Parkinson DiseaseNCT04228770
Pharmacist-led Perioperative Medicines Optimisation
A study testing Meeting with pharmacist in people with Parkinson Disease, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Meeting with pharmacist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jan 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Teaching Hospital NHS Trust
Leeds, LS9 7TF
Sophie Blow, sophie.blow@nhs.net
About this study
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.
- Conditions
- Parkinson Disease
- Being tested
- Meeting with pharmacist
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meeting with pharmacistBehavioural
Meeting with pharmacist to support drug management following their routine surgery.
| Study group | Role | What they receive |
|---|---|---|
| Warfarin patients | Experimental | Patients on high risk medication - warfarin Receives: Behavioral: Meeting with pharmacist |
| Parkinson's patients | Experimental | Patients with high risk disease - parkinson's Receives: Behavioral: Meeting with pharmacist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interview with Pharmacist
Interview with Pharmacist to support the management of the patients drug regime
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start10 Jan 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228770
- Sponsor's protocol ID
- PH18/112828
- Status last verified
- Jan 2020
- First submitted
- 10 Jan 2020
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist-led Perioperative Medicines Optimisation
- ClinicalTrials.gov ID
- NCT04228770
- Acronym / sponsor ID
- PH18/112828
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warfarin patients | Experimental | Behavioral: Meeting with pharmacistPatients on high risk medication - warfarin |
| Parkinson's patients | Experimental | Behavioral: Meeting with pharmacistPatients with high risk disease - parkinson's |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meeting with pharmacistMeeting with pharmacist to support drug management following their routine surgery. | Behavioural | Parkinson's patients, Warfarin patients |
Primary outcome
Interview with Pharmacist
Time frame: 1 hour
Interview with Pharmacist to support the management of the patients drug regime
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meeting with pharmacist in people with Parkinson Disease, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Jan 2020. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie Blow, MPharm (0113 392 3339, sophie.blow@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interview with Pharmacist (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2020.