Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001474448
Ethics application status
Approved
Date submitted
20/10/2016
Date registered
24/10/2016
Date last updated
24/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacist involvement in helping patients at discharge from hospital and the effect on their wellbeing and readmission to hospital
Scientific title
Pharmacist involvement to enhance identification and management of patients at discharge from hospital with increased risk of medication related problems and effect on quality of life and readmission to hospital: a double arm, randomised clinical trial.
Secondary ID [1] 290343 0
Nil known
Universal Trial Number (UTN)
U1111-1184-2331
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Readmission to hospital 300621 0
Quality of Life 300624 0
Medication errors 300665 0
Adverse events related to medications 300666 0
Condition category
Condition code
Public Health 300465 300465 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For patients enrolled to the intervention arm, they will be provided with the current standard of care (which involves a clinical review of medications, some may have a medicines reconciliation on admission (they qualify for this based on the local criteria for this), counselling on only specific medications such as warfarin or home intravenous antibiotics) by the ward pharmacist AND a more comprehensive, individualised discharge service by the study pharmacist. This will occur only on discharge from hospital as a single event (if the patient is to go home outside of pharmacy hours, the discharge service will occur the next working day and education will occur via telephone) The discharge service is expected to take up to an hour (however this will vary patient to patient). It will include:

Patient counselling of medicines
Discharge medication reconciliation
Organise a compliance aid if necessary
Returning patient’s own medicines
Medication card and medicine information leaflets
Assist with access to medication
Review of the medication related information on the discharge summary
Comprehensive General Physician and community pharmacist handover (including medication changes, discharge medication list, ongoing monitoring, any drug interactions)

If deemed necessary, a referral to a Clinical Pharmacist working in the PHO
The participants will also be asked to complete a single question health literacy test and a quality of life survey.
Every intervention provided to each participant will be documented on an 'intervention' form for analysis at the end of the trial.
Intervention code [1] 296156 0
Prevention
Intervention code [2] 296187 0
Treatment: Other
Comparator / control treatment
For patients enrolled in the control arm, the ward clinical pharmacist will provide the current standard of care which involves a clinical review of medications, some may have a medicines reconciliation on admission (qualify based on the local criteria for this), counselling on only specific medications such as warfarin or home intravenous antibiotics, with no intervention on discharge. The patients will also be asked to complete a single question health literacy test and a quality of life survey.
Control group
Active

Outcomes
Primary outcome [1] 299907 0
The primary outcome measure is the rate of readmission within 28 days to hospital, the data will be generated via an electronic report by the hospital admission reporting system which links into the patient medical record.
Timepoint [1] 299907 0
Readmission rate within 28 days of index admission
Secondary outcome [1] 328478 0
A secondary outcome measure is the effect on patient quality of life using the EQ5D Quality of Life assessment tool.
Timepoint [1] 328478 0
QOL to be measured at admission to hospital, and at day 14 and 28 post discharge
Secondary outcome [2] 328479 0
A cost-effectiveness analysis will be undertaken to compare the pharmacist intervention service with usual care, using the primary outcome measure of the difference in readmission rates at 7 and 28 days.
Timepoint [2] 328479 0
Cost associated with readmission rate within 7 and 28 days of index admission
Secondary outcome [3] 328591 0
The primary outcome measure is the rate of readmission within 7 days to hospital, the data will be generated via an electronic report by the hospital admission reporting system which links into the patient medical record.
Timepoint [3] 328591 0
Readmission within 7 days of index admission

Eligibility
Key inclusion criteria
Eligible participants are adult (over 18 years) patients being treated on the Internal Medicine ward at Dunedin Hospital who are identified as being high risk for readmission by an electronic prioritisation tool. Patients meet inclusion criteria if they are allocated a certain score using a prioritisation tool on admission. The cut off score for inclusion is still to be decided (the electronic tool validation is underway currently).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who don't meet a certain score by the electronic prioritization tool (that identifies those at high risk for readmission) will be excluded from the study. Those who are unable to provide informed consent will be excluded from the study.

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)
The electronic tool generating the ‘scores’ that indicate risk of readmission for patients will do so in a format that lists the patients on the Internal Medicine ward by surname consistently. Those newly admitted patients who reach the cut off score will be entered into the spreadsheet with the randomised allocations to intervention (1) or control (2), in order of surname. The allocation sequence is not concealed from the researcher enrolling patients
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/11/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment outside Australia
Country [1] 8326 0
New Zealand
State/province [1] 8326 0
Otago

Funding & Sponsors
Funding source category [1] 294729 0
Hospital
Name [1] 294729 0
Health Research South
Country [1] 294729 0
New Zealand
Primary sponsor type
Hospital
Name
Health Research South
Address
Health Research South
PO Box 56
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 293575 0
None
Name [1] 293575 0
Address [1] 293575 0
Country [1] 293575 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296147 0
Health and Disability Ethics Committees (HDECs)
Ethics committee address [1] 296147 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington
6011
Ethics committee country [1] 296147 0
New Zealand
Date submitted for ethics approval [1] 296147 0
13/06/2016
Approval date [1] 296147 0
15/08/2016
Ethics approval number [1] 296147 0
16/NTB/107

Summary
Brief summary
During your hospital stay your medicines may change. The aim of this project is to find out if patients who get extra education from a pharmacist when being discharged mean they can manage any changes better. We also want to find out if the pharmacist work has an impact on readmission to hospital and quality of life.
This project needs two groups of patients. One will receive the usual standard of quality care and will complete a brief questionnaire to measure your ‘quality of life’. The second group will complete the same questionnaire and have some additional time with a specialised pharmacist.
By doing this we can see if there is any difference between the 2 groups and work out if the extra pharmacist time reduces readmission to hospital and improves patients’ quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69722 0
A/Prof Rhiannon Braund
Address 69722 0
School of Pharmacy
University of Otago
The Adams Building
18 Frederick Street, Dunedin.
Dunedin 9054
New Zealand
Country 69722 0
New Zealand
Phone 69722 0
+64 3 479 7240
Fax 69722 0
Email 69722 0
[email protected]
Contact person for public queries
Name 69723 0
A/Prof Rhiannon Braund
Address 69723 0
School of Pharmacy
University of Otago
The Adams Building
18 Frederick Street, Dunedin.
Dunedin 9054
New Zealand
Country 69723 0
New Zealand
Phone 69723 0
+64 3 479 7240
Fax 69723 0
Email 69723 0
[email protected]
Contact person for scientific queries
Name 69724 0
A/Prof Rhiannon Braund
Address 69724 0
School of Pharmacy
University of Otago
The Adams Building
18 Frederick Street, Dunedin.
Dunedin 9054
New Zealand
Country 69724 0
New Zealand
Phone 69724 0
+64 3 479 7240
Fax 69724 0
Email 69724 0
[email protected]

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

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