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| Tracking Information | |||||
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| First Received Date ICMJE | March 14, 2001 | ||||
| Last Updated Date | October 31, 2008 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00012740 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Casefinding and Referral System for Older Veterans Within Primary Care | ||||
| Official Title ICMJE | A Casefinding and Referral System for Older Veterans Within Primary Care | ||||
| Brief Summary | Underdiagnosis and undertreatment of elderly persons remains a widespread problem. While many innovative geriatric care programs exist within VHA, we still lack a systematic process for identifying at-risk elders from the larger VA population who are likely to benefit from specialized geriatric services. |
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| Detailed Description | Background: Underdiagnosis and undertreatment of elderly persons remains a widespread problem. While many innovative geriatric care programs exist within VHA, we still lack a systematic process for identifying at-risk elders from the larger VA population who are likely to benefit from specialized geriatric services. Objectives: Our goal is to improve care for at-risk older veterans through a comprehensive system of casefinding, assessment, referral and follow-up within the primary care setting. We hypothesize that subjects receiving this intervention will have more complete evaluation and treatment for selected geriatric conditions (i.e., falls, urinary incontinence, functional status impairments, depression, and cognitive deficits), better continuity of care, less decline in functional status, and better general health than subjects receiving usual care. Methods: This randomized controlled trial is being performed at the Sepulveda VA Outpatient Clinic. The study sample is composed of community-dwelling veterans aged 65 and older who are not receiving VA geriatric services. Veterans are mailed a health screening survey to identify those at risk for decline based on criteria established in pilot work. At-risk respondents who are in the intervention group receive a structured telephone assessment (casefinding) and referral to appropriate geriatric services, including a geriatric assessment and teaching clinic integrated with primary care, and telephone case management. Subjects in the control group receive usual care. Major outcome measures collected by telephone interview at baseline, 12, 24, and 36 months include functional status, self-rated health, satisfaction, and health care utilization. Medical records are reviewed for evidence of evaluation and treatment of the target conditions. Status: Data collection for this project was completed on September 30, 2001. The subject recruitment phase was completed in August, 1998. Collection of 36 month follow-up data has been completed for all subjects enrolled. Data analysis and preparation of publication is in press. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Casefinding and Referral System | ||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 792 | ||||
| Completion Date | September 2001 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Subjects have to have a score of 4 or higher in a screening questionnaire and have been seen at clinic in the past 18 months. Exclusion Criteria: |
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| Gender | Both | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00012740 | ||||
| Responsible Party | Rubenstein, Laurence - Principal Investigator, Department of Veterans Affairs | ||||
| Study ID Numbers ICMJE | IIR 95-050 | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | July 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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