Alabama Veterans Rural Health Initiative (AVRHI)

• ClinicalTrials.gov Identifier: NCT01394081
• Recruitment Status: Completed
• First Posted: July 14, 2011
• Results First Posted: April 23, 2018
• Last Update Posted: April 23, 2018
• Sponsor: Tuscaloosa Research & Education Advancement Corporation
• Collaborators: Tuscaloosa Veterans Affairs Medical Center; VA Office of Research and Development; US Department of Veterans Affairs
• Information provided by (Responsible Party): Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Problems With Access to Health Care; Health Behavior	Other: Enhanced Engagement and Enrollment (EEE); Other: Administrative Outreach (AO)	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 203 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective randomized control trial
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Alabama Veterans Rural Health Initiative
• Actual Study Start Date: October 1, 2008
• Actual Primary Completion Date: October 1, 2010
• Actual Study Completion Date: October 1, 2013

Arms and Interventions

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.	Other: Enhanced Engagement and Enrollment (EEE); Consists of motivational interviewing, educational outreach, and patient navigation.; Other Name: Enhanced Engagement and Enrollment
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).	Other: Administrative Outreach (AO); Consists of giving information about enrolling for VA medical care or scheduling an appointment; Other Name: Treatment-as-usual

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Alabama

Birmingham VAMC

Birmingham, Alabama, United States, 35233

Tuscaloosa VAMC

Tuscaloosa, Alabama, United States, 35404

Sponsors and Collaborators

Tuscaloosa Research & Education Advancement Corporation

Tuscaloosa Veterans Affairs Medical Center

VA Office of Research and Development

US Department of Veterans Affairs

Investigators

• Principal Investigator: Lori Davis, M.D.; Tuscaloosa VAMC

More Information

Publications of Results:

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.

• Responsible Party: Lori Davis, MD, ACOS Research and Development, Tuscaloosa Research & Education Advancement Corporation
• ClinicalTrials.gov Identifier: NCT01394081
• Other Study ID Numbers: 00134
• First Posted: July 14, 2011
• Results First Posted: April 23, 2018
• Last Update Posted: April 23, 2018
• Last Verified: September 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Individual participant data will not be shared

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation:

Veterans; Health Care Utilization; Rural Health; Patient Navigation; Motivational Interviewing