General Practitioner (GP) Practice Based Pharmacist Input to Medicines Optimisation

NCT03241498 | Completed

• 1 other identifier: QUB B16/46
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a United Kingdom (UK) based multi-centre study which will evaluate the impact of a medication optimisation intervention (delivered in GP practices by pharmacists to patients at risk of medication related problems), on healthcare resource utilisation and patient outcomes. Pharmacists in 4 areas across the UK (3 in England and 1 in Northern Ireland) will engage with patients, thought to be at a higher risk of medication related problems, within their GP practice in order to help identify areas for improvement

Conditions

Medication Adherence

Keywords

Medicines optimisation; Healthcare resource utilisation; HRQOL; Pharmacist-led; GP based

Outcome Measures

Primary Outcomes (3)

• Number of unplanned hospital admissions

  Number of unplanned admissions to hospital over the follow-up period will be collected for both control and intervention patients

  Recruitment - 6 months post intervention

• Number of A&E attendances

  Number of attendance to the A\&E department over the follow-up period will be collected for both control and intervention patients

  Recruitment - 6 months post intervention

• Number of GP consultations

  Number of unplanned consultations with the patient's GP over the follow-up period will be collected for both control and intervention patients

  Recruitment - 6 months post intervention

Secondary Outcomes (7)

• Medication appropriateness index (MAI) score

  Recruitment - 6 months post intervention

• Number of medication related problems

  Recruitment - 6 months post intervention

• Health-related quality of life (HRQOL)

  Recruitment - 6 months post intervention

• Medication Adherence report scale (MARS)

  Recruitment - 6 months post intervention

• Beliefs about medicines questionnaire (BMQ)

  Recruitment - 6 months post intervention

Study Arms (2)

Control arm

NO INTERVENTION

All patients allocated to the control group, who on checking meet the study entry criteria and who consent (written informed consent) to participate in the research, will be asked to complete the three study questionnaires (see below) and will be advised that repeat questionnaires will be distributed by post at the end of the study (6 months) for completion at home and return by post. The patients will continue to receive all services provided by the GP practice (normal care) but will not receive the bespoke clinical pharmacist intervention which is being evaluated in this research study.

Intervention arm

EXPERIMENTAL

Participants meeting all study entry criteria who are allocated to the intervention group will also be asked to complete the three study questionnaires. Having completed the questionnaires they will receive the medicines optimisation intervention by the clinical pharmacist. They will be asked to return for repeat appointments with the clinical pharmacist at 2 and 4 months and will be advised that they will be asked to complete the study questionnaires again at the end of the study (at home, via post at 6 months).

Other: Medicines optimisation

Interventions

Medicines optimisation OTHER

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are included in the study if they have any of the following:
• Have had at least 1 unplanned hospital admission or 2 or more accident and emergency department (A\&E) attendances in the previous 12 months.
• Prescribed ≥ 6 regular oral/systemic, long term medicines.
• Has ≥ 2 long-term chronic conditions.

You may not qualify if:

• Patient is residing in a nursing home or a care home.
• Patient is considered unable to give written informed consent e.g. Alzheimer's disease.
• Palliative care patients.
• Patient has had ≥ 4 unplanned admissions to hospital in the previous 6 months.
• Patient is participating in another intervention research project within the practice.

Sponsors & Collaborators

• Queen's University, Belfast: lead
• Medicines Optimisation Innovation Centre (MOIC): collaborator
• Association of the British Pharmaceutical Industry (ABPI): collaborator

Study Sites (1)

Northern Health and Social Care Trust

Antrim, Northern Ireland, United Kingdom

Location

Related Publications (1)

• Syafhan NF, Al Azzam S, Williams SD, Wilson W, Brady J, Lawrence P, McCrudden M, Ahmed M, Scott MG, Fleming G, Hogg A, Scullin C, Horne R, Ahir H, McElnay JC. General practitioner practice-based pharmacist input to medicines optimisation in the UK: pragmatic, multicenter, randomised, controlled trial. J Pharm Policy Pract. 2021 Jan 4;14(1):4. doi: 10.1186/s40545-020-00279-3.

  PMID: 33397509 DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• James C McElnay, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective, multi-centre, randomised intervention study will be conducted simultaneously in four different regions of the United Kingdom (UK), namely: 1. Northern Health and Social Care Trust (NHSCT) and Western Health and Social Care Trust (WHSCT), Northern Ireland 2. North West Coast Academic Health Science Network (AHSN), England 3. Wessex AHSN, England 4. Eastern AHSN, England Two GP practices will participate in the research in each of these four geographical areas. The pragmatic sample size at each site will be 50 intervention patients and 50 control patients completing a six month follow-up period i.e. a total of 800 patients (400 intervention and 400 control patients) across the eight participating GP practices. An over-recruitment of 20%, i.e. 60 each of both control and interventions patients per practice, will be recruited into the study to take account of patients who drop out of the study and/or are lost to follow up.

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 7, 2017
• Study Start: December 1, 2016
• Primary Completion: March 31, 2018
• Study Completion: May 31, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)