Decision Making, SharedNCT04272177
Influence of Shared-Decision Making in Reducing Decision Conflict on the Choice of Awakening Agent After General Anesthesia
A study testing Shared decision making with the used of patient decision aids in people with Decision Making, Shared, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
General anesthesia is an important procedure for patients undergoing a surgery. When awakening is required after the surgery, the supply of anesthetic gas is terminated together with the administration of reversal drugs. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Decision Making, Shared
- What is being tested?
- Shared decision making with the used of patient decision aids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,309 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Mar 2020to 20 Sep 2020
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who receive general anesthesia
- Adults older than 20 years
- Communicable with Mandarin
- Patients who receive anesthesia consulting
Who cannot join
- Patients who do not receive general anesthesia
- Patients receive spinal anesthesia
- Not communicable with Mandarin.
- Emergency patient who do not receive anesthesia consulting
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Shuang Ho Hospital, Taipei Medical University
New Taipei City, 23561
About this study
Official title: Influence of Shared-Decision Making in Reducing Decision Conflict on the Choice of Awakening Agent After General Anesthesia: A Multicenter Randomized Controlled Trial
General anesthesia is an important procedure for patients undergoing a surgery. When awakening is required after the surgery, the supply of anesthetic gas is terminated together with the administration of reversal drugs. Acetylcholinesterase inhibitors were the main drugs of choice in the past, most of the patients will awake in 15 to 30 minutes. The breathing circuit will then be extracted when patient breathing has recovered to normal.
sugammadex, a new generation reversal drug, is a type of selective relaxant-binding agent which recover patient muscle and breathing activities at around 3 minutes. In comparison with neostigmine, sugammadex has a shorter awakening time and lower risk of bradycardia, postoperative nausea vomiting, and postoperative residual paralysis. However, the drug has not been widely applied in Taiwan because it is not covered by the national insurance. We believe it would the patients to understand the characteristics of sugammadex in fair perspectives and increase the operation power of surgical rooms if shared decision making with the use of Patient Decision Aids (PDAs) is used during anesthesia consultation.
Read the detailed description
Background:
A PDA was developed to be administered during anethesia consultation for surgical patients. We expect the PDA would benefit the intervention group in the aspects of knowledge and communication in choosing reversal drugs.The aim of this study is to conduct a multicenter randomized controlled trial (RCT) to evaluate the benefit of PDAs on decision making.
Patients and Methods:
Decision aids are interventions designed to help surgical patients with general anethesia to choose their options of neostigmine or sugammadex by providing information on those options. In this multicenter RCT, surgical patients are randomly divided into SDM and control groups. In control group, patients will receive details of anesthesia using single introductory sheet. In SDM group, PDA will be used as a tool to explain the benefits and harms between the traditional reversal drugs and sugammadex. And by following SDM principles, the patients are guided to consider their individual values and preferences and helped to make a choice that best meet their needs. This study will be conducted in 2 hospitals (Shuang Ho Hospital and Chi Mei Medical Center). The outcomes are decision conflicts and decision-making difficulties after consultation of the patients.
Hypothesis:
The patients of the SDM group are predicted to have lower decisional conflict scores and higher knowledge scores when compared with controlled group. Our study hopes to support the efficacy of PDAs in helping surgical patients to make a choice that best meet their needs.
- Conditions
- Decision Making, Shared
- Being tested
- Shared decision making with the used of patient decision aids
- Keywords
- shared decision making, sugammadex, patient decision aids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared decision making with the used of patient decision aidsOther
PDA is used to explain choices of reversal drugs using SDM approach during consultation. The patients and medical staff explore the preferences with PDA and make decision together.
| Study group | Role | What they receive |
|---|---|---|
| SDM group | Experimental | Shared decision making using PDAs. PDAs is used as a tool explain the advantages and disadvantages of the traditional reversal drugs and sugammadex. And by following SDM principles, the patients are guided to consider their individual values and preferences and helped to make a choice that best meet their needs. Receives: Other: Shared decision making with the used of patient decision aids |
| Control group | No intervention | Current approach to explain details of anesthesia using a single introductory sheet made by the two hospitals or provided by the pharmaceutical companies is used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision conflicts
Mean score of decisional conflict scale by SURE test (developed by Ottawa University) using a five-item scale: 1. disagree strongly; 2. disagree; 3. neutral; 4. agree; 5. agree strongly.
Measured: One day after surgery
Knowledge
Mean score of understanding of reversal drugs by SURE test (developed by Ottawa University) using a five-item scale: 1. disagree strongly; 2. disagree; 3. neutral; 4. agree; 5. agree strongly.
Measured: One day after surgery
Secondary outcomes (1)
Percentage of choices of reversal drugs
Percentage of choices of reversal drugs
Measured: 10 minutes before anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start20 Mar 2020
- Primary completion20 Aug 2020
- Study completion20 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decision Making, SharedStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3,309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chi Mei Medical Hospital
- Responsible party
- Principal investigator, Ka-Wai Tam, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272177
- Sponsor's protocol ID
- N201909073
- Other IDs
- 10812-015
- Status last verified
- Mar 2021
- First submitted
- 13 Feb 2020
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Shared-Decision Making in Reducing Decision Conflict on the Choice of Awakening Agent After General Anesthesia: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04272177
- Acronym / sponsor ID
- N201909073
- Conditions
- Decision Making, Shared
- Keywords
- shared decision making, sugammadex, patient decision aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,309 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Collaborators
- Chi Mei Medical Hospital
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 17 Feb 2020 (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.
General anesthesia is an important procedure for patients undergoing a surgery. When awakening is required after the surgery, the supply of anesthetic gas is terminated together with the administration of reversal drugs. Acetylcholinesterase inhibitors were the main drugs of choice in the past, most of the patients will awake in 15 to 30 minutes. The breathing circuit will then be extracted when patient breathing has recovered to normal.
sugammadex, a new generation reversal drug, is a type of selective relaxant-binding agent which recover patient muscle and breathing activities at around 3 minutes. In comparison with neostigmine, sugammadex has a shorter awakening time and lower risk of bradycardia, postoperative nausea vomiting, and postoperative residual paralysis. However, the drug has not been widely applied in Taiwan because it is not covered by the national insurance. We believe it would the patients to understand the characteristics of sugammadex in fair perspectives and increase the operation power of surgical rooms if shared decision making with the use of Patient Decision Aids (PDAs) is used during anesthesia consultation.
Detailed description
Background:
A PDA was developed to be administered during anethesia consultation for surgical patients. We expect the PDA would benefit the intervention group in the aspects of knowledge and communication in choosing reversal drugs.The aim of this study is to conduct a multicenter randomized controlled trial (RCT) to evaluate the benefit of PDAs on decision making.
Patients and Methods:
Decision aids are interventions designed to help surgical patients with general anethesia to choose their options of neostigmine or sugammadex by providing information on those options. In this multicenter RCT, surgical patients are randomly divided into SDM and control groups. In control group, patients will receive details of anesthesia using single introductory sheet. In SDM group, PDA will be used as a tool to explain the benefits and harms between the traditional reversal drugs and sugammadex. And by following SDM principles, the patients are guided to consider their individual values and preferences and helped to make a choice that best meet their needs. This study will be conducted in 2 hospitals (Shuang Ho Hospital and Chi Mei Medical Center). The outcomes are decision conflicts and decision-making difficulties after consultation of the patients.
Hypothesis:
The patients of the SDM group are predicted to have lower decisional conflict scores and higher knowledge scores when compared with controlled group. Our study hopes to support the efficacy of PDAs in helping surgical patients to make a choice that best meet their needs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDM group | Experimental | Other: Shared decision making with the used of patient decision aidsShared decision making using PDAs. PDAs is used as a tool explain the advantages and disadvantages of the traditional reversal drugs and sugammadex. And by following SDM principles, the patients are guided to consider their individual values and preferences and helped to make a choice that best meet their needs. |
| Control group | No intervention | –Current approach to explain details of anesthesia using a single introductory sheet made by the two hospitals or provided by the pharmaceutical companies is used. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who receive general anesthesia
- Adults older than 20 years
- Communicable with Mandarin
- Patients who receive anesthesia consulting
Key exclusion criteria (4 listed)
- Patients who do not receive general anesthesia
- Patients receive spinal anesthesia
- Not communicable with Mandarin.
- Emergency patient who do not receive anesthesia consulting
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 |
|---|---|---|
| Shared decision making with the used of patient decision aidsPDA is used to explain choices of reversal drugs using SDM approach during consultation. The patients and medical staff explore the preferences with PDA and make decision together. | Other | SDM group |
Primary outcome
Decision conflicts
Time frame: One day after surgery
Mean score of decisional conflict scale by SURE test (developed by Ottawa University) using a five-item scale: 1. disagree strongly; 2. disagree; 3. neutral; 4. agree; 5. agree strongly.
Knowledge
Time frame: One day after surgery
Mean score of understanding of reversal drugs by SURE test (developed by Ottawa University) using a five-item scale: 1. disagree strongly; 2. disagree; 3. neutral; 4. agree; 5. agree strongly.
1 secondary outcome
Percentage of choices of reversal drugs
Time frame: 10 minutes before anesthesia
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 19 Mar 2021.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared decision making with the used of patient decision aids in people with Decision Making, Shared, run by Taipei Medical University Shuang Ho 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 4 inclusion and 4 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 19 Mar 2021. 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?
Decision conflicts (time frame: One day after surgery). The study lists 2 primary outcomes in all. 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 19 Mar 2021.