Effectiveness of patient-oriented education and medication management intervention in people with decompensated cirrhosis.

People with chronic disease often have poor comprehension of their disease and medications, which can negatively affect health outcomes. In a randomised-controlled trial, we found that patients with decompensated cirrhosis who received a pharmacist-led, patient-oriented education and medication management intervention (n = 57) had greater knowledge of cirrhosis and key self-care tasks compared with usual care (n = 59). Intervention patients also experienced improved quality of life. Dedicated resources are needed to support implementation of evidence-based measures at local centres to improve outcomes.

RCT Entities:   Population Interventions Outcomes

Effective chronic disease management requires patients and their caregivers to have the necessary knowledge and skills to engage in self‐care tasks, self‐monitor for evolving complications, adhere to clinician recommendations and cultivate positive health behaviours. However, many patients have poor comprehension of chronic disease, mismanage their medications and fail to adopt important lifestyle modifications.

In 2017, we published a brief communication article that encouraged research at a local level to identify the educational needs and preferences of patients under the care of local healthcare centres to develop appropriate chronic disease education strategies. As an example of chronic disease in a local setting, we described poor patient knowledge of disease, medications, self‐monitoring, and dietary and lifestyle modifications among 50 Australians with liver cirrhosis, consistent with findings from an American study. Our pilot study data subsequently informed the development of a patient‐oriented education and medication management intervention, targeted to people with decompensated cirrhosis. The intervention was driven by a clinical pharmacist and implemented as a randomised‐controlled trial in a multidisciplinary hepatology outpatient centre.

The study protocol has been published. In brief, eligible adults with a history of decompensated cirrhosis were invited to participate when they attended for routine outpatient follow up at one of seven concurrent general hepatology clinics. Consenting patients were randomised to receive the education intervention or usual care. Usual care participants received routine review and education from their hepatologist according to the standard model of care in the clinic throughout the study period. Intervention participants received up to four additional contacts (at t 0, t 1, t 2 and t 3) over a 6‐ to 8‐month period from a trained clinical pharmacist in person or via telehealth, in addition to usual care. During these contacts, patients received medication and disease education according to the study protocol in addition to reactive advice tailored to patients' individual needs.

All patients completed a survey at baseline (t 0) and follow up (t 3) that contained measures for study endpoints, including self‐reported medication adherence (Morisky Medication Adherence Scale),4, 5, 6 medication and illness beliefs (Beliefs about Medicines Questionnaires and Brief‐Illness Perception Questionnaire (Brief‐IPQ) ), health‐related quality of life (QoL) (Chronic Liver Disease Questionnaire (CLDQ), modified to exclude question 29 as previously described ) and knowledge of cirrhosis self‐management tasks (eight ‘knowledge’ questions adapted from Volk et al. by a clinician panel (KH, EP, JM, PV and LH)). Surveys were completed independently by the patient or with the aid of a study coordinator or caregiver/family member according to individual need and preference to reflect a real‐world scenario. Hot deck imputation was utilised as per the study protocol to assign missing responses to individual questionnaire items, but not entirely missing questionnaire tools (knowledge questions were not imputed). Data from 12 patients (10.3%) included imputation (median (interquartile range, IQR: 2.0 (1.0–3.5) imputed values out of a total 124 items across all baseline and follow‐up questionnaires). A sensitivity analysis was conducted to evaluate the choice made with regard to handling missing data (with and without imputation). There was no difference in tested values in terms of variation above or below the significance threshold (α = 0.050).

The study was approved by the Human Research Ethics Committees at The University of Queensland (UQ2016000032) and the Metro South Hospital and Health Service (HREC/15/QPAH/688), and informed written consent was obtained from all participants. The trial was registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12616000780459).

One hundred and sixteen patients were randomised (59 to receive usual care and 57 to receive the intervention). Baseline characteristics of participants have been published. Although liver disease severity (Model for End‐Stage Liver Disease and Child‐Pugh score) was not significantly different between groups, intervention patients were taking more medications (median (IQR): 10.0 (6.5–12.0) vs 8.0 (6.0–9.5); Mann–Whitney U‐test P = 0.006) and had a lower self‐reported level of education (proportion educated to middle school or below: 53.1% vs 32.7%; Pearson's χ 2 P = 0.036).

Despite more patients having lower education levels (educated to middle school level or below), we found that intervention patients answered a greater number of ‘knowledge’ questions correctly at follow up than usual care patients (P = 0.009; Table 1). Specifically, intervention patients had greater awareness of the importance of maintaining a low‐salt diet (P = 0.002) and safe over‐the‐counter analgesia (P < 0.001). Among 33 intervention and 32 usual care patients who answered all eight questions at baseline and follow up, the overall count of correct responses improved among the intervention group (median (IQR): 5.0 (4.0–6.0) to 6.0 (4.0–6.5); Wilcoxon signed‐rank test P = 0.027), but not the usual care group (median (IQR): 4.0 (3.0–5.0) to 4.0 (4.0–6.0); Wilcoxon signed‐rank test P = 0.243). This is consistent with other studies that found low health literacy does not prevent patients from benefiting from education interventions.12, 13

Table 1

Patient responses to knowledge and self‐care questions at baseline and follow up

	Baseline (t 0)			Follow up (t 3)
Questions	Usual care (n = 52)	Intervention (n = 48)	P	Usual care (n = 40)	Intervention (n = 36)	P
For people with cirrhosis who have minor aches and pains, (what is) the safest over‐the‐counter medication?† Paracetamol	27 (61.4%)	35 (79.5%)	0.062	22 (55.0%)	35 (97.2%)	<0.001
If people with cirrhosis get swelling in the belly, legs or feet, should they cut down on drinking fluids to help with this problem? No‡	12 (23.1%)	15 (31.2%)	0.358	18 (45.0%)	20 (55.6%)	0.358
If the sodium level in your blood is low, does this mean you need to eat more salt? No	26 (50.0%)	30 (62.5%)	0.208	23 (57.5%)	32 (88.9%)	0.002
How often do you keep to the ‘low salt diet’ restriction? (self‐report) All/most of the time	37 (71.2%)	37 (77.1%)	0.499	28 (70.0%)	30 (83.3%)	0.172
How often do you eat out or get take away food? (self‐report) Fortnightly or less often	32 (61.5%)	32 (66.7%)	0.594	23 (57.5%)	22 (61.1%)	0.749
How frequently do you check your blood pressure? (self‐report) At least once a month	27 (51.9%)	27 (56.2%)	0.664	22 (55.0%)	17 (47.2%)	0.498
How frequently do you weigh yourself? (self‐report) Daily/weekly	25 (48.1%)	26 (54.2%)	0.543	22 (55.0%)	21 (58.3%)	0.770
Do you regularly bring your medications/list to your medical appointments? (self‐report) Yes	29 (55.8%)	26 (54.2%)	0.872	22 (55.0%)	22 (61.1%)	0.590
Total score† 1 point for each correct response	4.0 (3.0–5.0)	5.0 (4.0–6.0)	0.065	4.0 (4.0–6.0)	6.0 (4.0–6.5)	0.009

Categorical data presented as count (%) and analysed using Pearson's χ 2 test. Total score presented as median (IQR) and analysed using the Mann–Whitney U‐test. †n = 44 usual care and n = 44 intervention patients at t 0, and n = 40 usual care and n = 36 intervention patients at t 3. ‡Except those prescribed a fluid restriction.

Intervention patients also reported greater self‐perceived understanding (Brief‐IPQ coherence) of liver disease at follow up compared with usual care (P = 0.004; Table 2). This is an important finding as lower coherence has previously been associated with ‘low’ medication adherence in people with decompensated cirrhosis. Medication beliefs have also been associated with ‘low’ adherence; however, medication beliefs and adherence were not modified by our study intervention (Supporting Information Tables S1 and S2 respectively). The lack of change in patients' medication beliefs in the current study was unsurprising, as necessity beliefs among intervention patients at baseline were comparable with what could be considered an ‘adherent’ population in other studies. The prevalence of ‘low’ adherence in our study cohort at baseline was also lower than previously reported in Australians with cirrhosis.15, 16 Therefore, there was limited room for improvement.

Table 2

Perceptions of illness among intervention and usual care participants at baseline and follow up

	Baseline (t 0)			Follow up (t 3)
Brief‐IPQ items	Usual care (n = 53)	Intervention (n = 52)	P	Usual care (n = 43)	Intervention (n = 39)	P
Consequences	6.0 (4.0–8.0)	7.0 (5.0–9.0)	0.239	5.0 (3.0–7.0)	8.0 (5.0–10.0)	0.005
Timeline	10.0 (6.0–10.0)	9.0 (5.0–10.0)	0.485	10.0 (5.0–10.0)	10.0 (8.5–10.0)	0.148
Personal control	5.0 (3.0–7.0)	5.0 (3.0–7.0)	0.874	5.0 (3.5–8.0)	6.0 (2.5–7.0)	0.443
Treatment control	8.0 (7.0–10.0)	8.0 (8.0–10.0)	0.593	8.0 (5.0–9.5)	9.0 (7.0–10.0)	0.108
Identity	5.0 (3.0–7.0)	7.0 (5.0–8.0)	0.057	4.0 (1.0–7.0)	6.0 (4.5–8.0)	0.003
Concern	8.0 (5.0–10.0)	9.0 (7.0–10.0)	0.034	7.0 (3.5–9.0)	8.0 (6.0–10.0)	0.106
Coherence	8.0 (5.0–9.0)	8.0 (6.0–9.5)	0.579	8.0 (5.5–9.0)	9.0 (7.5–10.0)	0.004
Emotional representation	5.0 (2.0–7.0)	5.5 (3.0–8.5)	0.075	5.0 (1.0–7.0)	6.0 (3.5–8.0)	0.286

Data presented as median (IQR) and analysed using the Mann–Whitney U‐test.

Compared to usual care, participants who received the intervention reported a greater perception of symptoms (Brief‐IPQ identity; P = 0.003) and impact of liver disease on daily life (Brief‐IPQ consequences; P = 0.005), which coincided with a reduction in median scores for these items among the usual care group (Table 2). This finding conflicted with responses to the QoL questionnaire (Table S3), which identified no difference between groups in terms of abdominal symptoms, activity, emotion, fatigue, systemic symptoms or worry. In fact, among the 38 intervention and 41 usual care patients with CLDQ questionnaire responses at baseline and follow up, those in the intervention group had a significant improvement in self‐reported QoL (median (IQR) global CLDQ score: 3.9 (3.3–5.1) to 4.3 (3.2–5.4); Wilcoxon signed‐rank test P = 0.044), whereas usual care patients did not (median (IQR) global CLDQ score: 4.0 (3.3–5.1) to 4.1 (3.1–5.6); Wilcoxon signed‐rank test P = 0.226). It therefore seems unlikely that intervention patients would experience greater consequences of disease on daily life and more symptoms (identity), as suggested by the results of the Brief‐IPQ. Rather, in the context of a significantly greater Brief‐IPQ coherence score, it could be suggested that intervention participants are better able to identify that the symptoms and impacts on daily life they are experiencing are directly or indirectly related to liver disease. Conversely, usual care patients, who report experiencing a similar frequency of abdominal activity, emotion, fatigue, systemic symptoms and worry to intervention patients, may attribute their symptoms to another cause. As patients with decompensated cirrhosis who are ineligible for transplant are currently incurable, improvement in self‐reported QoL is a significant outcome, as this is often a key goal of treatment in end‐stage or palliative diseases. As the global CLDQ score for non‐cirrhotic patients with chronic liver disease is approximately 5.1, and those with Child‐Pugh A and Child‐Pugh B/C cirrhosis report average scores of 4.5 and 3.8, respectively, the observed improvement of 0.4 among the intervention group may also be clinically meaningful.

Discussion

To our knowledge, this is the first randomised‐controlled trial of a pharmacist‐led education and medication management intervention in people with decompensated cirrhosis. Previous studies of simple education interventions and one chronic disease case–management intervention have demonstrated mixed results for improving endpoints in people with cirrhosis.1, 2, 17 Our multifaceted intervention – which was informed by our pilot study to target the educational needs of local patients with cirrhosis and delivered in a patient‐oriented modality to suit preferences and level of engagement – supports our hypothesis that implementation of local initiatives is important to improve patients' knowledge of chronic disease and improve health outcomes.

As a single‐centre local study, we acknowledge the fact that our findings have inherent bias. Results from a multivariable analysis are likely to be less biased than results emanating from a series of univariable analyses; however, our study was not powered for this. We evaluated the impact of a single clinical pharmacist at one of the largest tertiary hepatology outpatient centres in Queensland, Australia. Participants were heterogeneous in terms of disease aetiology, severity and multimorbidity, which are consistent with the ambulatory population of patients managed by our centre. Due to the nature of the intervention, information provided to patients and their caregivers was staggered and tailored according to clinical relevance. Intensity of care from treating clinicians and nurses was similarly tailored, and patients may have been reviewed by medical staff with different levels of experience (consultant physician, basic physician trainee or advanced gastroenterology trainee).

Our study is one example of a successful local measure that was implemented with mindful study design to target deficits in patient knowledge that we identified at our own centre. These findings have substantial implications for evolving ambulatory patient management, as opportunity to empower patients in their own healthcare becomes paramount in an increasingly overburdened healthcare system. Dedicated resources are needed to support implementation of evidence‐based measures at local centres to improve outcomes.

Table S1. General and specific medication beliefs reported by usual care and intervention participants at baseline and follow up.

Table S2. Patient responses to the self‐reported medication adherence questionnaire at baseline and follow up.

Table S3. Health‐related quality of life reported by intervention and usual care participants at baseline and follow up.

Click here for additional data file.