search
Back to results

Project SHARE (Senior Health and Alcohol Risk Education)

Primary Purpose

Alcohol Consumption

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Patient-provider education
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcohol Consumption focused on measuring At-risk drinking, Alcohol education, Effectiveness, Cost-effectiveness

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sansum-Santa Barbara Medical Foundation Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Patient-provider education

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
April 6, 2005
Last Updated
August 11, 2012
Sponsor
University of California, Los Angeles
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT00107640
Brief Title
Project SHARE (Senior Health and Alcohol Risk Education)
Official Title
Costs of Preventing Alcohol Problems in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption
Keywords
At-risk drinking, Alcohol education, Effectiveness, Cost-effectiveness

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patients not assigned to the experimental condition received usual care, which may or may not have included alcohol education.
Arm Title
Patient-provider education
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient-provider education
Intervention Description
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.
Primary Outcome Measure Information:
Title
At-risk drinking at 6 month followup
Description
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
Title
At-risk drinking at 12 month followup
Description
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
Secondary Outcome Measure Information:
Title
Health-related quality of life at 6 months
Description
Health-related quality of life (HRQL) is measured using the SF-6D.
Time Frame
6 months
Title
Depressive symptoms
Description
Depressive symptoms are measured using the Geriatric Depression Scale.
Time Frame
12 months
Title
Mental Composite Score at 6 months
Description
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
Title
Healthcare utilization
Description
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)
Title
Outpatient service costs
Description
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)
Title
Direct recruitment and intervention costs
Description
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)
Title
Health-related quality of life at 12 month followup
Description
Health-related quality of life (HRQL) is measured using the SF-6D.
Time Frame
12 months
Title
Mental Composite Score at 12 month followup
Description
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
Title
Physical Composite Score at 6 month followup
Description
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
Title
Physical Composite Score at 12 month followup
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Ettner, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sansum-Santa Barbara Medical Foundation Clinics
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93111
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26254687
Citation
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.
Results Reference
derived
PubMed Identifier
24766757
Citation
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.
Results Reference
derived
Links:
URL
http://www.sansumclinic.org/
Description
Sansum - Santa Barbara Medical Foundation Clinic

Learn more about this trial

Project SHARE (Senior Health and Alcohol Risk Education)

We'll reach out to this number within 24 hrs