Project SHARE (Senior Health and Alcohol Risk Education)

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Costs of Preventing Alcohol Problems in Older Adults

Conditions
-----------------
Alcohol Consumption

Intervention / Treatment
-----------------
* Behavioral: Patient-provider education


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Patients not assigned to the experimental condition received usual care, which may or may not have included alcohol education. | |
| Experimental: Patient-provider education<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life at 6 months | Health-related quality of life (HRQL) is measured using the SF-6D. | 6 months | 
| Depressive symptoms | Depressive symptoms are measured using the Geriatric Depression Scale. | 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). | 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. | 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. | 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. | 12 months (cumulative) | 
| Health-related quality of life at 12 month followup | Health-related quality of life (HRQL) is measured using the SF-6D. | 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). | 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). | 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). | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
At-risk drinking, Alcohol education, Effectiveness, Cost-effectiveness