Enabling Advance Directive Completion
Completed · Not applicable
Conditions studied: Advance Directives
In brief
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.
Key facts
- Study ID
- NCT01746368
- Run by
- US Department of Veterans Affairs
- People needed
- 50
- Starts
- 2013-04-01
- Expected to finish
- 2014-02-01
- Last updated by the study team
- 2015-06-12
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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 advance care planning (ACP) session
You may not qualify if…
- 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 VA Medical Center (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
Where it is running
- Tuscaloosa VA Medical Center, Tuscaloosa, AL — Tuscaloosa, Alabama, United States
Full record on ClinicalTrials.gov
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