Video Decision Aid for Emergency Care Planning

(VIDEO-ED Trial)

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

900 Participants Needed

Trial Summary

What is the purpose of this trial?

A randomized controlled trial of a video decision aid in the Emergency Department Setting to improve advance care planning documentation.

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 Video Decision Aid for Emergency Care Planning?

Research shows that video decision aids help people make better decisions about their future medical care by reducing their preference for life-prolonging treatments and increasing their understanding and satisfaction with their choices. ^{1 2 3 4 5}

Is the Video Decision Aid for Emergency Care Planning safe for humans?

There is no specific safety data available for the Video Decision Aid for Emergency Care Planning, but the use of videos to communicate patient safety information has been explored, suggesting that such tools are generally considered safe for enhancing patient participation in care. ^{6 7 8 9 10}

How is the Video Decision Aid treatment different from other treatments for advance care planning?

The Video Decision Aid is unique because it uses multimedia to help patients understand and make decisions about their future medical care based on their personal values and preferences, rather than focusing solely on medical treatments. This approach encourages conversations between patients and caregivers, promoting shared decision-making and aligning care with what matters most to the patient. ^{3 4 11 12 13}

Eligibility Criteria

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 do not speak English or Spanish.

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

Those with a POLST

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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]

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]

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]

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]

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]

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]

References

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

Randomized, Controlled Trial of an Advance Care Planning Video Decision Support Tool for Patients With Advanced Heart Failure. [2022]

2. England 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. [2023]

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

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

4. United States 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. [2023]

5. United States 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. [2022]

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

Development of an adverse-event coping scale (AECS) using item response theory. [2015]

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

Communicating Patient Safety Information Through Video and Oral Formats-A Comparison. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. [2019]

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

An Innovative and Integrative Approach to Breaking Down Barriers to Traditional Morbidity and Mortality Conference. [2023]

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

Nurse, Patient, and Care Partner Perceptions of a Personalized Safety Plan Screensaver. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Development of an interactive computer program for advance care planning. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Video decision support tool promoting values conversations in advanced care planning in cancer: protocol of a randomised controlled trial. [2021]

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

Preparing Older Adults with Serious Illness to Formulate Their Goals for Medical Care in the Emergency Department. [2022]