Trial Outcomes & Findings for Sleep Specialty Consultation: Improving Management of Sleep Disorders (NCT NCT00390572)
NCT ID: NCT00390572
Last Updated: 2015-04-24
Results Overview
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.
COMPLETED
NA
156 participants
10 months after baseline
2015-04-24
Participant Flow
A total of 156 subjects were consented and enrolled in the study, but 15 were excluded before randomization for not meeting entry criteria and 4 withdrew because they found study procedures too demanding. The remaining 137 continued in the study and were randomly assigned.
Participant milestones
| Measure |
Sleep Specialty Consultation
Participants randomized to receive a one-time sleep consultation at beginning of study
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.
|
Treatment as Usual
Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
69
|
|
Overall Study
COMPLETED
|
60
|
64
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
| Measure |
Sleep Specialty Consultation
Participants randomized to receive a one-time sleep consultation at beginning of study
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.
|
Treatment as Usual
Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
4
|
|
Overall Study
health condition
|
0
|
1
|
Baseline Characteristics
Sleep Specialty Consultation: Improving Management of Sleep Disorders
Baseline characteristics by cohort
| Measure |
Sleep Specialty Consultation
n=68 Participants
Participants randomized to receive a one-time sleep consultation at beginning of study
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.
|
Treatment as Usual
n=69 Participants
Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
55.4 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
69 participants
n=7 Participants
|
137 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 months after baselinePopulation: Data was included for all participants.
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.
Outcome measures
| Measure |
Sleep Specialty Consultation
n=68 Participants
Participants randomized to receive a one-time sleep consultation at beginning of study
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.
|
Treatment as Usual
n=69 Participants
Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
|
|---|---|---|
|
Provider Adherence to Sleep Specialist Recommendations
Substance Abuse Outpatient Clinic Referral
|
4 participants
|
1 participants
|
|
Provider Adherence to Sleep Specialist Recommendations
Ferritin Level Check Ordered
|
4 participants
|
0 participants
|
|
Provider Adherence to Sleep Specialist Recommendations
Sleep Clinic Referral
|
8 participants
|
4 participants
|
|
Provider Adherence to Sleep Specialist Recommendations
Polysomnography Referral for Apnea
|
32 participants
|
3 participants
|
|
Provider Adherence to Sleep Specialist Recommendations
Polysomnography Referral for Any Reason
|
33 participants
|
4 participants
|
|
Provider Adherence to Sleep Specialist Recommendations
Mental Health Clinic Referral
|
13 participants
|
4 participants
|
|
Provider Adherence to Sleep Specialist Recommendations
Posttraumatic Stress Disorder Clinic Referral
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 10 monthsChanges 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.
Outcome measures
| Measure |
Sleep Specialty Consultation
n=68 Participants
Participants randomized to receive a one-time sleep consultation at beginning of study
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.
|
Treatment as Usual
n=69 Participants
Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
|
|---|---|---|
|
Diary Sleep: Total Wake Time and Total Sleep Time
Total Sleep Time
|
401.2 minutes
Standard Deviation 69.9
|
397.0 minutes
Standard Deviation 75.9
|
|
Diary Sleep: Total Wake Time and Total Sleep Time
Total Wake Time
|
59.7 minutes
Standard Deviation 42.0
|
79.6 minutes
Standard Deviation 58.7
|
PRIMARY outcome
Timeframe: 10 Months after BaselinePopulation: Data from all participants was included.
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.
Outcome measures
| Measure |
Sleep Specialty Consultation
n=68 Participants
Participants randomized to receive a one-time sleep consultation at beginning of study
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.
|
Treatment as Usual
n=69 Participants
Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
|
|---|---|---|
|
Sleep Efficiency
|
87 percentage of time in bed spent sleeping
Standard Deviation 9.7
|
83.5 percentage of time in bed spent sleeping
Standard Deviation 11.7
|
PRIMARY outcome
Timeframe: 10 MonthsPopulation: Data from all participants were included in analyses.
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.
Outcome measures
| Measure |
Sleep Specialty Consultation
n=68 Participants
Participants randomized to receive a one-time sleep consultation at beginning of study
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.
|
Treatment as Usual
n=69 Participants
Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
|
|---|---|---|
|
Sleep Quality
|
8.3 units on a scale
Standard Deviation 3.7
|
9.5 units on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: 10 monthsChanges 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.
Outcome measures
| Measure |
Sleep Specialty Consultation
n=68 Participants
Participants randomized to receive a one-time sleep consultation at beginning of study
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.
|
Treatment as Usual
n=69 Participants
Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
|
|---|---|---|
|
Sleepiness
|
69 percentage of participants
|
50 percentage of participants
|
Adverse Events
Sleep Specialty Consultation
Treatment as Usual
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place