A Phase 2 interventional study of Patient-provider education in Alcohol Consumption, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2012-08-14.
Sponsored by University of California, Los Angeles · Phase 2, Interventional, and Health services research
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.
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."
925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.
This study's enrollment of 1,186 is above the median of 108 across 802 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 193 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients not assigned to the experimental condition received usual care, which may or may not have included alcohol 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.
At-risk drinking at 6 month followup
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.
Time frame: 6 months
At-risk drinking at 12 month followup
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.
Time frame: 12 months
Health-related quality of life at 6 months
Health-related quality of life (HRQL) is measured using the SF-6D.
Time frame: 6 months
Depressive symptoms
Depressive symptoms are measured using the Geriatric Depression Scale.
Time frame: 12 months
Mental Composite Score at 6 months
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).
Time frame: 6 months
Healthcare utilization
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.
Time frame: 12 months (cumulative)
Outpatient service costs
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.
Time frame: 12 months (cumulative)
Direct recruitment and intervention costs
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.
Time frame: 12 months (cumulative)
Health-related quality of life at 12 month followup
Health-related quality of life (HRQL) is measured using the SF-6D.
Time frame: 12 months
Mental Composite Score at 12 month followup
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).
Time frame: 12 months
Physical Composite Score at 6 month followup
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).
Time frame: 6 months
Physical Composite Score at 12 month followup
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).
Time frame: 12 months
This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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University of California, Los Angeles