Clinical trial NCT00390572: Sleep Specialty Consultation: Improving Management of Sleep Disorders
Official title: Sleep Specialty Consultation: Improving Management of Sleep Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorders
Keywords: sleep
consultation and referral
outcome assessment
primary care
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-10-20
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Provider Adherence to Sleep Specialist Recommendations
timeFrame: 10 months after baseline
measure: Diary Sleep: Total Wake Time and Total Sleep Time
timeFrame: 10 months
measure: Sleep Efficiency
timeFrame: 10 Months after Baseline
measure: Sleep Quality
timeFrame: 10 Months
Secondary outcomes:
measure: Sleepiness
timeFrame: 10 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
References:
citation: 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.
citation: Edinger JD, Ulmer CS, Grubber J, Zervakis JB, Olsen MK. Effects of a One-Time Sleep Specialty Consultation on Sleep Problem Management in Primary Care. [Abstract]. Sleep. 2011 Oct 20; 34(Suppl):A337,0984.
citation: Zervakis JB, Ulmer CS, Edinger JD. Can a One-Time Sleep Specialty Consultation Enhance Providers' Attention to Sleep Problems in Primary Care? [Abstract]. Sleep. 2010 Mar 1; 33(Suppl):A365,1092.
citation: Edinger JD, Grubber J, Ulmer C, Zervakis J, Olsen M. A Collaborative Paradigm for Improving Management of Sleep Disorders in Primary Care: A Randomized Clinical Trial. Sleep. 2016 Jan 1;39(1):237-47. doi: 10.5665/sleep.5356.