NCT01394081

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

April 23, 2018

Completed
Last Updated

April 23, 2018

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

July 12, 2011

Results QC Date

January 8, 2014

Last Update Submit

September 12, 2017

Conditions

Problems With Access to Health CareHealth Behavior

Keywords

VeteransHealth Care UtilizationRural HealthPatient NavigationMotivational Interviewing

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Days Until VA Clinic Appointment

    6 months

Study Arms (2)

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.

Other: Enhanced Engagement and Enrollment (EEE)

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).

Other: Administrative Outreach (AO)

Interventions

Enhanced Engagement and Enrollment (EEE)OTHER

Consists of motivational interviewing, educational outreach, and patient navigation.

Also known as: Enhanced Engagement and Enrollment
Enhanced Engagement and Enrollment (EEE)
Administrative Outreach (AO)OTHER

Consists of giving information about enrolling for VA medical care or scheduling an appointment

Also known as: Treatment-as-usual
Administrative Outreach (AO)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pending active legal charges or current/expected incarceration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Birmingham VAMC

Birmingham, Alabama, 35233, United States

Location

Tuscaloosa VAMC

Tuscaloosa, Alabama, 35404, United States

Location

Related Publications (3)

  • 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.

    PMID: 24330220RESULT

  • 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.

    PMID: 25156143RESULT

  • 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.

    PMID: 23331256RESULT

MeSH Terms

Conditions

Health BehaviorPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

BehaviorTreatment Adherence and Compliance

Limitations and Caveats

Single geographic location; open label; bundled components of EEE intervention.

Results Point of Contact

Title
Lori L. Davis, MD
Organization
Tuscaloosa VA Medical Center
Lori.Davis@va.gov
205-554-2000

Study Officials

  • Lori Davis, M.D.

    Tuscaloosa VAMC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Prospective randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ACOS Research and Development

Study Record Dates

First Submitted

July 12, 2011

First Posted

July 14, 2011

Study Start

October 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2013

Last Updated

April 23, 2018

Results First Posted

April 23, 2018

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared

Locations

US(2)