Sleep Specialty Consultation: Improving Management of Sleep Disorders

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00390572
First received: October 18, 2006
Last updated: February 6, 2014
Last verified: March 2010
  Purpose

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.


Condition Intervention
Sleep Disorders
Procedure: Sleep specialty evaluation
Behavioral: Behavior treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sleep Specialty Consultation: Improving Management of Sleep Disorders

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Sleep measures and health care utilization [ Time Frame: 5 and 10 months after baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sleepiness, fatigue, mood, quality of life, and satisfaction with medical care [ Time Frame: 5 and 10 months after baseline ] [ Designated as safety issue: No ]

Enrollment: 156
Study Start Date: January 2007
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Participants randomized to receive a one-time sleep consultation at beginning of study
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� primary care providers
Other Name: sleep specialty consultation
Behavioral: Behavior treatment
Sleep specialty evaluation includes education about the specific sleep disorders and relevant treatment recommendations, including sleep hygiene
Other Name: sleep hygiene
Placebo Comparator: Arm 2
Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
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� primary care providers
Other Name: sleep specialty consultation
Behavioral: Behavior treatment
Sleep specialty evaluation includes education about the specific sleep disorders and relevant treatment recommendations, including sleep hygiene
Other Name: sleep hygiene

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390572

Locations
United States, North Carolina
VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Investigators
Principal Investigator: Jack D. Edinger, PhD Department of Veterans Affairs
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00390572     History of Changes
Other Study ID Numbers: IIR 05-213, 0016, 01147
Study First Received: October 18, 2006
Last Updated: February 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
primary health care
consultation and referral
outcome assessment

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014