Sleep Disorders
Conditions
Keywords
sleep, consultation and referral, outcome assessment, primary care
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.
Interventions
BEHAVIORALSleep 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.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Provider Adherence to Sleep Specialist Recommendations | 10 months after baseline | 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. |
| Diary Sleep: Total Wake Time and Total Sleep Time | 10 months | 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. |
| Sleep Efficiency | 10 Months after Baseline | 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. |
| Sleep Quality | 10 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleepiness | 10 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 68 |
| Treatment as Usual Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period). | 69 |
| Total | 137 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | health condition | 0 | 1 |
| Overall Study | Lost to Follow-up | 8 | 4 |
Baseline characteristics
| Characteristic | Sleep Specialty Consultation | Treatment as Usual | Total |
|---|---|---|---|
| Age, Continuous | 55.0 years STANDARD_DEVIATION 13.7 | 55.9 years STANDARD_DEVIATION 13.4 | 55.4 years STANDARD_DEVIATION 13.5 |
| Region of Enrollment United States | 68 participants | 69 participants | 137 participants |
| Sex: Female, Male Female | 14 Participants | 15 Participants | 29 Participants |
| Sex: Female, Male Male | 54 Participants | 54 Participants | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 68 | 0 / 69 |
| serious Total, serious adverse events | 0 / 68 | 0 / 69 |
Outcome results
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.
Time frame: 10 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sleep Specialty Consultation | Diary Sleep: Total Wake Time and Total Sleep Time | Total Sleep Time | 401.2 minutes | Standard Deviation 69.9 |
| Sleep Specialty Consultation | Diary Sleep: Total Wake Time and Total Sleep Time | Total Wake Time | 59.7 minutes | Standard Deviation 42 |
| Treatment as Usual | Diary Sleep: Total Wake Time and Total Sleep Time | Total Sleep Time | 397.0 minutes | Standard Deviation 75.9 |
| Treatment as Usual | Diary Sleep: Total Wake Time and Total Sleep Time | Total Wake Time | 79.6 minutes | Standard Deviation 58.7 |
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.
Time frame: 10 months after baseline
Population: Data was included for all participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sleep Specialty Consultation | Provider Adherence to Sleep Specialist Recommendations | Ferritin Level Check Ordered | 4 participants |
| Sleep Specialty Consultation | Provider Adherence to Sleep Specialist Recommendations | Mental Health Clinic Referral | 13 participants |
| Sleep Specialty Consultation | Provider Adherence to Sleep Specialist Recommendations | Sleep Clinic Referral | 8 participants |
| Sleep Specialty Consultation | Provider Adherence to Sleep Specialist Recommendations | Posttraumatic Stress Disorder Clinic Referral | 1 participants |
| Sleep Specialty Consultation | Provider Adherence to Sleep Specialist Recommendations | Polysomnography Referral for Any Reason | 33 participants |
| Sleep Specialty Consultation | Provider Adherence to Sleep Specialist Recommendations | Substance Abuse Outpatient Clinic Referral | 4 participants |
| Sleep Specialty Consultation | Provider Adherence to Sleep Specialist Recommendations | Polysomnography Referral for Apnea | 32 participants |
| Treatment as Usual | Provider Adherence to Sleep Specialist Recommendations | Substance Abuse Outpatient Clinic Referral | 1 participants |
| Treatment as Usual | Provider Adherence to Sleep Specialist Recommendations | Ferritin Level Check Ordered | 0 participants |
| Treatment as Usual | Provider Adherence to Sleep Specialist Recommendations | Sleep Clinic Referral | 4 participants |
| Treatment as Usual | Provider Adherence to Sleep Specialist Recommendations | Polysomnography Referral for Apnea | 3 participants |
| Treatment as Usual | Provider Adherence to Sleep Specialist Recommendations | Polysomnography Referral for Any Reason | 4 participants |
| Treatment as Usual | Provider Adherence to Sleep Specialist Recommendations | Mental Health Clinic Referral | 4 participants |
| Treatment as Usual | Provider Adherence to Sleep Specialist Recommendations | Posttraumatic Stress Disorder Clinic Referral | 1 participants |
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.
Time frame: 10 Months after Baseline
Population: Data from all participants was included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Specialty Consultation | Sleep Efficiency | 87 percentage of time in bed spent sleeping | Standard Deviation 9.7 |
| Treatment as Usual | Sleep Efficiency | 83.5 percentage of time in bed spent sleeping | Standard Deviation 11.7 |
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.
Time frame: 10 Months
Population: Data from all participants were included in analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Specialty Consultation | Sleep Quality | 8.3 units on a scale | Standard Deviation 3.7 |
| Treatment as Usual | Sleep Quality | 9.5 units on a scale | Standard Deviation 3.5 |
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.
Time frame: 10 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sleep Specialty Consultation | Sleepiness | 69 percentage of participants |
| Treatment as Usual | Sleepiness | 50 percentage of participants |