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Trial registered on ANZCTR
Registration number
ACTRN12617000926336
Ethics application status
Approved
Date submitted
15/06/2017
Date registered
27/06/2017
Date last updated
27/06/2017
Type of registration
Retrospectively registered
Titles & IDs
Public title
Implementation of a service to improve quality use of medicines and outcomes in older hospital patients
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Scientific title
Implementation of a Multidisciplinary Multiple Medication Management Service (4MS) to Improve Quality Use of Medicines and Outcomes in Older Inpatients at RNSH
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Secondary ID [1]
291736
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
hyperpolypharmacy
302928
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frailty
302930
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falls
302931
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adverse effects
302933
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Condition category
Condition code
Mental Health
302409
302409
0
0
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Studies of normal psychology, cognitive function and behaviour
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Respiratory
302410
302410
0
0
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Chronic obstructive pulmonary disease
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Cardiovascular
303064
303064
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0
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Coronary heart disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Cycles of usual care period (~4 weeks) followed by intervention period (~4 weeks) will be conducted on 3-5 medical units including general medicine, cardiology and respiratory medicine.Depending on when the patient is recruited, patient will be assigned to usual care (period 1) or intervention (period 2).
Screen all patients aged over 65 years admitted to medical service at Royal North Shore Hospital. Obtain informed consent from participant or person responsible. Obtain baseline data for all participants on sociodemographics, reason for admission, medications, comorbidities, falls, probable one year survival and cognition. Administer a frailty questionnaire (Reported Edmonton Frail Scale).
Intervention: After consent is obtained, study pharmacist obtains best possible medication history and documents on standard hospital medication history form (medication management plan; MMP).
Study pharmacist will also generate a medication optimisation plan as documented on the MMP. Ideally, this should be completed within 48 hours of the patient's admission but may be delayed. A copy of this plan is to be provided in the medical notes.
If the patient is taking a medication that contributes to the drug burden index (DBI), that is, taking a medication with sedative and/or anticholinergic effects, the DBI will be calculated online using a DBI calculator, which has been shown to be a reliable and validated computerised clinical decision support system to report DBI of older patients taking multiple medications.
The plan is discussed with the patient/carer, General Practitioner (GP) and the patient's treating team (registrar +/- consultant). The patient's team will decide whether to make any changes to medicines, at their own discretion, They can decide to agree or disagree with the recommendations outlined in the plan by the pharmacist.
The intervention will run over a period of approximately 4 weeks,
The study pharmacist will also record the time taken by staff involved to review medicines (pharmacist, admitting team, consults, case conferences etc). Where possible, the study pharmacist will prompt the patient's usual team pharmacist to document any changes made to medicines and reasons for changes that are not already documented through routine care. Where possible and clinically appropriate, the study pharmacist will call the patient's GP to explain changes made on discharge.
The patient will be followed up at 1 and 6 months from their discharge date by phone call to patient/carer and/or GP and/or facility manager and medical records. The patient may choose to receive an email or postal mail containing the follow-up questions. Questions will be on their medicines, falls, readmission, institutionalisation and mortality (which can be confirmed with Births, Deaths and Marriages when necessary).
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Intervention code [1]
297843
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Prevention
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Intervention code [2]
298206
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Treatment: Other
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Comparator / control treatment
Cycles of usual care period (~4 weeks) followed by intervention period (~4 weeks) will be conducted on 3-5 medical units including general medicine, cardiology and respiratory medicine. Depending on when the patient is recruited, patient will be assigned to usual care (period 1) or intervention (period 2).
Screen all patients aged over 65 years admitted to medical service at Royal North Shore Hospital. Obtain informed consent from participant or person responsible. Obtain baseline data for all participants on sociodemographics, reason for admission, medications, comorbidities, falls, probable one year survival and cognition. Administer a frailty questionnaire (Reported Edmonton Frail Scale). In cases where the routine ward pharmacist has not already done so, the research pharmacist obtains best possible medication history and documents history on hospital medication history form (MMP).
No medication optimisation plan will be provided to the team for discussion. No plan to discuss recommendations to medications to the patient, GP or treating team will occur.
If the patient is taking a medication that contributes to the drug burden index (DBI), that is, taking a medication with sedative and/or anticholinergic effects, the DBI will be calculated online using a DBI calculator, which has been shown to be a reliable and validated computerised clinical decision support system to report DBI of older patients taking multiple medications. The DBI score will not be discussed with the patient's team, patient or GP.
The patient will be followed up at 1 and 6 months from their discharge date by phone call to patient/carer and/or GP and/or facility manager and medical records. The patient may choose to receive an email or postal mail containing the follow-up questions. Questions will be on their medicines, falls, readmission, institutionalisation and mortality (which can be confirmed with Births, Deaths and Marriages when necessary).
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Control group
Active
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Outcomes
Primary outcome [1]
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To compare the prevalence of cessation or dose reduction of admission medications between the usual care and intervention groups. This will be assessed by comparing medications on admission (according to the MMP) and the medications as documented in the patient's hospital discharge summary, A medication is defined as any prescribed or non-prescribed medication including over the counter medications but excluding complementary or herbal medicines and supplements.
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Assessment method [1]
301819
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Timepoint [1]
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At discharge, follow up at 1 month and 6 months after discharge
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Primary outcome [2]
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Compare between usual care and intervention groups prevalence of change in quality use of medicines indicators in older adults (e.g. Drug Burden Index, Beers Criteria, STOPP/START criteria)
If the participant is taking a medication that has DBI score, their score will be calculated on admission, discharge and 1 and 6 months after discharge.
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Assessment method [2]
302448
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Timepoint [2]
302448
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Admission, discharge, 1 and 6 month follow up
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Primary outcome [3]
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Compare between usual care and intervention groups prevalence of change in quality use of medicines indicators in older adults (e.g. Drug Burden Index, Beers Criteria, STOPP/START criteria).
The number of medications that a patient is taking that is listed on the Beers criteria will be quantified and compared on admission, discharge and 1 and 6 months after discharge.
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Assessment method [3]
302502
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Timepoint [3]
302502
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Admission, discharge, 1 and 6 month follow up
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Secondary outcome [1]
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Prevalence of falls. On hospital admission, the patient will be asked if they have experienced a fall in the preceding 6 months, Any falls during hospital (inpatient falls) will be extracted from review of the patient's medical records.
During the 1 and 6 month (post discharge) follow up (via phone call, email or postal mail), the patient will be asked if they have had a fall since discharge. They will also be asked if their fall required them to present to hospital. This will be compared between intervention and control groups using chi-square tests (prevalence) and independent t tests.
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Assessment method [1]
333956
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Timepoint [1]
333956
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Discharge (to collect data on any inpatient falls) and 1 and 6 months after discharge;
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Secondary outcome [2]
333957
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Patient evaluation of medication management.
At discharge, patients will be asked two questions to rank their satisfaction with their medication management in hospital on a likert scale from 1 to 10. These questions were designed specifically for this study. Descriptive statistics will be used to summarise this.
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Assessment method [2]
333957
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Timepoint [2]
333957
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On discharge
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Secondary outcome [3]
335348
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Hospital readmissions.
Compare between usual care and intervention groups clinical outcomes such as hospital readmissions, at 1 and 6 months after discharge.
During the 1 and 6 months follow up (via phone call, email or postal mail) questions on whether patient has been readmitted to hospital will be asked. Where appropriate this may be confirmed with the GP or hospital electronic medical records.
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Assessment method [3]
335348
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Timepoint [3]
335348
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1 and 6 months since discharge
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Secondary outcome [4]
335349
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Institutionalisation
Compare between usual care and intervention groups clinical outcomes such as institutionalisation at 1 and 6 months after discharge.
During the 1 and 6 months follow up (via phone call, email or postal mail) questions on the participants living status (home independent, home with carer, home with services, aged care facility) will be asked. This will be confirmed with the patient/GP/Facility manager.
Institutionalisation on follow up will be compared between intervention and control groups using chi-square tests.
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Assessment method [4]
335349
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Timepoint [4]
335349
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1 and 6 months since discharge
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Secondary outcome [5]
335350
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Prevalence of adverse drug reactions.
This will be compared between intervention and control groups using chi-square tests. Prevalence of adverse drug reactions will be extracted from review of routinely collected data in the medical records on discharge. During the 1 and 6 month (post discharge) follow up (via phone call, email or postal mail) the patient will be asked if they have had experienced an adverse drug reaction since hospital discharge.
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Assessment method [5]
335350
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Timepoint [5]
335350
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Discharge and 1 and 6 month post discharge
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Secondary outcome [6]
335351
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GP evaluation of the intervention.
At discharge, General Practitioners (GPs) will be asked 3 questions on their opinions of the 4MS report (that will be faxed and/or emailed to them on discharge) and 5 questions on their opinions on the process of medication review in hospital. Descriptive statistics will be used to summarise this.
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Assessment method [6]
335351
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Timepoint [6]
335351
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At discharge
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Secondary outcome [7]
335354
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Length of stay.
Length of stay will be collected from medical records and compared between the intervention and control group using independent t test.
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Assessment method [7]
335354
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Timepoint [7]
335354
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At discharge
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Secondary outcome [8]
335356
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Mortality
Mortality at 1 and 6 months post-discharge will be compared between intervention and control groups using chi-square tests. Mortality may be confirmed with medical records, GP, and/or Births, Deaths and Marriages when necessary.
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Assessment method [8]
335356
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Timepoint [8]
335356
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1 and 6 months post-discharge
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Secondary outcome [9]
335357
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Prevalence of pressure areas.
This will be compared between intervention and control groups using chi-square tests. Prevalence of pressure areas during admission will be extracted from review of the medical records. If a patient has a pressure area this will routinely be documented in the medical records. This will be collected in the following categories: pressure area on admission (Yes/no), new pressure area, pressure area worsened during admission, pressure area same during admission.
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Assessment method [9]
335357
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Timepoint [9]
335357
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At discharge
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Secondary outcome [10]
335358
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Hospital doctor feedback of the intervention.
Hospital doctors will be emailed, or handed in person, questions on their thoughts of the 4MS. These questions were specifically designed for this study to better understand barriers and enablers of implementing the 4MS.
A focus group will be run by a medical officer (who is independent from the study) after each phase (~8 weeks; ~4 weeks control and ~4 weeks intervention) of the study to evaluate the opinions of hospital staff including in hospital doctors,
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Assessment method [10]
335358
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Timepoint [10]
335358
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Approximately 8 weeks
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Secondary outcome [11]
335365
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Feasibility: Economic evaluation will be performed.
A cost analysis will be undertaken which will consider the time and cost involved (e.g. hourly rate of pharmacist) to generate the medication optimisation plan and discuss the report with the registrar/consultant.
Descriptive statistics including mean, median and range will be used to analyse this outcome.
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Assessment method [11]
335365
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Timepoint [11]
335365
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After intervention period (~4 weeks) for each cycle
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Secondary outcome [12]
336020
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Prevalence of adverse drug withdrawal events
This will be compared between intervention and control groups using chi-square tests.
Prevalence of adverse drug withdrawal events will be extracted from review of routinely collected data in the medical records on discharge. During the 1 and 6 month (post discharge) follow up (via phone call, email or postal mail) the patient will be asked if they have had experienced an adverse drug withdrawal events since hospital discharge.
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Assessment method [12]
336020
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Timepoint [12]
336020
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discharge, 1 and 6 months post-discharge
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Secondary outcome [13]
336241
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**This is a primary outcome**
Compare between usual care and intervention groups prevalence of change in quality use of medicines indicators in older adults (e.g. Drug Burden Index, Beers Criteria, STOPP/START)
The number of medications that a patient is taking that is listed on the STOPP/START criteria will be quantified and compared on admission, discharge and 1 and 6 months after discharge.
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Assessment method [13]
336241
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Timepoint [13]
336241
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Admission, discharge, 1 and 6 month follow up
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Secondary outcome [14]
336244
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Compare between usual care and intervention groups prevalence of change in quality use of medicines indicators in older adults e.g. drug class, drug dose, drug interactions
The number of medications that a patient is taking according to their drug class will be compared on admission, discharge and 1 and 6 months after discharge.
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Assessment method [14]
336244
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Timepoint [14]
336244
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Admission, discharge, 1 and 6 month follow up
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Secondary outcome [15]
336245
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Compare between usual care and intervention groups prevalence of change in quality use of medicines indicators in older adults e.g. drug class, drug dose, drug interactions
The number of medications that a patient is taking that require dosage adjustments will be compared on admission, discharge and 1 and 6 months after discharge.
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Assessment method [15]
336245
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Timepoint [15]
336245
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Admission, discharge, 1 and 6 month follow up
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Secondary outcome [16]
336246
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Compare between usual care and intervention groups prevalence of change in quality use of medicines indicators in older adults e.g. drug class, drug dose, drug interactions
The number of drug interactions that are severe will be compared on admission, discharge and 1 and 6 months after discharge.
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Assessment method [16]
336246
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Timepoint [16]
336246
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Admission, discharge, 1 and 6 month follow up
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Eligibility
Key inclusion criteria
• Male and female patients aged 65 years or older
• Admitted to a service within the division of medicine
• Expected to remain in hospital for at least 72 hours after recruitment
• Expected to survive the acute admission
• Informed consent can be obtained from patient or a person responsible
• Taking 10 or more medications on admission
• Able to communicate in English (or a translator is available)
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Patients in terminal phase of illness who are expected to die during current admission (as documented in the medical notes available on the ward).
• Inability of patient or a person responsible to give consent and participate in an interview in English
• Predicted hospital stay <72 hours
• During admission to high dependency units e.g. Intensive Care Unit, Coronary Care Unit or Respiratory Care Unit
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Only applicable for randomised controlled trials.
This is a pre-post intervention study.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Only applicable for randomised controlled trials.
This is a pre-post intervention study.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Each medical unit will be studied for 2 consecutive periods of ~4 weeks. Depending on the month the patient is recruited, patient will be assigned to usual care (Period 1) or intervention (Period 2). Period 1 will serve as the control and Period 2 is when the intervention will occur.
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
To assess the primary outcome, change in the prevalence of stopping a medication between admission and discharge will be compared between the usual care (control) and 4MS (intervention) groups. Prevalence of other validated indicators of quality use of medicines in older adults (that include drug class, dose and interactions) will also be compared. This will use the chi-square analysis.
Secondary prescribing outcomes will be compared between discharge and 1 and 6 months post discharge similarly using chi square for proportions and t tests for continuous variables. Clinical outcomes will be compared between the usual care and 4MS groups in the same way.
Feasibility: Economic evaluation (cost analysis) will be performed by the executive unit
Opinions of clinicians and patients – descriptive statistics and qualitative analyses
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
19/06/2017
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Date of last participant enrolment
Anticipated
30/12/2017
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Actual
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Date of last data collection
Anticipated
30/06/2018
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
8379
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Royal North Shore Hospital - St Leonards
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Recruitment postcode(s) [1]
16447
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2065 - St Leonards
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Funding & Sponsors
Funding source category [1]
296232
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Hospital
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Name [1]
296232
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Royal North Shore Hospital (Ramsay Research and Teaching Fund )
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Address [1]
296232
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Kolling Institute
Royal North Shore Hospital
Pacific Hwy, St Leonards
NSW 2065
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Country [1]
296232
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Australia
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Primary sponsor type
Hospital
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Name
Royal North Shore Hospital
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Address
Royal North Shore Hospital
Reserve Road, St Leonards
NSW 2065
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Country
Australia
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Secondary sponsor category [1]
295149
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University
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Name [1]
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University of Sydney
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Address [1]
295149
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The University of Sydney
Camperdown NSW 2006
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Country [1]
295149
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
297471
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Northern Sydney Local Health District Research Office
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Ethics committee address [1]
297471
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NSLHD Research Office
Level 13, Kolling Building
Royal North Shore Hospital
St Leonards NSW 2065?
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Ethics committee country [1]
297471
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Australia
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Date submitted for ethics approval [1]
297471
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13/03/2017
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Approval date [1]
297471
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14/06/2017
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Ethics approval number [1]
297471
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RESP/17/52
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Summary
Brief summary
Australia has an ageing population with an associated increase in people living with multiple chronic diseases. There has been a major increase in polypharmacy (multiple medicines use) in Australia over the past decade and the prevalence continues to rise, especially in older adults. Polypharmacy can lead to medication errors, adverse drug reactions, falls, confusion, frailty, loss of independence, hospitalisation and mortality.
Evidence is emerging that supervised withdrawal of harmful or unnecessary medicines (deprescribing) is safe and may improve quality of life in older people. Over 90% of older adults surveyed in a range of settings, including Royal North Shore Hospital inpatients stated they would like to stop one of their medicines if their doctor said it was possible.
An acute hospital stay represents a missed opportunity to review a patient’s medicines and reduce polypharmacy. In the Royal North Shore Hospital (RNSH) inpatient aged care service, the prevalence of hyperpolypharmacy increases from 45.8% on admission to 60.4% on discharge. Involvement of clinical pharmacists has been shown to improve care of hospitalised patients.
The main barriers to optimising medicines during admission are a focus on the acute presenting problem; inadequate information on the patient’s comorbidities and medications prior to admission; difficulties reaching consensus between the patient, multiple specialists and general practitioner; inadequate time with short length of stay; and lack of expertise by junior medical officers, who do most of the prescribing.
Failure to address polypharmacy in hospital results in longer lengths of stay due to adverse drug events, and a higher likelihood of readmission. We propose testing a new service at RNSH to improve Quality Use of Medicines by older patients across the continuum of care. Quality Use of Medicines, which is a pillar of Australia’s National Medicines Policy, is best achieved through partnership between consumers, clinicians, academics and policy makers. Such partnership is central to the Multidisciplinary Multiple Medicines Management Service (4MS) that will be tested in this proposal.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Sarah Hilmer
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Address
74150
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Level 12
Kolling Building
Royal North Shore Hospital
Reserve Rd, St Leonards
NSW 2065
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Country
74150
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Australia
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Phone
74150
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+61 2 9926 4481
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Fax
74150
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+61 2 9926 4053
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Email
74150
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[email protected]
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Contact person for public queries
Name
74151
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Prof Sarah Hilmer
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Address
74151
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Level 12
Kolling Building
Royal North Shore Hospital
Reserve Rd, St Leonards
NSW 2065
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Country
74151
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Australia
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Phone
74151
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+61 2 9926 4481
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Fax
74151
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+61 2 9926 4053
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Email
74151
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[email protected]
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Contact person for scientific queries
Name
74152
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Prof Sarah Hilmer
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Address
74152
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Level 12
Kolling Building
Royal North Shore Hospital
Reserve Rd, St Leonards
NSW 2065
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Country
74152
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Australia
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Phone
74152
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+61 2 9926 4481
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Fax
74152
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+61 2 9926 4053
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Email
74152
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF