Video Decision Aid for Emergency Care Planning

(VIDEO-ED Trial)

Not currently recruiting at 3 trial locations

Overseen By Angelo Volandes

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Non english speakers, Legally blind, ICU care, 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: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a video decision aid (a tool to support decision-making) can help individuals make better plans for their future medical care in emergencies. Researchers will compare two groups: one will watch a video and engage in a discussion about advance care planning, while the other will receive the usual care planning services. The trial seeks participants who are 65 or older or those aged 50 to 64 with a serious illness. English or Spanish speakers who do not require intensive care may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance future care planning tools.

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 decision aid is safe for use in emergency care planning?

Research has shown that video tools for planning future medical care are generally safe. Studies have found that these tools help people understand their choices without causing harm. No reports indicate negative effects from using these video tools in this setting. Designed to provide information and support decision-making, patients usually find them easy to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional emergency care planning, which often involves verbal discussions or written documents, the Video Decision Aid uses visual storytelling to help patients understand their care options. This method can make complex information more accessible and engaging, potentially leading to better-informed decisions. Researchers are excited because this approach could improve how patients participate in their own care planning, especially in high-pressure emergency situations where clarity is crucial.

What evidence suggests that the Video Decision Aid is effective for improving advance care planning documentation?

Research has shown that video decision aids, which participants in this trial may receive, can assist people in planning their future healthcare. Studies have found that these tools increase the likelihood of individuals documenting their healthcare wishes. For example, one study found that using a video decision aid helped more patients make clear choices about their care. Another study noted that patients using these aids often chose comfort care, which focuses on quality of life. Additionally, using video aids was linked to increased use of hospice services and reduced healthcare costs. Overall, video decision aids support informed decision-making about future medical care. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals aged over 79, or those over 49 with a serious illness indicator. Participants must be English or Spanish speakers and not require ICU-level care. It excludes people who are legally blind or have a POLST (Physician Orders for Life-Sustaining Treatment).

Inclusion Criteria

I am 65 years old or older.

I am between 50 and 64 years old and have a serious illness.

Exclusion Criteria

I need care in the intensive care unit due to my unstable health condition.

Those with a POLST

I am legally blind.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants receive a video decision aid and engage in an advance care planning discussion in the Emergency Department

1 day

1 visit (in-person)

Follow-up

Participants' advance care planning documentation is monitored in the electronic health record

6 months

Follow-up assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Video Decision Aid

Trial Overview The study tests if a video decision aid can help improve advance care planning documentation in the emergency department compared to standard ACP information sheets.

How Is the Trial Designed?

Group I: Video Experimental Treatment 1 Intervention

Video decision aid and advance care planning discussion

Group II: Control arm Active Control 1 Intervention

Usual advance care planning services provided at the study site.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

University of California, Davis

Collaborator

Trials

958

Recruited

4,816,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A feasibility study involving 61 older adults in the emergency department showed that 71% completed at least one module of the PREPARE ACP education program, indicating strong engagement with the technology.

Participants found the PREPARE website easy to use, with an average rating of 8.4 out of 10, suggesting that technology can effectively facilitate advance care planning conversations for older patients in the ED.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparing Older Adults with Serious Illness to Formulate Their Goals for Medical Care in the Emergency Department. Ouchi, K., Knabben, V., Rivera-Reyes, L., et al.[2022]

Patients with advanced heart failure who used a video decision support tool were significantly more likely to choose comfort care over life-prolonging treatments compared to those who only received verbal information, with 51% selecting comfort care in the intervention group versus 30% in the control group (P<0.001).

The video intervention also led to a higher likelihood of patients forgoing CPR (68% vs. 35%) and intubation (77% vs. 48%), and participants had better knowledge about their care options, scoring an average of 4.1 out of 6 compared to 3.0 in the control group (P<0.001).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, Controlled Trial of an Advance Care Planning Video Decision Support Tool for Patients With Advanced Heart Failure. El-Jawahri, A., Paasche-Orlow, MK., Matlock, D., et al.[2022]

A study involving 134 patients found that 90% rated the animated video on patient safety as good or very good, while 100% of those receiving oral information felt the same, indicating high satisfaction with both methods.

Despite the positive feedback for the video, 74% of patients who received both formats preferred the oral presentation, suggesting that while videos can enhance understanding, they should not replace traditional verbal communication for optimal patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communicating Patient Safety Information Through Video and Oral Formats-A Comparison. Bånnsgård, M., Nouri, A., Finizia, C., et al.[2023]

Video decision aids significantly reduced patients' preferences for aggressive life-prolonging treatments, such as cardiopulmonary resuscitation and intubation, indicating they may help patients make more informed choices about their care.

These aids also increased patients' willingness to engage in goals-of-care conversations and improved their knowledge of advance care planning, suggesting they are effective tools for enhancing patient understanding and decision-making in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Video Decision Aid on Advance Care Planning With Adult Patients: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Shu, X., Chen, Q., Zhou, Y., et al.[2023]

The study developed an Adverse-Event Coping Scale (AECS) based on responses from 140 patients, demonstrating good reliability (coefficient of 0.82) and a one-dimensional structure with 11 items.

Higher AECS scores indicate that patients are facing serious adverse drug events (ADEs) and are making significant efforts to cope, which can help clinicians identify when timely interventions are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an adverse-event coping scale (AECS) using item response theory. Park, T., Hadsall, RS., Schommer, JC., et al.[2015]

A symposium with 31 healthcare professionals highlighted that preventing adverse events in community care requires a multi-faceted approach involving policy changes at various levels, including system integration and improved communication among providers.

Key recommendations from the symposium include prioritizing education for clinicians and caregivers, enhancing organizational culture, and leveraging technology to improve patient safety and reduce adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. Masotti, P., Green, M., McColl, MA.[2019]

This study aims to evaluate the effectiveness of a video decision support tool (VDST) in enhancing advance care planning (ACP) discussions between cancer patients and their caregivers, focusing on personal values and shared decision-making.

The trial will compare ACP completion rates and communication congruence between patient-caregiver dyads using the VDST versus usual care, providing insights into innovative methods for engaging patients in ACP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video decision support tool promoting values conversations in advanced care planning in cancer: protocol of a randomised controlled trial. Michael, N., O'Callaghan, C., Georgousopoulou, E., et al.[2021]

The PRagmatic trial Of Video Education in Nursing homes involved 360 nursing homes and aimed to evaluate the effectiveness of an Advance Care Planning Video Program, which was implemented in intervention facilities to improve advance care planning practices among patients with advanced dementia or cardiopulmonary disease.

This study highlights the potential of video decision support tools to enhance patient-focused care in nursing homes, with a structured approach to implementation and monitoring that could serve as a model for future research in complex healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting. Mor, V., Volandes, AE., Gutman, R., et al.[2023]

The use of a video decision aid significantly increased knowledge about the POLST form among 50 older adults, with scores rising from 11.24 to 14.32, indicating a strong improvement in understanding advance care planning options.

Participants also reported higher satisfaction with their decisions and less decisional conflict after using the video aid, suggesting that such tools can effectively support patients in making informed choices about their healthcare preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Video Decision Aid to Reduce Decisional Conflict in Physician Orders for Life-Sustaining Treatment (POLST) Decision-Making. Gallegos, JV., Edelstein, B., Moss, AH.[2022]

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 new multimedia decision aid for advance care planning, called 'Making Your Wishes Known: Planning Your Medical Future', was developed to address the limitations of traditional advance directives, providing tailored education and decision-making tools.

Pilot testing with 50 adult volunteers and 34 cancer patients showed high satisfaction and accuracy in representing patients' wishes, indicating its potential effectiveness in facilitating advance care planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an interactive computer program for advance care planning. Green, MJ., Levi, BH.[2018]

A new approach to Morbidity and Mortality (M&M) Conferences has led to a 29% increase in overall satisfaction and a 50% increase in satisfaction regarding the addressing of process improvement issues over 5 years.

The hands-on, educational focus of the revamped M&M Conferences has resulted in 100% of faculty applying what they learn to their practice, suggesting that this model could enhance discussions about adverse events and improve patient safety across the medical community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Innovative and Integrative Approach to Breaking Down Barriers to Traditional Morbidity and Mortality Conference. Tresselt, E., Darnell Bowens, C., Dhar, A.[2023]

A personalized patient safety plan dashboard was created to enhance communication among care team members, patients, and families by displaying important safety information related to common geriatric syndromes.

Interviews with nurses, patients, and caregivers revealed positive feedback on the dashboard's clinical decision support and safety content, highlighting the need for ongoing improvements based on user experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse, Patient, and Care Partner Perceptions of a Personalized Safety Plan Screensaver. Duckworth, M., Leung, E., Fuller, T., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6033645/

An Advance Care Planning Video Decision Support Tool ... The primary outcome was documented advance directives to forgo hospitalization by 6 months. Secondary outcomes included preferences for comfort care, directives ...

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2682518

An Advance Care Planning Video Decision Support Tool ... This cluster randomized clinical trial tests whether an advance care planning video (vs usual care) has an effect on documented advance ...

3. researchgate.net researchgate.net/publication/365249053_The_Effectiveness_of_Video_Decision_Aid_on_Advance_Care_Planning_With_Adult_Patients_A_Systematic_Review_and_Meta-analysis_of_Randomized_Controlled_Trials

The Effectiveness of Video Decision Aid on Advance Care ... The purpose of this review was to examine the effect of video decision aids on adult patients' advance care planning-related outcomes.

4. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.116.021937

Randomized, Controlled Trial of an Advance Care ... This study examined the impact of a video decision support tool and patient checklist on advance care planning for patients with heart failure.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4978682/

Use of Video Decision Aids to Promote Advance Care ... Implementing ACP video decision aids was associated with improved ACP documentation, greater use of hospice, and decreased costs.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26109115/

Video decision aids to assist with advance care planning The objective of this study was to evaluate the impact of video decision aids on patients' preferences regarding life-sustaining treatments (primary outcome).

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833774

An Intervention to Increase Advance Care Planning Among ... The results of this study suggest that implementing patient video decision aids along with bolstering clinician communication skills can improve clinical ACP ...

8. acpdecisions.org acpdecisions.org/10-ways-video-decision-aids-support-the-care-of-seriously-ill-populations/

10 Ways Video Decision Aids Support the Care of Seriously Ill ... The Bottom Line. Evidence shows that advance care planning initiatives aimed at high-risk, high-needs patients improve outcomes and patient ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04149704?tab=table

Videos for Advance Care Planning in Young Adults Patients' and caregivers' knowledge, preferences (goals of care, CPR, ventilation), and decisional conflict be assessed before and after the ACP video decision ...

10. bmjopen.bmj.com bmjopen.bmj.com/content/12/7/e060201

What is the evidence for efficacy of advance care planning ... This review provides the most comprehensive evidence to date regarding the efficacy of ACP on key patient outcomes and healthcare use/costs.