Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123409
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2005-07-20
Brief Title:
Telephone Disease Management At-Risk Drinking TDM II
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Telephone Disease Management At-Risk Drinking TDM 11
Status:
COMPLETED
Status Verified Date:
2014-06
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:
The aim of this study is to test for improvements in treatment outcomes for primary care patients with at-risk drinking when cared for using telephone disease management TDM compared to those treated with usual care Based on our pilot data TDM for at-risk drinking may be a viable method for reducing alcohol consumption in this population
Hypotheses The hypotheses for this research plan are 1 A significantly greater proportion of patients assigned to TDM will obtain improvement in drinking outcomes compared to usual care 2 TDM will lead to greater access to behavioral health care and higher intensity of treatment relative to usual care This effect will be moderated by logistics such as transportation problems physical functioning and employment status 3 More patients assigned to TDM will receive guideline adherent care
Hypotheses The hypotheses for this research plan are 1 A significantly greater proportion of patients assigned to TDM will obtain improvement in drinking outcomes compared to usual care 2 TDM will lead to greater access to behavioral health care and higher intensity of treatment relative to usual care This effect will be moderated by logistics such as transportation problems physical functioning and employment status 3 More patients assigned to TDM will receive guideline adherent care
Detailed Description:
We propose to randomize 200 patients with at-risk drinking from four primary care clinics at the PVAMC and three Community Based Outpatient Clinics CBOCs Patients will be identified for participation by 1 referrals from primary care clinicians based on existing screening and clinical exams or 2 from the screening of a random subset of patients with an appointment in the primary care clinic A baseline assessment will establish eligibility for participation in the study The baseline assessment will also allow identification of those patients who screen positive but do not have a definable behavioral health problem and those with severe symptoms who may need more intensive help than provided by the study
Consenting eligible patients will be randomly assigned to TDM or the lower intensity intervention of usual care For those patients assigned to usual care the physician will administer further evaluations and treatment as heshe sees fit For those assigned to TDM the primary care provider remains the agent of treatment but a Behavioral Health Specialist BHS is made available to maintain regularly scheduled telephone contact develop a treatment plan monitor treatment effectiveness assess and encourage treatment adherence and offer support and education The role of the health specialist is defined by a treatment manual that adheres to the recommendations of VA practice guidelines TDM is based on a chronic care model of treatment and includes a minimum of three BAI sessions The health specialist will communicate assessment information with the PCP in order to coordinate treatment decisions
The principal outcomes of the study relate to reduction in alcohol use within recommended guidelines as well as access and utilization of behavioral health services over the course of 12 months Results favoring TDM may provide a low-cost highly efficient mechanism for integrating behavioral health with primary care for these patients This project thus meets several of the priority areas for HSRD funding including improving access to care the implementation of practice guidelines use of telemedicine and patient-centered care
Consenting eligible patients will be randomly assigned to TDM or the lower intensity intervention of usual care For those patients assigned to usual care the physician will administer further evaluations and treatment as heshe sees fit For those assigned to TDM the primary care provider remains the agent of treatment but a Behavioral Health Specialist BHS is made available to maintain regularly scheduled telephone contact develop a treatment plan monitor treatment effectiveness assess and encourage treatment adherence and offer support and education The role of the health specialist is defined by a treatment manual that adheres to the recommendations of VA practice guidelines TDM is based on a chronic care model of treatment and includes a minimum of three BAI sessions The health specialist will communicate assessment information with the PCP in order to coordinate treatment decisions
The principal outcomes of the study relate to reduction in alcohol use within recommended guidelines as well as access and utilization of behavioral health services over the course of 12 months Results favoring TDM may provide a low-cost highly efficient mechanism for integrating behavioral health with primary care for these patients This project thus meets several of the priority areas for HSRD funding including improving access to care the implementation of practice guidelines use of telemedicine and patient-centered care
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