ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Decompensated liver cirrhosis

Condition category

Condition code

Oral and Gastrointestinal

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]

Lifestyle

Intervention code [2]

Behaviour

Intervention code [3]

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]

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]

Discrepancies present at baseline vs. at 6 months.

Secondary outcome [1]

Self-reported medication adherence as indicated using the 8-Question Morisky Medication Adherence Scale which ranks adherence as 'High', 'Medium' or 'Low'.

Timepoint [1]

Adherence ranking at baseline vs. at 6 months

Secondary outcome [2]

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]

Quality of life at baseline vs. at 6 months

Secondary outcome [3]

Illness perceptions as indicated by completion of the Brief Illness Perceptions Questionnaire and patient interview.

Timepoint [3]

Illness perceptions at baseline vs. at 6 months

Secondary outcome [4]

Medication beliefs as indicated by completion of the Beliefs about Medications (General and Specific) Questionnaire and patient interview.

Timepoint [4]

Medication beliefs at baseline vs. at 6 months

Secondary outcome [5]

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]

Knowledge at baseline vs. at 6 months

Secondary outcome [6]

Frequency of liver-related hospitalisations as determined by patient medical record review.

Timepoint [6]

Frequency of hospitalisations within 6 months, 12 months and 3 years

Secondary outcome [7]

Frequency of non-liver related hospitalisations as determined by patient medical record review.

Timepoint [7]

Frequency of hospitalisations within 6 months, 12 months and 3 years

Secondary outcome [8]

All-cause mortality as determined by patient medical record review.

Timepoint [8]

All-cause mortality rate at 6 months, 12 months and 3 years

Secondary outcome [9]

Liver-related mortality as determined by patient medical record review.

Timepoint [9]

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?

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]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Queensland

Address [1]

The University of Queensland
St Lucia, QLD 4072

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

The Princess Alexandra Hospital

Address [2]

199 Ipswich Road
Woolloongabba, QLD 4102

Country [2]

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]

Hospital

Name [1]

The Princess Alexandra Hospital

Address [1]

199 Ipswich Road
Woolloongabba, QLD 4102

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Hospital and Health Service HREC

Ethics committee address [1]

Centres for Health Research
Level 7, Translational Research Institute
37 Kent St
Woolloongabba, QLD 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/10/2015

Approval date [1]

10/12/2015

Ethics approval number [1]

HREC/15/QPAH/688

Ethics committee name [2]

University of Queensland Medical Research Ethics Committee

Ethics committee address [2]

The University of Queensland
Brisbane, QLD 4072

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

12/01/2016

Approval date [2]

14/01/2016

Ethics approval number [2]

UQ2016000032

Summary

Brief summary

The overall objective of the study is to investigate if a personalised education and medication management intervention reduces medication related problems for patients with decompensated cirrhosis.

The morbidity and healthcare costs associated with complications of decompensated liver cirrhosis are substantial, as patients require complex medical care and have very high use of hospital services. People with cirrhosis are often prescribed multiple medications for therapeutic or prophylactic use, and the number of medications prescribed on hospital discharge is a risk factor for early readmission.
 
Medication-related problems (MRPs) contribute to patient morbidity, hospitalisation and mortality in many chronic health conditions in the Australian community. The prevalence of MRPs has not been formally investigated in patients with cirrhosis, although a recent pilot study identified the prevalence of discrepancies between patient-reported and medical-record documented medications, and a lack of patient knowledge about their liver disease, medications and self-care tasks. The study identified only 44.5% of all medication entries to be concordant between patients and their medical records. Discrepancies of clinical significance were identified in 27 of 50 patients (54%) with a mean of 3.12 discrepancies per patient (range 1 to 8 discrepancies). Medication discrepancies were associated with older age (p=0.04), polypharmacy (p<0.01) and poorer levels of adherence (p<0.01). 

Gaps in patients’ disease-specific knowledge, medication-management skills, and lower levels of engagement in treatment may be a barrier to effective clinician-patient interaction and impair disease management. Limitations within the current outpatient model of care for cirrhosis patients include:

* No designated clinician role for medication reconciliation or regular disease education
* Lack of patient assistance to develop skills in the day-to-day management of their health condition
* Lack of adequate information about opportunities for self-management or the need for medication adherence 
* Time constrained hepatologists and limited contact with patients

Pharmacist-driven education and medication-management interventions have been shown to reduce hospital admissions, increase adherence to therapy and improve patient outcomes in other studies of collaborative outpatient practice. It is hypothesised that patient-centred education and medication-management intervention may address the complex relationship between patient knowledge, adherence and medication-management to improve outcomes for people with cirrhosis and reduce the burden on hospital resources.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Elizabeth E Powell

Address

Level 5, West Wing, Translational Research Institute
37 Kent St
Woolloongabba QLD 4102

Country

Australia

Phone

+61734438015

Fax

e.powell@uq.edu.au

Contact person for public queries

Name

Elizabeth E Powell

Address

Level 5, West Wing, Translational Research Institute
37 Kent St
Woolloongabba QLD 4102

Country

Australia

Phone

+61734438015

Fax

e.powell@uq.edu.au

Contact person for scientific queries

Name

Elizabeth E Powell

Address

Level 5, West Wing, Translational Research Institute
37 Kent St
Woolloongabba QLD 4102

Country

Australia

Phone

+61734438015

Fax

e.powell@uq.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Dimensions AI	Effectiveness of patient-oriented education and medication management intervention in people with decompensated cirrhosis	2020	https://doi.org/10.1111/imj.14986
Dimensions AI	Medication Discrepancies and Regimen Complexity in Decompensated Cirrhosis: Implications for Medication Safety	2021	https://doi.org/10.3390/ph14121207

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically