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

Trial Summary

What is the purpose of this trial?

The goal of this research is to increase patients' knowledge about advance care planning (ACP) discussions and hospice care for patients with serious illness receiving home-based care.

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 data supports the effectiveness of the treatment ACP Video Intervention for Life-Limiting Illness?

Research shows that using video decision aids in advance care planning (ACP) can help patients make choices about life-sustaining treatments that align with their values and preferences, suggesting that the ACP Video Intervention may be effective in guiding patients with life-limiting illnesses. ^{1 2 3 4 5}

Is the ACP Video Intervention safe for humans?

The research articles reviewed do not provide specific safety data for the ACP Video Intervention, but they focus on its use in improving communication and decision-making for end-of-life care, suggesting it is generally considered safe for these purposes. ^{1 2 6 7 8}

What makes the Home ACP Video treatment unique for life-limiting illness?

The Home ACP Video treatment is unique because it uses video interventions to facilitate advance care planning (ACP), which helps patients and their families discuss and make decisions about end-of-life care. This approach is different from traditional methods as it provides visual and structured guidance, making it easier for patients to understand and engage in the planning process. ^{2 4 6 8 9}

Eligibility Criteria

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 speak English or one of the 25 languages offered for the video.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Video decision aids to assist with advance care planning: a systematic review and meta-analysis. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Implementation of a quality improvement programme to support advance care planning in five hospitals across a health region. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Complex advance care planning interventions for chronic serious illness: how do they work: a scoping review. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Using a self-directed workbook to support advance care planning with long term care home residents. [2021]

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

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

6. England pubmed.ncbi.nlm.nih.gov

Implementing advance care planning in nursing homes - study protocol of a cluster-randomized clinical trial. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of introducing advance care planning on a thoracic medicine inpatient ward: an exploratory mixed method study. [2021]

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

Nursing Home Characteristics Associated With Implementation of an Advance Care Planning Video Intervention. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Collaborative advance care planning in advanced cancer patients: col-ACP -study - study protocol of a randomised controlled trial. [2023]