Trial Outcomes & Findings for Alabama Veterans Rural Health Initiative (NCT NCT01394081)
NCT ID: NCT01394081
Last Updated: 2018-04-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
203 participants
Primary outcome timeframe
6 months
Results posted on
2018-04-23
Participant Flow
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.
Participant milestones
| Measure |
Enhanced Enrollment and Engagement (EEE)
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.
|
Administrative Outreach (AO)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
102
|
|
Overall Study
COMPLETED
|
101
|
102
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alabama Veterans Rural Health Initiative
Baseline characteristics by cohort
| Measure |
Enhanced Enrollment and Engagement (EEE)
n=101 Participants
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)
n=102 Participants
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
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.72 years
STANDARD_DEVIATION 14.24 • n=93 Participants
|
55.39 years
STANDARD_DEVIATION 14.60 • n=4 Participants
|
55.6 years
STANDARD_DEVIATION 14.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=93 Participants
|
94 Participants
n=4 Participants
|
189 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
49 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=93 Participants
|
67 Participants
n=4 Participants
|
119 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Consenting participants who were randomized and lived in rural location.
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.
Outcome measures
| Measure |
Enhanced Enrollment and Engagement(EEE)
n=101 Participants
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)
n=102 Participants
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.
|
|---|---|---|
|
Attendance at a VA Appointment
|
88 participants
|
59 participants
|
SECONDARY outcome
Timeframe: 6 monthsThe 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.
Outcome measures
| Measure |
Enhanced Enrollment and Engagement(EEE)
n=101 Participants
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)
n=102 Participants
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.
|
|---|---|---|
|
Days Until VA Clinic Appointment
|
12 days
Standard Deviation 49.8
|
98 days
Standard Deviation 93.1
|
Adverse Events
Enhanced Enrollment and Engagement (EEE)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Administrative Outreach (AO)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enhanced Enrollment and Engagement (EEE)
n=101 participants at risk
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)
n=102 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Hospitalization
|
0.99%
1/101 • Number of events 1 • 6 months
same definition as clinicaltrials.gov
|
0.00%
0/102 • 6 months
same definition as clinicaltrials.gov
|
|
Cardiac disorders
Death resulting from heart attack
|
0.00%
0/101 • 6 months
same definition as clinicaltrials.gov
|
0.98%
1/102 • Number of events 1 • 6 months
same definition as clinicaltrials.gov
|
|
Vascular disorders
Hospitalization
|
0.00%
0/101 • 6 months
same definition as clinicaltrials.gov
|
0.98%
1/102 • Number of events 1 • 6 months
same definition as clinicaltrials.gov
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place