Randomized Clinical Study Comparing the Effectiveness of the Stanford Letter to the Traditional Advance Directive in Bone Marrow Transplant Recipients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- ACP completion rate defined as a completed Advance Directive tool (either Stanford Letter or standard CA AD) brought to Stanford University for upload into the medical record
Study Overview
Brief Summary
The purpose of the proposed research study is to evaluate whether bone marrow transplant patients prefer the Stanford letter advance care planning tool to the standard Advance directive.
Completion of advance care planning prior to BMT is very important, but not often done. The investigators believe that the Stanford Letter will be preferred by patients and will allow them to feel more comfortable and share more of their wishes with family members and the medical team.
Detailed Description
PRIMARY OBJECTIVES I. To compare advance care planning (ACP) completion rate amongst bone marrow transplant (BMT) recipients receiving the Stanford Letter versus the traditional advance directive (AD) through a prospective, pilot randomized controlled trial (RCT).
SECONDARY OBJECTIVES:
I. To evaluate differences in patient preference for choice to prolong life following completion of the ACP tool in each group.
II. To assess uncertainty with decision making regarding end of life care following completion of the ACP tool in each group.
III. To explore patient understanding of and satisfaction with the ACP tool in each group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All BMT patients at Stanford who are adults and give consent
Exclusion Criteria
- •Less than 18 years of age
Arms & Interventions
Group I (Stanford Letter, interview)
Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the Stanford Letter and complete and return the form by the day of BMT. After completion of the Stanford Letter, patients undergo a semi-structured, research staff-led interview to evaluate personal perceptions of uncertainty with end-of-life decisions, understanding of the ACP form received, and satisfaction with the ACP form.
Intervention: Stanford Letter (Other)
Group I (Stanford Letter, interview)
Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the Stanford Letter and complete and return the form by the day of BMT. After completion of the Stanford Letter, patients undergo a semi-structured, research staff-led interview to evaluate personal perceptions of uncertainty with end-of-life decisions, understanding of the ACP form received, and satisfaction with the ACP form.
Intervention: Interview (Other)
Group II (traditional advance directive, interview)
Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the CA Advance Health Care Directive Form and complete and return the form by the day of BMT. After completion of the CA Advance Health Care Directive Form, patients undergo interview as in Group I.
Intervention: Interview (Other)
Group I (Stanford Letter, interview)
Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the Stanford Letter and complete and return the form by the day of BMT. After completion of the Stanford Letter, patients undergo a semi-structured, research staff-led interview to evaluate personal perceptions of uncertainty with end-of-life decisions, understanding of the ACP form received, and satisfaction with the ACP form.
Intervention: Questionnaire Administration (Other)
Group II (traditional advance directive, interview)
Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the CA Advance Health Care Directive Form and complete and return the form by the day of BMT. After completion of the CA Advance Health Care Directive Form, patients undergo interview as in Group I.
Intervention: Questionnaire Administration (Other)
Group II (traditional advance directive, interview)
Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the CA Advance Health Care Directive Form and complete and return the form by the day of BMT. After completion of the CA Advance Health Care Directive Form, patients undergo interview as in Group I.
Intervention: CA Advance Health Care Directive Form (Other)
Outcomes
Primary Outcomes
ACP completion rate defined as a completed Advance Directive tool (either Stanford Letter or standard CA AD) brought to Stanford University for upload into the medical record
Time Frame: Up to BMT day 0
The chi-square (X\^2) test will be used to determine a significant difference in proportion of ACP tool completion and preferences for choice to prolong life between the two groups.
Secondary Outcomes
- Satisfaction with the ACP tool measured using qualitative and quantitative data obtained through the semi-structured interview and DCS(within 28 days of ACP completion)
- Patient preferences for life sustaining measures measured via answers to the ACP questions related to use of cardiopulmonary resuscitation and use of mechanical intubation(Up to BMT day 0)
- Uncertainty with decision making regarding end of life care measured related to the Decisional Conflict Scale (DCS) results(Up to BMT day 0)
- Understanding of the ACP tool measured using qualitative and quantitative data obtained through the semi-structured interview and DCS(within 28 days of ACP completion)