Project SHARE (Senior Health and Alcohol Risk Education)

Costs of Preventing Alcohol Problems in Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Consumption
• Intervention / Treatment: Behavioral: Patient-provider education

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."

• Study Type: Interventional
• Enrollment (Actual): 1186
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Barbara, California, United States, 93111
      • Sansum-Santa Barbara Medical Foundation Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Susan Ettner, PhD, University of California, Los Angeles

Publications and helpful links

General Publications

• Barnes AJ, Xu H, Tseng CH, Ang A, Tallen L, Moore AA, Marshall DC, Mirkin M, Ransohoff K, Duru OK, Ettner SL. The Effect of a Patient-Provider Educational Intervention to Reduce At-Risk Drinking on Changes in Health and Health-Related Quality of Life Among Older Adults: The Project SHARE Study. J Subst Abuse Treat. 2016 Jan;60:14-20. doi: 10.1016/j.jsat.2015.06.019. Epub 2015 Jul 8.
• Ettner SL, Xu H, Duru OK, Ang A, Tseng CH, Tallen L, Barnes A, Mirkin M, Ransohoff K, Moore AA. The effect of an educational intervention on alcohol consumption, at-risk drinking, and health care utilization in older adults: the Project SHARE study. J Stud Alcohol Drugs. 2014 May;75(3):447-57. doi: 10.15288/jsad.2014.75.447.

Helpful Links

• Sansum - Santa Barbara Medical Foundation Clinic

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: April 6, 2005
• First Submitted That Met QC Criteria: April 6, 2005
• First Posted (Estimate): April 7, 2005

Study Record Updates

• Last Update Posted (Estimate): August 14, 2012
• Last Update Submitted That Met QC Criteria: August 11, 2012
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Cost-effectiveness; Effectiveness; At-risk drinking; Alcohol education
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: NIAAATAL13990; R01AA013990 (U.S. NIH Grant/Contract); 5R01AA013990-02 (U.S. NIH Grant/Contract)