Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000282189
Ethics application status
Approved
Date submitted
30/01/2019
Date registered
25/02/2019
Date last updated
11/04/2019
Date data sharing statement initially provided
25/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
DCMedsRec; Reducing hospital readmission by enhanced My Health Record use in Community Pharmacy. An ADHA Digital Test Beds project
Scientific title
A randomised controlled trial of a community pharmacy medicines reconciliation intervention for people discharged on four or more medicines using MyHealthRecord to reduce 30-day unplanned hospital re-admissions.
Secondary ID [1] 296319 0
ADHA reference : DH1011
Universal Trial Number (UTN)
U1111-1222-1787
Trial acronym
DCMedsRec
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polypharmacy 310029 0
Medication misadventure 311666 0
Condition category
Condition code
Public Health 310289 310289 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The DCMedsRec intervention involves the delivery of a structured medicines reconciliation service in a community pharmacy within a week of hospital discharge. The participant will have a medicines reconciliation interview with a community pharmacist who will use the participants MyHealthRecord discharge summary as the basis for the reconciliation to consolidate medicines knowledge and use, dispose of unwanted medicines and prescriptions and use health literacy principles to enhance medicines understanding and adherence to recommended use. This will be done face to face, one on one, in the community pharmacy of the participants selection and is expected take approximately 20 minutes (maybe up to 30 minutes if on large number of medicines). Approved medicines information resources (print and electronic) may be used in this process. The community pharmacist will deliver the intervention. The outcome of 30-day unplanned readmission will be the primary outcome of adherence and patients may have ongoing interaction with their pharmacist as in the normal course of their healthcare. There are no other specific strategies to assess or monitor adherence. Fidelity to the intervention will be monitored by completion of the checklist of specific activities for the service on the submitted payment claim form from the pharmacy.
Intervention code [1] 312647 0
Treatment: Other
Intervention code [2] 312648 0
Behaviour
Comparator / control treatment
Control group participants will receive usual care from a pharmacy on discharge (Standard care). This may vary from dispensing of prescriptions alone to more engagement with the patient. It is dependent on the pharmacist delivering a service eat a point in time. The plan is for the intervention to be systematic to achieve the reduction in risk for patients. Control group care is an ad hoc process and not possible to specifically describe.
Control group
Active

Outcomes
Primary outcome [1] 307762 0
30-day unplanned re-admission to hospital as determined by review of the hospital's electronic medical record. Only re-admission to Box Hill Hospital will be identified.
Timepoint [1] 307762 0
30 days post initial discharge
Secondary outcome [1] 352807 0
Patient experience of service will be evaluated via one-on-one semi structured phone interviews within 2 weeks of the service. This call will be less than 10 minutes duration.
Timepoint [1] 352807 0
On completion of intervention for an individual participant
Secondary outcome [2] 352808 0
Pharmacist experience of service delivery will be assessed using focus groups on completion of the intervention period. Focus groups will be moderated by the researchers and with consent recorded so that transcripts may be generated to capture all relevant input. Researchers will also take notes during the session. It is expected each focus group will take less than an hour.
Timepoint [2] 352808 0
On completion of intervention period

Eligibility
Key inclusion criteria
All patients discharged from trial hospital with 4 or more medications at discharge
Residential postcode in trial hospital network catchment area
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with emergency department visits only (not admitted to a ward)
Patients admitted to short stay units
Discharge to nursing home, another hospital or other institutional setting
Discharge with 3 or less prescription items
Residential postcode outside EH network catchment district
Under 18 years of age

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)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention to treat principles will be followed in this trial. To investigate for any possible selection bias, student’s t test for numerical variables and the chi-square test for categorical variables will be applied to all demographic, co-morbidity and medication information to verify whether randomization processes obtained homogeneous study samples within intervention and control groups. For the primary outcome of 30-day all-cause readmission, risk ratios with 95% confidence intervals will be calculated. Time to readmission will be assessed using Kaplan-Meier survival analyses and Cox regression. Multiple imputation will be used to impute missing values if required. The significance level for all analyses will be p?<?0.05. All data linkage, management and statistical analysis will be undertaken in SAS 9.4 (SAS Institute, Inc, Cary, NC, USA).
To assess risk factors for readmission – multivariate logistic regression will be undertaken

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/04/2019
Actual
Date of last participant enrolment
Anticipated
28/02/2020
Actual
Date of last data collection
Anticipated
30/03/2020
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12179 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 24347 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 300915 0
Government body
Name [1] 300915 0
Australian Digital Health Agency
Country [1] 300915 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health
Address
Level 4
5 Arnold St, Box Hill
Victoria 3128
Country
Australia
Secondary sponsor category [1] 300480 0
University
Name [1] 300480 0
Monash University
Address [1] 300480 0
Eastern Health Clinical School
Level 2
5 Arnold St, Box Hill
Victoria 3128
Country [1] 300480 0
Australia
Other collaborator category [1] 280389 0
University
Name [1] 280389 0
Deakin University
Address [1] 280389 0
221 Burwood Hwy,
Burwood VIC 3125
Country [1] 280389 0
Australia
Other collaborator category [2] 280390 0
Commercial sector/Industry
Name [2] 280390 0
Pharmaceutical Society of Australia
Address [2] 280390 0
1/381 Royal Parade,
Parkville VIC 3052
Country [2] 280390 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301683 0
Eastern Health
Ethics committee address [1] 301683 0
Ethics committee country [1] 301683 0
Australia
Date submitted for ethics approval [1] 301683 0
01/02/2019
Approval date [1] 301683 0
27/03/2019
Ethics approval number [1] 301683 0
48678

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

Contacts
Principal investigator
Name 87778 0
Mr Gregory Duncan
Address 87778 0
Eastern Health Clinical School
Medicine, Nursing and Health Sciences
Monash University
Level 2, 5 Arnold St
Box Hill VIC 3128
Country 87778 0
Australia
Phone 87778 0
+61412040320
Fax 87778 0
Email 87778 0
gregory.duncan@monash.edu
Contact person for public queries
Name 87779 0
Gregory Duncan
Address 87779 0
Eastern Health Clinical School
Medicine, Nursing and Health Sciences
Monash University
Level 2, 5 Arnold St
Box Hill VIC 3128
Country 87779 0
Australia
Phone 87779 0
+61412040320
Fax 87779 0
Email 87779 0
gregory.duncan@monash.edu
Contact person for scientific queries
Name 87780 0
Gregory Duncan
Address 87780 0
Eastern Health Clinical School
Medicine, Nursing and Health Sciences
Monash University
Level 2, 5 Arnold St
Box Hill VIC 3128
Country 87780 0
Australia
Phone 87780 0
+61412040320
Fax 87780 0
Email 87780 0
gregory.duncan@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Awaiting organisational feedback on making dataset available


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.