Advance DirectivesBMTSLPRCTNCT03028961
Stanford Letter or Traditional Advance Directive in Advance Care Planning in Patients Undergoing Bone Marrow Transplant
A study testing Stanford Letter, Interview and Questionnaire Administration in people with Advance Directives and Bone Marrow Transplant, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Advance Directives, Bone Marrow Transplant
- What is being tested?
- Stanford Letter, Interview and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2017to 27 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All BMT patients at Stanford who are adults and give consent
Who cannot join
- Less than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Palo Alto, California, 94304
About this study
Official title: 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.
Read the 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:
- 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
- Being tested
- Stanford Letter, Interview, Questionnaire Administration, CA Advance Health Care Directive Form
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stanford LetterOther
Also called Communication Intervention
Receive and complete the Stanford Letter
InterviewOther
Undergo semi-structured, research staff-led interview
Questionnaire AdministrationOther
Ancillary studies
CA Advance Health Care Directive FormOther
Also called Communication Intervention
Receive and complete the CA Advance Health Care Directive Form
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Interview; Other: Questionnaire Administration; Other: CA Advance Health Care Directive Form |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within 28 days of ACP completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start3 Mar 2017
- Primary completion14 Sep 2018
- Study completion27 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance DirectivesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lori Muffly, MD, Principal investigator, Stanford Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028961
- Sponsor's protocol ID
- BMT313
- Acronym
- BMTSLPRCT
- Status last verified
- Jun 2022
- First submitted
- 13 Jan 2017
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Study Comparing the Effectiveness of the Stanford Letter to the Traditional Advance Directive in Bone Marrow Transplant Recipients
- ClinicalTrials.gov ID
- NCT03028961
- Acronym / sponsor ID
- BMTSLPRCT / BMT313
- Conditions
- Advance Directives, Bone Marrow Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Stanford Letter, interview) | Experimental | Other: Stanford Letter, Other: Interview, Other: Questionnaire AdministrationPatients 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 (traditional advance directive, interview) | Active comparator | Other: Interview, Other: Questionnaire Administration, Other: CA Advance Health Care Directive FormPatients 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All BMT patients at Stanford who are adults and give consent
Key exclusion criteria (1 listed)
- Less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stanford LetterAlso: Communication InterventionReceive and complete the Stanford Letter | Other | Group I (Stanford Letter, interview) |
| InterviewUndergo semi-structured, research staff-led interview | Other | Group I (Stanford Letter, interview), Group II (traditional advance directive, interview) |
| Questionnaire AdministrationAncillary studies | Other | Group I (Stanford Letter, interview), Group II (traditional advance directive, interview) |
| CA Advance Health Care Directive FormAlso: Communication InterventionReceive and complete the CA Advance Health Care Directive Form | Other | Group II (traditional advance directive, interview) |
Primary outcome
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
Time frame: Up to BMT day 0
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.
4 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
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
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
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
Time frame: within 28 days of ACP completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Muffly, MD principal investigator
Stanford Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stanford Letter, Interview and Questionnaire Administration in people with Advance Directives and Bone Marrow Transplant, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Up to BMT day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.