Pharmacist-led Medicines Management Outpatient Service

Phase 4

Completed

• Conditions: Patients at High Risk of Medicine-related Problems
• Interventions: Other: Medicines Management Outpatient service

• Registration Number: NCT01534559
• Lead Sponsor: Queen's University, Belfast

Brief Summary

It widely accepted that a number of medication related problems can occur after the patient has been discharged from the hospital. An obvious extension of the ongoing integrated medicines management programme (IMMP) is therefore to provide a medicines management clinic within an outpatient setting as well as follow-up telephone calls from a clinical pharmacist. This study aims to assess the influence a pharmacist-led medicines management outpatient service on patients at high risk of medication related problems.

It is anticipated that this service will

* Ensure continuity of pharmaceutical care for patients post discharge.

* Reinforce patient education in order to improve knowledge and understanding of the medication prescribed.

* Ensure that both prescription medicines and OTC preparations are used appropriately.

* Facilitate the communication with other members of healthcare team in order to agree and implement measures to overcome medication related problems.

Detailed Description

Patient safety and wellbeing are central concerns within the health service. Recent publications have highlighted the importance of medicines management and have called for local strategies to be introduced. An Integrated Medicines Management Programme (IMMP) has been implemented within Northern Health and Social Care Trust to ensure that a co-ordinated pharmacy service is available throughout the hospital stay for its medical patients. The IMMP has resulted in a number of benefits including improved patient safety, more effective use of medications, reduced length of stay, reduced readmissions rates, improved communication across the healthcare interface and user satisfaction.

It is widely accepted that a number of medication related problems can occur post discharge when complicated medication regimens can often prove confusing. This can lead to mismanagement of medicines and early rehospitalisation of patients. Although these problems are frequently commented upon, research in this area is still lacking. The present project aims to examine an extension of the present IMM service by evaluating the impact/patient benefit of a customised outpatient service provided by clinical pharmacy staff to patients post-discharge. An increase in patients' medicines adherence, a greater satisfaction with information about their medicines, improved beliefs about the necessity of their medicines, a decrease in medicines-related problems, a decrease in re-hospitalisation rates, extended time to re-hospitalisation, and a decrease in overall costs of patients care is anticipated.

This study will be carried out as a collaboration between the School of Pharmacy at Queen's University Belfast and the Northern Health and Social Care Trust (2 sites; Antrim Area Hospital and Whiteabbey Hospital).

Study Timeline

• Study First Submitted: 2012-02-13
• Study First Submitted QC: 2012-02-15
• Study First Posted: 2012-02-16
• Study Start: 2014-11
• Primary Completion: 2017-12
• Study Completion: 2018-04
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Patients (>= 18 years old) admitted into one of the study hospitals as acute/unscheduled medical admission and meet at least one of the following criteria:

• Prescribed five or more regular long term medications.
• Have three or more changes to medications during hospital stay.
• Past history of medication related problems.
• Patient referred to the medicines management clinic service by hospital doctor or clinical pharmacist due to concerns about ability to manage medicines in primary care.

Exclusion Criteria

• Patient being discharged to residential/nursing homes
• Palliative care patients
• Patients unable to give informed consent e.g. Alzheimer's Disease
• Patients unable to use telephone at home.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Outpatient Medicine Management Clinic	Medicines Management Outpatient service	Consented patients will attend two outpatient clinic appointments to receive help with any (potential) medicine-related problems

Primary Outcome Measures

Name	Time	Method
Time to readmission to hospital	Over 12 month post discharge

Secondary Outcome Measures

Name	Time	Method
Number of GP consultations and GP home visits	over 12 month post discharge
Number of Accident and Emergency (A&E) visits	over 12 month post discharge
Health-related quality of life (HRQOL)	Over 12 months post discharge, every 4 months	This will be assessed using EQ-5D questionnaire
Number of Readmission	Over 12 months post discharge
Cost Utility Analysis	Over 12 month post discharge.
Medication Adherence Assessments;	Over 12 month post discharge. Every 4 months.	Adherence will be assessed using the medication adherence report scale (MARS). Beliefs about medicines will be assessed using the validated beliefs about medicines questionnaire (BMQ).
Medication Appropriateness Index (MAI) score	Will be assessed at dischrge and 4, 8 and 12 month post discharge

Trial Locations

Locations (1)

Northern Health and Social Care Trust; 🇬🇧 Antrim, Northern Ireland, United Kingdom