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

Trial Summary

What is the purpose of this trial?

Our goal is to compare two types of advance directives forms available in English and Spanish to determine which is more easy to use for 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 data supports the effectiveness of the treatment Stanford Letter Project Form?

Research suggests that advance directives, like the Stanford Letter Project Form, can improve end-of-life care by ensuring patients' wishes are known and respected. The use of story-based approaches in advance directives has been shown to effectively capture patient values, which can lead to better alignment of medical care with patient preferences. ^{1 2 3 4 5}

Is it safe to use advance directives like the Stanford Letter or traditional forms?

There is no specific safety data available for advance directives like the Stanford Letter or traditional forms, but they are generally considered safe as they are documents used to guide healthcare decisions rather than medical treatments. ^{1 2 4 6 7}

How does the Stanford Letter treatment differ from traditional forms for advance directives?

The Stanford Letter treatment is unique because it uses a personalized letter format to help patients express their end-of-life care wishes, potentially increasing completion rates and patient satisfaction compared to traditional advance directive forms. This approach focuses on what matters most to the patient, offering a more individualized and potentially more meaningful way to document their preferences. ^{1 3 8 9 10}

Research Team

VJ Periyakoil, MD

Principal Investigator

Stanford University

Eligibility Criteria

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.

Exclusion Criteria

I am younger than 18 years old.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Patients' attitudes toward advance directives and end-of-life treatment decisions. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Physician orders for life-sustaining treatment form: honoring end-of-life directives for nursing home residents. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Using stories to assess values and establish medical directives. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Practical methods to increase use of advance medical directives. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of an educational program on medical students' conversations with patients about advance directives: a randomized trial. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Advance directives in Utah. Information from death certificates and informants. [2004]

8. Luxembourg pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Prospective Randomized Study of Advance Directives in Allogeneic Hematopoietic Cell Transplantation Recipients. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

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