- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01394081
Alabama Veterans Rural Health Initiative (AVRHI)
The purpose of the Alabama Veterans Rural Health Initiative is to better understand access and barriers to health care and to enhance veteran enrollment or engagement in health care services of veterans residing in rural areas. It describes an intervention that is adaptable for use by other VA facilities that serve veterans in rural settings, and importantly, this study will improve our understanding of barriers to care and evaluate a method for enhancing access to care. The anticipated impact is that more veterans in rural areas who were previously under-utilizing VA services will receive and attend a health care appointment. This gain may improve preventative and primary care health care and reduce long term health care morbidity, expense and burden. This study may also identify previously unknown barriers to care that can be surmounted by innovative access and health care delivery approaches.
The primary objective is to evaluate an innovative approach for enhanced enrollment and engagement outreach intervention (EEE intervention) for rural veterans in VA health care services. This study entails a two-cell design, addressing this objective with a prospective, randomized controlled multi-site clinical trial that evaluates an active intervention compared to administrative outreach (AO, control condition) on whether or not a rurally-residing veteran obtains and attends a VA appointment.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
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Birmingham, Alabama, United States, 35233
- Birmingham Vamc
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Tuscaloosa, Alabama, United States, 35404
- Tuscaloosa VAMC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Veterans who live in rural Alabama counties who have either never enrolled or have previously enrolled but have not accessed a VA in 2 years or more
- Signed informed consent
- Any race, social class or ethnicity
Exclusion Criteria:
- Pending active legal charges or current/expected incarceration
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Enhanced Engagement and Enrollment (EEE)
Enhanced Engagement and Enrollment (EEE) consists of the outreach worker (interventionalist) engaging the participant in education (about VA resources and medical care), navigating the patient through the VA eligibility, enrollment, and scheduling processes, and using motivational interview to focus on ambivalence about attending a VA appointment.
|
Consists of motivational interviewing, educational outreach, and patient navigation.
Other Names:
|
|
Active Comparator: Administrative Outreach (AO)
Administrative Outreach (AO) consists of the outreach worker giving the participants an application package to VA enrollment or phone number for the scheduling clerk.
This intervention does not involve education, patient navigation (guidance through VA eligibility, enrollment, and scheduling processes) or motivational interviews (interviews focused on ambivalence about attending a VA appointment).
|
Consists of giving information about enrolling for VA medical care or scheduling an appointment
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attendance at a VA Appointment
Time Frame: 6 months
|
Attendance at a VA appointment was derived from VA clinical records, defined as the participant attending a scheduled VA clinic appointment.
Participants who did not attend a VA clinic appointment be the end of 6-month observation period were classified as censored at 6 months.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Days Until VA Clinic Appointment
Time Frame: 6 months
|
The number of days from day of randomization to day that the participant attended the VA clinic appointment (derived from the VA medical records).
Participants who did not attend a VA clinic appointment be the end of 6-month observation period were classified as censored at 6 months.
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lori Davis, M.D., Tuscaloosa VAMC
Publications and helpful links
General Publications
- Hilgeman MM, Mahaney-Price AF, Stanton MP, McNeal SF, Pettey KM, Tabb KD, Litaker MS, Parmelee P, Hamner K, Martin MY, Hawn MT, Kertesz SG, Davis LL; Alabama Veterans Rural Health Initiative (AVRHI) Steering Committee. Alabama Veterans Rural Health Initiative: a pilot study of enhanced community outreach in rural areas. J Rural Health. 2014 Spring;30(2):153-63. doi: 10.1111/jrh.12054. Epub 2013 Dec 15.
- Mahaney-Price AF, Hilgeman MM, Davis LL, McNeal SF, Conner CM, Allen RS. Living will status and desire for living will help among rural Alabama veterans. Res Nurs Health. 2014 Oct;37(5):379-90. doi: 10.1002/nur.21617. Epub 2014 Aug 23.
- Allen RS, Guadagno RE, Parmelee P, Minney JA, Hilgeman MM, Tabb KD, McNeil SF, Houston T, Kertesz S, Davis L. Internet connectivity among rural Alabama veterans: baseline findings from the Alabama Veterans Rural Health Initiative Project. Rural Remote Health. 2013 Apr-Jun;13(2):2138. Epub 2013 Jan 21.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 00134
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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