Clinical trial NCT01534559: Pharmacist-led Medicines Management Outpatient Service
Official title: A Pharmacist-led Medicines Management Outpatient Service for Patients at High Risk of Medication Related Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients at High Risk of Medicine-related Problems
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
First posted: 2012-02-16
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Primary outcomes:
measure: Time to readmission to hospital
timeFrame: Over 12 month post discharge
Secondary outcomes:
measure: Number of Readmission
timeFrame: Over 12 months post discharge
measure: Number of GP consultations and GP home visits
timeFrame: over 12 month post discharge
measure: Number of Accident and Emergency (A&E) visits
timeFrame: over 12 month post discharge
measure: Medication Appropriateness Index (MAI) score
timeFrame: Will be assessed at dischrge and 4, 8 and 12 month post discharge
measure: Health-related quality of life (HRQOL)
timeFrame: Over 12 months post discharge, every 4 months
measure: Medication Adherence Assessments;
timeFrame: Over 12 month post discharge. Every 4 months.
measure: Cost Utility Analysis
timeFrame: Over 12 month post discharge.
Other outcomes:
Locations:
city: Antrim
country: United Kingdom
facility: Northern Health and Social Care Trust
state: Northern Ireland
Study officials:
affiliation: Queen's University, Belfast
name: James C McElnay, BSc, PhD
role: STUDY_CHAIR
affiliation: Northern Health and Social Care Trust
name: Michael G Scott, BSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: