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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03638934
Collaborator
National Institute of Health, Korea (Other), National Clinical Research Coordination Center, Seoul, Korea (Other), National Evidence-Based Healthcare Collaborating Agency (Other)
250
1
2
28
271.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Videos about ACP
  • Other: Brochure about Life-Sustaining Treatment Act
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel AssignmentParallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Efficacy of Decision Aid for Advanced Care Planning(RCT) for General Population: Randomized Controlled Trial
Actual Study Start Date :
Apr 27, 2018
Actual Primary Completion Date :
May 25, 2018
Actual Study Completion Date :
May 25, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Videos about ACP

Subjects in experimental group get three videos about advanced care planning based on Smart Management Strategy for Health (SMASH). After they finish watching the materials, they fill out the questionnaire.

Other: Videos about ACP
Three videos about advanced care planning are provided for self-education.

Active Comparator: Brochure for Life-Sustaining Treatment

Subjects in the group get 13-page brochure entitled, Understanding the Life-Sustaining Treatment Act. After they finish watching the materials, they fill out the questionnaire.

Other: Brochure about Life-Sustaining Treatment Act
Brochure about Life-Sustaining Treatment Act are provided for self-education.

Outcome Measures

Primary Outcome Measures

  1. Changes in Advance Care Preference [Baseline, within 1 week]

    Comparison the result of Advance Care Preference questionnaire

Secondary Outcome Measures

  1. Changes in Hospital Anxiety and Depression Scale [Baseline, within 1 week]

    Comparison the result of Hospital Anxiety and Depression Scale questionnaire

  2. Changes in CPR knowledge [Baseline, within 1 week]

    Comparison the result of Changes in CPR knowledge questionnaire

  3. Changes in palliative care / advance care planning knowledge score [Baseline, within 1 week]

    Comparison the result of Changes in palliative care / advance care planning knowledge score questionnaire

  4. Changes in No CPR preference in terminal status [Baseline, within 1 week]

    Comparison the result of No CPR preference in terminal status questionnaire

  5. Changes in End-of-Life care [Baseline, within 1 week]

    Comparison the result of End-of-Life care preference questionnaire

  6. Satisfaction on educational materials [Baseline, within 1 week]

    The result of Satisfaction on educational materials questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 03080

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Young Ho Yun, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Young Ho Yun, Principal Investigator, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT03638934
Other Study ID Numbers:
  • HC15C1391-4
First Posted:
Aug 20, 2018
Last Update Posted:
Aug 20, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Young Ho Yun, Principal Investigator, Seoul National University Hospital

Study Results

No Results Posted as of Aug 20, 2018