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

April 6, 2005
August 11, 2012
May 2005
September 2008   (final data collection date for primary outcome measure)
  • 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.
  • Hazardous and harmful drinking
  • Health-related quality of life
  • Utilization and costs
Complete list of historical versions of study NCT00107640 on ClinicalTrials.gov Archive Site
  • 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).
  • Alcohol knowledge
  • Alcohol-related self-efficacy
  • Functional status
Not Provided
Not Provided
 
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.

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."

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Alcohol Consumption
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.
  • 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.
    Intervention: Behavioral: Patient-provider education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1186
September 2009
September 2008   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00107640
NIAAATAL13990, R01AA013990, 5R01AA013990-02
No
Susan Ettner, University of California, Los Angeles
University of California, Los Angeles
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Susan Ettner, PhD University of California, Los Angeles
University of California, Los Angeles
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP