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Alabama Veterans Rural Health Initiative (AVRHI)

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Conditions Problems With Access to Health Care
Health Behavior
Interventions Other: Enhanced Engagement and Enrollment (EEE)
Other: Administrative Outreach (AO)
Enrollment 203
Recruitment Details Rural veterans unlikely to be currently receiving VHA services were targeted for outreach, and therefore, recruitment design did not represent a population-based sampling strategy.
Pre-assignment Details  
Arm/Group Title Enhanced Enrollment and Engagement (EEE) Administrative Outreach (AO)
Hide Arm/Group Description The EEE intervention includes 1) an educational video about the services and mission of the VHA to mitigate possible negative beliefs about the VHA system of care; 2) a motivational interviewing component to address ambivalence and promote behavior change; and 3) a patient navigator model to help patients overcome systems barriers to enrolling and obtaining an initial appointment. This intervention was provided by a rural health outreach worker. The Administrative Outreach (AO) includes a VHA enrollment document package without education, patient navigation, or motivational interview. The usual procedures for the VA to enroll the veteran were then followed by VA staff not associated with the research study.
Period Title: Overall Study
Started 101 102
Completed 101 102
Not Completed 0 0
Arm/Group Title Enhanced Enrollment and Engagement (EEE) Administrative Outreach (AO) Total
Hide Arm/Group Description The EEE intervention includes 1) an educational video about the services and mission of the VHA to mitigate possible negative beliefs about the VHA system of care; 2) a motivational interviewing component to address ambivalence and promote behavior change; and 3) a patient navigator model to help patients overcome systems barriers to enrolling and obtaining an initial appointment. The Administrative Outreach includes a VHA enrollment document package without education, patient navigation, or motivational interview. The usual procedures for the VA to enroll the veteran were then followed by VA staff not associated with the research study. Total of all reporting groups
Overall Number of Baseline Participants 101 102 203
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 102 participants 203 participants
55.72  (14.24) 55.39  (14.60) 55.6  (14.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 102 participants 203 participants
Female
6
   5.9%
8
   7.8%
14
   6.9%
Male
95
  94.1%
94
  92.2%
189
  93.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 102 participants 203 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   1.0%
1
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
49
  48.5%
34
  33.3%
83
  40.9%
White
52
  51.5%
67
  65.7%
119
  58.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Attendance at a VA Appointment
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Consenting participants who were randomized and lived in rural location.
Arm/Group Title Enhanced Enrollment and Engagement(EEE) Administrative Outreach (AO)
Hide Arm/Group Description:
The EEE intervention includes 1) an educational video about the services and mission of the VHA to mitigate possible negative beliefs about the VHA system of care; 2) a motivational interviewing component to address ambivalence and promote behavior change; and 3) a patient navigator model to help patients overcome systems barriers to enrolling and obtaining an initial appointment.
The Administrative Outreach includes a VHA enrollment document package without education, patient navigation, or motivational interview. The usual procedures for the VA to enroll the veteran were then followed by VA staff not associated with the research study.
Overall Number of Participants Analyzed 101 102
Measure Type: Number
Unit of Measure: participants
88 59
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enhanced Enrollment and Engagement(EEE), Administrative Outreach (AO)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
2.Secondary Outcome
Title Days Until VA Clinic Appointment
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enhanced Enrollment and Engagement (EEE) Administrative Outreach (AO)
Hide Arm/Group Description:
The EEE intervention includes 1) an educational video about the services and mission of the VHA to mitigate possible negative beliefs about the VHA system of care; 2) a motivational interviewing component to address ambivalence and promote behavior change; and 3) a patient navigator model to help patients overcome systems barriers to enrolling and obtaining an initial appointment.
Administrative Outreach (AO) includes a VHA enrollment document package without education, patient navigation, or motivational interview. The usual procedures for the VA to enroll the veteran were then followed by VA staff not associated with the research study.
Overall Number of Participants Analyzed 101 102
Mean (Standard Deviation)
Unit of Measure: days
12  (49.8) 98  (93.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Enhanced Enrollment and Engagement (EEE), Administrative Outreach (AO)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Log Rank
Comments log rank Mantel Cox χ2 = 25.4
Time Frame 6 months
Adverse Event Reporting Description same definition as clinicaltrials.gov
 
Arm/Group Title Enhanced Enrollment and Engagement (EEE) Administrative Outreach (AO)
Hide Arm/Group Description Enhanced Enrollment and Engagement (EEE) intervention includes 1) an educational video about the services and mission of the VHA to mitigate possible negative beliefs about the VHA system of care; 2) a motivational interviewing component to address ambivalence and promote behavior change; and 3) a patient navigator model to help patients overcome systems barriers to enrolling and obtaining an initial appointment. Administrative Outreach (AO) includes a VHA enrollment document package without education, patient navigation, or motivational interview. The usual procedures for the VA to enroll the veteran were then followed by VA staff not associated with the research study.
All-Cause Mortality
Enhanced Enrollment and Engagement (EEE) Administrative Outreach (AO)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/101 (0.00%)      0/102 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Enhanced Enrollment and Engagement (EEE) Administrative Outreach (AO)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/101 (0.99%)      2/102 (1.96%)    
Cardiac disorders     
Hospitalization * [1]  1/101 (0.99%)  1 0/102 (0.00%)  0
Death resulting from heart attack * [2]  0/101 (0.00%)  0 1/102 (0.98%)  1
Vascular disorders     
Hospitalization * [3]  0/101 (0.00%)  0 1/102 (0.98%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Unrelated hospitalization due to preexisting complication with pacemaker.
[2]
Death unrelated to study procedures; a heart attack was reported as a cause of death, stemming from chronic heart disease
[3]
Hospitalization due to preexisting high blood pressure; not related to study procedures
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enhanced Enrollment and Engagement (EEE) Administrative Outreach (AO)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/101 (0.00%)      0/102 (0.00%)    
Single geographic location; open label; bundled components of EEE intervention.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lori L. Davis, MD
Organization: Tuscaloosa VA Medical Center
Phone: 205-554-2000 ext 3819
EMail: Lori.Davis@va.gov
Layout table for additonal information
Responsible Party: Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier: NCT01394081     History of Changes
Other Study ID Numbers: 00134
First Submitted: July 12, 2011
First Posted: July 14, 2011
Results First Submitted: January 8, 2014
Results First Posted: April 23, 2018
Last Update Posted: April 23, 2018