Sleep Specialty Consultation: Improving Management of Sleep Disorders

NCT ID: NCT00390572

Last Updated: 2015-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2010-12-31

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.

Conditions

Sleep Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sleep Specialty Consultation

Participants randomized to receive a one-time sleep consultation at beginning of study

Group Type: EXPERIMENTAL

Sleep Specialty Consultation

Intervention Type: BEHAVIORAL

The Sleep Specialty Consultation (SSC) consisted 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.

Treatment as Usual

Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sleep Specialty Consultation

The Sleep Specialty Consultation (SSC) consisted 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22172964 (View on PubMed)

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.

Reference Type: RESULT

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.

Reference Type: RESULT

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.

Reference Type: DERIVED

PMID: 26285003 (View on PubMed)

Other Identifiers

0016

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

01147

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IIR 05-213

Identifier Type: -

Identifier Source: org_study_id