Sleep Specialty Consultation: Improving Management of Sleep Disorders

Sleep Disorders Clinical Trial

Official title:

Sleep Specialty Consultation: Improving Management of Sleep Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00390572
• Other study ID #: IIR 05-213
• Secondary ID: 001601147
• Status: Completed
• Phase: N/A
• First received: October 18, 2006
• Last updated: April 6, 2015
• Start date: January 2007
• Est. completion date: December 2010

Study information

• Verified date: August 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

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.

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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Provider Adherence to Sleep Specialist Recommendations	Provider outcomes included the provider's number of participant sleep lab referrals, referrals to other specialty clinics for evaluation/treatment participant sleep problems, and presence of newly initiated sleep-focused therapies for participants. Information about these outcomes was obtained via review of provider orders and information included in notes entered into the VA's computerized medical record system (CPRS). To quantify this outcome, the number of participants referred by providers for sleep-focused diagnostic tests and interventions was compared across arms.	10 months after baseline	No
Primary	Diary Sleep: Total Wake Time and Total Sleep Time	Changes in sleep from baseline to subsequent follow-up periods were evaluated using both actigraphy and electronic diaries via a personal digital assistant (PDA). Primary outcome measures derived from the PDA included total sleep time (TST), total wake time (TWT: SOL+WASO), and sleep efficiency (SE). Wrist Actigraphy. Mini-Mitter® Actiwatch actigraphs were used to derive the primary objective estimates of TST, TWT, and SE. Mean values of TST, TWT and SE were obtained for each participant at baseline, 5 months and 10 months post-randomization and served as the actigraphic dependent measures in study analyses.	10 months	No
Primary	Sleep Efficiency	Changes in sleep from baseline to subsequent follow-up periods were evaluated using both actigraphy and electronic diaries via a personal digital assistant (PDA). Primary outcome measures derived from the PDA included total sleep time (TST), total wake time (TWT: SOL+WASO), and sleep efficiency (SE). Wrist Actigraphy. Mini-Mitter® Actiwatch actigraphs were used to derive the primary objective estimates of TST, TWT, and SE. Mean values of TST, TWT and SE were obtained for each participant at baseline, 5 months and 10 months post-randomization and served as the actigraphic dependent measures in study analyses.	10 Months after Baseline	No
Primary	Sleep Quality	Changes in overall sleep quality were evaluated using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-rating scale that yields a quantitative index of general sleep quality/disturbances. The PSQI is composed of 4 open-ended questions and 19 self-rated items (0-3 scale) assessing sleep quality and disturbances over a 1-month interval. The PSQI yields a global score of sleep quality ranging from 0 to 21. A score of <= 5 on the PSQI is considered normal sleep quality.	10 Months	No
Secondary	Sleepiness	Changes in subjectively assessed daytime sleep propensity were measured using the Epworth Sleepiness Scale (ESS), a commonly employed in both sleep research and clinical applications. The ESS items inquire about the chance of dozing off in each 8 different situations. Responses are rated on a 4 point scale reflecting the respondents perceived likelihood of falling asleep. To quanitfy this outcome, the percentage of participants achieving normal sleep (less than 10 on ESS) was compared across arms at 10 months.	10 months	No