Pharmaceutical PreparationsPEPPRNCT03938428
The Patient Experience of a Paramedic-Pharmacist Referral Pathway for Clinical Medication Reviews
An observational study of Pharmaceutical Preparations and Accidental Fall, run by Yorkshire Ambulance Service NHS Trust at 1 site in United Kingdom.
Trial summary
This study seeks to understand how patients feel about their medicines before and after receiving a clinical medication review. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Pharmaceutical Preparations, Accidental Fall, Allied Health Personnel
- What is being tested?
- Survey
- How many people
- 132 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jul 2019to 30 Jun 2020
- Phase
- Observational
- 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 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will be conducted from a single site (Yorkshire Ambulance Service NHS Trust). YAS staff make around 70-100 falls referral pathways a month in the Leeds area, and after exclusions relating to the PREFACS projects, it is anticipated that around 55 patients per month will be eligible to receive a pharmacist-led clinical medication review and will therefore be eligible for this study, up to a maximum of 550 patients.
Who may be able to join
- Received a pharmacist-led clinical medication review following a falls referral made by a paramedic from Yorkshire Ambulance
- Registered with a GP in the Leeds area
- Has capacity to consent to take part in the study
Who cannot join
- Did not receive a pharmacist-led clinical medication review after a Yorkshire Ambulance Service paramedic made a falls referral
- Not registered with a GP in the Leeds area
- Does not have capacity to consent to take part in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Yorkshire Ambulance Service NHS Trust
Wakefield, West Yorkshire, WF2 0XQ
Jane Shewan, +441924584224, yas.ressearch@nhs.net
Rebecca McLaren
About this study
This study seeks to understand how patients feel about their medicines before and after receiving a clinical medication review.
Read the detailed description
Falls in people aged 65 years and over are a common reason for calling the emergency ambulance service. Falls can be serious, with about 1 in 20 people having to be taken to hospital because they have been injured. Thankfully, in more than 4 out of 10 cases, people are not seriously injured and can be left at home. However, it is important that the reason for the fall is found and future falls are prevented where possible.
Yorkshire Ambulance Service can already make a referral to another local service to get specialist practical help for falls prevention when people are left at home after a fall. Research has shown that the safe use of medicines can prevent future falls, but that did not form. Now a new service has been set up for Yorkshire Ambulance Service to refer patients to the Leeds GP Confederation. A pharmacist working in the patients GP surgery will undertake a review of the patient's use of their medicines.
We would like to find out about how patients feel about using their medicines before and after the medicines review by a pharmacist. We would also like to know how they feel about the medicines review itself, to help decide whether this scheme should continue or be expanded to other areas. To do this, we are going to send a questionnaire to patients who receive a medicines review. The questionnaire will be sent by post, take about 10 minutes to fill out and include a stamped addressed envelope so people who take part will not have to pay for postage.
- Being tested
- Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Patients who are eligible for this study will have been previously identified as part of the PREFACES project. The pharmacist who has conducted the clinical medication review will obtain verbal permission from the patient to be contacted by the research study team. This will be documented on the referral outcome document that is returned to the YAS clinical team. A member of YAS clinical staff from the PREFACES project will forward the name and residential address of patients who have agreed to be contacted to the research paramedic for this study. A covering letter, participant information sheet, questionnaire and consent form, will be posted to potential participants. A stamped addressed envelope will be included to enable return of the completed booklet at no costs to participants.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who express a change in emotion relating to how they feel about their medicines, following a pharmacist-led clinical medication review.
Measured: 1 month
Secondary outcomes (1)
Patient expressed emotion
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start24 Jul 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmaceutical PreparationsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yorkshire Ambulance Service NHS Trust
- Sponsor type
- Other government
- Collaborators
- NIHR Yorkshire and Humber Patient Safety Translational Research Centre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938428
- Sponsor's protocol ID
- YASRD114
- Other IDs
- 263976
- Acronym
- PEPPR
- Status last verified
- Aug 2019
- First submitted
- 2 May 2019
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Patient Experience of a Paramedic-Pharmacist Referral Pathway for Clinical Medication Reviews
- ClinicalTrials.gov ID
- NCT03938428
- Acronym / sponsor ID
- PEPPR / YASRD114
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Yorkshire Ambulance Service NHS TrustOther government
- Collaborators
- NIHR Yorkshire and Humber Patient Safety Translational Research Centre
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 6 May 2019 (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.
This study seeks to understand how patients feel about their medicines before and after receiving a clinical medication review.
Detailed description
Falls in people aged 65 years and over are a common reason for calling the emergency ambulance service. Falls can be serious, with about 1 in 20 people having to be taken to hospital because they have been injured. Thankfully, in more than 4 out of 10 cases, people are not seriously injured and can be left at home. However, it is important that the reason for the fall is found and future falls are prevented where possible.
Yorkshire Ambulance Service can already make a referral to another local service to get specialist practical help for falls prevention when people are left at home after a fall. Research has shown that the safe use of medicines can prevent future falls, but that did not form. Now a new service has been set up for Yorkshire Ambulance Service to refer patients to the Leeds GP Confederation. A pharmacist working in the patients GP surgery will undertake a review of the patient's use of their medicines.
We would like to find out about how patients feel about using their medicines before and after the medicines review by a pharmacist. We would also like to know how they feel about the medicines review itself, to help decide whether this scheme should continue or be expanded to other areas. To do this, we are going to send a questionnaire to patients who receive a medicines review. The questionnaire will be sent by post, take about 10 minutes to fill out and include a stamped addressed envelope so people who take part will not have to pay for postage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted from a single site (Yorkshire Ambulance Service NHS Trust). YAS staff make around 70-100 falls referral pathways a month in the Leeds area, and after exclusions relating to the PREFACS projects, it is anticipated that around 55 patients per month will be eligible to receive a pharmacist-led clinical medication review and will therefore be eligible for this study, up to a maximum of 550 patients.
Key inclusion criteria (3 listed)
- Received a pharmacist-led clinical medication review following a falls referral made by a paramedic from Yorkshire Ambulance
- Registered with a GP in the Leeds area
- Has capacity to consent to take part in the study
Key exclusion criteria (3 listed)
- Did not receive a pharmacist-led clinical medication review after a Yorkshire Ambulance Service paramedic made a falls referral
- Not registered with a GP in the Leeds area
- Does not have capacity to consent to take part in the study
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 |
|---|---|---|
| SurveyPatients who are eligible for this study will have been previously identified as part of the PREFACES project. The pharmacist who has conducted the clinical medication review will obtain verbal permission from the patient to be contacted by the research study team. This will be documented on the referral outcome document that is returned to the YAS clinical team. A member of YAS clinical staff from the PREFACES project will forward the name and residential address of patients who have agreed to be contacted to the research paramedic for this study. A covering letter, participant information sheet, questionnaire and consent form, will be posted to potential participants. A stamped addressed envelope will be included to enable return of the completed booklet at no costs to participants. | Other | – |
Primary outcome
Proportion of patients who express a change in emotion relating to how they feel about their medicines, following a pharmacist-led clinical medication review.
Time frame: 1 month
1 secondary outcome
Patient expressed emotion
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Pharmaceutical Preparations
Active, not recruiting
HERDA: Pharmacist-Led Culturally Adapted Intervention for Depression Medication Adherence
Depression
Recruiting
Interest of PHARMaceutical Conciliation to Understand Drug Interactions, Phytotherapy, and Targeted Therapies in Chronic Myeloid Leukemia
Chronic Myeloid Leukemia
Not yet recruiting
Impact of Pharmaceutical Intervention in Self-Medication: Focus on Pain Management in Pharmacies
Self-medication for Pain, Limits on Advice From Community Pharmacists and Referral to a Primary Care Practitioner
Not yet recruiting
A Digital Tool to Help Doctors and Pharmacists Prescribe Medicines More Safely for Older Adults in Oman
Polypharmacy
Not yet recruitingPhase 4
Innovative and Cooperative Pathway Integrating Oncogeriatric, Pharmaceutical and Pharmacological Follow-up in Elderly Patients.
Elderly, Breast Cancer
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?
An observational study of Pharmaceutical Preparations and Accidental Fall, run by Yorkshire Ambulance Service 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 3 inclusion and 3 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 12 Aug 2019. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who express a change in emotion relating to how they feel about their medicines, following a pharmacist-led clinical medication review. (time frame: 1 month). 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 12 Aug 2019.