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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

Scientific title
The Medicines Management Mapping Project: Using risk stratification and care coordination to bridge the care continuum gap

Secondary ID [1] 295480 0
Nil Known
Universal Trial Number (UTN)
U1111-1216-9890
Trial acronym
MMMP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication-related harm 308742 0
Polypharmacy 308743 0
Multimorbidity 308744 0
Condition category
Condition code
Public Health 307680 307680 0 0
Health service research

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 301794 0
Early detection / Screening
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.
Control group
Active

Outcomes
Primary outcome [1] 306662 0
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.
Timepoint [1] 306662 0
30 days after discharge initially and 90 days (primary endpoint).
Primary outcome [2] 306663 0
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.
Timepoint [2] 306663 0
30 days after discharge initially and 90 days (primary endpoint).
Primary outcome [3] 306709 0
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.
Timepoint [3] 306709 0
30 days after discharge from hospital. (Primary endpoint).
Secondary outcome [1] 349172 0
Timeliness of medication management review service provided after hospital discharge. This will measure how long after discharge the medication management interview was provided.
Timepoint [1] 349172 0
30 days after hospital discharge (secondary endpoint).
Secondary outcome [2] 349173 0
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
Timepoint [2] 349173 0
30 days after discharge (secondary endpoint).
Secondary outcome [3] 349174 0
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
Timepoint [3] 349174 0
30 days after discharge. (Secondary endpoint)
Secondary outcome [4] 349176 0
Self-assessed quality of life - as measured by the EQ-5D-3L
Timepoint [4] 349176 0
At randomisation and then at 30 days and 90 days after discharge (Secondary endpoint).

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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/07/2018
Actual
23/07/2018
Date of last participant enrolment
Anticipated
Actual
26/09/2018
Date of last data collection
Anticipated
Actual
20/01/2019
Sample size
Target
200
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 11395 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 23296 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 300069 0
Charities/Societies/Foundations
Name [1] 300069 0
Pharmaceutical Society of Western Australia - JM O'Hara Research Fund
Country [1] 300069 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Hwy, CRAWLEY Western Australia 6009
Country
Australia
Secondary sponsor category [1] 299465 0
Hospital
Name [1] 299465 0
Sir Charles Gairdner Hospital
Address [1] 299465 0
Sir Charles Gairdner Hospital
C Block
Hospital Avenue, NEDLANDS, Western Australia 6009
Country [1] 299465 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300916 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee [EC00271]
Ethics committee address [1] 300916 0
Ethics committee country [1] 300916 0
Australia
Date submitted for ethics approval [1] 300916 0
26/02/2018
Approval date [1] 300916 0
19/04/2018
Ethics approval number [1] 300916 0
RGS856

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

Contacts
Principal investigator
Name 85266 0
Ms Deirdre T Criddle
Address 85266 0
Ground Floor, A Block Sir Charles Gairdner Hospital
Hospital Avenue, NEDLANS 6009 WA
Country 85266 0
Australia
Phone 85266 0
+61 406 569 461
Fax 85266 0
+61 6457 4731
Email 85266 0
deirdre.criddle@health.wa.gov.au
Contact person for public queries
Name 85267 0
Deirdre T Criddle
Address 85267 0
Ground Floor, A Block Sir Charles Gairdner Hospital
Hospital Avenue, NEDLANS 6009 WA
Country 85267 0
Australia
Phone 85267 0
+61 406 569 461
Fax 85267 0
+61 6457 4731
Email 85267 0
deirdre.criddle@health.wa.gov.au
Contact person for scientific queries
Name 85268 0
Deirdre T Criddle
Address 85268 0
Ground Floor, A Block Sir Charles Gairdner Hospital
Hospital Avenue, NEDLANS 6009 WA
Country 85268 0
Australia
Phone 85268 0
+61 406 569 461
Fax 85268 0
+61 6457 4731
Email 85268 0
deirdre.criddle@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is no reason for individual participant data to be published. Only collated data will be published.


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.