ABSTRACT
Introduction: Patients with end-stage liver disease (ESLD) suffer from myriad symptoms due to the systemic effects of the disease and unpredictable acute episodes, which contribute to progressive deterioration in quality of life (QOL). Despite clear evidence that palliative care (PC) improves QOL in other serious illnesses, PC is underutilized and delayed for ESLD patients. Through a comparative effectiveness trial of specialist led consultative PC (Model 1) versus trained hepatologist led PC (Model 2), we aim to build evidence on introducing PC into the routine outpatient care of ESLD patients. Objective: We hypothesize that trained hepatologist led PC model will have a better improvement in QOL compared to consultative PC model. Methods: This two-arm, multicenter cluster-randomized trial assesses the effectiveness of two PC models for patients with ESLD. Fourteen clinical centers will recruit 1260 patient-caregiver dyads. Each center is the unit of randomization. Hepatologists at sites randomized to the Model 2 have undergone web-based training in the principles of PC as pertained to ESLD. PC intervention is delivered over four visits (initial, one, two, and three months). Follow-up assessments occur at 6, 9, and 12 months. Eligible patients are those with new onset or ongoing complications of ESLD with a caregiver willing to participate. Outcomes: The primary outcome is change in patients' QOL from baseline to three months. Secondary outcomes include symptom burden, depression, distress, satisfaction with care, caregiver burden and QOL, goal concordant care, and health care utilization. Challenges and Contributions Engagement: A research advisory board has been developed with representatives from the participating centers, who have provided active feedback on the protocol, outcomes, study methods, and training program. Intervention Fidelity: Intervention fidelity will be maintained by adherence to a visit agenda and providers in both models completing a PC checklist after each study visit.
Subject(s)
End Stage Liver Disease/nursing , Palliative Care/methods , Palliative Care/statistics & numerical data , Randomized Controlled Trials as Topic , Adult , Aged , Aged, 80 and over , Female , Humans , Longitudinal Studies , Male , Middle Aged , Surveys and QuestionnairesABSTRACT
Non-adherence in patients with chronic liver disease is a problem resulting in various consequences ranging from disease deterioration to death. Insufficient medication adherence leads to enormous health care costs. Family caregivers can essentially contribute to improving adherence. The aim of this project was to develop a work instruction specifically dedicated to optimize adherence in this patient group and their family caregivers. The project team utilized the principles of participatory action research. A systematic literature research aimed at identifying interventions for improving medication adherence in patients with chronic liver disease. Findings of patient experiences from literature as well as clinical experience of nurses were evaluated for their practicability in the local context. Research revealed that information for patients and family caregivers, supportive relationships with health care professionals, helpful communication, the use of memory aids and integration of medication intake into everyday life were the most helpful adherence-enhancing interventions. The work instruction serves to integrate these interventions into clinical practice in order to ensure optimal medication adherence.
