<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03241498</url>
  </required_header>
  <id_info>
    <org_study_id>QUB B16/46</org_study_id>
    <nct_id>NCT03241498</nct_id>
  </id_info>
  <brief_title>General Practitioner (GP) Practice Based Pharmacist Input to Medicines Optimisation</brief_title>
  <official_title>GP Practice Based Pharmacist Input to Medicines Optimisation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen's University, Belfast</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medicines Optimisation Innovation Centre (MOIC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Association of the British Pharmaceutical Industry (ABPI)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Queen's University, Belfast</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a United Kingdom (UK) based multi-centre study which will evaluate the impact of&#xD;
      a medication optimisation intervention (delivered in GP practices by pharmacists to patients&#xD;
      at risk of medication related problems), on healthcare resource utilisation and patient&#xD;
      outcomes. Pharmacists in 4 areas across the UK (3 in England and 1 in Northern Ireland) will&#xD;
      engage with patients, thought to be at a higher risk of medication related problems, within&#xD;
      their GP practice in order to help identify areas for improvement&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Drug therapy is growing more complex as patients increasingly suffer from a number of&#xD;
      co-morbidities. Accordingly, in clinical medicine, a wide range of medication related&#xD;
      problems may arise (1). A medication related problem (MRP) is defined as &quot;an event or&#xD;
      circumstance involving drug therapy that actually or potentially interferes with desired&#xD;
      health outcomes&quot; (2). These problems have been found to lead to more hospital admissions and&#xD;
      thus increase the cost of healthcare provision (3, 4). For instance, Winterstein et al.&#xD;
      carried out a meta-analysis of research in this area which showed that 7.1% of hospital&#xD;
      admissions were attributable to a drug related problem, of which 59% appeared avoidable (5).&#xD;
      Moreover, a large study in the United Kingdom showed that these admissions cost the National&#xD;
      Health Service (NHS) up to £466 million annually, which is 0.59% of the British health care&#xD;
      budget (6).&#xD;
&#xD;
      Medication related problems (MRPs) remain a serious concern particularly in primary care&#xD;
      settings. A recent UK study found that one in 20 prescription items in general practice&#xD;
      included an error, affecting 1 in 8 patients. Although the majority of these errors were&#xD;
      described as being either mild or moderate in severity, 1 in 550 of all prescription items&#xD;
      contained an error determined to be severe (7). In addition, significant medication wastage&#xD;
      has been found within general practice settings in England with an estimated £300 million&#xD;
      worth of prescribed medications being wasted each year in primary and community care (8).&#xD;
      Optimisation of drug therapy and prevention of MRPs can reduce health care expenditure,&#xD;
      potentially save lives and enhance patient quality of life (9-13).&#xD;
&#xD;
      Medicines optimisation is defined as 'a person-centred approach to safe and effective&#xD;
      medicines use, to ensure people obtain the best possible outcomes from their medicines.&#xD;
      Medicines optimisation applies to people who may or may not take their medicines effectively.&#xD;
      Shared decision-making is an essential part of evidence-based medicine, seeking to use the&#xD;
      best available evidence to guide decisions about the care of the individual patient, taking&#xD;
      into account their needs, preferences and values' (14, 15, 16).&#xD;
&#xD;
      Medicines optimisation requires more patient engagement and professional collaboration within&#xD;
      health and social care settings. It focuses on actions taken by all health and social care&#xD;
      practitioners. To support the medicines optimisation agenda a guide on medicines optimisation&#xD;
      has been produced by The Royal Pharmaceutical Society (RPS) the aim of which is to help&#xD;
      patients make the most of their medicines (17). This guide involves four key principles for&#xD;
      medicines optimisation in order to achieve improved patient outcomes (16). These principles&#xD;
      are as follows:&#xD;
&#xD;
      (i) Aim to understand the patient's experience (ii) Evidence based choice of medicines (iii)&#xD;
      Ensure medicines use is as safe as possible (iv) Make medicines optimisation part of routine&#xD;
      practice&#xD;
&#xD;
      In order to support the implementation of the guiding principles, NHS England launched the&#xD;
      prototype medicines optimisation dashboard in 2014. The dashboard aims to 'encourage Clinical&#xD;
      Commissioning Groups (CCGs) and healthcare Trusts to think more about how well their patients&#xD;
      are supported to use medicines and less about focusing on cost and volume of drugs' (16).&#xD;
&#xD;
      Primary care systems have started utilising a team based approach to care delivery.&#xD;
      Pharmacists have been increasingly recognised as a part of the healthcare professional team&#xD;
      within primary care settings in many countries (18). This integration of pharmacists into&#xD;
      primary health care systems was found to have significant benefits that included reduction of&#xD;
      errors, effective identification and resolution of medication related problems, improvements&#xD;
      in medication adherence, improved patient outcomes, relief of work pressure on GPs, improved&#xD;
      communication and cooperation between health professionals, and strengthened team working&#xD;
      within primary care (18-22).&#xD;
&#xD;
      Despite the expansion of the role of pharmacists in the primary health care setting, limited&#xD;
      research has been conducted to evaluate the impact of pharmacist input on health service&#xD;
      utilisation and cost.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">May 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>A prospective, multi-centre, randomised intervention study will be conducted simultaneously in four different regions of the United Kingdom (UK), namely:&#xD;
Northern Health and Social Care Trust (NHSCT) and Western Health and Social Care Trust (WHSCT), Northern Ireland&#xD;
North West Coast Academic Health Science Network (AHSN), England&#xD;
Wessex AHSN, England&#xD;
Eastern AHSN, England&#xD;
Two GP practices will participate in the research in each of these four geographical areas. The pragmatic sample size at each site will be 50 intervention patients and 50 control patients completing a six month follow-up period i.e. a total of 800 patients (400 intervention and 400 control patients) across the eight participating GP practices. An over-recruitment of 20%, i.e. 60 each of both control and interventions patients per practice, will be recruited into the study to take account of patients who drop out of the study and/or are lost to follow up.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of unplanned hospital admissions</measure>
    <time_frame>Recruitment - 6 months post intervention</time_frame>
    <description>Number of unplanned admissions to hospital over the follow-up period will be collected for both control and intervention patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of A&amp;E attendances</measure>
    <time_frame>Recruitment - 6 months post intervention</time_frame>
    <description>Number of attendance to the A&amp;E department over the follow-up period will be collected for both control and intervention patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of GP consultations</measure>
    <time_frame>Recruitment - 6 months post intervention</time_frame>
    <description>Number of unplanned consultations with the patient's GP over the follow-up period will be collected for both control and intervention patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medication appropriateness index (MAI) score</measure>
    <time_frame>Recruitment - 6 months post intervention</time_frame>
    <description>MAI scores will be calculated at the beginning and end of the project for each patient recruited into the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of medication related problems</measure>
    <time_frame>Recruitment - 6 months post intervention</time_frame>
    <description>Number of medication related problems will be calculated at the beginning and end of the project for each patient recruited into the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life (HRQOL)</measure>
    <time_frame>Recruitment - 6 months post intervention</time_frame>
    <description>HRQOL scores will be calculated using the EQ-5D tool at the beginning and end of the project for each patient recruited into the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Adherence report scale (MARS)</measure>
    <time_frame>Recruitment - 6 months post intervention</time_frame>
    <description>MARS scores will be calculated at the beginning and end of the project for each patient recruited into the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beliefs about medicines questionnaire (BMQ)</measure>
    <time_frame>Recruitment - 6 months post intervention</time_frame>
    <description>BMQ scores will be calculated at the beginning and end of the project for each patient recruited into the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction with GP services</measure>
    <time_frame>Recruitment - 6 months post intervention</time_frame>
    <description>Patients will be asked to complete a bespoke satisfaction questionnaire in order to assess their satisfaction with the new service which has been provided</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient laboratory data relevant to medications being received</measure>
    <time_frame>Recruitment - 6 months post intervention</time_frame>
    <description>Pertinent laboratory data will be collected throughout the intervention period and follow-up</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">356</enrollment>
  <condition>Medication Adherence</condition>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All patients allocated to the control group, who on checking meet the study entry criteria and who consent (written informed consent) to participate in the research, will be asked to complete the three study questionnaires (see below) and will be advised that repeat questionnaires will be distributed by post at the end of the study (6 months) for completion at home and return by post. The patients will continue to receive all services provided by the GP practice (normal care) but will not receive the bespoke clinical pharmacist intervention which is being evaluated in this research study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants meeting all study entry criteria who are allocated to the intervention group will also be asked to complete the three study questionnaires. Having completed the questionnaires they will receive the medicines optimisation intervention by the clinical pharmacist. They will be asked to return for repeat appointments with the clinical pharmacist at 2 and 4 months and will be advised that they will be asked to complete the study questionnaires again at the end of the study (at home, via post at 6 months).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medicines optimisation</intervention_name>
    <arm_group_label>Intervention arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients are included in the study if they have any of the following:&#xD;
&#xD;
          -  Have had at least 1 unplanned hospital admission or 2 or more accident and emergency&#xD;
             department (A&amp;E) attendances in the previous 12 months.&#xD;
&#xD;
          -  Prescribed ≥ 6 regular oral/systemic, long term medicines.&#xD;
&#xD;
          -  Has ≥ 2 long-term chronic conditions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is residing in a nursing home or a care home.&#xD;
&#xD;
          -  Patient is considered unable to give written informed consent e.g. Alzheimer's&#xD;
             disease.&#xD;
&#xD;
          -  Palliative care patients.&#xD;
&#xD;
          -  Patient has had ≥ 4 unplanned admissions to hospital in the previous 6 months.&#xD;
&#xD;
          -  Patient is participating in another intervention research project within the practice.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James C McElnay, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen's University, Belfast</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northern Health and Social Care Trust</name>
      <address>
        <city>Antrim</city>
        <state>Northern Ireland</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>December 13, 2019</last_update_submitted>
  <last_update_submitted_qc>December 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Queen's University, Belfast</investigator_affiliation>
    <investigator_full_name>James McElnay</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Medicines optimisation</keyword>
  <keyword>Healthcare resource utilisation</keyword>
  <keyword>HRQOL</keyword>
  <keyword>Pharmacist-led</keyword>
  <keyword>GP based</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Final results will be disseminated through relevant academic press</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03241498
org study id: QUB B16/46
nct id: NCT03241498
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is a United Kingdom (UK) based multi-centre study which will evaluate the impact of
      a medication optimisation intervention (delivered in GP practices by pharmacists to patients
      at risk of medication related problems), on healthcare resource utilisation and patient
      outcomes. Pharmacists in 4 areas across the UK (3 in England and 1 in Northern Ireland) will
      engage with patients, thought to be at a higher risk of medication related problems, within
      their GP practice in order to help identify areas for improvement
Drug therapy is growing more complex as patients increasingly suffer from a number of
      co-morbidities. Accordingly, in clinical medicine, a wide range of medication related
      problems may arise (1). A medication related problem (MRP) is defined as "an event or
      circumstance involving drug therapy that actually or potentially interferes with desired
      health outcomes" (2). These problems have been found to lead to more hospital admissions and
      thus increase the cost of healthcare provision (3, 4). For instance, Winterstein et al.
      carried out a meta-analysis of research in this area which showed that 7.1% of hospital
      admissions were attributable to a drug related problem, of which 59% appeared avoidable (5).
      Moreover, a large study in the United Kingdom showed that these admissions cost the National
      Health Service (NHS) up to £466 million annually, which is 0.59% of the British health care
      budget (6).

      Medication related problems (MRPs) remain a serious concern particularly in primary care
      settings. A recent UK study found that one in 20 prescription items in general practice
      included an error, affecting 1 in 8 patients. Although the majority of these errors were
      described as being either mild or moderate in severity, 1 in 550 of all prescription items
      contained an error determined to be severe (7). In addition, significant medication wastage
      has been found within general practice settings in England with an estimated £300 million
      worth of prescribed medications being wasted each year in primary and community care (8).
      Optimisation of drug therapy and prevention of MRPs can reduce health care expenditure,
      potentially save lives and enhance patient quality of life (9-13).

      Medicines optimisation is defined as 'a person-centred approach to safe and effective
      medicines use, to ensure people obtain the best possible outcomes from their medicines.
      Medicines optimisation applies to people who may or may not take their medicines effectively.
      Shared decision-making is an essential part of evidence-based medicine, seeking to use the
      best available evidence to guide decisions about the care of the individual patient, taking
      into account their needs, preferences and values' (14, 15, 16).

      Medicines optimisation requires more patient engagement and professional collaboration within
      health and social care settings. It focuses on actions taken by all health and social care
      practitioners. To support the medicines optimisation agenda a guide on medicines optimisation
      has been produced by The Royal Pharmaceutical Society (RPS) the aim of which is to help
      patients make the most of their medicines (17). This guide involves four key principles for
      medicines optimisation in order to achieve improved patient outcomes (16). These principles
      are as follows:

      (i) Aim to understand the patient's experience (ii) Evidence based choice of medicines (iii)
      Ensure medicines use is as safe as possible (iv) Make medicines optimisation part of routine
      practice

      In order to support the implementation of the guiding principles, NHS England launched the
      prototype medicines optimisation dashboard in 2014. The dashboard aims to 'encourage Clinical
      Commissioning Groups (CCGs) and healthcare Trusts to think more about how well their patients
      are supported to use medicines and less about focusing on cost and volume of drugs' (16).

      Primary care systems have started utilising a team based approach to care delivery.
      Pharmacists have been increasingly recognised as a part of the healthcare professional team
      within primary care settings in many countries (18). This integration of pharmacists into
      primary health care systems was found to have significant benefits that included reduction of
      errors, effective identification and resolution of medication related problems, improvements
      in medication adherence, improved patient outcomes, relief of work pressure on GPs, improved
      communication and cooperation between health professionals, and strengthened team working
      within primary care (18-22).

      Despite the expansion of the role of pharmacists in the primary health care setting, limited
      research has been conducted to evaluate the impact of pharmacist input on health service
      utilisation and cost.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: A prospective, multi-centre, randomised intervention study will be conducted simultaneously in four different regions of the United Kingdom (UK), namely:
Northern Health and Social Care Trust (NHSCT) and Western Health and Social Care Trust (WHSCT), Northern Ireland
North West Coast Academic Health Science Network (AHSN), England
Wessex AHSN, England
Eastern AHSN, England
Two GP practices will participate in the research in each of these four geographical areas. The pragmatic sample size at each site will be 50 intervention patients and 50 control patients completing a six month follow-up period i.e. a total of 800 patients (400 intervention and 400 control patients) across the eight participating GP practices. An over-recruitment of 20%, i.e. 60 each of both control and interventions patients per practice, will be recruited into the study to take account of patients who drop out of the study and/or are lost to follow up.
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Number of unplanned hospital admissions
time frame: Recruitment - 6 months post intervention
description: Number of unplanned admissions to hospital over the follow-up period will be collected for both control and intervention patients
measure: Number of A&E attendances
time frame: Recruitment - 6 months post intervention
description: Number of attendance to the A&E department over the follow-up period will be collected for both control and intervention patients
measure: Number of GP consultations
time frame: Recruitment - 6 months post intervention
description: Number of unplanned consultations with the patient's GP over the follow-up period will be collected for both control and intervention patients
measure: Medication appropriateness index (MAI) score
time frame: Recruitment - 6 months post intervention
description: MAI scores will be calculated at the beginning and end of the project for each patient recruited into the study
measure: Number of medication related problems
time frame: Recruitment - 6 months post intervention
description: Number of medication related problems will be calculated at the beginning and end of the project for each patient recruited into the study
measure: Health-related quality of life (HRQOL)
time frame: Recruitment - 6 months post intervention
description: HRQOL scores will be calculated using the EQ-5D tool at the beginning and end of the project for each patient recruited into the study
measure: Medication Adherence report scale (MARS)
time frame: Recruitment - 6 months post intervention
description: MARS scores will be calculated at the beginning and end of the project for each patient recruited into the study
measure: Beliefs about medicines questionnaire (BMQ)
time frame: Recruitment - 6 months post intervention
description: BMQ scores will be calculated at the beginning and end of the project for each patient recruited into the study
measure: Patient satisfaction with GP services
time frame: Recruitment - 6 months post intervention
description: Patients will be asked to complete a bespoke satisfaction questionnaire in order to assess their satisfaction with the new service which has been provided
measure: Patient laboratory data relevant to medications being received
time frame: Recruitment - 6 months post intervention
description: Pertinent laboratory data will be collected throughout the intervention period and follow-up
arm group label: Control arm
arm group type: No Intervention
description: All patients allocated to the control group, who on checking meet the study entry criteria and who consent (written informed consent) to participate in the research, will be asked to complete the three study questionnaires (see below) and will be advised that repeat questionnaires will be distributed by post at the end of the study (6 months) for completion at home and return by post. The patients will continue to receive all services provided by the GP practice (normal care) but will not receive the bespoke clinical pharmacist intervention which is being evaluated in this research study.
arm group label: Intervention arm
arm group type: Experimental
description: Participants meeting all study entry criteria who are allocated to the intervention group will also be asked to complete the three study questionnaires. Having completed the questionnaires they will receive the medicines optimisation intervention by the clinical pharmacist. They will be asked to return for repeat appointments with the clinical pharmacist at 2 and 4 months and will be advised that they will be asked to complete the study questionnaires again at the end of the study (at home, via post at 6 months).
intervention type: Other
intervention name: Medicines optimisation
arm group label: Intervention arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: James C McElnay, PhD
role: Principal Investigator
affiliation: Queen's University, Belfast
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Queen's University, Belfast
investigator full name: James McElnay
investigator title: Professor
sharing ipd: No
ipd description: Final results will be disseminated through relevant academic press