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Completed

NCT Number: NCT00107640

Project SHARE (Senior Health and Alcohol Risk Education)

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.

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Key information

Conditions

Alcohol Consumption Alcohol Drinking Behavior Drinking Behavior

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sansum-Santa Barbara Medical Foundation Clinics

Santa Barbara, California, 93111, United States

About this study

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."

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient-provider education

Behavioral

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 outcomes

  1. At-risk drinking at 6 month followup

    Time frame: 6 months

    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.

  2. At-risk drinking at 12 month followup

    Time frame: 12 months

    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 outcomes

  1. Health-related quality of life at 6 months

    Time frame: 6 months

    Health-related quality of life (HRQL) is measured using the SF-6D.

  2. Depressive symptoms

    Time frame: 12 months

    Depressive symptoms are measured using the Geriatric Depression Scale.

  3. Mental Composite Score at 6 months

    Time frame: 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).

  4. Healthcare utilization

    Time frame: 12 months (cumulative)

    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.

  5. Outpatient service costs

    Time frame: 12 months (cumulative)

    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.

  6. Direct recruitment and intervention costs

    Time frame: 12 months (cumulative)

    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.

  7. Health-related quality of life at 12 month followup

    Time frame: 12 months

    Health-related quality of life (HRQL) is measured using the SF-6D.

  8. Mental Composite Score at 12 month followup

    Time frame: 12 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).

  9. Physical Composite Score at 6 month followup

    Time frame: 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).

  10. Physical Composite Score at 12 month followup

    Time frame: 12 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).

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Costs of Preventing Alcohol Problems in Older Adults

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Apr 7, 2005
Registry last updated
Aug 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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