NCT04228770

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

12 months

First QC Date

January 10, 2020

Last Update Submit

January 10, 2020

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Interview with Pharmacist

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

    1 hour

Study Arms (2)

Warfarin patients

EXPERIMENTAL

Patients on high risk medication - warfarin

Behavioral: Meeting with pharmacist

Parkinson's patients

EXPERIMENTAL

Patients with high risk disease - parkinson's

Behavioral: Meeting with pharmacist

Interventions

Meeting with pharmacistBEHAVIORAL

Meeting with pharmacist to support drug management following their routine surgery.

Parkinson's patientsWarfarin patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeds Teaching Hospital NHS Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Pharmacists

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Central Study Contacts

Sophie Blow, MPharm

CONTACT

0113 392 3339sophie.blow@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2020

First Posted

January 14, 2020

Study Start

January 10, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 14, 2020

Record last verified: 2020-01

Locations

GB(1)