Video Intervention for Advance Care Planning

Overseen By Lori Henault, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Disqualifiers: Visual impairment, Psychological state, Cognitive impairment

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a video program called I kua na'u "Let Me Carry Out Your Last Wishes," designed to help Native Hawaiians (NHs) better understand and engage in Advance Care Planning (ACP), which involves making decisions about future medical care. The researchers aim to determine if using video, a key part of NH culture, can improve how well ACP aligns with NHs' preferences for their care, especially in serious illness situations. Participants will use personal video declarations to share their wishes with loved ones and healthcare providers. This trial suits NH adults over 55 who have an ongoing relationship with a primary care provider and have been referred by a community organization. As an unphased trial, this study offers a unique opportunity for participants to contribute to culturally relevant healthcare solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using video interventions for advance care planning rather than medication changes.

What prior data suggests that this video intervention is safe for advance care planning?

Research has shown that the "I kua na'u" video for planning future medical care is safe for use. Earlier studies found this video-based learning tool easy to use and understand. Designed specifically for Native Hawaiians, it respects their cultural traditions and preferences. The studies assessed the video's quality and confirmed it aids decision-making without causing harm. Notably, no negative effects have been reported from using the video, indicating it is a safe choice for trial participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Let Me Carry Out Your Last Wishes" video intervention because it offers a unique approach to advance care planning (ACP) by using a visual decision aid. Unlike traditional methods that rely on verbal conversations or written documents, this video format can make complex information more accessible and easier to understand. By potentially enhancing comprehension and engagement, the video aims to empower individuals to make more informed decisions about their end-of-life care preferences. This could lead to better alignment between patients' wishes and the care they receive, which is a significant improvement over current ACP practices.

What evidence suggests that this video intervention is effective for advance care planning?

Research shows that the "I kua na'u" video program, available to participants in this trial, helps Native Hawaiians make informed decisions about future healthcare planning. Studies have found that planning ahead improves end-of-life experiences for patients and their families. The video, culturally relevant and storytelling-based, aids Native Hawaiians in expressing their wishes. Previous evaluations confirmed the video's high quality and suitability for this community. This approach is expected to boost interest, understanding, and completion of healthcare planning among participants. ^{1 2 3 4 6}

Who Is on the Research Team?

Michael Paasche-Orlow, MD, MPH

Principal Investigator

Tufts Medical Center

Are You a Good Fit for This Trial?

This trial is for Native Hawaiian adults over the age of 55 who have seen their primary care provider at least twice before. They must be referred by a community organization and able to participate in discussions about future medical care planning. Those with severe visual impairments or significant cognitive issues cannot join.

Inclusion Criteria

I am over 55 years old.

Referral by collaborating community organization

Pre-existing relationship with a primary care provider (PCP, minimum of two prior visits to PCP)

Exclusion Criteria

I cannot see videos well due to my poor eyesight.

You have significant memory or thinking problems, as shown by a test called the Short Portable Mental Status Questionnaire.

psychological state not appropriate for ACP discussions as determined by RA or clinician

Timeline for a Trial Participant

Development

Development of the I kua na'u ACP video program with focus group testing and stakeholder interviews

2 years

Implementation

Implementation of the video intervention in the Native Hawaiian community, including a pre-post study design and a randomized controlled trial

3 years

Follow-up

Participants are monitored for changes in ACP engagement, knowledge, and decisional conflict

6 months

Follow-up interviews at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• I kua na'u "Let Me Carry Out Your Last Wishes"

Trial Overview

The study tests an Advance Care Planning video program called I kua na'u, designed for Native Hawaiians. It aims to inform them about medical options like palliative care and encourage sharing their health care wishes through personal video stories with family and doctors.

How Is the Trial Designed?

Group I: Randomized Clinical Trial: Intervention Group Experimental Treatment 1 Intervention

In the ambulatory clinics we will conduct a randomized controlled trial (N=110), and randomize (1:1) to either the video (intervention) or usual care (control) arm. The intervention group will use the ACP video decision aid. All participants will have a baseline survey, be randomized to intervention or control, and receive a post-intervention survey, which includes the same items as the baseline survey. Follow-up in person or by phone interviews will be done at three and six months.

Group II: Pre-Post Trial Experimental Treatment 1 Intervention

Native Hawaiian participants from Homestead and Group Assisted Living (N=110) will partake in a pre-post study design. Participants will receive a baseline survey (as described below), view the ACP video intervention, and receive a post-intervention survey, which includes the same items as the baseline survey. In-person or phone interviews will be done at three and six months.

Group III: Randomized Clinical Trial: Control Group Active Control 1 Intervention

In the ambulatory clinics we will conduct a randomized controlled trial (N=110), and randomize (1:1) to either the video (intervention) or usual care (control) arm. The control group will receive usual care. All participants will have a baseline survey, be randomized to intervention or control, and receive a post-intervention survey, which includes the same items as the baseline survey. Follow-up in person or by phone interviews will be done at three and six months.

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

University of Hawaii

Collaborator

Trials

122

Recruited

55,200+

Queen's Medical Center

Collaborator

Trials

24

Recruited

4,900+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37884121/

I kua na'u "Let me carry out your last wishes" Clinical trial ...

Our protocol aims to evaluate the efficacy of our video-based educational intervention for Native Hawaiians to support decision making in this community.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714423002884

I kua na'u "Let me carry out your last wishes" Clinical trial ...

Our protocol aims to evaluate the efficacy of our video-based educational intervention for Native Hawaiians to support decision making in this community and ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10814879/

I kua na'u "Let Me Carry Out Your Last Wishes" Clinical ...

Our protocol aims to evaluate the efficacy of our video-based educational intervention for Native Hawaiians to support decision making in this community and ...

4.

researchgate.net

researchgate.net/publication/374958060_I_kua_na'u_Let_me_carry_out_your_last_wishes_Clinical_trial_protocol_to_promote_advance_care_planning_among_native_Hawaiian_populations

I kua na'u "Let me carry out your last wishes" Clinical trial ...

A quality assessment was conducted by two independent reviewers. Both tools met all 12 IPDAS criteria. These results confirm their quality and suitability for ...

5.

clinicaltrial.be

clinicaltrial.be/en/details/176564?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

I Kua Na'u Advance Care Planning for Native Hawaiian ...

ACP is the most consistent factor associated with better end-of-life outcomes in patients with advanced illness and their caregivers. The lack ...

6.

ord.queens.org

ord.queens.org/wp-content/uploads/2024/11/7-Hale-I-Kua-Nau-Poster.pdf

I Kua Na'u - Research

The I Kua Na'u (“Let me carry out your last wishes”) randomized control study utilizes video interventions targeted at the different cultural contexts in which ...