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Perioperative Recommendations for Medication Safety

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ClinicalTrials.gov Identifier: NCT04240301
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : May 28, 2020
Sponsor:
Collaborators:
World Federation of Societies of Anesthesiologists
University of California, San Francisco
Aga Khan University
University of Toronto
University of Minnesota
University of Auckland, New Zealand
Information provided by (Responsible Party):
Karen C. Nanji,M.D.,M.P.H., Massachusetts General Hospital

Brief Summary:
The purpose of the proposed research is to create and disseminate expert-based recommendations for perioperative medication safety that are tailored to country income level, using the World Bank's four country income groups: high, upper-middle, lower-middle, and low income. The specific aims of the research are to: 1) Develop consensus-based perioperative medication safety recommendations, 2) Prioritize the recommendations by their level of clinical importance for implementation in high, upper-middle, lower-middle and low income countries, and disseminate the recommendations; and 3) Evaluate the initial adoption of the recommendations in each country income group.

Condition or disease
Perioperative Medication Safety

Detailed Description:

The overall objective of the proposed research is to create and disseminate expert-based recommendations for perioperative medication safety that are tailored to country income level, using the World Bank's four country income groups: high, upper-middle, lower-middle, and low income. The proposed project will include the entire medication use process (ordering, dispensing, preparing, administering, documenting and monitoring). The specific aims of the research are to:

  1. Develop consensus-based perioperative medication safety recommendations. Approach: This study will use the extensively studied RAND-UCLA Delphi Method to achieve consensus, with an expert panel consisting of anesthesiologists, surgeons, nurses and medication safety experts from each of the World Bank's four country income groups.
  2. Prioritize the recommendations by their level of clinical importance for implementation in high, upper-middle, lower-middle and low income countries, and disseminate the recommendations. Approach: The expert panel members will rank each recommendation by its importance as a next step in improving medication safety in each country income group. A Condorcet ranking method will be used to combine individual rankings into a single list of recommendations ranked by the importance of implementation for each country income group. The investigators will then execute a comprehensive dissemination strategy.
  3. Evaluate the initial adoption of the recommendations in each country income group. Approach: The investigators will conduct qualitative, one-on-one, semi-structured interviews of the expert panel members, to evaluate their perceptions of initial adoption of the recommendations in each country income group. A grounded theory approach will be used to identify common themes.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Other
Time Perspective: Other
Official Title: Global PRoMiSe (Perioperative Recommendations for Medication Safety): A Consensus-Based, Generalizable Approach
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024



Primary Outcome Measures :
  1. Expert-based medication safety recommendations. [ Time Frame: 3 years ]
    Four tiers of stepwise recommendations, corresponding to each of the World Bank's four country income groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Our expert panel will consist of 120 members, 30 from each of the World Bank's four county country income groups: high, upper-middle, lower-middle, and low income. Expert panel members will be anesthesiologists, surgeons, operating room nurses, nurse anesthetists, pharmacists and patient safety experts.
Criteria

Inclusion Criteria:

  • Anesthesiologists, surgeons, operating room nurses, nurse anesthetists, pharmacists and patient safety experts

Exclusion Criteria:

  • None

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): NCT04240301


Contacts
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Contact: Karen C. Nanji, M.D., M.P.H. (617) 724-8544 KNANJI@mgh.harvard.edu

Sponsors and Collaborators
Karen C. Nanji,M.D.,M.P.H.
World Federation of Societies of Anesthesiologists
University of California, San Francisco
Aga Khan University
University of Toronto
University of Minnesota
University of Auckland, New Zealand
Investigators
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Principal Investigator: Karen C. Nanji, M.D., M.P.H. Massachusetts General Hospital
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Karen C. Nanji,M.D.,M.P.H., Assistant Professor of Anesthesia at Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04240301    
Other Study ID Numbers: 2019P003567
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be available to other researchers. Aggregate data post-analysis may be shared with collaborators at other institutions.

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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 Karen C. Nanji,M.D.,M.P.H., Massachusetts General Hospital:
medication safety
anesthesiology
perioperative