Enabling Advance Directive Completion (EADCRAV)
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Purpose
Objectives: The objectives of the pilot study are 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 is a prospective, randomized, controlled, unblinded pilot study. Alabama Veterans who receive care through the Tuscaloosa VA Medical Center are 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 are collected, analyzed, and evaluated. The length of the study is one year.
Methods: The setting for the study is Tuscaloosa VA Medical Center care sites. A convenience sample of fifty subjects is 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 is all-inclusive, excepting current Hospice or Palliative Care. Selection procedures include self-referral and referral by Tuscaloosa VA Medical Center staff. Entry requirements are the meeting of all inclusion criteria and verification of no exclusion criteria. The Nurse-Supported Advance Care Planning Intervention is a manualized education, support, and guidance session provided by a Registered Nurse that includes information about risks, benefits, and alternatives of specific choices. The Care-as-Usual is a session with the social worker who explains what the Advance Directive is, and guides 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 is projected for a six month duration. The primary study outcome measure is Advance Directive completion rate. This pilot is 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 VHA mission to provide Veteran-centered care. It lays the groundwork to address a health care disparity related to Advance Directive completion. 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.
| Condition | Intervention |
|---|---|
|
Advance Directives |
Other: The Nurse-Supported Advance Care Planning Intervention Other: Care-as-Usual |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Enabling Advance Directive Completion by Rural Alabama Veterans: A Pilot Study |
- The primary study outcome measure is Advance Directive completion rate. [ Time Frame: Up to 1 month after intervention ] [ Designated as safety issue: No ]We adhere to the Intent-to-Treat principle, classifying subjects based on randomized group assignment. We will present Advance Directive completion (presence of the scanned Advance Directive in CPRS/Vista Imaging) rates for both the Nurse-Supported ACP Intervention and Care-as-Usual groups.
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Nurse-Supported Advance Care Planning Intervention
The Nurse-Supported Advance Care Planning Intervention is a manualized education, support, and guidance session provided by a Registered Nurse that includes information about risks, benefits, and alternatives of specific choices.
|
Other: The Nurse-Supported Advance Care Planning Intervention
This intervention is a manualized education, support, and guidance session provided by a Registered Nurse that includes information about risks, benefits, and alternatives of specific choices. It incorporates an application of the Theory for Enabling Safety. J Clin Nurs. 2007 Feb;16(2):382-90. Relatives in end-of-life care--part 2: a theory for enabling safety. Ohl n J, et. al. |
|
Active Comparator: Care-as-Usual
The Care-as-Usual is a session with the social worker who explains what the Advance Directive is, and guides the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects who desire information about risks, benefits, and alternatives of specific choices receive that information from the Primary Care Provider.
|
Other: Care-as-Usual
The Care-as-Usual is a session with the social worker who explains what the Advance Directive is, and guides the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices.
Other Name: SW session
|
Detailed Description:
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 are 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 will be prospectively randomized to either the Nurse-Supported Advance Care Planning Intervention or Care-as-Usual. The Nurse-Supported Advance Care Planning Intervention is a manualized education, support, and guidance session provided by a Registered Nurse that includes information about risks, benefits, and alternatives of specific choices. The Care-as-Usual is a session with the social worker who explains what the Advance Directive is, and guides 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 will be collected, analyzed, and evaluated.
Status:
The Tuscaloosa VA Medical Center IRB has approved this study. This study is not yet open to enrollment
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Signed informed consent
- Male or female
- Any race or ethnic origin
- 19 years of age (i.e. minors are excluded)
- Veteran indicates he/she has no Advance Directive
- Speaks and understands English
- Any category of rurality through urbanity of home residence or place of habitation
- Veteran is willing to extend the screening/baseline visit or return within 30 days for the ACP session
Exclusion Criteria:
- Diagnosis of dementia (all causes) or other cognitive disorder documented in computerized patient record system problem list. (Note: this would include, for example, a mental disability that precludes informed consent capacity, e.g. a documented condition including an age level equivalency understanding of a child of age 6)
- Diagnosis of serious mental illness (i.e. schizophrenia, schizoaffective disorder, bipolar I, major depression with psychotic features) documented in computerized patient record system problem list
- Actively considering plans of suicide or homicide per self report during screening interview direct question
- Psychotic symptoms that impair the subject's ability to give informed consent
- Current hospice care or palliative care recipient. (Note: The major predicted potential impact of this intervention is for Veterans who typically receive little or no ACP support. Veterans who receive palliative care/hospice care at Tuscaloosa VAMC typically receive timely and full ACP support including Advance Directive completion support if desired. Veterans receiving palliative care and hospice care at Tuscaloosa VA Medical Center may tire easily and/or have pain/discomfort problems that could easily be exacerbated by research procedures. These research procedures themselves have the potential to add to end of life distress.)
- Currently incarcerated
Contacts and Locations| Contact: Ann F Mahaney-Price, BSN MS DNP | (205) 554-2000 ext 3574 | ann.mahaney-price@va.gov |
| United States, Alabama | |
| VA Medical Center, Tuscaloosa, AL | Recruiting |
| Tuscaloosa, Alabama, United States, 35404 | |
| Contact: Ann F Mahaney-Price, BSN MS DNP 205-554-2000 ext 3574 ann.mahaney-price@va.gov | |
| Contact: Lori L Davis, MD AB (205) 554-3819 lori.davis@va.gov | |
| Principal Investigator: Ann F Mahaney-Price, BSN MS DNP | |
| Principal Investigator: | Ann F Mahaney-Price, BSN MS DNP | VA Medical Center, Tuscaloosa, AL |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01746368 History of Changes |
| Other Study ID Numbers: | NRI 10-311 |
| Study First Received: | November 29, 2012 |
| Last Updated: | May 15, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
advance directives |
ClinicalTrials.gov processed this record on May 19, 2013