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

220 Participants Needed

Trial Summary

What is the purpose of this trial?

Communication surrounding serious illness decision making is formalized in Advance Care Planning (ACP), a process involving verbal or written information designed to inform patients of possible medical options including palliative and hospice care services. Numerous studies have suggested that improved ACP rates better align health care delivery with patient preferences. Despite expansion of ACP services in the health care system, Native Hawaiians (NHs) consistently have negligible rates of ACP and low use of palliative and hospice care services. To address these shortcomings, our multi-disciplinary community and research group has partnered to create the I kua na'u "Let Me Carry Out Your Last Wishes" ACP video intervention. Our Community-Based Collaborative Approach will create, develop and test the I kua na'u comprehensive video-based ACP program honoring the history, opinions, and culture of NHs. Indeed, NH culture is primarily an oral tradition in which the spoken word permeates the life of NHs and is the normal way of interacting with neighbors, including in its most recent adaptation with the use of video media. The I kua na'u program will include videos tailored for the different settings in which older NHs live and get medical care. The videos will explain the importance of ACP, empower NHs to tell their story ('olelo Kama'ilio; "Talk Story") by allowing the recording of personal video declarations of ACP wishes, and the ability to share the personal video declaration with family, friends and clinicians. The overall objective is to conduct a five-year program that includes two years of development of the I kua na'u ACP video program with focus group testing, and then three years of implementation in the NH community. Demonstrating the effectiveness of using the video program in NHs represents an essential step to implement this tool in practice. The Specific Aim is to compare the ACP engagement, knowledge, decisional conflict, and ACP completion rates in 220 NHs over the age of 55 in: (a) a pre-post study design in 110 people living on Homestead or Assisted Living using the video intervention, and (b) a randomized trial of 110 people recruited from Ambulatory Clinics.

Research Team

Michael Paasche-Orlow, MD, MPH

Principal Investigator

Tufts Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+