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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
Scientific title
Implementation of a Multidisciplinary Multiple Medication Management Service (4MS) to Improve Quality Use of Medicines and Outcomes in Older Inpatients at RNSH
Secondary ID [1] 291736 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hyperpolypharmacy 302928 0
frailty 302930 0
falls 302931 0
adverse effects 302933 0
Condition category
Condition code
Mental Health 302409 302409 0 0
Studies of normal psychology, cognitive function and behaviour
Respiratory 302410 302410 0 0
Chronic obstructive pulmonary disease
Cardiovascular 303064 303064 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 297843 0
Prevention
Intervention code [2] 298206 0
Treatment: Other
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).
Control group
Active

Outcomes
Primary outcome [1] 301819 0
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.
Timepoint [1] 301819 0
At discharge, follow up at 1 month and 6 months after discharge
Primary outcome [2] 302448 0
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.
Timepoint [2] 302448 0
Admission, discharge, 1 and 6 month follow up
Primary outcome [3] 302502 0
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.
Timepoint [3] 302502 0
Admission, discharge, 1 and 6 month follow up
Secondary outcome [1] 333956 0
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.
Timepoint [1] 333956 0
Discharge (to collect data on any inpatient falls) and 1 and 6 months after discharge;
Secondary outcome [2] 333957 0
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.
Timepoint [2] 333957 0
On discharge
Secondary outcome [3] 335348 0
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.
Timepoint [3] 335348 0
1 and 6 months since discharge
Secondary outcome [4] 335349 0
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.
Timepoint [4] 335349 0
1 and 6 months since discharge
Secondary outcome [5] 335350 0
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.
Timepoint [5] 335350 0
Discharge and 1 and 6 month post discharge
Secondary outcome [6] 335351 0
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.
Timepoint [6] 335351 0
At discharge
Secondary outcome [7] 335354 0
Length of stay.

Length of stay will be collected from medical records and compared between the intervention and control group using independent t test.
Timepoint [7] 335354 0
At discharge
Secondary outcome [8] 335356 0
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.
Timepoint [8] 335356 0
1 and 6 months post-discharge
Secondary outcome [9] 335357 0
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.
Timepoint [9] 335357 0
At discharge
Secondary outcome [10] 335358 0
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,
Timepoint [10] 335358 0
Approximately 8 weeks
Secondary outcome [11] 335365 0
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.
Timepoint [11] 335365 0
After intervention period (~4 weeks) for each cycle
Secondary outcome [12] 336020 0
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.
Timepoint [12] 336020 0
discharge, 1 and 6 months post-discharge
Secondary outcome [13] 336241 0
**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.
Timepoint [13] 336241 0
Admission, discharge, 1 and 6 month follow up
Secondary outcome [14] 336244 0
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.
Timepoint [14] 336244 0
Admission, discharge, 1 and 6 month follow up
Secondary outcome [15] 336245 0
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.
Timepoint [15] 336245 0
Admission, discharge, 1 and 6 month follow up
Secondary outcome [16] 336246 0
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.
Timepoint [16] 336246 0
Admission, discharge, 1 and 6 month follow up

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)
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
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.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
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.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/06/2017
Date of last participant enrolment
Anticipated
30/12/2017
Actual
Date of last data collection
Anticipated
30/06/2018
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8379 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 16447 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 296232 0
Hospital
Name [1] 296232 0
Royal North Shore Hospital (Ramsay Research and Teaching Fund )
Country [1] 296232 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Royal North Shore Hospital
Reserve Road, St Leonards
NSW 2065
Country
Australia
Secondary sponsor category [1] 295149 0
University
Name [1] 295149 0
University of Sydney
Address [1] 295149 0
The University of Sydney
Camperdown NSW 2006
Country [1] 295149 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297471 0
Northern Sydney Local Health District Research Office
Ethics committee address [1] 297471 0
Ethics committee country [1] 297471 0
Australia
Date submitted for ethics approval [1] 297471 0
13/03/2017
Approval date [1] 297471 0
14/06/2017
Ethics approval number [1] 297471 0
RESP/17/52

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74150 0
Prof Sarah Hilmer
Address 74150 0
Level 12
Kolling Building
Royal North Shore Hospital
Reserve Rd, St Leonards
NSW 2065
Country 74150 0
Australia
Phone 74150 0
+61 2 9926 4481
Fax 74150 0
+61 2 9926 4053
Email 74150 0
[email protected]
Contact person for public queries
Name 74151 0
Sarah Hilmer
Address 74151 0
Level 12
Kolling Building
Royal North Shore Hospital
Reserve Rd, St Leonards
NSW 2065
Country 74151 0
Australia
Phone 74151 0
+61 2 9926 4481
Fax 74151 0
+61 2 9926 4053
Email 74151 0
[email protected]
Contact person for scientific queries
Name 74152 0
Sarah Hilmer
Address 74152 0
Level 12
Kolling Building
Royal North Shore Hospital
Reserve Rd, St Leonards
NSW 2065
Country 74152 0
Australia
Phone 74152 0
+61 2 9926 4481
Fax 74152 0
+61 2 9926 4053
Email 74152 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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