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Trial registered on ANZCTR
Registration number
ACTRN12618001168246
Ethics application status
Approved
Date submitted
10/07/2018
Date registered
16/07/2018
Date last updated
15/10/2019
Date data sharing statement initially provided
15/10/2019
Date results provided
15/10/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
The Medicines Management Mapping Project: Using risk stratification and care coordination to bridge the care continuum gap
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Scientific title
The Medicines Management Mapping Project: Using risk stratification and care coordination to bridge the care continuum gap
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Secondary ID [1]
295480
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Nil Known
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Universal Trial Number (UTN)
U1111-1216-9890
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Trial acronym
MMMP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Medication-related harm
308742
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Polypharmacy
308743
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Multimorbidity
308744
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Condition category
Condition code
Public Health
307680
307680
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patients will be randomized into either the Intervention Group, or Non-intervention Group after consenting to participate.
The Clinical Pharmacy Research Team (CPRT) will collect information on all patients during the patient’s hospital stay and monthly after discharge (by phone interview.)
Non-Intervention Group will receive usual care from the treating hospital team. If any member of the hospital team believes a patient in this group needs a medicines management service such as a Home Medicines Review (HMR) after hospital discharge, the CPRT will not interfere in any way with the usual hospital referral process.
Intervention Group, will receive usual care from the treating hospital team, in addition to having a risk tool applied. If any member of the hospital team believes a patient in this group needs a medicines management service such as a Home Medicines Review (HMR) after hospital discharge, the CPRT will not interfere in any way with the usual hospital referral process.
The risk tool identifies and counts risk-factors associated with medicines-related problems in vulnerable groups. The risk tool has been developed from work conducted previously at Sir Charles Gairdner Hospital from a complex patient cohort. (http://mm2017shpa.com/wp-content/uploads/2017/11/Poster-145_Gupta.pdf.) If the patient scores highly on the risk tool, the patient will be triaged for referral for a Community HMR or a hospital outreach medication management review service. A HMR is a service where a pharmacist visits the patient at home and reviews all medicines. This pharmacist will contact the patient’s usual GP and Community Pharmacist, visit the patient in the home within a week from discharge and resolve any medication-related problems. They will provide a report to the GP and the Hospital Team – where it will be put on the Patient’s Medical Record.
All patients will be contacted by phone at 30 days and 90 days to find out what happened in the previous time period. For example if any Emergency department visits were needed, or if any medication management services were received.
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Intervention code [1]
301794
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Early detection / Screening
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Comparator / control treatment
Usual care will be provided to patients randomised to the Non-intervention arm. This means that the hospital team can refer to medication management services as they see fit.
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Control group
Active
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Outcomes
Primary outcome [1]
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Hospital health utilisation as measured by the composite outcome;
Number of Emergency hospital presentations and/or
Number of unplanned hospital admissions
Assessed by audit of hospital records, and questions answered by patient at 30 day telephone interview.
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Assessment method [1]
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Timepoint [1]
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30 days after discharge initially and 90 days (primary endpoint).
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Primary outcome [2]
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Time to next emergency visit or unplanned hospitalisation (as a composite outcome). Assessed by audit of hospital records, and questions answered by patient at 30 day telephone interview.
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Assessment method [2]
306663
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Timepoint [2]
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30 days after discharge initially and 90 days (primary endpoint).
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Primary outcome [3]
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Number of medication management services provided after hospital discharge as measured by patient telephone survey and also as provided by Community Accredited Pharmacist conducting the HMR.
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Assessment method [3]
306709
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Timepoint [3]
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30 days after discharge from hospital. (Primary endpoint).
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Secondary outcome [1]
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Timeliness of medication management review service provided after hospital discharge. This will measure how long after discharge the medication management interview was provided.
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Assessment method [1]
349172
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Timepoint [1]
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30 days after hospital discharge (secondary endpoint).
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Secondary outcome [2]
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Satisfaction with the explanation of medicines on leaving hospital - measured by describing options on a Likert scale;
1 Very satisfied 2 Satisfied 3 Neither satisfied or dissatisfied 4 Dissatisfied
5 Very dissatisfied
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Assessment method [2]
349173
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Timepoint [2]
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30 days after discharge (secondary endpoint).
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Secondary outcome [3]
349174
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Satisfaction with the medication management service provided after hospital discharge - measured by describing options on a Likert scale;
1 Very satisfied 2 Satisfied 3 Neither satisfied or dissatisfied 4 Dissatisfied
5 Very dissatisfied
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Assessment method [3]
349174
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Timepoint [3]
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30 days after discharge. (Secondary endpoint)
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Secondary outcome [4]
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Self-assessed quality of life - as measured by the EQ-5D-3L
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Assessment method [4]
349176
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Timepoint [4]
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At randomisation and then at 30 days and 90 days after discharge (Secondary endpoint).
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Eligibility
Key inclusion criteria
Patients admitted to a medical and surgical ward at SCGH over a twelve-week period at Sir Charles Gairdner Hospital who have capacity to consent, hold a Medicare card, reside the Perth North Metropolitan region and are able to be contacted by phone.
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Minimum age
18
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 unable to consent to the trial.
Patients who are already enrolled in the trial.
Patients who are residents of an aged care facility.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
200 patients will be recruited and randomized (100 patients in each arm) over a twelve-week period on a selected medical and surgical ward. This is a pilot study and will provide estimates of outcomes of interest that will be used in a subsequent full-sized study. Hence, the precision will not be to the level that would be achieved in a full-sized study.
Time to next emergency visit or unplanned hospitalisation will be analysed using multivariable Cox proportional hazards regression, to assess the effect of the intervention, after adjustment for covariates. Possible covariates include: age, sex, and number and type of chronic conditions. Continuous outcome variables will be analysed using Analysis of Variance, after adjustment for covariates. Effect sizes for comparison between intervention and non-intervention groups will be presented as mean difference and 95% confidence intervals. Data on categorical outcome variables will be analysed using chi-squared tests and where the categorical outcome variable has two categories, using multivariable logistic regression. All analyses will be carried out using SPSS version 24. Two-sided p-values less than 5% will be considered as statistically significant.
Uptake of referral for the medication management services and satisfaction with the service will be compared by chi squared tests, whilst time taken to conduct the medication review will be compared using the t-test.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
23/07/2018
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Actual
23/07/2018
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Date of last participant enrolment
Anticipated
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Actual
26/09/2018
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Date of last data collection
Anticipated
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Actual
20/01/2019
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Sample size
Target
200
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Accrual to date
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Final
200
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
11395
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
23296
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
300069
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Charities/Societies/Foundations
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Name [1]
300069
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Pharmaceutical Society of Western Australia - JM O'Hara Research Fund
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Address [1]
300069
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21 Hamilton Street, SUBIACO Western Australia, 6008
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Country [1]
300069
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Australia
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Primary sponsor type
University
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Name
University of Western Australia
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Address
35 Stirling Hwy, CRAWLEY Western Australia 6009
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Country
Australia
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Secondary sponsor category [1]
299465
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Hospital
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Name [1]
299465
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Sir Charles Gairdner Hospital
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Address [1]
299465
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Sir Charles Gairdner Hospital
C Block
Hospital Avenue, NEDLANDS, Western Australia 6009
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Country [1]
299465
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
300916
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Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee [EC00271]
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Ethics committee address [1]
300916
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Level 2, A Block, Sir Charles Gairdner Hospital Hospital Avenue, NEDLANDS WA 6009
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Ethics committee country [1]
300916
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Australia
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Date submitted for ethics approval [1]
300916
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26/02/2018
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Approval date [1]
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19/04/2018
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Ethics approval number [1]
300916
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RGS856
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Summary
Brief summary
Key Research question(s) 1. Will the proposed MMMP model, using a risk tool to stratify patients (The Intervention) increase access to medication management services post discharge compared with those receiving usual care? 2. Will the proposed MMMP model using a risk tool to identify “at-risk” patients (The Intervention) reduce the hospital health utilisation (emergency department visits, hospital admission and length-of-stay) at 30 or 90 days post discharge compared with those receiving usual care? This project aims to reduce the risk of medication misadventure across care transitions by increasing identification of patients at-risk, and hence referral to pharmacist led medication management services. Hypothesis: The routine application of an easy to use, bedside tool can facilitate identification of at-risk patients and trigger referral to an appropriate medication management pathway in the community following hospital discharge. Improving medication management across the continuum continues to be one of the greatest challenges in modern health care. A report to Government on the Home Medicines Review (HMR) declared strong ‘widespread’ unconditional support for hospital-initiated medication review (HIMR) early post-discharge, acknowledging this gap in care. Yet nearly a decade on, there is no nationally accepted pathway for HIMRs to ensure our most vulnerable patients are supported following a hospital admission. A recent Australian systematic review highlighted those most in need of medication review remain underserved, including indigenous and Culturally and Linguistically Diverse populations, and those recently discharged from hospital. Application of the risk tool will facilitate identification of “at-risk” patients and ensure handover to a community medication management service most suited to the individual patient. ‘Risk Stratification’ uses a process to identify people likely to suffer an unplanned hospital admission. There are currently no international or national risk stratification solutions, focused on medication misadventure that can be readily applied to the Australian context. By identifying patients at risk, appropriate coordinated care can be provided to them. The period 7-10 days after hospital discharge is a particularly vulnerable time, and associated with a significant risk of medication related problems. Studies have shown about half of the patients discharged from hospital experience a medical error, with 19% - 23% suffering an adverse event, most commonly an adverse drug event. Through use of a structured framework, actively assessing risk, hospital staff will identify and triage high-risk patients for pharmacist-led medication management services in the community setting. This should improve identification of those at risk and improve care across the continuum.
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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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Ms Deirdre T Criddle
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Address
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Ground Floor, A Block Sir Charles Gairdner Hospital
Hospital Avenue, NEDLANS 6009 WA
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Country
85266
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Australia
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Phone
85266
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+61 406 569 461
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Fax
85266
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+61 6457 4731
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Email
85266
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[email protected]
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Contact person for public queries
Name
85267
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Deirdre T Criddle
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Address
85267
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Ground Floor, A Block Sir Charles Gairdner Hospital
Hospital Avenue, NEDLANS 6009 WA
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Country
85267
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Australia
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Phone
85267
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+61 406 569 461
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Fax
85267
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+61 6457 4731
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Email
85267
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[email protected]
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Contact person for scientific queries
Name
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Deirdre T Criddle
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Address
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Ground Floor, A Block Sir Charles Gairdner Hospital
Hospital Avenue, NEDLANS 6009 WA
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Country
85268
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Australia
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Phone
85268
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+61 406 569 461
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Fax
85268
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+61 6457 4731
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Email
85268
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
There is no reason for individual participant data to be published. Only collated data will be published.
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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.
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