Clinical trial NCT04240301: Perioperative Recommendations for Medication Safety
Official title: Global PRoMiSe (Perioperative Recommendations for Medication Safety): A Consensus-Based, Generalizable Approach
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perioperative Medication Safety
Keywords: medication safety
anesthesiology
perioperative
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: World Federation of Societies of Anesthesiologists
name: University of California, San Francisco
name: Aga Khan University
name: University of Toronto
name: University of Minnesota
name: University of Auckland, New Zealand
First posted: 2020-01-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Expert-based medication safety recommendations.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Karen C. Nanji, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
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