Problems With Access to Health CareAVRHINCT01394081
Alabama Veterans Rural Health Initiative
A study testing Enhanced Engagement and Enrollment (EEE) and Administrative Outreach (AO) in people with Problems With Access to Health Care and Health Behavior, run by Tuscaloosa Research & Education Advancement Corporation at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Problems With Access to Health Care, Health Behavior
- What is being tested?
- Enhanced Engagement and Enrollment (EEE) and Administrative Outreach (AO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2008to 1 Oct 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pending active legal charges or current/expected incarceration
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Birmingham VAMC
Birmingham, Alabama, 35233
Tuscaloosa VAMC
Tuscaloosa, Alabama, 35404
About this study
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.
Read the detailed description
Access, enrollment, and engagement with primary and specialty health care services present significant challenges for rural populations worldwide. The Alabama Veterans Rural Health Initiative evaluated an innovative outreach intervention combining motivational interviewing, patient navigation, and health services education to promote utilization of the United States Veterans Administration Healthcare System (VA) by veterans who live in rural locations.
- Being tested
- Enhanced Engagement and Enrollment (EEE), Administrative Outreach (AO)
- Keywords
- Veterans, Health Care Utilization, Rural Health, Patient Navigation, Motivational Interviewing
- Medical subject headings
- Health Behavior, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Engagement and Enrollment (EEE)Other
Also called Enhanced Engagement and Enrollment
Consists of motivational interviewing, educational outreach, and patient navigation.
Administrative Outreach (AO)Other
Also called Treatment-as-usual
Consists of giving information about enrolling for VA medical care or scheduling an appointment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Administrative Outreach (AO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Days Until VA Clinic Appointment
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study start1 Oct 2008
- Primary completion1 Oct 2010
- Study completion1 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Problems With Access to Health CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized control trial
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuscaloosa Research & Education Advancement Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Tuscaloosa Veterans Affairs Medical Center, VA Office of Research and Development, US Department of Veterans Affairs
- Responsible party
- Principal investigator, Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
- Investigators
- Lori Davis, M.D., Principal investigator, Tuscaloosa VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394081
- Sponsor's protocol ID
- 00134
- Acronym
- AVRHI
- Status last verified
- Sep 2017
- First submitted
- 12 Jul 2011
- Last updated
- 23 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared
Publications
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.
PubMed 24330220Mahaney-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.
PubMed 25156143Allen 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.
PubMed 23331256
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alabama Veterans Rural Health Initiative
- ClinicalTrials.gov ID
- NCT01394081
- Acronym / sponsor ID
- AVRHI / 00134
- Keywords
- Veterans, Health Care Utilization, Rural Health, Patient Navigation, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Tuscaloosa Research & Education Advancement CorporationUniversity, hospital or other
- Collaborators
- Tuscaloosa Veterans Affairs Medical Center, VA Office of Research and Development, US Department of Veterans Affairs
- Study start
- 1 Oct 2008 (actual)
- Primary completion
- 1 Oct 2010 (actual)
- Study completion
- 1 Oct 2013 (actual)
- First posted
- 14 Jul 2011 (estimated)
- Results
- Posted 23 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Access, enrollment, and engagement with primary and specialty health care services present significant challenges for rural populations worldwide. The Alabama Veterans Rural Health Initiative evaluated an innovative outreach intervention combining motivational interviewing, patient navigation, and health services education to promote utilization of the United States Veterans Administration Healthcare System (VA) by veterans who live in rural locations.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Enhanced Engagement and Enrollment (EEE) | Experimental | Other: Enhanced Engagement and Enrollment (EEE)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. |
| Administrative Outreach (AO) | Active comparator | Other: Administrative Outreach (AO)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). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Pending active legal charges or current/expected incarceration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Engagement and Enrollment (EEE)Also: Enhanced Engagement and EnrollmentConsists of motivational interviewing, educational outreach, and patient navigation. | Other | Enhanced Engagement and Enrollment (EEE) |
| Administrative Outreach (AO)Also: Treatment-as-usualConsists of giving information about enrolling for VA medical care or scheduling an appointment | Other | Administrative Outreach (AO) |
Primary outcome
Attendance at a VA Appointment
Time frame: 6 months
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.
1 secondary outcome
Days Until VA Clinic Appointment
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24330220Hilgeman 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.
- Results publication: PubMed 25156143Mahaney-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.
- Results publication: PubMed 23331256Allen 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Davis, M.D. principal investigator
Tuscaloosa VAMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Engagement and Enrollment (EEE) and Administrative Outreach (AO) in people with Problems With Access to Health Care and Health Behavior, run by Tuscaloosa Research & Education Advancement Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance at a VA Appointment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01394081, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2018.