Project SHARE (Senior Health and Alcohol Risk Education)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Susan Ettner, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00107640
First received: April 6, 2005
Last updated: August 11, 2012
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Alcohol Consumption
Behavioral: Patient-provider education
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Costs of Preventing Alcohol Problems in Older Adults

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • At-risk drinking at 6 month followup [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Health-related quality of life (HRQL) is measured using the SF-6D.

  • Depressive symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Depressive symptoms are measured using the Geriatric Depression Scale.

  • Mental Composite Score at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months (cumulative) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months (cumulative) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months (cumulative) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Health-related quality of life (HRQL) is measured using the SF-6D.

  • Mental Composite Score at 12 month followup [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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).


Enrollment: 1186
Study Start Date: May 2005
Study Completion Date: September 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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."

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107640

Locations
United States, California
Sansum-Santa Barbara Medical Foundation Clinics
Santa Barbara, California, United States, 93111
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Susan Ettner, PhD University of California, Los Angeles
  More Information

Additional Information:
No publications provided

Responsible Party: Susan Ettner, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00107640     History of Changes
Other Study ID Numbers: NIAAATAL13990, R01AA013990, 5R01AA013990-02
Study First Received: April 6, 2005
Last Updated: August 11, 2012
Health Authority: United States: Federal Government

Keywords provided by University of California, Los Angeles:
At-risk drinking
Alcohol education
Effectiveness
Cost-effectiveness

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior

ClinicalTrials.gov processed this record on April 17, 2014