Project SHARE (Senior Health and Alcohol Risk Education)
This study has been completed.
Sponsor:
University of California, Los Angeles
Collaborator:
Information provided by (Responsible Party):
Susan Ettner, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00107640
First received: April 6, 2005
Last updated: August 11, 2012
Last verified: September 2010
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Purpose
Older adults become more sensitive to alcohol, and alcohol also interacts adversely with their common medical conditions and medications. The aim of Project SHARE (Senior Health and Alcohol Risk Education) is to see whether patient and provider education can decrease risky alcohol use and reduce health care costs in persons 60 years of age and older.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcohol Consumption |
Behavioral: Patient-provider education |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Health Services Research |
| Official Title: | Costs of Preventing Alcohol Problems in Older Adults |
Resource links provided by NLM:
Further study details as provided by University of California, Los Angeles:
Primary Outcome Measures:
- At-risk drinking at 6 month followup [ Time Frame: 6 months ] [ Designated as safety issue: No ]At-risk drinking is alcohol use that (either alone or in conjunction with selected comorbidities, symptoms and/or medications) poses health risks. It is measured using the CARET instrument developed by Moore and colleagues.
- At-risk drinking at 12 month followup [ Time Frame: 12 months ] [ Designated as safety issue: No ]At-risk drinking is alcohol use that (either alone or in conjunction with selected comorbidities, symptoms and/or medications) poses health risks. It is measured using the CARET instrument developed by Moore and colleagues.
Secondary Outcome Measures:
- Health-related quality of life at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Health-related quality of life (HRQL) is measured using the SF-6D.
- Depressive symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]Depressive symptoms are measured using the Geriatric Depression Scale.
- Mental Composite Score at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]We used self-reported SF12 data from baseline, 6- and 12-month written surveys to construct Mental Composite Score (MCS) and Physical Composite Score (PCS).
- Healthcare utilization [ Time Frame: 12 months (cumulative) ] [ Designated as safety issue: No ]We used self-reported data from 3-month, 6-month and 12-month written patient surveys to measure cumulative healthcare utilization by type (e.g., hospitalizations, emergency department visits, physician visits, etc.) over the twelve months following baseline.
- Outpatient service costs [ Time Frame: 12 months (cumulative) ] [ Designated as safety issue: No ]We used administrative data on clinic-based services linked to Medicare fee schedules to construct cumulative measures of outpatient service costs (from the Medicare perspective) for the twelve months following baseline.
- Direct recruitment and intervention costs [ Time Frame: 12 months (cumulative) ] [ Designated as safety issue: No ]We collected data on the resources used directly for recruitment (e.g., clinic-based staff time, phones, postage, etc.) and the intervention (e.g., cost of health educator time, supplies, opportunity costs of the physician's time, etc.) spent on the intervention, to construct overall measures of the per-patient cost of recruitment and intervention.
- Health-related quality of life at 12 month followup [ Time Frame: 12 months ] [ Designated as safety issue: No ]Health-related quality of life (HRQL) is measured using the SF-6D.
- Mental Composite Score at 12 month followup [ Time Frame: 12 months ] [ Designated as safety issue: No ]We used self-reported SF12 data from baseline, 6- and 12-month written surveys to construct Mental Composite Score (MCS) and Physical Composite Score (PCS).
- Physical Composite Score at 6 month followup [ Time Frame: 6 months ] [ Designated as safety issue: No ]We used self-reported SF12 data from baseline, 6- and 12-month written surveys to construct Mental Composite Score (MCS) and Physical Composite Score (PCS).
- Physical Composite Score at 12 month followup [ Time Frame: 12 months ] [ Designated as safety issue: No ]We used self-reported SF12 data from baseline, 6- and 12-month written surveys to construct Mental Composite Score (MCS) and Physical Composite Score (PCS).
| Enrollment: | 1186 |
| Study Start Date: | May 2005 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Usual care
Patients not assigned to the experimental condition received usual care, which may or may not have included alcohol education.
|
|
|
Experimental: Patient-provider education
Experimental patients received an intervention consisting of the following components: written reports and educational materials, a telephone health educator intervention (at baseline, 3 and 6 months), and a brief provider intervention.
|
Behavioral: Patient-provider education
Experimental patients received an intervention consisting of the following components: written reports and educational materials, a telephone health educator intervention (at baseline, 3 and 6 months), and a brief provider intervention.
|
Detailed Description:
Alcohol use in the elderly is an increasingly important public health problem. Alcohol-related risks and problems in older persons may come from the interaction between alcohol and diminished health or medication use. The proposed study is a randomized trial of the effectiveness and cost-effectiveness of an integrated patient-provider intervention to prevent risky alcohol use among older adults. The intervention will include a tested screening and education system that was developed especially for older adults and their providers, supplemented by a well-established intervention for physicians. The proposed research design involves randomization of 31 primary care physicians in seven clinics and their eligible patients aged 60+ to the intervention versus "usual care."
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 60 and over
- At-risk drinkers
- Patient of participating physician
Exclusion Criteria:
- Severe cognitive impairment
- Terminally ill or deceased
- Expected to move out of area or into nursing home within following year
- Could not fill out written surveys in English
- Likely dependent drinker
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107640
Locations
| United States, California | |
| Sansum-Santa Barbara Medical Foundation Clinics | |
| Santa Barbara, California, United States, 93111 | |
Sponsors and Collaborators
University of California, Los Angeles
Investigators
| Principal Investigator: | Susan Ettner, PhD | University of California, Los Angeles |
More Information
Additional Information:
No publications provided
| Responsible Party: | Susan Ettner, Professor, University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00107640 History of Changes |
| Other Study ID Numbers: | NIAAATAL13990, R01AA013990, 5R01AA013990-02 |
| Study First Received: | April 6, 2005 |
| Last Updated: | August 11, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of California, Los Angeles:
|
At-risk drinking Alcohol education Effectiveness Cost-effectiveness |
Additional relevant MeSH terms:
|
Alcohol Drinking Drinking Behavior |
ClinicalTrials.gov processed this record on May 22, 2013