Project SHARE (Senior Health and Alcohol Risk Education)

Alcohol Consumption Clinical Trial

Official title:

Costs of Preventing Alcohol Problems in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00107640
• Other study ID #: NIAAATAL13990
• Secondary ID: R01AA0139905R01A
• Status: Completed
• Phase: Phase 2
• First received: April 6, 2005
• Last updated: August 11, 2012
• Start date: May 2005
• Est. completion date: September 2009

Study information

• Verified date: September 2010
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1186
• Est. completion date: September 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking

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.

Locations

Country	Name	City	State
United States	Sansum-Santa Barbara Medical Foundation Clinics	Santa Barbara	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Health-related quality of life at 6 months	Health-related quality of life (HRQL) is measured using the SF-6D.	6 months	No
Secondary	Depressive symptoms	Depressive symptoms are measured using the Geriatric Depression Scale.	12 months	No
Secondary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Health-related quality of life at 12 month followup	Health-related quality of life (HRQL) is measured using the SF-6D.	12 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Sansum - Santa Barbara Medical Foundation Clinic