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

NCT03028961 | Completed DMC

• 1 other identifier: BMT313
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Advance Directives; Bone Marrow Transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  Up to BMT day 0

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

  Up to BMT day 0

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

  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

  within 28 days of ACP completion

Study Arms (2)

Group I (Stanford Letter, interview)

EXPERIMENTAL

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: Stanford Letter; Other: Interview; Other: Questionnaire Administration

Group II (traditional advance directive, interview)

ACTIVE COMPARATOR

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

Interventions

Stanford Letter OTHER

Receive and complete the Stanford Letter

Also known as: Communication Intervention

Group I (Stanford Letter, interview)

Interview OTHER

Undergo semi-structured, research staff-led interview

Group I (Stanford Letter, interview); Group II (traditional advance directive, interview)

Questionnaire Administration OTHER

Ancillary studies

Group I (Stanford Letter, interview); Group II (traditional advance directive, interview)

CA Advance Health Care Directive Form OTHER

Receive and complete the CA Advance Health Care Directive Form

Also known as: Communication Intervention

Group II (traditional advance directive, interview)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Less than 18 years of age

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Lori Muffly, MD

  Stanford Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 23, 2017
• Study Start: March 3, 2017
• Primary Completion: September 14, 2018
• Study Completion: July 27, 2021
• Last Updated: June 14, 2022

Record last verified: 2022-06

Locations

US (1)