Enabling Advance Directive Completion

NCT01746368 | Completed Results DMC

• 1 other identifier: NRI 10-311
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advance Directives

Keywords

advance directives

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Completed an Advance Directive

  An advance directive was considered completed upon confirmation of the scanned document in the medical record.

  Up to 1 month after intervention

Secondary Outcomes (1)

• Satisfaction

  For participants who received the allocated intervention, up to one month after intervention; for all others, up to 90 days after consenting to the study.

Study Arms (2)

Nurse-Supported Advance Care Planning Intervention

EXPERIMENTAL

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.

Other: The Nurse-Supported Advance Care Planning Intervention

Care-as-Usual

ACTIVE COMPARATOR

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. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.

Other: Care-as-Usual

Interventions

The Nurse-Supported Advance Care Planning Intervention OTHER

This 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. It incorporated an application of the Theory for Enabling Safety.

Also known as: Enabling Intervention, RN session

Nurse-Supported Advance Care Planning Intervention

Care-as-Usual OTHER

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.

Also known as: As Usual (AU) Intervention, SW session

Care-as-Usual

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Male or female
• Any race or ethnic origin
• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Tuscaloosa, Alabama, 35404, United States

Location

Related Publications (1)

• Ohlen J, Andershed B, Berg C, Frid I, Palm CA, Ternestedt BM, Segesten K. Relatives in end-of-life care--part 2: a theory for enabling safety. J Clin Nurs. 2007 Feb;16(2):382-90. doi: 10.1111/j.1365-2702.2006.01474.x.

  PMID: 17239074 RESULT

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Limitations and Caveats

The local Institutional Review Board directed that the advance directive completion and satisfaction data for one participant randomized to the Nurse-Supported Advance Care Planning Intervention be excluded from analysis.

Results Point of Contact

• Title: Ann Mahaney-Price, DNP
• Organization: Tuscaloosa VA Medical Center (Retired)

amparnp@yahoo.com

205-409-8301

Study Officials

• Ann F Mahaney-Price, BSN MS DNP

  VA Medical Center, Tuscaloosa, AL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: December 10, 2012
• Study Start: April 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: June 12, 2015
• Results First Posted: June 12, 2015

Record last verified: 2015-05

Locations

US (1)