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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

Tracking Information
First Submitted Date  ICMJE February 13, 2020
First Posted Date  ICMJE February 17, 2020
Last Update Posted Date March 18, 2020
Estimated Study Start Date  ICMJE March 20, 2020
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2020)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2020)
Percentage of choices of reversal drugs [ Time Frame: 10 minutes before anesthesia ]
Percentage of choices of reversal drugs
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Shared-Decision Making in Reducing Decision Conflict on the Choice of Awakening Agent After General Anesthesia
Official Title  ICMJE Influence of Shared-Decision Making in Reducing Decision Conflict on the Choice of Awakening Agent After General Anesthesia: A Multicenter Randomized Controlled Trial
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Decision Making, Shared
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Shared decision making with the used of patient decision aids
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 13, 2020)
2926
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04272177
Other Study ID Numbers  ICMJE N201909073
10812-015 ( Other Identifier: Chi Mei Medical Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Ka-Wai Tam, Taipei Medical University Shuang Ho Hospital
Study Sponsor  ICMJE Taipei Medical University Shuang Ho Hospital
Collaborators  ICMJE Chi Mei Medical Hospital
Investigators  ICMJE Not Provided
PRS Account Taipei Medical University Shuang Ho Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP