Perioperative Medication SafetyNCT04240301
Perioperative Recommendations for Medication Safety
An observational study of Perioperative Medication Safety, run by Karen C. Nanji,M.D.,M.P.H. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Medication Safety
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Anesthesiologists, surgeons, operating room nurses, nurse anesthetists, pharmacists and patient safety experts
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- 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.
- Conditions
- Perioperative Medication Safety
- Keywords
- medication safety, anesthesiology, perioperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Expert-based medication safety recommendations.
Four tiers of stepwise recommendations, corresponding to each of the World Bank's four country income groups.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start16 Aug 2023
- Primary completion27 Aug 2026
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Perioperative Medication SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karen C. Nanji,M.D.,M.P.H.
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor-investigator, Karen C. Nanji,M.D.,M.P.H., Massachusetts General Hospital
- Investigators
- Karen C. Nanji, M.D., M.P.H., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240301
- Sponsor's protocol ID
- 2019P003567
- Status last verified
- Nov 2025
- First submitted
- 21 Jan 2020
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be available to other researchers. Aggregate data post-analysis may be shared with collaborators at other institutions.
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.
PubMed 21940742Nanji 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.
PubMed 26501385Llewellyn 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.
PubMed 19157353Orser 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.
PubMed 11220422Shridhar 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.
PubMed 22165377Webster 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.
PubMed 11669430Wahr 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.
PubMed 28039240Whitaker 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.
PubMed 27548778Utley 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.
PubMed 17323658Nanji 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.
PubMed 32606066
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global PRoMiSe (Perioperative Recommendations for Medication Safety): A Consensus-Based, Generalizable Approach
- ClinicalTrials.gov ID
- NCT04240301
- Acronym / sponsor ID
- 2019P003567
- Conditions
- Perioperative Medication Safety
- Keywords
- medication safety, anesthesiology, perioperative
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Karen C. Nanji,M.D.,M.P.H.University, hospital or other
- 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
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 27 Aug 2026 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Anesthesiologists, surgeons, operating room nurses, nurse anesthetists, pharmacists and patient safety experts
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 21940742Merry 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.
- Background: PubMed 26501385Nanji 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.
- Background: PubMed 19157353Llewellyn 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.
- Background: PubMed 11220422Orser 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.
- Background: PubMed 22165377Shridhar 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.
- Background: PubMed 11669430Webster 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.
- Background: PubMed 28039240Wahr 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.
- Background: PubMed 27548778Whitaker 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.
- Background: PubMed 17323658Utley 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.
- Derived from this study: PubMed 32606066Nanji 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.
- Individual participant dataSharing planned: No. No IPD will be available to other researchers. Aggregate data post-analysis may be shared with collaborators at other institutions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen C. Nanji, M.D., M.P.H. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Medication Safety, run by Karen C. Nanji,M.D.,M.P.H. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expert-based medication safety recommendations. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04240301, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.