Clinical trial NCT03638934: Efficacy of Self-education Program for Advanced Care Planning(RCT) for General Population
Official title: Efficacy of Decision Aid for Advanced Care Planning(RCT) for General Population: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Advance care planning
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Health, Korea
name: National Clinical Research Coordination Center, Seoul, Korea
name: National Evidence-Based Healthcare Collaborating Agency
First posted: 2018-08-20
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Advance Care Preference
timeFrame: Baseline, within 1 week
Secondary outcomes:
measure: Changes in Hospital Anxiety and Depression Scale
timeFrame: Baseline, within 1 week
measure: Changes in CPR knowledge
timeFrame: Baseline, within 1 week
measure: Changes in palliative care / advance care planning knowledge score
timeFrame: Baseline, within 1 week
measure: Changes in No CPR preference in terminal status
timeFrame: Baseline, within 1 week
measure: Changes in End-of-Life care
timeFrame: Baseline, within 1 week
measure: Satisfaction on educational materials
timeFrame: Baseline, within 1 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Young Ho Yun
role: PRINCIPAL_INVESTIGATOR
References: