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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01534559|
Recruitment Status : Recruiting
First Posted : February 16, 2012
Last Update Posted : April 7, 2016
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|
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|
|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|
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)
No Intervention: Control
Patients will receive the normal care provided by the hospital
- Time to readmission to hospital [ Time Frame: Over 12 month post discharge ]
- Number of Readmission [ Time Frame: Over 12 months post discharge ]
- Number of GP consultations and GP home visits [ Time Frame: over 12 month post discharge ]
- Number of Accident and Emergency (A&E) visits [ Time Frame: over 12 month post discharge ]
- Medication Appropriateness Index (MAI) score [ Time Frame: Will be assessed at dischrge and 4, 8 and 12 month post discharge ]
- Health-related quality of life (HRQOL) [ Time Frame: Over 12 months post discharge, every 4 months ]This will be assessed using EQ-5D questionnaire
- 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).
- Cost Utility Analysis [ Time Frame: Over 12 month post discharge. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534559
|Contact: Anita Hogg, BSc, MPSNIemail@example.com|
|Contact: Ghaith Al-Taani, BSc, MScfirstname.lastname@example.org|
|Northern Health and Social Care Trust||Recruiting|
|Co Antrim, Northern Ireland, United Kingdom|
|Contact: Anita Hogg, BSc MPSNI +442894424757 email@example.com|
|Contact: Mohanad Odeh, BSc, MSc +442890972033 firstname.lastname@example.org|
|Principal Investigator: Michael G Scott, PhD FPSNI|
|Study Chair:||James C McElnay, BSc, PhD||Queen's University, Belfast|
|Principal Investigator:||Michael G Scott, BSc, PhD||Northern Health and Social Care Trust|