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Trial registered on ANZCTR


Registration number
ACTRN12616000780459
Ethics application status
Approved
Date submitted
3/05/2016
Date registered
15/06/2016
Date last updated
11/02/2021
Date data sharing statement initially provided
2/05/2019
Date results provided
11/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Medication Management and Medication-Related Problems in People with Chronic Liver Disease
Scientific title
Medication Management and Medication-Related Problems in People with Chronic Liver Disease
Secondary ID [1] 288878 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Decompensated liver cirrhosis 298177 0
Condition category
Condition code
Oral and Gastrointestinal 298339 298339 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of a patient-orientated, multi-faceted, collaborative service targeting patients with decompensated cirrhosis in order to obtain an accurate, complete list of medications, identify medication-related problems and needs, and to educate patients on their disease and medication self-management. The intervention will be conducted by a clinical pharmacist in a tertiary hospital hepatology outpatient clinic in addition to usual care (hepatologist review).

The initial encounter with each patient (and carer or family member if present) will involve a face-to-face interview in a private clinic room. The interview will include open and closed questions to ascertain medication-taking behaviour (including adherence) and individual medication-related needs. Advice will be provided by the pharmacist per-protocol and reactively according to the patient’s needs. The pharmacist will also conduct a clinical review of currently prescribed therapy during the interview. Participants will be required to bring their current medications in to clinic and their medication history will be verified with their medical records, the local pharmacy's dispensing history and/or general practitioner's history. Verification will occur while the patient is present to confirm the currency of therapy. The subsequent reconciled list will be used by the pharmacist to construct a medication guide using the Queensland Health state-wide approved template. The guide will be printed as a booklet which contains information such as the active ingredient, strength, common brands, indication and directions to take for each medication. Patients will be shown how to navigate the hard copy guide and encouraged to take it to all medical appointments and use it at home to aid compliance and memory. The reconciled list of medications will also be made available to other clinicians in the patient's electronic medical record.

The duration of the interview will vary depending on the intensity of intervention required by each patient. Up to 60 minutes will be allocated for each interview.

Following the interview and clinical review, the pharmacist will collaborate with the patient's general practitioner and hepatologist to optimise therapy, facilitate resolution of medication-related problems and monitor issues where required. This will be done in person, via email or over the telephone as appropriate and communication will be documented in the patient's medical record.

Subsequent contact with patients will occur at week 4-6, week 12-14 and at 6 months. These follow-up contacts will be conducted in person if the patient has a pre-scheduled appointment for routine review with a hepatologist in the clinic, or via telephone if the patient is not scheduled for hepatology review within the allocated time frame. Patient contact at 4-6 weeks, 12-14 weeks and 6 months will be used to follow-up previously identified medication-related problems, confirm any changes to therapy within the preceding weeks, reiterate medication and lifestyle advice and encourage self-monitoring and medication adherence using the medication list as an aid. Follow-up contacts will take approximately 15 minutes.

Participants will be surveyed using validated tools for the study endpoints at baseline and again at 6 months.
Intervention code [1] 294425 0
Lifestyle
Intervention code [2] 294426 0
Behaviour
Intervention code [3] 294427 0
Treatment: Other
Comparator / control treatment
Usual care - hepatologist review only. Participants will be surveyed using validated tools for the study endpoints at baseline and again at 6 months.
Control group
Active

Outcomes
Primary outcome [1] 297925 0
A composite endpoint of frequency (counts of) and severity (measure of clinical significance) of discrepancies between patient-reported and clinician-documented 'current' medications. Discrepancies (between medication names, doses and frequency of administration) will be documented during face-to-face and telephone interviews at week 0, 4, 13 and 26 (week 0 and 26 only for ‘standard care’ participants). The clinical significance of discrepancies will be determined by a panel (including a hepatologist, pharmacist, pharmacologist and nurse). Data will be presented both qualitatively (description of high-risk discrepancies) and quantitatively (chi-square / Fisher's exact test for statistically significant differences between intervention and control groups at baseline and 6 months).
Timepoint [1] 297925 0
Discrepancies present at baseline vs. at 6 months.
Secondary outcome [1] 322647 0
Self-reported medication adherence as indicated using the 8-Question Morisky Medication Adherence Scale which ranks adherence as 'High', 'Medium' or 'Low'.
Timepoint [1] 322647 0
Adherence ranking at baseline vs. at 6 months
Secondary outcome [2] 322648 0
Self-reported quality of life (QoL) as indicated using the Chronic Liver Disease Questionnaire which examines impact domains of QoL specific to common symptoms of liver disease.
Timepoint [2] 322648 0
Quality of life at baseline vs. at 6 months
Secondary outcome [3] 322649 0
Illness perceptions as indicated by completion of the Brief Illness Perceptions Questionnaire and patient interview.
Timepoint [3] 322649 0
Illness perceptions at baseline vs. at 6 months
Secondary outcome [4] 322650 0
Medication beliefs as indicated by completion of the Beliefs about Medications (General and Specific) Questionnaire and patient interview.
Timepoint [4] 322650 0
Medication beliefs at baseline vs. at 6 months
Secondary outcome [5] 322651 0
A composite endpoint of patients' knowledge of key lifestyle modifications, medication management techniques and other self-care tasks as determined by patient interview and measured using a pre-post questionnaire design. This questionnaire has been designed for the purposes of this study.
Timepoint [5] 322651 0
Knowledge at baseline vs. at 6 months
Secondary outcome [6] 322652 0
Frequency of liver-related hospitalisations as determined by patient medical record review.
Timepoint [6] 322652 0
Frequency of hospitalisations within 6 months, 12 months and 3 years
Secondary outcome [7] 322653 0
Frequency of non-liver related hospitalisations as determined by patient medical record review.
Timepoint [7] 322653 0
Frequency of hospitalisations within 6 months, 12 months and 3 years
Secondary outcome [8] 322654 0
All-cause mortality as determined by patient medical record review.
Timepoint [8] 322654 0
All-cause mortality rate at 6 months, 12 months and 3 years
Secondary outcome [9] 322655 0
Liver-related mortality as determined by patient medical record review.
Timepoint [9] 322655 0
Liver-related mortality rate at 6 months, 12 months and 3 years

Eligibility
Key inclusion criteria
Eligible participants will be adults aged 18 years or older with cirrhosis and current or previous chronic liver failure (CLF)-related complication(s), including ascites, variceal bleeding, spontaneous bacterial peritonitis, sepsis, encephalopathy, liver cancer or liver-related renal dysfunction.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include inability to provide informed consent and intensive management by other health care teams (i.e. liver transplant team, palliative care).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation allocation concealed in a series of opaque, sealed envelopes containing INTERVENTION or USUAL CARE.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be used by drawing "INTERVENTION" or "USUAL CARE" (n=60 of each) randomly from a bowl by a third party. Sequentially drawn allocations will be enclosed in sealed envelopes and opened in their drawn order by a third party when a new patient is enrolled.
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/01/2016
Date of last participant enrolment
Anticipated
30/06/2016
Actual
17/10/2016
Date of last data collection
Anticipated
17/10/2019
Actual
30/04/2020
Sample size
Target
130
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5583 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 13036 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 293300 0
University
Name [1] 293300 0
The University of Queensland
Country [1] 293300 0
Australia
Funding source category [2] 293505 0
Hospital
Name [2] 293505 0
The Princess Alexandra Hospital
Country [2] 293505 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
St Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 292107 0
Hospital
Name [1] 292107 0
The Princess Alexandra Hospital
Address [1] 292107 0
199 Ipswich Road
Woolloongabba, QLD 4102
Country [1] 292107 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294777 0
Metro South Hospital and Health Service HREC
Ethics committee address [1] 294777 0
Ethics committee country [1] 294777 0
Australia
Date submitted for ethics approval [1] 294777 0
15/10/2015
Approval date [1] 294777 0
10/12/2015
Ethics approval number [1] 294777 0
HREC/15/QPAH/688
Ethics committee name [2] 294778 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 294778 0
Ethics committee country [2] 294778 0
Australia
Date submitted for ethics approval [2] 294778 0
12/01/2016
Approval date [2] 294778 0
14/01/2016
Ethics approval number [2] 294778 0
UQ2016000032

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

Contacts
Principal investigator
Name 64766 0
Prof Elizabeth E Powell
Address 64766 0
Level 5, West Wing, Translational Research Institute
37 Kent St
Woolloongabba QLD 4102
Country 64766 0
Australia
Phone 64766 0
+61734438015
Fax 64766 0
Email 64766 0
[email protected]
Contact person for public queries
Name 64767 0
Elizabeth E Powell
Address 64767 0
Level 5, West Wing, Translational Research Institute
37 Kent St
Woolloongabba QLD 4102
Country 64767 0
Australia
Phone 64767 0
+61734438015
Fax 64767 0
Email 64767 0
[email protected]
Contact person for scientific queries
Name 64768 0
Elizabeth E Powell
Address 64768 0
Level 5, West Wing, Translational Research Institute
37 Kent St
Woolloongabba QLD 4102
Country 64768 0
Australia
Phone 64768 0
+61734438015
Fax 64768 0
Email 64768 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
Dimensions AIEffectiveness of patient-oriented education and medication management intervention in people with decompensated cirrhosis2020https://doi.org/10.1111/imj.14986
Dimensions AIMedication Discrepancies and Regimen Complexity in Decompensated Cirrhosis: Implications for Medication Safety2021https://doi.org/10.3390/ph14121207
N.B. These documents automatically identified may not have been verified by the study sponsor.