Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390572
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2006-10-18
Brief Title:
Sleep Specialty Consultation Improving Management of Sleep Disorders
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Sleep Specialty Consultation Improving Management of Sleep Disorders
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sleep disorders are prevalent health problems that reduce quality of life increase risks for medical disease and enhance healthcare costsutilization 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 eg 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 costsutilization 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 eg 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 medicalpsychiatric 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 inpatientoutpatient utilization this finding could have important cost-saving implications to the VA system
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 inpatientoutpatient utilization this finding could have important cost-saving implications to the VA system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0016 | OTHER_GRANT | None | None |
| 01147 | OTHER_GRANT | VA RD | None |