Pharmacist-led Perioperative Medicines Optimisation

January 10, 2020 updated by: The Leeds Teaching Hospitals NHS Trust

Patients attend pre-assessment clinics (POAC) who require an elective operation and who are having a general anaesthetic. At POAC patients are asked about their health, and past medical conditions to assess their fitness for anaesthetic, a list of medicines taken is documented. Patients can then be given a date for surgery. During their stay in hospital patients will see a pharmacist who confirms what medicines are being taken, and ensures those medicines are prescribed and available during the patients stay.

This study is aimed at improving the care of patients who are admitted for elective surgery. The study will review two different interventions made prior to a patient's admission for surgery. One will look at a group of patients taking a high risk medicine and the other a group of patients with a high risk disease. The high risk medicine chosen is warfarin, and the high risk disease is Parkinson's disease. It is known that inappropriate or lack of medicines management in these groups can result in delayed surgery, poorer surgical outcomes and can affect a patient's recovery after surgery. Due to patient numbers and the variability between patients being too great, and a lack of research in this area a controlled trial cannot be performed. This complex intervention will review the interventions made, to understand how and why the interventions change care and what it is specifically within the interventions that are exerting a positive effect to improve care. All elective surgical patients who attend POAC at St James' University Hospital who are either, taking warfarin or who have Parkinson's disease will be seen by a pharmacist. An accurate drug history will be taken and if changes are required to medications these will be resolved at the POAC appointment. Patients will be provided with an individualised perioperative medication plan.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant has capacity.
  • Participants must be attending the POAC at St James' University Hospital
  • Scheduled elective surgery or other procedures requiring general anaesthesia
  • Male or Female, aged 18 years or above.
  • Diagnosed with Parkinson's Disease or taking warfarin
  • In the Investigator's opinion, is able and willing to comply with all requirements of the intervention.

Exclusion Criteria:

  • Female participant who is pregnant, lactating or planning pregnancy during the course of the intervention.
  • Under 17years of age
  • Participants who are having a local anaesthetic
  • Any who are having emergency surgery
  • Participants who are unable to provide consent
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk or may influence the result, or the participant's ability to participate in the intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Warfarin patients
Patients on high risk medication - warfarin
Behavioral: Meeting with pharmacist
Meeting with pharmacist to support drug management following their routine surgery.
EXPERIMENTAL: Parkinson's patients
Patients with high risk disease - parkinson's
Behavioral: Meeting with pharmacist
Meeting with pharmacist to support drug management following their routine surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interview with Pharmacist
Time Frame: 1 hour
Interview with Pharmacist to support the management of the patients drug regime
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Leeds Teaching Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 10, 2020

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

January 10, 2020

First Submitted That Met QC Criteria

January 10, 2020

First Posted (ACTUAL)

January 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PH18/112828

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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