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

Stanford University126 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

QUADRUPLE

Conditions

Advance Directives Bone Marrow Transplant

Interventions

Stanford LetterOTHER

Receive and complete the Stanford Letter

InterviewOTHER

Undergo semi-structured, research staff-led interview

Questionnaire AdministrationOTHER

Ancillary studies

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All BMT patients at Stanford who are adults and give consent Exclusion Criteria: * Less than 18 years of age

Locations (1)

Stanford University, School of Medicine

Palo Alto, California, United States

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

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.

Time frame: Up to BMT day 0

Secondary Outcomes

Patient preferences for life sustaining measures measured via answers to the ACP questions related to use of cardiopulmonary resuscitation and use of mechanical intubation

The 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.

Time frame: Up to BMT day 0

Uncertainty with decision making regarding end of life care measured related to the Decisional Conflict Scale (DCS) results

Will be measured using the DCS uncertainty sub-scale (score 0-15; higher score indicates greater uncertainty). Scores from each group will be compared by t-tests.

Time frame: Up to BMT day 0

Understanding of the ACP tool measured using qualitative and quantitative data obtained through the semi-structured interview and DCS

Will be measured using the DCS effective decision-making sub-scale (score 0-15; higher scores indicate 6 less effective decision-making). Likert scores of understanding of the ACP from each group will be summarized and compared by t-tests.

Time frame: within 28 days of ACP completion

Satisfaction with the ACP tool measured using qualitative and quantitative data obtained through the semi-structured interview and DCS

Will be measured using the DCS effective decision-making sub-scale (score 0-15; higher scores indicate 6 less effective decision-making). Scores from each group will be compared by t-tests. Likert scores of satisfaction with the ACP will be summarized and compared by group using t-tests.

Data from ClinicalTrials.gov

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