Abstract
BackgroundPeople with decompensated cirrhosis require complex medical care and are often prescribed an intricate and frequently changing medication and lifestyle regimen. However, many patients mismanage their medications or have poor comprehension of their disease and self-management tasks. This can lead to harm, hospitalization, and death.Methods/designA patient-oriented education and medication management intervention has been developed for implementation at a tertiary hospital hepatology outpatient center in Queensland, Australia. Consenting patients with decompensated cirrhosis will be randomly allocated to education intervention or usual care treatment arms when they attend routine follow-up appointments. In the usual care arm, participants will be reviewed by their hepatologist according to the current model of care in the hepatology clinic. In the intervention arm, participants will be reviewed by a clinical pharmacist to receive the education and medication management intervention at baseline in addition to review by their hepatologist. Intervention participants will also receive three further educational contacts from the clinical pharmacist within the following 6-month period, in addition to routine hepatologist review that is scheduled within this time frame. All participants will be surveyed at baseline and follow-up (approximately 6 months post-enrollment). Validated questionnaire tools will be used to determine participant adherence, medication beliefs, illness perceptions, and quality of life. Patients’ knowledge of dietary and lifestyle modifications, their current medications, and other clinical data will be obtained from the survey, patient interview, and medical records. Patient outcome data will be collected at 52 weeks.DiscussionThe intervention described within this protocol is ready to adapt and implement in hepatology ambulatory care centers globally. Investigation of potentially modifiable variables that may impact medication management, in addition to the effect of a clinical pharmacist-driven education and medication management intervention on modifying these variables, will provide valuable information for future management of these patients.Trial registrationAustralian and New Zealand Clinical Trial Registry identifier: ACTRN12616000780459. Registered on 15 June 2016.
Highlights
People with decompensated cirrhosis require complex medical care and are often prescribed an intricate and frequently changing medication and lifestyle regimen
Authors of meta-analyses and researchers in randomized controlled trials have found that clinical pharmacist interventions improved achievement of therapeutic targets in people with diabetes [10], hypertension [38, 39], and hyperlipidemia [40]
Addressing Medication-related problem (MRP), discrepancies, nonadherence, and patient knowledge deficits related to prescribed therapy may improve outcomes for patients with decompensated cirrhosis
Summary
People with decompensated cirrhosis require complex medical care and are often prescribed an intricate and frequently changing medication and lifestyle regimen. Many patients mismanage their medications or have poor comprehension of their disease and self-management tasks. This can lead to harm, hospitalization, and death. Many patients lack the knowledge and skills required to contribute effectively to disease management [3, 4] On average, this patient group has approximately three hospital admissions each year [1, 5], reflecting the high burden of illness and use of health care resources. More medicines are prescribed and/or the medication regimen is altered This increases opportunities for miscommunication and nonadherence, thereby increasing the risk of medication errors and rehospitalization
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