Sleep Specialty Consultation: Improving Management of Sleep Disorders

NCT00390572 | Completed Results

• 3 other identifiers: IIR 05-213001601147
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorders

Keywords

sleep; consultation and referral; outcome assessment; primary care

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (1)

• Sleepiness

  10 months

Study Arms (2)

Sleep Specialty Consultation

EXPERIMENTAL

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

Behavioral: Sleep Specialty Consultation

Treatment as Usual

NO INTERVENTION

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

Interventions

Sleep Specialty Consultation 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.

Sleep Specialty Consultation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related Publications (4)

• 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.

  PMID: 22172964 RESULT

• 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.

  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.

  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.

  PMID: 26285003 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Results Point of Contact

• Title: Christi S. Ulmer, PhD
• Organization: VA HSRD

christi.ulmer@va.gov

9192860411

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2006
• First Posted: October 20, 2006
• Study Start: January 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 24, 2015
• Results First Posted: November 5, 2014

Record last verified: 2014-08

Locations

US (1)