Advance Directives Clinical Trial
Official title:
Enabling Advance Directive Completion by Rural Alabama Veterans: A Pilot Study
Objectives: The objectives of the pilot study were to (1) test the feasibility of
recruitment, randomization, and retention; (2) test the feasibility of a standardized
Nurse-Supported Advance Care Planning Intervention; (3) evaluate the feasibility of the
assessment process and data collection procedures; (4) evaluate the Veterans' satisfaction
with the intervention and their Advance Directive decisions; and (5) evaluate preliminary
effects of the Nurse-Supported Advance Care Planning Intervention.
Research Design: This was a prospective, randomized, controlled, unblinded pilot study.
Alabama Veterans who received care through the Tuscaloosa VA Medical Center were randomized
to either the Nurse-Supported Advance Care Planning Intervention or Care-as-Usual in a 2:1
ratio respectively. Data related to recruitment, randomization, and retention; study
completion by subjects; completeness of data collection; Veterans' satisfaction; and
preliminary effects of the intervention were collected, analyzed, and evaluated. The length
of the study was one year.
Methods: The setting for the study was Tuscaloosa VA Medical Center care sites. A
convenience sample of fifty subjects was recruited from Tuscaloosa VA outpatient clinics
including Selma, residential settings, Home Based Primary Care, and the Mobile Health Unit.
The level of care of subjects was all-inclusive, excepting current Hospice or Palliative
Care. Selection procedures included self-referral and referral by Tuscaloosa VA Medical
Center staff. Entry requirements were the meeting of all inclusion criteria and verification
of no exclusion criteria. The Nurse-Supported Advance Care Planning Intervention was a
manualized education, support, and guidance session provided by a Registered Nurse that
included information about risks, benefits, and alternatives of specific choices. The
Care-as-Usual was a session with the social worker who explained what the Advance Directive
is, and guided the Veteran regarding the process of completing the Advance Directive
document, without providing information about risks, benefits, and alternatives of specific
choices. Study enrollment period was six months. The primary study outcome measure was
Advance Directive completion rate. This pilot was not a hypothesis testing study. The
underlying hypothesis of the eventual full study is that the Nurse-Supported Advance Care
Planning Intervention is associated with Advance Directive completion rates at least
comparable to that of the As-Usual care.
Significance: This study supports the Veterans Health Administration (VHA) mission to
provide Veteran-centered care. It provides important information needed to plan a full study
of the effectiveness of a specific Nurse-Supported Advance Care Planning Intervention to
facilitate Advance Directive completion by rural Alabama Veterans.
Background:
The VHA mission to serve the health care needs of America's veterans assumes a
veteran-centered approach - one that evolves not only from the health team's assessment of
needs, but especially one that begins with the veteran's assessment of his or her own needs.
Preliminary data from the Alabama Veterans Rural Health Initiative study suggest that
approximately 30% of rural Alabama veterans do not have an Advance Directive and want help
completing one. Rural Alabama veterans live in counties with a higher percent of African
American minorities, lower levels of education, and higher family poverty rates, than the
average for the US population at large. Prior studies have demonstrated that disparities in
Advance Directive completion rates may be related to race, level of income, and level of
education. VHA research priorities include addressing the challenges of minority health care
needs and the disparities that arise in healthcare delivery. Although many studies evidence
the effectiveness of education and counseling in facilitating Advance Directive completion,
data are lacking that demonstrate the efficacy of resource-conservative nursing
interventions to enable Advance Directive completion by rural, southern minorities. This
pilot lays the groundwork to address this evidence gap.
Objectives:
The objectives of the pilot study were to (1) test the feasibility of recruitment,
randomization, and retention; (2) test the feasibility of a standardized Nurse-Supported
Advance Care Planning Intervention; (3) evaluate the feasibility of the assessment process
and data collection procedures; (4) evaluate the Veterans' satisfaction with the
intervention and their Advance Directive decisions; and (5) evaluate preliminary effects of
the Nurse-Supported Advance Care Planning Intervention.
Methods:
A prospective, randomized, controlled pilot study. Fifty Alabama veterans who receive care
at the Tuscaloosa VA Medical Center were randomized to either the Nurse-Supported Advance
Care Planning Intervention or Care-as-Usual. The Nurse-Supported Advance Care Planning
Intervention was a manualized education, support, and guidance session provided by a
Registered Nurse that included information about risks, benefits, and alternatives of
specific choices. The Care-as-Usual was a session with the social worker who explained what
the Advance Directive is, and guided the Veteran regarding the process of completing the
Advance Directive document, without providing information about risks, benefits, and
alternatives of specific choices. Data related to recruitment, randomization, and retention;
study completion by subjects; completeness of data collection; Veterans' satisfaction; and
preliminary effects of the intervention were collected, analyzed, and evaluated.
Status:
The Tuscaloosa VA Medical Center Institutional Review Board (IRB) has approved this study.
Study is closed.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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