Video Decision Support for Advance Care Planning in Geriatric Patients With Frailty

Randomized, Controlled Trial of a Video Decision Support for Advance Care Planning in Geriatric Patients With Frailty

As the proportion of the aging population continues to rise, age-related frailty syndrome, characterized by a decline in the function of multiple physiological systems and accompanied by vulnerability to stress, has become a significant issue. It has been associated with higher mortality rates, hospitalization rates, risk of falls, occurrence of fractures, decreased mobility, depression, cognitive decline, dementia, loneliness, and admission to long-term care facilities. Advance care planning is a thoughtful and communicative process that helps individuals, while still cognitively capable, to pre-determine and express their preferences for medical care in the event of future incapacity. With the ongoing development in the field of frailty and the rapid aging of the population, the increasing age may be accompanied by severe illnesses, symptom burden, functional dependence, caregiver burden, and extensive medical utilization. The importance of advance care planning is increasingly emphasized, but its implementation and promotion remain challenging. In addition to systematic promotion from a policy perspective, tools to assist patients in decision-making have been proposed. Video decision aids can encourage people to engage in advance care planning by sparking conversations about informed consent and helping individuals contemplate the choices they may face. Video decision aids can also assist individuals in envisioning future scenarios and reflecting on their decisions. Previous randomized controlled trials have explored the benefits of such video tools for specific patient populations, such as cancer patients, heart failure patients, and elderly individuals hospitalized. However, there is a need for innovative approaches to enhance the knowledge, willingness, and actual signing rates of advance care planning for frail elderly individuals. This study aims to develop a video decision aid specifically tailored for the elderly frail population undergoing advance care planning.

Through a randomized controlled trial, the study aims to validate its actual benefits, expecting to assist the elderly frail population in understanding and expressing their willingness for advance care planning, increasing the actual willingness to sign advance directives, and helping clinical healthcare teams achieve person-centered, high-quality care for this population.

Study Overview

• Status: Recruiting
• Conditions: Frail Elderly
• Intervention / Treatment: Behavioral: video decision aid

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hsien-Liang Solomon Huang, MSc; Phone Number: 266832 +886-2312-3456; Email: tennishuang@gmail.com

Study Locations

• Taiwan
  • Taipei City, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital Research Ethics Committee
    • Contact: National Taiwan University Hospital Research Ethics Committee; Phone Number: 8857 +886-2312-3456; Email: fctsai@ntu.edu.tw
    • Principal Investigator: Hsien-Liang Solomon Huang, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age > or = 65 y/o can communicate and sign informed consent diagnosed to be frailty with clinical frailty scale 4-7

Exclusion Criteria:

• impaired visual acuity or hearing that can't watch video had signed advance decision before

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
Active Comparator: with video decision aid; video decision aid	Behavioral: video decision aid; video decision aid for advance care planning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients completed advance decision	The advance decision must be completed by the patients and uploaded to the National Health insurance system	from enrollment to 4 weeks after watching video decision aid

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Publications and helpful links

General Publications

• Thompson JS, Matlock DD, McIlvennan CK, Jenkins AR, Allen LA. Development of a Decision Aid for Patients With Advanced Heart Failure Considering a Destination Therapy Left Ventricular Assist Device. JACC Heart Fail. 2015 Dec;3(12):965-76. doi: 10.1016/j.jchf.2015.09.007.

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: frailty; shared decision making; advance care planning
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 202312031RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: the data will include personal data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No