SHARE Model Communication Course and Do-not-resuscitate S... | NCT03876691

Studies
SHARE Model Communication Course and Do-not-resuscitate Signing

NCT03876691

Sponsor

Chang Gung Memorial Hospital

Status

Completed

Last Update Posted

Mar 15, 2019Actual

Enrollment

145Actual

Phase

Not provided

Conditions

Trauma Injury

Interventions

Patients
Physician

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 22, 2017Actual

Primary Completion Date

Apr 20, 2018Actual

Completion Date

May 21, 2018Actual

First Submitted Date

Feb 25, 2019

First Submission Date that Met QC Criteria

Mar 13, 2019

First Posted Date

Mar 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2019

Last Update Posted Date

Mar 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aimed to investigate the effect of attending a SHARE model communication course by emergency physicians on patient notification and signing of do-not-resuscitate (DNR) orders for critical patients in the emergency room.

Detailed Description

An observation form designed based on the SHARE model was completed by two observers who noted the communication process between physicians and patients and family members during patient notification and signing a DNR order. To assess the influence of physicians attending a SHARE model course on the signing of DNR orders, a propensity score-matched population was created to reduce the potential selection bias of patients and family members.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

145Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Do not resuscitate		Patients who are suggested to family about a do-not-resuscitate order treatment by physicians.	Other: Patients Other: Physician

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patients	Other	Patients who are considered as terminally ill and would not benefit from aggressive treatment, who physicians suggest to family about a do-not-resuscitate.	Do not resuscitate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with DNR singing observation form	The content of the observation form was filled by observers during the explanation process	up to 5 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are considered as terminally ill and would not benefit from aggressive treatment, who physicians suggest to family about a "Do not resuscitate" order.
Patients who was not register with "Do- not- resuscitate" on their health insurance card.

Exclusion Criteria:

Trauma patients.
Suicide patients.
Patients of age less than 20.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

The research subjects consisted of attending physicians, who were willing to inform consent forms, in the emergency department between May 2017 and April 2018.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
TSANG-TANG Hsieh, MD	Chang Gung Memorial Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Chang Gung Memorial Hospital		Kaohsiung City		83301	Taiwan

ID	Term
D000081084	Accidental Injuries

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D010820	Physicians

Ancestor Terms

ID	Term
D006282	Health Personnel
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided