Pharmacist-led Medicines Management Outpatient Service (MMC)

A Pharmacist-led Medicines Management Outpatient Service for Patients at High Risk of Medication Related Problems

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.

Study Overview

• Status: Completed
• Conditions: Patients at High Risk of Medicine-related Problems
• Intervention / Treatment: Other: Medicines Management Outpatient service

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Northern Ireland
    • Antrim, Northern Ireland, United Kingdom, BT41 2RL
      • Northern Health and Social Care Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Outpatient Medicine Management Clinic; Consented patients will attend two outpatient clinic appointments to receive help with any (potential) medicine-related problems	Other: Medicines Management Outpatient service; New customised clinical pharmacy service (medicines management clinic and follow-up phone calls); Other Names: Medicines Management Clinic; Pharmacist-led outpatient service
No Intervention: Control; Patients will receive the normal care provided by the hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to readmission to hospital	Over 12 month post discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Readmission		Over 12 months post discharge
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
Medication Appropriateness Index (MAI) score		Will be assessed at dischrge and 4, 8 and 12 month post discharge
Health-related quality of life (HRQOL)	This will be assessed using EQ-5D questionnaire	Over 12 months post discharge, every 4 months
Medication Adherence Assessments;	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).	Over 12 month post discharge. Every 4 months.
Cost Utility Analysis		Over 12 month post discharge.

Collaborators and Investigators

• Sponsor: Queen's University, Belfast
• Investigators: Study Chair: James C McElnay, BSc, PhD, Queen's University, Belfast; Principal Investigator: Michael G Scott, BSc, PhD, Northern Health and Social Care Trust

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: February 13, 2012
• First Submitted That Met QC Criteria: February 15, 2012
• First Posted (Estimate): February 16, 2012

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: QUB B11/34