NCT03028961

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advance Directives
• Bone Marrow Transplant

Interventions

Type	Name	Description
OTHER	Stanford Letter	Receive and complete the Stanford Letter
OTHER	Interview	Undergo semi-structured, research staff-led interview
OTHER	Questionnaire Administration	Ancillary studies
OTHER	CA Advance Health Care Directive Form	Receive and complete the CA Advance Health Care Directive Form

Timeline

• Start date: 2017-03-03
• Primary completion: 2018-09-14
• Completion: 2021-07-27
• First posted: 2017-01-23
• Last updated: 2022-06-14

Locations

1 site across 1 country: United States