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| Name | Class |
|---|---|
| Tuscaloosa Veterans Affairs Medical Center | FED |
| VA Office of Research and Development | FED |
| US Department of Veterans Affairs | FED |
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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.
Access, enrollment, and engagement with primary and specialty health care services present significant challenges for rural populations worldwide. The Alabama Veterans Rural Health Initiative evaluated an innovative outreach intervention combining motivational interviewing, patient navigation, and health services education to promote utilization of the United States Veterans Administration Healthcare System (VA) by veterans who live in rural locations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Engagement and Enrollment (EEE) | Experimental | 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. |
|
| Administrative Outreach (AO) | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Engagement and Enrollment (EEE) | Other | Consists of motivational interviewing, educational outreach, and patient navigation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Attendance at a VA Appointment | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Days Until VA Clinic Appointment | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lori Davis, M.D. | Tuscaloosa VAMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham VAMC | Birmingham | Alabama | 35233 | United States | ||
| Tuscaloosa VAMC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24330220 | Result | 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. | |
| 25156143 |
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Individual participant data will not be shared
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Rural veterans unlikely to be currently receiving VHA services were targeted for outreach, and therefore, recruitment design did not represent a population-based sampling strategy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced Enrollment and Engagement (EEE) | The EEE intervention includes 1) an educational video about the services and mission of the VHA to mitigate possible negative beliefs about the VHA system of care; 2) a motivational interviewing component to address ambivalence and promote behavior change; and 3) a patient navigator model to help patients overcome systems barriers to enrolling and obtaining an initial appointment. This intervention was provided by a rural health outreach worker. |
| FG001 | Administrative Outreach (AO) | The Administrative Outreach (AO) includes a VHA enrollment document package without education, patient navigation, or motivational interview. The usual procedures for the VA to enroll the veteran were then followed by VA staff not associated with the research study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Enrollment and Engagement (EEE) | The EEE intervention includes 1) an educational video about the services and mission of the VHA to mitigate possible negative beliefs about the VHA system of care; 2) a motivational interviewing component to address ambivalence and promote behavior change; and 3) a patient navigator model to help patients overcome systems barriers to enrolling and obtaining an initial appointment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Attendance at a VA Appointment | 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. | Consenting participants who were randomized and lived in rural location. | Posted | Number | participants | 6 months |
|
6 months
same definition as clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enhanced Enrollment and Engagement (EEE) | Enhanced Enrollment and Engagement (EEE) intervention includes 1) an educational video about the services and mission of the VHA to mitigate possible negative beliefs about the VHA system of care; 2) a motivational interviewing component to address ambivalence and promote behavior change; and 3) a patient navigator model to help patients overcome systems barriers to enrolling and obtaining an initial appointment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Cardiac disorders | Non-systematic Assessment | Unrelated hospitalization due to preexisting complication with pacemaker. |
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Single geographic location; open label; bundled components of EEE intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lori L. Davis, MD | Tuscaloosa VA Medical Center | 205-554-2000 | 3819 | Lori.Davis@va.gov |
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| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D000074822 | Treatment Adherence and Compliance |
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Prospective randomized control trial
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|
| Administrative Outreach (AO) | Other | Consists of giving information about enrolling for VA medical care or scheduling an appointment |
|
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| Tuscaloosa |
| Alabama |
| 35404 |
| United States |
| Result |
| 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. |
| 23331256 | Result | 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. |
| BG001 | Administrative Outreach (AO) | The Administrative Outreach includes a VHA enrollment document package without education, patient navigation, or motivational interview. The usual procedures for the VA to enroll the veteran were then followed by VA staff not associated with the research study. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Administrative Outreach (AO) | The Administrative Outreach includes a VHA enrollment document package without education, patient navigation, or motivational interview. The usual procedures for the VA to enroll the veteran were then followed by VA staff not associated with the research study. |
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|
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| Secondary | Days Until VA Clinic Appointment | 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. | Posted | Mean | Standard Deviation | days | 6 months |
|
|
|
|
| 0 |
| 101 |
| 1 |
| 101 |
| 0 |
| 101 |
| EG001 | Administrative Outreach (AO) | Administrative Outreach (AO) includes a VHA enrollment document package without education, patient navigation, or motivational interview. The usual procedures for the VA to enroll the veteran were then followed by VA staff not associated with the research study. | 0 | 102 | 2 | 102 | 0 | 102 |
|
| Death resulting from heart attack | Cardiac disorders | Non-systematic Assessment | Death unrelated to study procedures; a heart attack was reported as a cause of death, stemming from chronic heart disease |
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| Hospitalization | Vascular disorders | Non-systematic Assessment | Hospitalization due to preexisting high blood pressure; not related to study procedures |
|
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