Supporting choice: an innovative model of integrated palliative care funded by a private health insurer.

BACKGROUND: The number of Australians dying each year is predicted to double in the next 25 years and there is an urgent need to establish sustainable models for providing high quality end-of-life care. An innovative community care model (Bupa Palliative Care Choices Program or BPCCP) was developed and piloted with the purpose of supporting patients in achieving their choices surrounding end-of-life care. AIMS: This study evaluates whether BPCCP patients were more likely to die in their place of choice compared with patients receiving standard care. Additional aims were evaluating patient and carer satisfaction and insurer cost. METHODS: This prospective, comparative cohort study comprises a clinical chart audit and survey of patient and carer experience. RESULTS: More BPCCP participants preferred to die at home (53% vs 31%). A lower proportion of BPCCP patients died in acute hospitals (10% vs 19%) and more of this cohort died at home (46% vs 26%). In both cohorts, nearly 90% of patients were able to die in their preferred location. Patient and carer satisfaction with the programme was very high in the small cohort who responded to the survey. There was a decrease in average claims spend per patient enrolled in the programme during the first 12-month period of implementation compared with historical claims spend for inpatients only. CONCLUSIONS: This evaluation of an innovative community palliative care intervention indicates that the extra services available to patients support the choice of dying at home and the ability to do so while generating claims cost efficiencies.

Testing pilocarpine drops for dry mouth in advanced cancer using n-of-1 trials: A feasibility study.

BACKGROUND: Dry mouth is a common and troublesome symptom in palliative care. Pilocarpine is a cholinergic agent that promotes salivation. AIM: This study aimed to test the feasibility of using n-of-1 trials to test pilocarpine drops compared to placebo, for patients of palliative care units with advanced cancer, who experienced dry mouth. DESIGN: This was an N-of-1 study, in which each participant was offered three cycles of pilocarpine drops 4% (6 mg tds) (3 days) and placebo drops (3 days) in random order. SETTING/PARTICIPANTS: Participants were patients of specialist palliative care services with advanced cancer assessed as having a dry mouth, defined as having a score of ⩾ 3 on an 11-point self-rated xerostomia numerical rating scale, from any cause. Patients self-completed a diary using validated symptom and quality-of-life scores. The randomisation order was unmasked at the end of each person's trial by a clinician independent of the trial to allow a treatment decisions for individual patients to be made. RESULTS: Nine patients completed at least 1 cycle; 33 cycles of data were completed in total, comprising 438 doses of pilocarpine. Four patients completed the trial: two responded and two did not. Most withdrawals related to deteriorating condition, unacceptable toxicity, non-compliance with study procedures or withdrawal of consent. Many issues contributed to slow recruitment and high withdrawal rate. CONCLUSION: The formulation of pilocarpine drops proved unacceptable to most participants. More work is required to determine an appropriate formulation, dose and method of delivery and then a retest of pilocarpine drops for this symptom.

Do pilocarpine drops help dry mouth in palliative care patients: a protocol for an aggregated series of n-of-1 trials.

BACKGROUND: It is estimated that 39,000 Australians die from malignant disease yearly. Of these, 60% to 88% of advanced cancer patients suffer xerostomia, the subjective feeling of mouth dryness. Xerostomia has significant physical, social and psychological consequences which compromise function and quality of life. Pilocarpine is one treatment for xerostomia. Most studies have shown some variation in individual response to pilocarpine, in terms of dose used, and timing and extent of response.We will determine a population estimate of the efficacy of pilocarpine drops (6 mg) three times daily compared to placebo in relieving dry mouth in palliative care (PC) patients. A secondary aim is to assess individual patients' response to pilocarpine and provide reports detailing individual response to patients and their treating clinician. METHODS/DESIGN: Aggregated n-of-1 trials (3 cycle, double blind, placebo-controlled crossover trials using standardized measures of effect). Individual trials will identify which patients respond to the medication. To produce a population estimate of a treatment effect, the results of all cycles will be aggregated. DISCUSSION: Managing dry mouth with treatment supported by the best possible evidence will improve functional status of patients, and improve quality of life for patients and carers. Using n-of-1 trials will accelerate the rate of accumulation of high-grade evidence to support clinical therapies used in PC. TRIAL REGISTRATION: Australia and New Zealand Clinical Trial Registry Number: 12610000840088.

Using aggregated single patient (N-of-1) trials to determine the effectiveness of psychostimulants to reduce fatigue in advanced cancer patients: a rationale and protocol.

BACKGROUND: It is estimated that 29% of deaths in Australia are caused by malignant disease each year and can be expected to increase with population ageing. In advanced cancer, the prevalence of fatigue is high at 70-90%, and can be related to the disease and/or the treatment. The negative impact of fatigue on function (physical, mental, social and spiritual) and quality of life is substantial for many palliative patients as well as their families/carers. METHOD/DESIGN: This paper describes the design of single patient trials (n-of-1 s or SPTs) of a psychostimulant, methylphenidate hydrochloride (MPH) (5 mg bd), compared to placebo as a treatment for fatigue, with a population estimate of the benefit by the aggregation of multiple SPTs. Forty patients who have advanced cancer will be enrolled through specialist palliative care services in Australia. Patients will complete up to 3 cycles of treatment. Each cycle is 6 days long and has 3 days treatment and 3 days placebo. The order of treatment and placebo is randomly allocated for each cycle. The primary outcome is a reduction in fatigue severity as measured by the Functional Assessment of Cancer Therapy-fatigue subscale (FACIT-F). Secondary outcomes include adverse events, quality of life, additional fatigue assessments, depression and Australian Karnovsky Performance Scale. DISCUSSION: This study will provide high-level evidence using a novel methodological approach about the effectiveness of psychostimulants for cancer-related fatigue. If effective, the findings will guide clinical practice in reducing this prevalent condition to improve function and quality of life. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12609000794202.

Pilot study to determine the optimal dose of methylphenidate for an n-of-1 trial for fatigue in patients with cancer.

PURPOSE: In advanced cancer, the prevalence of fatigue is high and can be related to treatment or disease. Methylphenidate hydrochloride (MPH) is a central nervous system stimulant that has been used to palliate fatigue. There is no standard dose for MPH when used for this indication; recommended doses range from 5­20 + mg/d. METHOD: To identify a dose to test formally in a subsequent n-of-1 trial of fatigue, we recruited patients with advanced cancer and a fatigue score of 4 or more on a 10-point scale. Following a 3-day baseline assessment, each patient titrated MPH at doses ranging from 5 mg/d to 15 mg twice daily at 3-day intervals. In a daily diary, patients recorded measures of fatigue, depression, toxicity, and symptom control. RESULTS: Ten patients provided consent, 9 completed 8 days and 5 received maximum dose at day 15. Three patients were unwilling to increase the dose to maximum levels as they were satisfied with the response at a lower dose. Across all patients, there was a pattern of rapidly improving fatigue and depression scores to day 9 (5 mg twice daily), with minimal improvement thereafter. CONCLUSION: The results indicate a dose of 5 mg twice daily for the definitive study. There was little correlation between performance status and maximum tolerated dose. No patient withdrew because of toxicity.

Developing guidelines for syringe driver management.

The aim of this project was to develop clinical practice guidelines for the use and administration of pharmacological agents for symptom control via syringe drivers within Australia. By developing evidence-based clinical practice guidelines for the use of this common device, this project aimed to improve patient outcomes, reduce practice variation, minimize errors and encourage more efficient use of resources. A literature review identified current literature regarding syringe driver management and an expert panel was assembled to assist in the development of the guidelines. The development of these practice guidelines provides an example of how palliative care practitioners can use a framework of contemporary evidence to enhance clinical practice.