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Pharmacist-led Perioperative Medicines Optimisation

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Meeting with pharmacist
Sponsored by
The Leeds Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Leeds Teaching Hospital NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Warfarin patients

Parkinson's patients

Arm Description

Patients on high risk medication - warfarin

Patients with high risk disease - parkinson's

Outcomes

Primary Outcome Measures

Interview with Pharmacist
Interview with Pharmacist to support the management of the patients drug regime

Secondary Outcome Measures

Full Information

First Posted
January 10, 2020
Last Updated
January 10, 2020
Sponsor
The Leeds Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04228770
Brief Title
Pharmacist-led Perioperative Medicines Optimisation
Official Title
Pharmacist-led Perioperative Medicines Optimisation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Warfarin patients
Arm Type
Experimental
Arm Description
Patients on high risk medication - warfarin
Arm Title
Parkinson's patients
Arm Type
Experimental
Arm Description
Patients with high risk disease - parkinson's
Intervention Type
Behavioral
Intervention Name(s)
Meeting with pharmacist
Intervention Description
Meeting with pharmacist to support drug management following their routine surgery.
Primary Outcome Measure Information:
Title
Interview with Pharmacist
Description
Interview with Pharmacist to support the management of the patients drug regime
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Blow, MPharm
Phone
0113 392 3339
Email
sophie.blow@nhs.net
Facility Information:
Facility Name
Leeds Teaching Hospital NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Blow
Email
sophie.blow@nhs.net

12. IPD Sharing Statement

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Pharmacist-led Perioperative Medicines Optimisation

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