None listed
Conditions
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.
Interventions
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 enc
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.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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).
Outcome results
None listed