- Title
- Patient-oriented education and medication management intervention for people with decompensated cirrhosis: study protocol for a randomized controlled trial
- Creator
- Hayward, Kelly L.; Martin, Jennifer H.; Cottrell, W. Neil; Karmakar, Antara; Horsfall, Leigh U.; Patel, Preya J.; Smith, David D.; Irvine, Katharine M.; Powell, Elizabeth E.; Valery, Patricia C.
- Relation
- Funding BodyNHMRCGrant Number1083090 http://purl.org/au-research/grants/nhmrc/1083090
- Relation
- Trials Vol. 18, no. 339
- Publisher Link
- http://dx.doi.org/10.1186/s13063-017-2075-4
- Publisher
- BioMed Central
- Resource Type
- journal article
- Date
- 2017
- Description
- Background: People 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/design: A 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. Discussion: The 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 registration: Australian and New Zealand Clinical Trial Registry identifier: ACTRN12616000780459. Registered on 15 June 2016.
- Subject
- liver cirrhosis; polypharmacy; clinical pharmacist; intervention study; patient education; medication reconciliation; medication errors; patient adherence; medication adherence; quality of life
- Identifier
- http://hdl.handle.net/1959.13/1397224
- Identifier
- uon:34210
- Identifier
- ISSN:1745-6215
- Rights
- © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
- Language
- eng
- Full Text
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