Efficacy of Self-education Program for Advanced Care Planning(RCT) for General Population

Healthy Clinical Trial

Official title:

Efficacy of Decision Aid for Advanced Care Planning(RCT) for General Population: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638934
• Other study ID #: HC15C1391-4
• Status: Completed
• Phase: N/A
• Start date: April 27, 2018
• Est. completion date: May 25, 2018

Study information

• Verified date: August 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study verifies efficacy of Self-education program for advanced care planning in general population. Half of participants will receive a 20 minutes video about advanced care planning while the other half will receive a 13-page brochure entitled, Understanding the Life-Sustaining Treatment Act.

Description:

This study validates effectiveness of decision aid that the investigators developed due to the rates of completing Advanced care planning are considerably low, which is led by the lack of information available to general population; whether they elevate the preference of healthy general population toward Advanced Care planning, reduce the burden of decision making, and support general population to overcome their crisis, compare to educational resources that are currently available.

Previous studies inform that educational video about advanced care planning increases the knowledge of care for life prolongation and affects the preference towards care for life prolongation and palliative care. However, previous studies focused mainly on patient populations, and the general population might differ in its understanding of disease, health care services, and ACP. In this study, we constructed ACP video decision support materials for the general population and compared their effectiveness in an RCT.

Primary outcome of this study is attitude and behavior change toward advanced care planning. Participants of this study will fill out the baseline questionnaire about ACP preference, end-of-life care preference, knowledge of ACP, etc. After that, participants will be allocated equally into the intervention group and the control group. Participants assigned to the intervention arm viewed the 20-minute educational decision support video entitled Advance Care Planning, which had been used and tested in studies with advanced cancer patients. Participants randomized to the attention-control arm received and read a 13-page brochure entitled, Understanding the Life-Sustaining Treatment Act, which was developed by the Ministry of Health and Welfare. After reading and watching the educational materials, patients will get another questionnaire about knowledge of ACP, satisfaction on the materials, ACP Preference, etc.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 25, 2018
• Est. primary completion date: May 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Subject 20 years old and more

• Subject who understands the purpose of the study and signs with informed consent form

Exclusion Criteria:

• Inability to speak, understand, or write Korean

• Inability to understand the contents of the provided materials due to poor eyesight and hearing

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Videos about ACP
Three videos about advanced care planning are provided for self-education.
• Brochure about Life-Sustaining Treatment Act
Brochure about Life-Sustaining Treatment Act are provided for self-education.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Seoul National University Hospital	National Clinical Research Coordination Center, Seoul, Korea, National Evidence-Based Healthcare Collaborating Agency, National Institute of Health, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Advance Care Preference	Comparison the result of Advance Care Preference questionnaire	Baseline, within 1 week
Secondary	Changes in Hospital Anxiety and Depression Scale	Comparison the result of Hospital Anxiety and Depression Scale questionnaire	Baseline, within 1 week
Secondary	Changes in CPR knowledge	Comparison the result of Changes in CPR knowledge questionnaire	Baseline, within 1 week
Secondary	Changes in palliative care / advance care planning knowledge score	Comparison the result of Changes in palliative care / advance care planning knowledge score questionnaire	Baseline, within 1 week
Secondary	Changes in No CPR preference in terminal status	Comparison the result of No CPR preference in terminal status questionnaire	Baseline, within 1 week
Secondary	Changes in End-of-Life care	Comparison the result of End-of-Life care preference questionnaire	Baseline, within 1 week
Secondary	Satisfaction on educational materials	The result of Satisfaction on educational materials questionnaire	Baseline, within 1 week