Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000746538
Ethics application status
Submitted, not yet approved
Date submitted
28/06/2015
Date registered
20/07/2015
Date last updated
7/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the impact of a pre-discharge medication review service on preventing hospital re-admissions in high risk patients-a pilot study.
Scientific title
Evaluating the impact of a pre-discharge medication review service on preventing hospital re-admissions in high risk patients-a pilot study.
Secondary ID [1] 284998 0
Nil known.
Universal Trial Number (UTN)
U1111-1159-3822
Trial acronym
PreDMR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication misadventure 292504 0
Poly-Pharmacy 295545 0
Co-morbidities 295546 0
Adverse drug reactions 295547 0
Poor compliance 295548 0
Condition category
Condition code
Public Health 292816 292816 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study subjects will receive a pre-discharge medication review (PreDMR) by the hospital clinical pharmacist. This meeting with the patient will occur during the hospital stay. The report will be faxed/emailed to the patient's GP within 72 hours of discharge. At day 7, day 90 and 180 post discharge the study patients will receive a phone call from the clinical pharmacist. The intention of the phone call is to assess patient compliance with prescribed medications. Compliance will be cross checked with the dispensary history from the patient's community pharmacy. Both the GP and the study patient will also receive a Likert style questionnaire designed to assess the utility and acceptability of the clinical report and follow-up contacts. QoL will also be assessed on day 7, day 90 and 180 post discharge. Control subjects will receive the same best practice care as the study subjects but their GP will not receive a PreDMR.
Intervention code [1] 289836 0
Prevention
Comparator / control treatment
The control hospital patient's: Control patients will be those attending another hospital and will be enrolled from those who give approval during the Friday pre-admission interviews. The pre-admission interviews are part of the usual care program at the control hospital. The control/comparator group will not receive a pre-discharge medication review nor the qualitative questionnaire. They will be phoned on days 30, 90, 180 and assessed for compliance, and this will be cross-checked with pharmacy dispensary history.
Control group
Active

Outcomes
Primary outcome [1] 292675 0
An evaluation of the rate of readmission, assessed through hospital records and phone contact with the patient/patient's carer/spouse/family.
Timepoint [1] 292675 0
Day 7, 90 and 180 days post discharge
Primary outcome [2] 295514 0
An evaluation of the rate of mortality assessed through hospital records and phone contact with the patient/patient's carer/spouse/family.
Timepoint [2] 295514 0
Day 7, 90 and 180 days post discharge
Primary outcome [3] 295515 0
An evaluation of the rate of morbidity assessed through hospital records and phone contact with the patient/patient's carer/spouse/family.
Timepoint [3] 295515 0
Day 7, 90 and 180 days post discharge
Secondary outcome [1] 309484 0
1. Litigation impact will be assess by comparing the total number of lawsuits files by study and control patients.
Timepoint [1] 309484 0
Lawsuits filed from the day of discharge to day 180 post discharge.
Secondary outcome [2] 309485 0
Quality of Life - assessed by the EUROHIS-QOL 8-item index.
Timepoint [2] 309485 0
Day 7, 90 and 180 days post discharge
Secondary outcome [3] 315660 0
Adherence - assessed by the Morisky Eight-Item Medication Adherence Scale
Timepoint [3] 315660 0
Day 7, 90 and 180 days post discharge
Secondary outcome [4] 315984 0
Patient assessment of the in-hospital pre-discharge medication review program using a questionnaire devised by the research student. with the approval of my university supervisors. It will be a Likert style question.
Timepoint [4] 315984 0
D7-D30 post discharge

Eligibility
Key inclusion criteria
The recruitment of eligible patients will be predicated upon the risk assessment tool as described by Angley and co-workers.

Patients were stratified as being at ‘high’
or ‘low’ risk of medication misadventure using a stratification instrument adapted from the Victorian Medication Alert Project and The Alfred Hospital Outreach Medication Review program. Patients who scored more than 5 points were at ‘high’ risk of medication misadventure. They will be invited to join the study or control cohorts.

The risk weighting per question is outlined in the attached file. Score per question ranges from 1 to 5.

Angley M, Pooniah A, Bong J., Padhye V, Shakib S, Spurling L. Implementing and evaluating a parallel post-discharge Home Medicines Review (HMR) model: Pharmacy Guild of Australia;
2011.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients will be excluded if they are to be discharged into an aged care facility (ACF), since each ACF has, under the Medicare provisions, a contracted consultant pharmacist who performs medication reviews within the ACF setting.

2. Patients will be excluded if they live outside of the Greater Sydney area, interstate (or further).

3. Patients will be excluded if they are unable agree to a medication review and the follow-up phone contact within the timeframe as set out for this study.

4. Patients will be excluded if there is an obvious language barrier which cannot be resolved with the aid of a family member.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data analysis/results.
1. Chi-squared analysis, with OR calculation and 95%CI for discrete variables.
2. Student’s t-test for normally distributed continuous variables.
3. Mann-Whitney test for non-normally distributed variables.
4. Kaplan-Meier survival curves.
5. Log-rank test and the Breslow test to determine any differences in the number or the timing of events.
6. Cox-Proportional Hazards model to determine the effect on the treatment and baseline variables on all-cause mortality and event-free survival.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/03/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
226
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3974 0
Norwest Private Hospital - Bella Vista
Recruitment hospital [2] 3975 0
Campbelltown Private Hospital - Campbelltown
Recruitment postcode(s) [1] 9881 0
2153 - Bella Vista
Recruitment postcode(s) [2] 9882 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 289616 0
Self funded/Unfunded
Name [1] 289616 0
Country [1] 289616 0
Primary sponsor type
University
Name
University of Tasmania
Address
Churchill Avenue, Hobart TAS 7005
Country
Australia
Secondary sponsor category [1] 288303 0
None
Name [1] 288303 0
Address [1] 288303 0
Country [1] 288303 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 291362 0
Campbelltown Private Hospital Ethics Committee
Ethics committee address [1] 291362 0
Ethics committee country [1] 291362 0
Australia
Date submitted for ethics approval [1] 291362 0
04/07/2015
Approval date [1] 291362 0
Ethics approval number [1] 291362 0
Ethics committee name [2] 294567 0
Norwest Private Hospital Medical Advisory Board
Ethics committee address [2] 294567 0
Ethics committee country [2] 294567 0
Australia
Date submitted for ethics approval [2] 294567 0
Approval date [2] 294567 0
18/02/2016
Ethics approval number [2] 294567 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 518 518 0 0
/AnzctrAttachments/366737-RST .pdf

Contacts
Principal investigator
Name 50006 0
Dr Tabish Zaidi
Address 50006 0
UTAS
College Road,
Sandy Bay Campus
Tasmania 7005
Country 50006 0
Australia
Phone 50006 0
+61 3 6226 1042
Fax 50006 0
Email 50006 0
[email protected]
Contact person for public queries
Name 50007 0
Tabish Zaidi
Address 50007 0
UTAS
College Road,
Sandy Bay Campus
Tasmania 7005
Country 50007 0
Australia
Phone 50007 0
+61 3 6226 1042
Fax 50007 0
Email 50007 0
[email protected]
Contact person for scientific queries
Name 50008 0
Tabish Zaidi
Address 50008 0
UTAS
College Road,
Sandy Bay Campus
Tasmania 7005
Country 50008 0
Australia
Phone 50008 0
+61 3 6226 1042
Fax 50008 0
Email 50008 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.