Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alabama Veterans Rural Health Initiative (AVRHI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394081


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Lori Davis, M.D. Tuscaloosa VAMC

Publications of Results:
Layout table for additonal information
Responsible Party: Lori Davis, MD, ACOS Research and Development, Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier: NCT01394081     History of Changes
Other Study ID Numbers: 00134
First Posted: July 14, 2011    Key Record Dates
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

Layout table for additional information
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