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Influence of Shared-Decision Making in Reducing Decision Conflict on the Choice of Awakening Agent After General Anesthesia

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ClinicalTrials.gov Identifier: NCT04272177
Recruitment Status : Not yet recruiting
First Posted : February 17, 2020
Last Update Posted : March 18, 2020
Sponsor:
Collaborator:
Chi Mei Medical Hospital
Information provided by (Responsible Party):
Ka-Wai Tam, Taipei Medical University Shuang Ho Hospital

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Decision Making, Shared Other: Shared decision making with the used of patient decision aids Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2926 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
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
Estimated Study Start Date : March 20, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: SDM group
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.
Other: Shared decision making with the used of patient decision aids
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.

No Intervention: Control group
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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Percentage of choices of reversal drugs [ Time Frame: 10 minutes before anesthesia ]
    Percentage of choices of reversal drugs



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who receive general anesthesia
  2. Adults older than 20 years
  3. Communicable with Mandarin
  4. Patients who receive anesthesia consulting

Exclusion Criteria:

  1. Patients who do not receive general anesthesia
  2. Patients receive spinal anesthesia
  3. Not communicable with Mandarin.
  4. Emergency patient who do not receive anesthesia consulting

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04272177


Contacts
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Contact: Ka-Wai Tam, PhD 886-2-2249-0088 ext 8860 kelvintam@h.tmu.edu.tw
Contact: Yun Yun Chou, M.L.S. 886-2-2249-0088 ext 8898 daliner@tmu.edu.tw

Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital
Chi Mei Medical Hospital
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Responsible Party: Ka-Wai Tam, Director of Shared Decision Making Resource Center, Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier: NCT04272177    
Other Study ID Numbers: N201909073
10812-015 ( Other Identifier: Chi Mei Medical Center )
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ka-Wai Tam, Taipei Medical University Shuang Ho Hospital:
shared decision making, sugammadex, patient decision aids