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Pharmacist-led Medicines Management Outpatient Service (MMC)

This study is currently recruiting participants.
Verified February 2012 by Queen's University, Belfast
Sponsor:
Information provided by (Responsible Party):
James McElnay, Queen's University, Belfast
ClinicalTrials.gov Identifier:
NCT01534559
First received: February 13, 2012
Last updated: February 15, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention Phase
High Risk of Medication-related Problems
 Other: Medicines Management Outpatient service
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Queen's University, Belfast:

Primary Outcome Measures:
  • Time to readmission to hospital [ Time Frame: Over 12 month post discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Readmission [ Time Frame: Over 12 months post discharge ] [ Designated as safety issue: No ]
  • Number of GP consultations and GP home visits [ Time Frame: over 12 month post discharge ] [ Designated as safety issue: No ]
  • Number of Accident and Emergency (A&E) visits [ Time Frame: over 12 month post discharge ] [ Designated as safety issue: No ]
  • Medication Appropriateness Index (MAI) score [ Time Frame: Will be assessed at dischrge and 4, 8 and 12 month post discharge ] [ Designated as safety issue: No ]
  • Health-related quality of life (HRQOL) [ Time Frame: Over 12 months post discharge, every 4 months ] [ Designated as safety issue: No ]
    This will be assessed using EQ-5D questionnaire

  • Medication Adherence Assessments; [ Time Frame: Over 12 month post discharge. Every 4 months. ] [ Designated as safety issue: No ]
    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).

  • Cost Utility Analysis [ Time Frame: Over 12 month post discharge. ] [ Designated as safety issue: No ]

Estimated Enrollment: 268
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Outpatient Medicine Management Clinic 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 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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534559

Contacts
Contact: Anita Hogg, BSc, MPSNI +442894424757 anita.hogg@northerntrust.hscni.net
Contact: Ghaith Al-Taani, BSc, MSc +447424748313 galtaani01@qub.ac.uk

Locations
United Kingdom
Northern Health and Social Care Trust Recruiting
Co Antrim, Northern Ireland, United Kingdom
Contact: Anita Hogg, BSc MPSNI     +442894424757     anita.hogg@northerntrust.hscni.net    
Contact: Ghaith AlTaani, BSc, MSc     +447424748313     galtaani01@qub.ac.uk    
Principal Investigator: Michael G Scott, PhD FPSNI            
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: James McElnay, Chief Investigator, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT01534559     History of Changes
Other Study ID Numbers: QUB B11/34
Study First Received: February 13, 2012
Last Updated: February 15, 2012
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on May 23, 2013