A randomized multicenter trial of a chronic disease management intervention for decompensated cirrhosis. The Australian Liver Failure (ALFIE) trial.

BACKGROUND AND AIMS: Improving the care of decompensated cirrhosis is a significant clinical challenge. The primary aim of this trial was to assess the efficacy of a chronic disease management (CDM) model to reduce liver-related emergency admissions (LREA). The secondary aims were to assess model effects on quality-of-care and patient-reported outcomes. APPROACH AND RESULTS: The study design was a 2-year, multicenter, randomized controlled study with 1:1 allocation of a CDM model versus usual care. The study setting involved both tertiary and community care. Participants were randomly allocated following a decompensated cirrhosis admission. The intervention was a multifaceted CDM model coordinated by a liver nurse. A total of 147 participants (intervention=75, control=71) were recruited with a median Model for End-Stage Liver Disease score of 19. For the primary outcome, there was no difference in the overall LREA rate for the intervention group versus the control group (incident rate ratio 0.89; 95% CI: 0.53-1.50, p=0.666) or in actuarial survival (HR=1.14; 95% CI: 0.66-1.96, p=0.646). However, there was a reduced risk of LREA due to encephalopathy in the intervention versus control group (HR=1.87; 95% CI: 1.18-2.96, p=0.007). Significant improvement in quality-of-care measures was seen for the performance of bone density (p<0.001), vitamin D testing (p<0.001), and HCC surveillance adherence (p=0.050). For assessable participants (44/74 intervention, 32/71 controls) significant improvements in patient-reported outcomes at 3 months were seen in self-management ability and quality of life as assessed by visual analog scale (p=0.044). CONCLUSIONS: This CDM intervention did not reduce overall LREA events and may not be effective in decompensated cirrhosis for this end point.

Nurse Led Clinics; a Novel Model of Care for Compensated Liver Cirrhosis: A Qualitative Analysis.

A nurse-led cirrhosis clinic model for management of stable, compensated cirrhotic patients is practised in our unit since 2013, wherein these patients are reviewed every six months by specialist nurses in community clinics under remote supervision of hepatologists. We evaluated the experiences of patients and healthcare providers involved in the model to understand the acceptability, strengths, and limitations of the model and obtain suggestions to improve. A qualitative design using in-depth interviews was employed, followed by thematic analysis of eight patients, one attending physician both nurse and hospital clinics, four hepatologists, and three experienced specialist nurses running the nurse-led cirrhosis clinic. Patients expressed satisfaction and a good understanding of the nurse-led cirrhosis clinic, preferring it to hospital clinics for better accessibility and the unique nurse-patient relationship. Upskilling and provision of professional care in a holistic manner were appreciated by specialist nurses. The hepatologists expressed confidence and satisfaction, although they acknowledged the difference between the medical training of specialist nurses and hepatologists. The greater availability of hospital clinic time for sick patients was welcomed. Increased specialist nurse staffing, regular forums to promote specialist nurse learning, and formalization of the referral process were suggested. No adverse experiences were reported by patients or staff. The nurse-led cirrhosis clinic model for compensated liver cirrhosis was well received by patients, hepatologists, and specialist nurses. Wider implementation of the model could be considered after further investigations in other settings.

Psychometric validation of the Partners in Health scale as a self-management tool in patients with liver cirrhosis.

BACKGROUND AND AIM: Liver cirrhosis is a chronic disease complicated by recurrent hospital admissions. Self-management skills could facilitate optimal disease management. At present there is no validated instrument for measuring self-management in these patients. Hence, we evaluated the internal reliability and construct validity of the Partners in Health (PIH) scale, a chronic condition self-management tool in cirrhotic patients. METHODS: In this prospective cohort study, the PIH scale was administered to 133 consenting patients within a Chronic Liver Failure Program of a tertiary hospital from February 2017 to May 2018. A Bayesian confirmatory factor analysis was used to evaluate a priori four-factor structure. Omega coefficients and 95% credible intervals (CrI) were used to assess internal reliability. Known-group validity was assessed in patients receiving active case management (n = 60) versus those without (n = 73). RESULTS: The mean (± standard deviation (SD)) age of the participants was 62 (±11) years. Model fit for the hypothesised model was adequate (posterior predictive P-value = 0.073) and all hypothesised factor loadings were substantial (>0.6) and significant (P < 0.001). Omega coefficients (95% CrI) for the PIH subscales of Knowledge, Partnership, Management and Coping were 0.88 (0.82-0.91), 0.68 (0.57-0.76), 0.92 (0.89-0.94) and 0.89 (0.85-0.92) respectively. The mean (±SD) overall PIH score was higher in patients receiving case management compared to those without case management (81 ± 12 vs 73 ± 17, P < 0.001). CONCLUSION: The dimensionality, known-group validity and reliability of the PIH scale for measuring self-management in patients with liver cirrhosis were confirmed. Its clinical predictive value requires further assessment.

Validation of Knowledge Questionnaire for Patients With Liver Cirrhosis.

BACKGROUND & AIMS: There is no validated questionnaire to assess disease knowledge and self-management in patients with liver cirrhosis. We developed and validated a Cirrhosis Knowledge Questionnaire (CKQ). METHODS: We created a preliminary CKQ comprising 10 questions relevant to self-management of cirrhosis, based on publications and clinical experiences. The CKQ was given to a pilot sample of 17 patients with decompensated cirrhosis to assess its face validity. In consultation with experts, we developed a second version of CKQ, comprising 14 multiple choice questions, and administered it to 116 patients with cirrhosis participating in a Chronic Liver Failure Program. The dimensionality of the construct was assessed using exploratory factor analysis and internal consistency was assessed with Cronbach's alpha. Known-group validity of the resulting instrument was assessed by comparing the performance of the CKQ in 69 patients with decompensated cirrhosis (mean age, 62 ± 13 years; 109 responses), with (n = 42) vs without (n = 67) case management. RESULTS: A 3-factor model with 7 questions related to variceal bleeding, ascites, and hepatic encephalopathy was considered the optimal dimensionality with excellent internal consistency (Cronbach's alpha = 0.82). The mean knowledge score was higher in patients with case management (5.6 ± 1.1) than in patients without case management (4.3 ± 2.1) (P = .002). CONCLUSIONS: We developed and validated a questionnaire with 7 questions on ascites, variceal bleeding, and hepatic encephalopathy to assess knowledge and self-management in patients with liver cirrhosis. Studies are needed to confirm its dimensionality and assess association of scores with patient outcomes.

The Chronic Liver Disease Nurse Role in Australia: Describing 10 Years of a New Role in Cirrhosis Management.

Cirrhosis of the liver is increasing, with growing patient numbers in hospital outpatient departments, as well as increasing admissions due to decompensated liver disease. Decompensated cirrhosis of the liver is a common and debilitating illness causing disability, readmissions to hospital, and decreased quality of life, and can lead to liver cancer. The advent of the chronic liver disease nurse (CLDN) position in our hospital in 2009 was the first role in Australia dedicated to providing care to patients with cirrhosis. The role incorporates the care of patients with stable compensated disease, case management of patients with complications of decompensated disease, and hepatocellular carcinoma coordination. After a pilot randomized controlled trial and almost 10 years of service, this article describes the role of the CLDN and presents key performance indicators that will assist other centers considering introducing the role or elements of it into their service.

Efficacy of High-Dose, Rapid, Hepatitis A and B Vaccination Schedules in Patients With Cirrhosis.

Patients with cirrhosis have increased morbidity from hepatitis A virus (HAV) and hepatitis B virus (HBV) infections, and vaccination against these infections is an important standard of care.1,2 However, vaccination in patients with cirrhosis is hindered by immune dysfunction and there is limited high-quality literature available. The aim of this work therefore was to compare immune responses of standard dose (SD) with high-dose accelerated (HDA) vaccination in cirrhotic patients.

Efficacy of a chronic disease management model for patients with chronic liver failure.

BACKGROUND & AIMS: Despite the economic impacts of chronic liver failure (CLF) and the success of chronic disease management (CDM) programs in routine clinical practice, there have been no randomized controlled trials of CDM for CLF. We investigated the efficacy of CDM programs for CLF patients in a prospective, controlled trial. METHODS: Sixty consecutive patients with cirrhosis and complications from CLF were assigned randomly to groups given intervention (n = 40) or usual care (n = 20), from 2009 to 2010. The 12-month intervention comprised 4 CDM components: delivery system redesign, self-management support, decision support, and clinical information systems. The primary outcome was the number of days spent in a hospital bed for liver-related reasons. Secondary outcomes were rates of other hospital use measures, rate of attendance at planned outpatient care, disease severity, quality of life, and quality of care. RESULTS: The intervention did not reduce the number of days patients spent in hospital beds for liver-related reasons, compared with usual care (17.8 vs 11.0 bed days/person/y, respectively; incidence rate ratio, 1.6; 95% confidence interval, 0.5-4.8; P = .39), or affect other measures of hospitalization. Patients given the intervention had a 30% higher rate of attendance at outpatient care (incidence rate ratio, 1.3; 95% confidence interval, 1.1-1.5; P = .004) and significant increases in quality of care, based on adherence to hepatoma screening, osteoporosis and vaccination guidelines, and referral to transplant centers (P < .05 for all). CONCLUSIONS: In a pilot study to determine the efficacy of CDM for patients with CLF, patients receiving CDM had significant increases in attendance at outpatient centers and quality of care, compared with patients who did not receive CDM. However, CDM did not appear to reduce hospital admission rates or disease severity or improve patient quality of life. Larger trials with longer follow-up periods are required to confirm these findings and assess cost effectiveness.

Perspectives of carers on the move from a hospital to a transitional care unit.

The authors describe carers' experiences of the traditional process of moving a relative into residential care from an acute hospital admission and how a transitional care unit affected this experience. Telephone interviews (total 31) confirmed that looking for permanent care was a stressful, time-consuming, and confusing process for all carers. The transitional care unit did not make a great difference to the stress of finding a residential care vacancy, but the overall experience of transitional care was positive, with carers feeling that it gave them time to consider residential care options. Carers felt that a hospital was not the best environment to assess ongoing care needs. The implementation of transitional care did not reduce the stress felt by carers when looking for a residential care facility, but it was an acceptable alternative to waiting for residential care in hospital.

Evidence-based clinical practice in falls prevention: a randomised controlled trial of a falls prevention service.

AIMS: Evidence-based guidelines recommend a range of treatments for falls and injury prevention. We undertook a randomised trial of a falls prevention service to screen for falls risk factors and recommend to GPs an evidenced base prescription for falls prevention. METHODS: All patients who presented with a fall to the Emergency Department at Flinders Medical Centre over a 22-week period were considered for the study. We excluded patients with dementia, resident in high care or those transferred to other hospitals and outside our catchment area. Of those who consented, we randomised patients between usual care or to an intervention consisting of a falls risk assessment and writing of an evidence-based prescription faxed to their GP for action. Patients were followed for six months and uptake of advice and fall rates were monitored. RESULTS: Four hundred and fifty patients presented with a fall-related attendance and of these 261 patients were eligible for inclusion in the trial. Of these 261 patients, 140 consented and were enrolled in the trial. Over the six months patients in the intervention group were more likely to uptake preventative advice (OR=12.3; 95%CI=4.2-35.9). We were unable to show a reduction in falls (OR= 1.7; 95%CI=0.7-4.4). CONCLUSIONS: A patient centered evidence-based approach is feasible and effective in increasing uptake of falls prevention advice. Long term compliance with advice needs further exploration.

Improving management of oesophageal varices in patients with cirrhosis.

PROBLEM: A retrospective audit of management of oesophageal varices in patients with cirrhosis identified the need to improve adherence to guidelines. DESIGN: Prospective audit of the effect of disseminating guidelines in 2004; prospective audit of the effect of a nurse coordinator for oesophageal variceal screening and surveillance from 2005 to 2008. SETTING: A major public hospital in Australia 2001-2008. Patients with cirrhosis of the liver and those who had experienced a variceal bleed were studied. KEY MEASURES FOR IMPROVEMENT: (1) Adherence with primary prevention protocols for prevention of primary variceal bleeding in patients with cirrhosis of the liver. (2) Adherence with protocols for acute management of variceal bleeding and secondary prevention of bleeding. STRATEGIES FOR CHANGE: Local protocols were developed and disseminated. A nurse coordinator was introduced to manage the primary prevention process according to a clinical protocol. EFFECTS OF CHANGE: The introduction of a nurse coordinator to manage the primary prevention process resulted in dramatic and rapid improvements in primary prevention. This has been maintained with our target of 90% adherence being achieved for the last 3 years. LESSONS LEARNT: Disseminating guidelines had little effect on primary prevention practice. Less than 1 year after a nurse coordinator was introduced to manage primary prevention, adherence to primary prevention guidelines increased from 13% to 79%. However, significant improvements in the management of acute variceal bleeding where medical staff have a clear responsibility for patient care were achieved through the development and dissemination of clear clinical protocols and the introduction of auditing and feedback mechanisms.

Attitudes to falls and injury prevention: what are the barriers to implementing falls prevention strategies?

OBJECTIVES: To ascertain the reasons for not taking up a fall or injury prevention strategy among older people who have sustained a fall and attended an emergency department. SUBJECTS: As part of another trial, we identified 60 people who attended the emergency department of a public hospital with a fall. MAIN MEASURES: Participants were interviewed to ascertain the reasons for not taking up a falls prevention strategy, their falls-related health state, and the likelihood of them undertaking a falls and injury prevention strategy. RESULTS: A total of 31 (52%) of the participants had considered falls prevention after their fall. There were high levels of reluctance to undertake a strategy with 43 (72%) reluctant to take exercise classes, 10 (59%) reluctant to cease psychotropic medications, 26 (43%) reluctant to have a home safety assessment and 17 (28%) reluctant to take osteoporotic medication. When asked specifically about taking up a strategy to prevent a worsening health state, 19 (63%) of participants would take up exercise, 17 (57%) a home safety assessment, 4 of the 17 (59%) already taking implicated medications would stop and 56 (93%) would begin osteoporotic medication. These decisions did not alter when the goal for treatment was to improve a much worse health state. In participants with a lower starting health state, home safety assessments were viewed more favourably. CONCLUSIONS: There were significant obstacles to the implementation of most falls prevention guidelines examined. Treatment for osteoporosis was more acceptable to participants than exercise classes, cessation of psychotropic medication, and having a home safety assessment. Osteoporosis treatment, which had the least resistance, also had the least impact on the participants' lifestyle.

Transitional care facility for elderly people in hospital awaiting a long term care bed: randomised controlled trial.

OBJECTIVE: To assess the effectiveness of moving patients who are waiting in hospital for a long term care bed to an off-site transitional care facility. DESIGN: Randomised controlled trial. SETTING: Three public hospitals in Southern Adelaide. PARTICIPANTS: 320 elderly patients (mean age 83 years) in acute hospital beds (212 randomised to intervention, 108 to control). INTERVENTIONS: A transitional care facility where all patients received a single assessment from a specialist elder care team and appropriate ongoing therapy. MAIN OUTCOME MEASURES: Length of stay in hospital, rates of readmission, deaths, and patient's functional level (modified Barthel index), quality of life (assessment of quality of life), and care needs (residential care scale) at four months. RESULTS: From admission, those in the intervention group stayed a median of 32.5 days (95% confidence interval 29 to 36 days) in hospital. In the control group the median length of stay was 43.5 days (41 to 51 days) (95% confidence interval for difference 6 to 16 days). Patients in the intervention group took a median of 21 days (6 to 27 days) longer to be admitted to permanent care than those in the control group. In both groups few patients went home (14 (7%) in the intervention group v 9 (9%) in the control group). There were no significant differences in death rates (28% v 27%) or rates of transfer back to hospital (28% v 25%). CONCLUSIONS: For frail elderly patients who are awaiting a residential care bed transfer out of hospital to an off-site transitional care unit with focus on aged care "unblocks beds" without adverse effects.