What side effects are associated with this type of intervention?

The most common treatments for Interstitial Lung Disease (ILD) include antifibrotic medications such as nintedanib and pirfenidone. Nintedanib is associated with side effects like diarrhea, nausea, and liver enzyme elevation. Pirfenidone can cause nausea, rash, and photosensitivity. Both medications aim to slow disease progression and reduce acute exacerbations but do not cure the disease. Additionally, systemic glucocorticoids are used in acute exacerbations, with potential side effects including immunosuppression, hyperglycemia, and osteoporosis.

What prior FDA approvals exist?

The FDA has approved pirfenidone and nintedanib for the treatment of idiopathic pulmonary fibrosis, a type of interstitial lung disease. These drugs have been shown to slow disease progression and improve outcomes. However, these pharmacological treatments are not directly related to advance care planning approaches such as Respecting Choices (First Steps) or Five Wishes, which focus on structured conversations and patient-driven planning for future healthcare decisions.

What other types of research exist?

Promising novel alternatives for advance care planning in ILD patients include: 1) Digital health platforms that facilitate continuous and dynamic advance care planning through mobile apps and online portals, allowing for real-time updates and easy access to care preferences. 2) Integrative palliative care models that combine telehealth consultations with in-person visits to provide comprehensive, personalized care planning. 3) Community-based programs that involve multidisciplinary teams, including social workers and palliative care specialists, to support patients and caregivers in advance care planning. These approaches aim to enhance patient engagement, improve communication across care settings, and ensure that care preferences are documented and respected.

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Advance Care Planning Approaches for Older Adults (EQUALACP Trial)

N/A

Waitlist Available

Led By Kimberly Johnson, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

age 65 or greater

Serious or chronic illness including: metastatic cancer; end stage renal disease; advanced liver disease, heart disease or lung disease; amyotrophic lateral sclerosis, severe Parkinson's disease; 2 or more unplanned hospitalizations in the last year; requiring assistance with any basic activity of daily living

Must not have

Current or prior use of non-hospice palliative care except inpatient palliative care consultation

Current or prior use of hospice

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months, one year

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two ways to help older African Americans and Whites plan their future medical care. One method uses a guided conversation with a trained person, and the other uses a simple form. The goal is to see which method is better at helping people document their care wishes.

Who is the study for?

This trial is for older adults aged 65 or above, living in their own homes, who can make decisions about their future healthcare. They must have a serious illness like advanced cancer, heart or lung disease, kidney failure, ALS or severe Parkinson's disease. Participants should not be surprised if told they might pass away within the next year and may need help with daily activities.

What is being tested?

The study compares two ways of planning future healthcare: one uses a structured conversation guided by trained facilitators (Respecting Choices First Steps), while the other involves patients filling out an easy-to-understand form called Five Wishes on their own.

What are the potential side effects?

Since this trial focuses on advance care planning rather than medical treatments, there are no direct physical side effects. However, discussing end-of-life care can be emotionally challenging and may cause distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 65 years old or older.

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I have a serious illness or have been frequently hospitalized.

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I have a serious illness or have been hospitalized twice last year.

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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have used palliative care services that were not part of hospice care.

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I am currently using or have used hospice care services.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months, one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months, one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of African Americans who complete advance care planning

Proportion of Whites who complete advance care planning

Secondary study objectives

Difference in Proportion of Whites versus African Americans who complete advance care planning

Patient Quality of Life

Patient Readiness to Engage in Advance Care Planning

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Structured Advance Care PlanningExperimental Treatment1 Intervention

In the structured advance care planning approach, patients will participate in a 60 to 90 minute facilitated advance care planning conversation with a trained person using Respecting Choices (First Steps) guide and will receive a state advance directive form. The advance care planning facilitator will follow-up as needed after the session to answer additional questions.

Group II: Patient Driven Advance Care PlanningActive Control1 Intervention

In the patient-driven advance care planning approach, patients receive a Five Wishes Form (easy to understand advance directive written in plain language), a state advance directive form, and at least two follow-up phone calls with an advance care planning contact who will answer questions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Respecting Choices First Steps

2018

N/A

~790

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Interstitial Lung Disease (ILD) include antifibrotic agents like pirfenidone and nintedanib. Pirfenidone works by inhibiting the synthesis of collagen and reducing fibroblast proliferation, which helps to slow the progression of fibrosis in the lungs. Nintedanib inhibits multiple tyrosine kinases involved in the signaling pathways that lead to fibrosis. Understanding these mechanisms is crucial for ILD patients as it helps them and their healthcare providers make informed decisions about their treatment options and manage expectations regarding disease progression. In the context of advance care planning, such as the Respecting Choices and Five Wishes approaches, this knowledge empowers patients to make choices that align with their values and preferences, ensuring that their care is consistent with their goals and improving their quality of life.

Consensus Guidelines on Interventional Therapies for Knee Pain (STEP Guidelines) from the American Society of Pain and Neuroscience.A prospective evaluation of treatment recommendations compared to outcomes for a lung cancer multidisciplinary team and legal implications.2019 American College of Rheumatology/Arthritis Foundation Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non-Systemic Polyarthritis, Sacroiliitis, and Enthesitis.