Clinical trial NCT03028961: Stanford Letter or Traditional Advance Directive in Advance Care Planning in Patients Undergoing Bone Marrow Transplant
Official title: Randomized Clinical Study Comparing the Effectiveness of the Stanford Letter to the Traditional Advance Directive in Bone Marrow Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advance Directives
Bone Marrow Transplant
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (INTERVENTION): 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.

GROUP II (CONTROL): Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the California (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.

After completion of study, patients are followed up periodically.

Eligibility criteria: Inclusion Criteria:

* All BMT patients at Stanford who are adults and give consent

Exclusion Criteria:

* Less than 18 years of age

Primary outcomes:
measure: 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
timeFrame: Up to BMT day 0
Secondary outcomes:
measure: Patient preferences for life sustaining measures measured via answers to the ACP questions related to use of cardiopulmonary resuscitation and use of mechanical intubation
timeFrame: Up to BMT day 0
measure: Uncertainty with decision making regarding end of life care measured related to the Decisional Conflict Scale (DCS) results
timeFrame: Up to BMT day 0
measure: Understanding of the ACP tool measured using qualitative and quantitative data obtained through the semi-structured interview and DCS
timeFrame: within 28 days of ACP completion
measure: Satisfaction with the ACP tool measured using qualitative and quantitative data obtained through the semi-structured interview and DCS
timeFrame: within 28 days of ACP completion
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford Cancer Institute
name: Lori Muffly, MD
role: PRINCIPAL_INVESTIGATOR
References: