Stanford Letter or Traditional Advance Directive in Advance Care Planning in Patients Undergoing Bone Marrow Transplant (BMTSLPRCT)

Stanford University

Status: Completed

Conditions: Bone Marrow Transplant; Advance Directives

Treatments: Other: Stanford Letter; Other: CA Advance Health Care Directive Form; Other: Interview; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT03028961

BMT313

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Less than 18 years of age

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 2 patient groups

Group I (Stanford Letter, interview)

Experimental group

Description:

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.

Treatment:

Other: Interview

Other: Stanford Letter

Other: Questionnaire Administration

Group II (traditional advance directive, interview)

Active Comparator group

Description:

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.

Treatment:

Other: Interview

Other: CA Advance Health Care Directive Form

Other: Questionnaire Administration