Pharmacist-led Medicines Management Outpatient Service (MMC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01534559
Recruitment Status : Unknown
Verified April 2016 by James McElnay, Queen's University, Belfast.
Recruitment status was:  Recruiting
First Posted : February 16, 2012
Last Update Posted : April 7, 2016
Information provided by (Responsible Party):
James McElnay, 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.

Condition or disease Intervention/treatment Phase
Patients at High Risk of Medicine-related Problems Other: Medicines Management Outpatient service Phase 4

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  (Clinical Trial)
Estimated Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Pharmacist-led Medicines Management Outpatient Service for Patients at High Risk of Medication Related Problems
Study Start Date : November 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

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

Primary Outcome Measures :
  1. Time to readmission to hospital [ Time Frame: Over 12 month post discharge ]

Secondary Outcome Measures :
  1. Number of Readmission [ Time Frame: Over 12 months post discharge ]
  2. Number of GP consultations and GP home visits [ Time Frame: over 12 month post discharge ]
  3. Number of Accident and Emergency (A&E) visits [ Time Frame: over 12 month post discharge ]
  4. Medication Appropriateness Index (MAI) score [ Time Frame: Will be assessed at dischrge and 4, 8 and 12 month post discharge ]
  5. Health-related quality of life (HRQOL) [ Time Frame: Over 12 months post discharge, every 4 months ]
    This will be assessed using EQ-5D questionnaire

  6. Medication Adherence Assessments; [ Time Frame: 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).

  7. Cost Utility Analysis [ Time Frame: Over 12 month post discharge. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01534559

Contact: Anita Hogg, BSc, MPSNI +442894424757
Contact: Ghaith Al-Taani, BSc, MSc +447424748313

United Kingdom
Northern Health and Social Care Trust Recruiting
Co Antrim, Northern Ireland, United Kingdom
Contact: Anita Hogg, BSc MPSNI    +442894424757   
Contact: Mohanad Odeh, BSc, MSc    +442890972033   
Principal Investigator: Michael G Scott, PhD FPSNI         
Sponsors and Collaborators
Queen's University, Belfast
Study Chair: James C McElnay, BSc, PhD Queen's University, Belfast
Principal Investigator: Michael G Scott, BSc, PhD Northern Health and Social Care Trust

Responsible Party: James McElnay, Chief Investigator, Queen's University, Belfast Identifier: NCT01534559     History of Changes
Other Study ID Numbers: QUB B11/34
First Posted: February 16, 2012    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: April 2016