Advance DirectivesEADCRAVNCT01746368
Enabling Advance Directive Completion
A study testing The Nurse-Supported Advance Care Planning Intervention and Care-as-Usual in people with Advance Directives, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advance Directives
- What is being tested?
- The Nurse-Supported Advance Care Planning Intervention and Care-as-Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Feb 2014
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, 35404
About this study
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.
Read more
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.
Read the 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 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.
- Conditions
- Advance Directives
- Being tested
- The Nurse-Supported Advance Care Planning Intervention, Care-as-Usual
- Keywords
- advance directives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Nurse-Supported Advance Care Planning InterventionOther
Also called Enabling Intervention, RN session
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.
Care-as-UsualOther
Also called As Usual (AU) Intervention, SW session
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Care-as-Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Completed an Advance Directive
An advance directive was considered completed upon confirmation of the scanned document in the medical record.
Measured: Up to 1 month after intervention
Secondary outcomes (1)
Satisfaction
Score on the Client Satisfaction Questionnaire-8 (CSQ-8). The overall score is produced by summing all item responses. For the CSQ-8, scores range from 8 to 32, with higher values indicating higher satisfaction.
Response options differ from item to item, but all are based on a four-point scale.
All items are positively worded; however, the directionality of response options span the spectrum from very negative to very positive; and, the numerical anchors for items are reversed randomly (from high to low or low to high) from item to item to minimize stereotypic response sets. The CSQ-8 has no subscales and reports a single score measuring a single dimension of overall satisfaction.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startApr 2013
- Primary completionJan 2014
- Study completionFeb 2014
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 (1)Papers the sponsor has linked to this study.
- Other trials for Advance DirectivesStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ann F Mahaney-Price, BSN MS DNP, Principal investigator, VA Medical Center, Tuscaloosa, AL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746368
- Sponsor's protocol ID
- NRI 10-311
- Acronym
- EADCRAV
- Status last verified
- May 2015
- First submitted
- 29 Nov 2012
- Last updated
- 12 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 17239074
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enabling Advance Directive Completion by Rural Alabama Veterans: A Pilot Study
- ClinicalTrials.gov ID
- NCT01746368
- Acronym / sponsor ID
- EADCRAV / NRI 10-311
- Conditions
- Advance Directives
- Keywords
- advance directives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Posted 12 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-Supported Advance Care Planning Intervention | Experimental | Other: The Nurse-Supported Advance Care Planning InterventionThe 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. |
| Care-as-Usual | Active comparator | Other: Care-as-UsualThe 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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.)
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 |
|---|---|---|
| The Nurse-Supported Advance Care Planning InterventionAlso: Enabling Intervention, RN sessionThis 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. | Other | Nurse-Supported Advance Care Planning Intervention |
| Care-as-UsualAlso: As Usual (AU) Intervention, SW sessionThe 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. | Other | Care-as-Usual |
Primary outcome
Number of Participants Who Completed an Advance Directive
Time frame: Up to 1 month after intervention
An advance directive was considered completed upon confirmation of the scanned document in the medical record.
1 secondary outcome
Satisfaction
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17239074Ohlen 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.
Related trials for Advance Directives
Recruiting
Mobile Health Application (PACT) to Improve Engagement in Advance Care Planning
Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
RecruitingObservational study
Advance Directive Implementation and Scientific Evaluation Study
Loss of Capability of Judgement
Recruiting
Motivational Interviewing to Enhance Advance Care Planning for Older Adults and Caregivers After Emergency Visits
Older Adults, Advance Care Planning
Enrolling by invitationObservational study
Advance Choice Document Implementation
Detention Under the Mental Health Act
Recruiting
Comparing the Stanford Letter Project Form to Traditional Advance Directives
Advance Directives, Palliative Care
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.
Ann F Mahaney-Price, BSN MS DNP principal investigator
VA Medical Center, Tuscaloosa, AL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Nurse-Supported Advance Care Planning Intervention and Care-as-Usual in people with Advance Directives, run by US Department of Veterans Affairs at 1 site 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 8 inclusion and 6 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 12 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 12 Jun 2015). 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?
Number of Participants Who Completed an Advance Directive (time frame: Up to 1 month after intervention). 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 NCT01746368, which also lists 1 linked publication.
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 12 Jun 2015.