ACP Video Intervention for Life-Limiting Illness

Overseen By Areej El-Jawahri, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Visual impairment, Acute psychiatric illness, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with serious illnesses learn more about planning for future medical care and hospice options. Participants will either continue with their usual care or receive a special visit from a clinician who will show them a video about advance care planning (ACP) and answer any questions. This trial suits those who have been told they likely have a year or less to live and speak one of the languages available in the video. As an unphased trial, this study offers a unique opportunity to gain valuable insights into planning for future care and making informed decisions.

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

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

What prior data suggests that this video intervention is safe for patients with serious illness?

Research shows that using videos for advance care planning (ACP) is generally safe. Studies have examined ACP videos designed to inform patients about their end-of-life care options. These videos help patients communicate their wishes to doctors and increase the documentation of these wishes. No reports indicate negative effects from watching these videos. As an educational tool rather than a medical treatment, the video is considered very low risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ACP Video Intervention because it offers a unique approach to advance care planning for patients with life-limiting illnesses. Unlike traditional methods that rely on face-to-face conversations or written materials, this intervention uses a video format that can be accessed at home. This method provides a more engaging and easily digestible way for patients to understand their care options and make informed decisions. Additionally, having a trained clinician discuss the video content and answer questions enhances patient understanding and comfort, which might lead to better patient outcomes and satisfaction.

What evidence suggests that the ACP Video Intervention is effective for increasing knowledge about advance care planning?

Research has shown that using a video for advance care planning (ACP) can facilitate communication between patients and doctors. In this trial, participants in the video intervention arm will access the ACP video, which studies have shown helps more people document their end-of-life choices, ensuring their wishes are known and respected. One study found that using videos for ACP was linked to fewer hospital visits at the end of life for those with serious illnesses. Overall, these videos help people understand their options, such as CPR (cardiopulmonary resuscitation) and hospice care, leading to better planning and decision-making. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over the age of 21 with serious illnesses who are receiving home-based care and have a life expectancy of one year or less, as determined by a specific algorithm. Participants must speak English or any of the other 25 languages available for the video intervention. It's not suitable for those with significant visual impairment or cognitive issues due to psychiatric illness.

Inclusion Criteria

I am 21 years old or older.

Have a one-year prognosis or less as determined by Clover Health's validated algorithm

Exclusion Criteria

Acute psychiatric illness or other comorbid condition that impairs cognitive ability to participate in advance care planning discussion as determined by the primary House Call Provider.

My vision is worse than 20/200 even with glasses or contacts.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive usual care or usual care plus a visit by a trained study clinician to provide access to the ACP video and discuss its content

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for outcomes such as knowledge about ACP, documentation rates, and satisfaction with communication

up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Home ACP Video

Trial Overview The study is testing whether a home Advance Care Planning (ACP) video can help increase understanding about ACP discussions and hospice care among patients with life-limiting illnesses. The aim is to improve patient knowledge through an educational video intervention.

How Is the Trial Designed?

Group I: Video intervention Experimental Treatment 1 Intervention

In addition to usual care, the intervention will entail having a visit by a trained study clinician to provide access to the ACP video. The study clinician will discuss the content of the video and answer any questions.

Group II: Usual Care Active Control 1 Intervention

Usual care entails receiving usual medical care by the home-based care team.

Home ACP Video is already approved in United States for the following indications:

Approved in United States as ACP Video Intervention for:

• Life-limiting illnesses
• Serious illnesses requiring home-based care

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

A systematic review of 10 trials with 2220 patients found that using video decision aids may significantly reduce the likelihood of patients preferring cardiopulmonary resuscitation, suggesting a shift in treatment preferences towards less aggressive interventions.

Video decision aids were associated with improved knowledge about advance care planning, indicating they can enhance patient understanding of their options, although more research is needed to assess their effectiveness in real clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video decision aids to assist with advance care planning: a systematic review and meta-analysis. Jain, A., Corriveau, S., Quinn, K., et al.[2019]

A pilot study involving 51 patients in a thoracic medicine ward showed that advance care planning (ACP) conversations were well-received, helping to uncover important patient values and preferences that were previously unknown to clinicians.

Both patients and clinicians expressed a positive attitude towards ACP, highlighting the need for management support, training, and dedicated time to effectively integrate ACP into routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of introducing advance care planning on a thoracic medicine inpatient ward: an exploratory mixed method study. Hjorth, NE., Schaufel, MA., Sigurdardottir, KR., et al.[2021]

In a 7-month study involving 1980 hospital patients, 28.2% were identified as potentially eligible for advance care planning (ACP), highlighting the importance of targeted screening in recognizing patients who may benefit from end-of-life discussions.

Of those deemed suitable for ACP discussions, 86% were offered the opportunity, and 73.8% agreed to start the process, demonstrating that a focused approach can significantly increase patient engagement in ACP, although it requires substantial clinical resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a quality improvement programme to support advance care planning in five hospitals across a health region. Schofield, G., Kreeger, L., Meyer, M., et al.[2022]

A self-directed advance care planning (ACP) workbook was distributed to 58 residents in long-term care homes, with 44 completing it, and it effectively helped residents articulate their end-of-life care preferences, showing that 70% wanted to be involved in care decisions.

While the workbook facilitated the expression of care preferences, there was limited evidence of actual conversations occurring between residents and staff or family about these preferences, indicating a need for follow-up protocols and staff training to enhance communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a self-directed workbook to support advance care planning with long term care home residents. Sussman, T., Kaasalainen, S., Lawrence, J., et al.[2021]

The study aims to improve advance care planning (ACP) in Norwegian nursing homes by implementing a structured ACP-guideline over 12 months, focusing on enhancing communication about end-of-life care among patients, relatives, and healthcare staff.

Using a mixed methods approach, the project will evaluate the effectiveness of the intervention through both quantitative data (like patient chart reviews) and qualitative data (such as interviews and observations), aiming to document ACP practices and align treatment with patient preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing advance care planning in nursing homes - study protocol of a cluster-randomized clinical trial. Sævareid, TJL., Lillemoen, L., Thoresen, L., et al.[2019]

The col-ACP study will evaluate a new advance care planning intervention for 270 palliative cancer patients and their relatives, aiming to improve communication about end-of-life decisions and enhance patients' quality of life over 16 weeks.

This innovative approach combines addressing communication barriers with a structured ACP process, potentially leading to better patient outcomes and understanding of the effectiveness of such interventions in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative advance care planning in advanced cancer patients: col-ACP -study - study protocol of a randomised controlled trial. Seifart, C., Koch, M., Leppin, N., et al.[2023]

In a study of 119 nursing homes (NHs) participating in the PROVEN trial, higher star-rated NHs were more likely to offer advance care planning (ACP) video interventions to residents, with offer rates of 69% for short-stay and 56% for long-stay residents.

The study found that participation of NH staff in regular check-in calls positively influenced the implementation of the ACP video intervention, particularly for long-stay residents, highlighting the importance of ongoing support and engagement in successfully integrating new educational programs into care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nursing Home Characteristics Associated With Implementation of an Advance Care Planning Video Intervention. Loomer, L., McCreedy, E., Belanger, E., et al.[2023]

A scoping review of 16 randomized controlled trials on advance care planning (ACP) interventions revealed that tailoring the content of these interventions to meet patients' specific needs was associated with a wider range of positive outcomes.

The study emphasized the importance of clearly defining how ACP interventions are expected to achieve their intended effects and considering the specific context in which they are implemented, as factors like participant characteristics and study methodology can significantly influence outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex advance care planning interventions for chronic serious illness: how do they work: a scoping review. Stevens, J., Deliens, L., Pype, P., et al.[2022]

Advanced care planning (ACP) has evolved from a legal concept to a significant focus in medical literature, highlighting its importance in end-of-life discussions.

This analysis aims to enhance nurses' understanding of ACP, equipping them to better communicate its components and benefits to patients and families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced care planning: The concept over time. Nicholson, B.[2021]

Citations

1. reporter.nih.gov reporter.nih.gov/search/KqMAeqqlzEO92N7sDhVN5Q/project-details/10876240

Project Details - NIH RePORTER We have developed a video-assisted, home-based ACP intervention (Home- ACP) to improve patient-clinician communication, increase ACP documentation, and lead to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8885779/

Effect of a Video-assisted Advance Care Planning ... Video-assisted ACP was modestly associated with reduced hospital transfers in the last 90 days of life among nursing home residents with advanced illness.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0885392419310589

Randomized Controlled Trial of Advance Care Planning ... The intervention was a video that provided information about ACP and end-of-life care options such as cardiopulmonary resuscitation (CPR) and palliative care.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2789397

Association of an Advance Care Planning Video and ... This nonrandomized controlled trial assesses whether an advance care planning intervention improved rates of advance care planning in older ...

5. journal.ilpnetwork.org journal.ilpnetwork.org/articles/10.31389/jltc.225

The Effectiveness of Advance Care Planning (ACP) ... ACP improves communication and documentation of end-of-life choices, the likelihood of dying in one's preferred place of care, and saves healthcare costs ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7399750/

Advance Care Planning Video Intervention Among Long ... This pragmatic cluster randomized clinical trial examines the effect of an advance care planning video program on hospital transfers, burdensome ...

7. acpdecisions.org acpdecisions.org/library/

The ACP Content Library - ACP Decisions Our video library consists of close to 500 videos in 25 different languages. They address a range of issues and fall under four categories.

8. youtube.com youtube.com/watch?v=Rc6gvjSo4YU

Advance Care Planning, Goals of Care and Health Care ... This thought-provoking webinar on advance care planning, goals of care and health care consent delved into how to make informed decisions ...