 14. Review.

Edinger JD, Ulmer CS, Means MK. Sensitivity and specificity of polysomnographic criteria for defining insomnia. J Clin Sleep Med. 2013 May 15;9(5):481-91. doi: 10.5664/jcsm.2672.

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00390572