Patients at High Risk of Medicine-related ProblemsPhase 4MMCNCT01534559
Pharmacist-led Medicines Management Outpatient Service
A Phase 4 study testing Medicines Management Outpatient service in people with Patients at High Risk of Medicine-related Problems, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients at High Risk of Medicine-related Problems
- What is being tested?
- Medicines Management Outpatient service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Apr 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northern Health and Social Care Trust
Antrim, Northern Ireland, BT41 2RL
About this study
Official title: A Pharmacist-led Medicines Management Outpatient Service for Patients at High Risk of Medication Related Problems
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.
Read the 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).
- Being tested
- Medicines Management Outpatient service
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicines Management Outpatient serviceOther
Also called Medicines Management Clinic, Pharmacist-led outpatient service
New customised clinical pharmacy service (medicines management clinic and follow-up phone calls)
| Study group | Role | What they receive |
|---|---|---|
| Outpatient Medicine Management Clinic | Experimental | Consented patients will attend two outpatient clinic appointments to receive help with any (potential) medicine-related problems Receives: Other: Medicines Management Outpatient service |
| Control | No intervention | Patients will receive the normal care provided by the hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to readmission to hospital
Measured: Over 12 month post discharge
Secondary outcomes (7)
Number of Readmission
Measured: Over 12 months post discharge
Number of GP consultations and GP home visits
Measured: over 12 month post discharge
Number of Accident and Emergency (A&E) visits
Measured: over 12 month post discharge
Medication Appropriateness Index (MAI) score
Measured: Will be assessed at dischrge and 4, 8 and 12 month post discharge
Health-related quality of life (HRQOL)
This will be assessed using EQ-5D questionnaire
Measured: Over 12 months post discharge, every 4 months
Medication Adherence Assessments;
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).
Measured: Over 12 month post discharge. Every 4 months.
Cost Utility Analysis
Measured: Over 12 month post discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startNov 2014
- Primary completionDec 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients at High Risk of Medicine-related ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James McElnay, Queen's University, Belfast
- Investigators
- James C McElnay, BSc, PhD, Study chair, Queen's University, BelfastMichael G Scott, BSc, PhD, Principal investigator, Northern Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534559
- Sponsor's protocol ID
- QUB B11/34
- Acronym
- MMC
- Status last verified
- Mar 2019
- First submitted
- 13 Feb 2012
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacist-led Medicines Management Outpatient Service for Patients at High Risk of Medication Related Problems
- ClinicalTrials.gov ID
- NCT01534559
- Acronym / sponsor ID
- MMC / QUB B11/34
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 16 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient Medicine Management Clinic | Experimental | Other: Medicines Management Outpatient serviceConsented patients will attend two outpatient clinic appointments to receive help with any (potential) medicine-related problems |
| Control | No intervention | –Patients will receive the normal care provided by the hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medicines Management Outpatient serviceAlso: Medicines Management Clinic, Pharmacist-led outpatient serviceNew customised clinical pharmacy service (medicines management clinic and follow-up phone calls) | Other | Outpatient Medicine Management Clinic |
Primary outcome
Time to readmission to hospital
Time frame: Over 12 month post discharge
7 secondary outcomes
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
Medication Adherence Assessments;
Time frame: Over 12 month post discharge. Every 4 months.
Cost Utility Analysis
Time frame: Over 12 month post discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James C McElnay, BSc, PhD study chair
Queen's University, Belfast
Michael G Scott, BSc, PhD principal investigator
Northern Health and Social Care Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Medicines Management Outpatient service in people with Patients at High Risk of Medicine-related Problems, run by Queen's University, Belfast at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to readmission to hospital (time frame: Over 12 month post discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019; AzTrials last refreshed its copy on 6 Nov 2026.