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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Advance Directives, Bone Marrow Transplant

Intervention / Treatment
-----------------
* Other: Stanford Letter
* Other: Interview
* Other: Questionnaire Administration
* Other: CA Advance Health Care Directive Form


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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (Stanford Letter, interview)<br>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<br>* Receive and complete the Stanford Letter<br>* Other names: Communication Intervention;Other: Interview<br>* Undergo semi-structured, research staff-led interview<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Group II (traditional advance directive, interview)<br>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<br>* Undergo semi-structured, research staff-led interview<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Other: CA Advance Health Care Directive Form<br>* Receive and complete the CA Advance Health Care Directive Form<br>* 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 |