Perioperative Recommendations for Medication Safety

Global PRoMiSe (Perioperative Recommendations for Medication Safety): A Consensus-Based, Generalizable Approach

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.

Study Overview

• Status: Not yet recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Karen C. Nanji, M.D., M.P.H.; Phone Number: (617) 724-8544; Email: KNANJI@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expert-based medication safety recommendations.	Four tiers of stepwise recommendations, corresponding to each of the World Bank's four country income groups.	3 years

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Merry AF, Webster CS, Hannam J, Mitchell SJ, Henderson R, Reid P, Edwards KE, Jardim A, Pak N, Cooper J, Hopley L, Frampton C, Short TG. Multimodal system designed to reduce errors in recording and administration of drugs in anaesthesia: prospective randomised clinical evaluation. BMJ. 2011 Sep 22;343:d5543. doi: 10.1136/bmj.d5543.
• Nanji KC, Patel A, Shaikh S, Seger DL, Bates DW. Evaluation of Perioperative Medication Errors and Adverse Drug Events. Anesthesiology. 2016 Jan;124(1):25-34. doi: 10.1097/ALN.0000000000000904.
• Llewellyn RL, Gordon PC, Wheatcroft D, Lines D, Reed A, Butt AD, Lundgren AC, James MF. Drug administration errors: a prospective survey from three South African teaching hospitals. Anaesth Intensive Care. 2009 Jan;37(1):93-8. doi: 10.1177/0310057X0903700105.
• Orser BA, Chen RJ, Yee DA. Medication errors in anesthetic practice: a survey of 687 practitioners. Can J Anaesth. 2001 Feb;48(2):139-46. doi: 10.1007/BF03019726.
• Shridhar Iyer U, Fah KK, Chong CK, Macachor J, Chia N. Survey of medication errors among anaesthetists in Singapore. Anaesth Intensive Care. 2011 Nov;39(6):1151-2. No abstract available.
• Webster CS, Merry AF, Larsson L, McGrath KA, Weller J. The frequency and nature of drug administration error during anaesthesia. Anaesth Intensive Care. 2001 Oct;29(5):494-500. doi: 10.1177/0310057X0102900508.
• Wahr JA, Abernathy JH 3rd, Lazarra EH, Keebler JR, Wall MH, Lynch I, Wolfe R, Cooper RL. Medication safety in the operating room: literature and expert-based recommendations. Br J Anaesth. 2017 Jan;118(1):32-43. doi: 10.1093/bja/aew379. Epub 2016 Dec 30.
• Whitaker D, Brattebo G, Trenkler S, Vanags I, Petrini F, Aykac Z, Longrois D, Loer SA, Gaszynski T, Sipylaite J, Copaciu E, Cerny V, Akeson J, Mellin-Olsen J, Abela C, Stecher A, Kozek-Langenecker S, Ratsep I; European Section and Board of Anaesthesiology of the UEMS. The European Board of Anaesthesiology recommendations for safe medication practice: First update. Eur J Anaesthesiol. 2017 Jan;34(1):4-7. doi: 10.1097/EJA.0000000000000531.
• Utley M, Gallivan S, Mills M, Mason M, Hargraves C. A consensus process for identifying a prioritised list of study questions. Health Care Manag Sci. 2007 Feb;10(1):105-10. doi: 10.1007/s10729-006-9003-6.
• Nanji KC, Merry AF, Shaikh SD, Pagel C, Deng H, Wahr JA, Gelb AW, Orser BA. Global PRoMiSe (Perioperative Recommendations for Medication Safety): protocol for a mixed-methods study. BMJ Open. 2020 Jun 30;10(6):e038313. doi: 10.1136/bmjopen-2020-038313.

Helpful Links

• The RAND/UCLA Appropriateness Method User's Manual

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 21, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: perioperative; anesthesiology; medication safety
• Other Study ID Numbers: 2019P003567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be available to other researchers. Aggregate data post-analysis may be shared with collaborators at other institutions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No