Trial record 2 of 2 for:    eee

Alabama Veterans Rural Health Initiative (AVRHI)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier:
NCT01394081
First received: July 12, 2011
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Rural Veterans (Focus of Study)
Other: Enhanced Enrollment or Engagement (EEE) Intervention Outreach A
Other: Outreach B - modified EEE
Other: Outreach C (Control)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Alabama Veterans Rural Health Initiative

Resource links provided by NLM:


Further study details as provided by Tuscaloosa Research & Education Advancement Corporation:

Primary Outcome Measures:
  • VA clinical utilization (appointment) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The primary outcome is derived from VA clinical records and is a VA clinic appointment that has been scheduled and attended by the research subject.


Secondary Outcome Measures:
  • Time until VA Clinical Utilization (clinic appointment) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The secondary outcome for each hypothesis is the time from randomization to the time that the subject attends the VA clinic appointment (derived from the VA medical records)


Estimated Enrollment: 700
Study Start Date: September 2009
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Outreach A (EEE)
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).
Other: Enhanced Enrollment or Engagement (EEE) Intervention Outreach A
A consists of motivational interviewing, education outreach, and patient navigation.
Active Comparator: Outreach B
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.
Other: Outreach B - modified EEE
Consists of education and patient navigation
Sham Comparator: Outreach C
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).
Other: Outreach C (Control)
Outreach C is education only (about VA resources and medical care)

Detailed 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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394081

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
Investigators
Study Chair: Sylvia Colon, M.D. IRB Tuscaloosa VAMC
  More Information