Trauma InjuryNCT03876691
SHARE Model Communication Course and Do-not-resuscitate Signing
An observational study of Trauma Injury, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Trauma Injury
- What is being tested?
- Patients and Physician
- How many people
- 145 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 May 2017to 21 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- Trauma patients.
- Suicide patients.
- Patients of age less than 20.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Attendance to SHARE Model Communication Course by Physicians Increases the Signing of Do-not-resuscitate Orders for Critical Patients in the Emergency Room
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.
Read the 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.
- Conditions
- Trauma Injury
- Being tested
- Patients, Physician
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatientsOther
Patients who are considered as terminally ill and would not benefit from aggressive treatment, who physicians suggest to family about a do-not-resuscitate.
PhysicianOther
The current emergency medical department departments within the preparation of the attending physician
| Study group | Role | What they receive |
|---|---|---|
| Do not resuscitate | Patients who are suggested to family about a do-not-resuscitate order treatment by physicians. Receives: Other: Patients; Other: Physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with DNR singing observation form
The content of the observation form was filled by observers during the explanation process
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start22 May 2017
- Primary completion20 Apr 2018
- Study completion21 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TSANG-TANG Hsieh, MD, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876691
- Sponsor's protocol ID
- CMRPG8G0681
- Status last verified
- Feb 2019
- First submitted
- 25 Feb 2019
- Last updated
- 15 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Attendance to SHARE Model Communication Course by Physicians Increases the Signing of Do-not-resuscitate Orders for Critical Patients in the Emergency Room
- ClinicalTrials.gov ID
- NCT03876691
- Acronym / sponsor ID
- CMRPG8G0681
- Conditions
- Trauma Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 22 May 2017 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 21 May 2018 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Do not resuscitate | – | Other: Patients, Other: PhysicianPatients who are suggested to family about a do-not-resuscitate order treatment by physicians. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Trauma patients.
- Suicide patients.
- Patients of age less than 20.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PatientsPatients who are considered as terminally ill and would not benefit from aggressive treatment, who physicians suggest to family about a do-not-resuscitate. | Other | Do not resuscitate |
| PhysicianThe current emergency medical department departments within the preparation of the attending physician | Other | Do not resuscitate |
Primary outcome
Number of participants with DNR singing observation form
Time frame: up to 5 months
The content of the observation form was filled by observers during the explanation process
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TSANG-TANG Hsieh, MD study chair
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Injury, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with DNR singing observation form (time frame: up to 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.