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

Randomized Clinical Study Comparing the Effectiveness of the Stanford Letter to the Traditional Advance Directive in Bone Marrow Transplant Recipients

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.

Study Overview

• Status: Completed
• Conditions: Bone Marrow Transplant; Advance Directives
• Intervention / Treatment: Other: Questionnaire Administration; Other: Stanford Letter; Other: Interview; Other: CA Advance Health Care Directive Form

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Less than 18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Other: Stanford Letter; Receive and complete the Stanford Letter; Other Names: Communication Intervention; Other: Interview; Undergo semi-structured, research staff-led interview
Active Comparator: 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.	Other: Questionnaire Administration; Ancillary studies; Other: Interview; Undergo semi-structured, research staff-led interview; Other: CA Advance Health Care Directive Form; Receive and complete the CA Advance Health Care Directive Form; Other Names: Communication Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to BMT day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	within 28 days of ACP completion

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Lori Muffly, MD, Stanford Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2017
• Primary Completion (Actual): September 14, 2018
• Study Completion (Actual): July 27, 2021

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (Estimate): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BMT313

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No