Pharmacist-led Medicines Management Outpatient Service

NCT ID: NCT01534559

Last Updated: 2019-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2018-04-30

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).

Conditions

Patients at High Risk of Medicine-related Problems

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Outpatient Medicine Management Clinic

Consented patients will attend two outpatient clinic appointments to receive help with any (potential) medicine-related problems

Group Type: EXPERIMENTAL

Medicines Management Outpatient service

Intervention Type: OTHER

New customised clinical pharmacy service (medicines management clinic and follow-up phone calls)

Control

Patients will receive the normal care provided by the hospital

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Medicines Management Outpatient service

New customised clinical pharmacy service (medicines management clinic and follow-up phone calls)

Intervention Type: OTHER

Other Intervention Names

Medicines Management Clinic; Pharmacist-led outpatient service

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University, Belfast

OTHER

Sponsor Role: lead

Responsible Party

James McElnay

Chief Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James C McElnay, BSc, PhD

Role: STUDY_CHAIR

Queen's University, Belfast

Michael G Scott, BSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Northern Health and Social Care Trust

Locations

Northern Health and Social Care Trust

Antrim, Northern Ireland, United Kingdom

Countries

United Kingdom

Other Identifiers

QUB B11/34

Identifier Type: -

Identifier Source: org_study_id