Overview

This trial is active, not recruiting.

Condition rural veterans (focus of study)
Treatments enhanced enrollment or engagement (eee) intervention outreach a, outreach b - modified eee, outreach c (control)
Sponsor Tuscaloosa Research & Education Advancement Corporation
Collaborator Department of Veterans Affairs
Start date September 2009
End date September 2016
Trial size 700 participants
Trial identifier NCT01394081, 00134

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 or engagement intervention (EEE intervention) for rural veterans in VA health care services. Phase I entails a two-cell design, addressing this objective with a prospective, randomized controlled multi-site clinical trial that evaluates an active intervention compared to a control treatment as usual (TAU)condition on whether or not a rurally-residing veteran obtains and attends a VA appointment. Phase II encompasses a three-cell design, addressing the above mentioned objective with a randomized controlled, multi-site clinical trial that evaluates two active interventions compared to a control intervention.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
Outreach A is Enhanced Engagement and Enrollment that consists of the outreach worker (interventionalist) engaging participant in education (about VA resources and medical care), patient navigation (through the VA eligibility, enrollment and scheduling processes), and motivational interview (focused on attending a VA appointment).
enhanced enrollment or engagement (eee) intervention outreach a
A consists of motivational interviewing, education outreach, and patient navigation.
(Active Comparator)
Outreach B is a modified Enhanced Engagement and Enrollment that consists of the outreach worker (interventionalist) engaging participant in education (about VA resources and medical care) and patient navigation (through the VA eligibility, enrollment and scheduling processes.
outreach b - modified eee
Consists of education and patient navigation
(Sham Comparator)
Outreach C is a proxy for treatment-as-usual or sham control engaging participant in education (about VA resources and medical care), and does not involve the active interventions of patient navigation (through the VA eligibility, enrollment and scheduling processes) and motivational interview (focused on attending a VA appointment).
outreach c (control)
Outreach C is education only (about VA resources and medical care)

Primary Outcomes

Measure
VA clinical utilization (appointment)
time frame: 6 months

Secondary Outcomes

Measure
Time until VA Clinical Utilization (clinic appointment)
time frame: 6 months

Eligibility Criteria

Male or female participants at least 19 years old.

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

Additional Information

Official title Alabama Veterans Rural Health Initiative
Description PHASE I I. Primary Hypothesis: Compared to veterans randomized to the control condition (Treatment as Usual; TAU), veterans who receive the enhanced enrollment or engagement intervention (EEE - patient navigation, motivational interviewing, and education), will be significantly more likely to attend a VA clinic appointment within 6 months of the comprehensive baseline evaluation. PHASE II I. Primary Hypothesis: Compared to veterans randomized to the control condition (Outreach C - education only), veterans who receive the enhanced enrollment or engagement (EEE) intervention (Outreach A - patient navigation, motivational interviewing, and education), will be significantly more likely to attend a VA clinic appointment within 6 months of the comprehensive baseline evaluation. II. Secondary Hypothesis: Compared to veterans randomized to the control condition (Outreach C), veterans who receive the patient navigation and education (Outreach B) will be significantly more likely to attend a VA clinic appointment within 6 months of the comprehensive baseline evaluation. III. Tertiary Hypothesis: Compared to veterans randomized to the patient navigation and education (Outreach B), veterans who receive the EEE intervention (Outreach A) will be significantly more likely to attend a VA clinic appointment within 6 months of the comprehensive baseline evaluation.
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by Tuscaloosa Research & Education Advancement Corporation.