Stanford Letter vs Traditional Forms for Advance Directives

(SLP Trial)

Overseen By VJ Periyakoil, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Under 18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which type of advance directive form is easier for patients to use. Participants will complete either the Stanford Letter Project Form (also known as the What Matters Most Letter) or the traditional California state advance directive. This study includes English and Spanish speakers who are 18 years or older. The trial focuses on ensuring patients can easily express their healthcare wishes. Those who have found medical forms confusing might be well-suited for this trial. As an unphased study, this trial provides a unique opportunity to contribute to research that simplifies healthcare decision-making for future patients.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these advance directive forms are safe to use?

In a previous study, researchers created the Stanford Letter Project Form to help individuals easily document their healthcare wishes. This form serves as an advance directive, allowing people to express their treatment preferences if they become unable to communicate. Research has shown that the form is user-friendly and involves no physical treatments, ensuring no safety risks.

Traditional advance directives, used in the control group, have long been a standard method for documenting healthcare wishes. Like the Stanford Letter, these forms focus on sharing values and preferences rather than medical treatments. Reports have not indicated any safety issues, as these forms are not medical procedures.

Both forms are safe, as they simply involve writing down healthcare wishes. No adverse events have been reported, as completing paperwork poses no physical risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different methods for completing advance directives could improve end-of-life planning. The Stanford Letter Project Form is unique because it emphasizes personal stories and values, making it easier for individuals to communicate their wishes in a relatable and meaningful way. Unlike traditional advance directives that often use complex legal language, the Stanford Letter is designed to be more user-friendly and accessible, potentially increasing the number of people who complete and understand their advance care plans. Researchers hope to find out if this approach leads to better alignment between patients’ wishes and the care they receive.

What evidence suggests that these advance directive forms are effective for ease of use?

This trial will compare the Stanford Letter Project form with traditional advance directives. Research has shown that the Stanford Letter Project form helps people create advance directives more easily. This form guides users to express their personal values and wishes for future medical care simply. It aims to make completing advance directives quicker and more accessible. Many people find it easier to use because it breaks down complicated decisions into easy steps. Although this trial doesn't focus on medical treatment, the form could simplify and enhance planning for future healthcare decisions. ^{1 2 3 4 6}

Who Is on the Research Team?

VJ Periyakoil, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults over the age of 18 who are interested in preparing advance directives, which are documents that outline a person's wishes regarding medical treatment if they become unable to communicate them.

Inclusion Criteria

I am over 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Consent and Randomization

Participants read the consent form and are randomly assigned to either the letter or traditional advance directives

1 week

Questionnaire Completion

Participants complete the assigned advance directive and answer questions about its clarity and ease of use

1-2 weeks

Data Collection and Analysis

Data is collected until reaching n=1000 and then analyzed for publication

Ongoing until completion

Follow-up

Participants are monitored for feedback on the ease of use and understanding of the advance directives

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Stanford Letter Project Form
• Traditional Advance Directives

Trial Overview The study is comparing two types of advance directive forms: the Stanford Letter Project Form and traditional forms. The goal is to see which form patients find easier to use. Participants will be randomly assigned one of these forms.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants in the intervention arm complete the Stanford letter advance directive

Group II: Control Active Control 1 Intervention

Participants in the control arm complete the California state traditional advance directive

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Over half of the study participants felt knowledgeable enough to issue advance directives and preferred to do so while healthy, indicating a proactive approach to end-of-life planning.

Patient education about advance directives may be more effective if provided before hospitalization, as aggressive education during hospital stays can be perceived as coercive, suggesting a need for more supportive and family-involved discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' attitudes toward advance directives and end-of-life treatment decisions. Nolan, MT., Bruder, M.[2019]

In the United States, there is a growing consensus on the importance of advance directives for guiding future medical decisions, highlighting their role in patient care.

The article proposes a story-based approach as the most effective method for understanding patient values in advance directives, supported by a newly developed and tested story-based directive form over the past two years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using stories to assess values and establish medical directives. Kielstein, R., Sass, HM.[2019]

The Directive to Physician and Durable Power of Attorney for Healthcare Decisions documents often lack clarity, which can lead to confusion about a patient's wishes during critical medical situations.

It is crucial for individuals to communicate their personal definitions of quality of life and treatment preferences to their families and healthcare providers, ensuring that their values are understood and respected in future healthcare decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of advance directives: a social work perspective on the myth versus the reality. Hoffman, MK.[2004]

Over 50% of individuals who died had completed advance directives, with higher prevalence among those over 65, women, nursing home residents, and hospice users, indicating a significant awareness and use of these documents in end-of-life care.

Despite the high completion rate, most family informants felt that advance directives had little impact on the decedent's care, although some noted they helped limit treatment and eased decision-making burdens for families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advance directives in Utah. Information from death certificates and informants. Jacobson, JA., Kasworm, E., Battin, MP., et al.[2004]

In a pilot study involving nursing homes in eastern Washington, the POLST form effectively communicated end-of-life wishes in 19 out of 21 cases, demonstrating its reliability in ensuring that patients' preferences are honored.

The study also found that an informed consent process was present in 16 of the 21 cases, indicating that the POLST form aligns well with existing advance directives and supports better end-of-life care planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician orders for life-sustaining treatment form: honoring end-of-life directives for nursing home residents. Meyers, JL., Moore, C., McGrory, A., et al.[2019]

Advanced directives vary widely in purpose and design, reflecting the diverse values and ideas of the organizations that create them, making it challenging for individuals to select the appropriate form for their needs.

Providing better information and counseling for the public and healthcare professionals is essential to enhance the validity and effectiveness of advanced directives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Different forms of patient advance directives and their importance to particular groups of people]. Lack, P.[2008]

The Patient Self Determination Act aims to improve the use of living wills by encouraging better advance planning and communication between patients and healthcare providers, addressing the previously low utilization of these documents.

A proposed model advance directive enhances the original Medical Directive by incorporating a broader range of illness scenarios and a treatment goals selection system, making it more relevant for elderly or chronically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The health care directive: learning how to draft advance care documents. Emanuel, L.[2008]

In a study involving 1,302 elderly participants, both written materials and a videotape were used to promote the use of advance medical directives, but the addition of the videotape did not significantly increase the placement rates compared to written materials alone.

The written materials alone increased the placement of advance directives from 21.2% to 35.0%, while the videotape group increased from 18.9% to 32.6%, indicating that while educational materials are effective, the video did not provide additional benefits in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical methods to increase use of advance medical directives. Brown, JB., Beck, A., Boles, M., et al.[2019]

A study involving 126 adult patients undergoing allogeneic hematopoietic cell transplantation found that the overall advance directive (AD) completion rate was high at 71.4%, which is better than historical rates, indicating an improvement in patient engagement regarding end-of-life care decisions.

The use of a novel Letter AD did not significantly increase completion rates compared to the traditional California AD, suggesting that while both formats are effective, the choice of AD type may not impact patient satisfaction or decision-making outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Randomized Study of Advance Directives in Allogeneic Hematopoietic Cell Transplantation Recipients. Tan, IT., Sundaram, V., Ramirez, Y., et al.[2021]

A new educational module on advance directives, specifically the durable power of attorney for health care (DPAHC), was developed for third-year medical students and tested in a randomized trial.

After participating in a two-hour seminar and reviewing written materials, students showed significant improvements in their knowledge, comfort, and skills related to discussing DPAHC, indicating the effectiveness of the educational intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an educational program on medical students' conversations with patients about advance directives: a randomized trial. Greenberg, JM., Doblin, BH., Shapiro, DW., et al.[2019]

Citations

1. med.stanford.edu med.stanford.edu/letter/what-matters-letter.html

What Matters Most | Letter Project - Stanford Medicine The Letter Project is intended to help people from various backgounds write a simple letter to their doctor and their loved ones about their values and life ...

2. med.stanford.edu med.stanford.edu/letter/advancedirective.html

Advance Directives | Letter Project - Stanford Medicine Use the Letter Project form to complete your Advance Directives in Minutes! ... Every adult should complete advance directives..... and most would, if they could!

3. med.stanford.edu med.stanford.edu/letter/friendsandfamily.html

Who Matters Most | Letter Project - Stanford Medicine The goal of Who Matters Most Letter template is to help all Americans complete the seven vital tasks of life review while they still can.

4. med.stanford.edu med.stanford.edu/content/dam/sm/letter/documents/Advance%20Directive%20-%20What%20Matters%20Most%20-%20Stanford.pdf

Advance Directive - What Matters Most An advance health care directive is a form that allows you to document how you want to be cared for in the future, if you cannot speak for yourself. What is the ...

5. med.stanford.edu med.stanford.edu/letter/research.html

Our Research | Letter Project - Stanford Medicine Who Matters Most: The goal of the Who Matters Most Letter template is to help all Americans complete the seven vital tasks of life review while they still can.

6. ama-assn.org ama-assn.org/practice-management/ama-steps-forward-program/advance-directives-how-talk-patients-about-them

Advance directives: How to talk with patients about them An easy letter template can help frame discussions about advance directives and goals of care and serious illness in terms of living well ...