Effectiveness, safety and cost-effectiveness of vaporized nicotine products versus nicotine replacement therapy for tobacco smoking cessation in a low-socioeconomic status Australian population: a study protocol for a randomized controlled trial.

BACKGROUND: In Australia, tobacco smoking rates have declined but inequalities remain with significantly higher smoking prevalence among low-socioeconomic populations. Clinical trial data suggest vaporized nicotine products (VNPs) aid smoking cessation. Most VNP trials have used refillable tank systems, but newer generation (pod) devices now comprise the largest market share yet have limited clinical trial evidence on safety and effectiveness. This study evaluates the effectiveness, safety and cost-effectiveness of VNPs (pod and tank device) compared with nicotine replacement therapy ([NRT]-gum or lozenge) for smoking cessation. METHODS: This is a two-arm, open-label, superiority, parallel group, randomized controlled trial (RCT) with allocation concealment and blinded outcome assessment. The RCT is conducted at the National Drug and Alcohol Research Centre at the University of New South Wales, Sydney, Australia. Participants are people who smoke daily, are interested in quitting and receive a government pension or allowance (N = 1058). Participants will be randomized (1:1 ratio) to receive 8 weeks of free: VNPs, with pod (40 mg/mL nicotine salt) and tank device (18 mg/mL freebase nicotine) in mixed flavours; or NRT (gum or lozenge; 4 mg). All participants will receive daily text message behavioural support for 5 weeks. Assessments will be undertaken by telephone at baseline, with three follow-up calls (two check-in calls within the first month and final follow-up at 7 months post randomization) to ascertain smoking status, treatment adherence and adverse events. The primary outcome is 6-month continuous abstinence verified by carbon monoxide breath test of ≤5ppm at 7-month follow-up. Safety and cost-effectiveness of VNPs versus NRT will also be evaluated. DISCUSSION: Further data are required to strengthen certainty of evidence for VNPs aiding smoking cessation, particularly for newer generation pod devices. To our knowledge, this trial is the first to offer choice of VNPs and no comparative effectiveness trial data exists for new pod devices. If effective, the findings can inform wider implementation of VNPs to aid smoking cessation in a priority group. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12621000076875. Registered on 29 January 2021.  https://www.anzctr.org.au.

Effectiveness of quality incentive payments in general practice (EQuIP-GP): a study protocol for a cluster-randomised trial of an outcomes-based funding model in Australian general practice to improve patient care.

BACKGROUND: There is international interest in whether improved primary care, in particular for patients with chronic or complex conditions, can lead to decreased use of health resources and whether financial incentives help achieve this goal. This trial (EQuIP-GP) will investigate whether a funding model based upon targeted, continuous quality incentive payments for Australian general practices increases relational continuity of care, and lessens health-service utilisation, for high-risk patients and children. METHODS: We will use a mixed methods approach incorporating a two-arm pragmatic cluster randomised control trial with nested qualitative case studies. We aim to recruit 36 general practices from Practice-Based Research Networks (PBRN) covering urban and regional areas of Australia, randomised into intervention and control groups. Control practices will provide usual care while intervention practices will be supported to implement a new service model incorporating incentives for relational continuity and timely access to appointments. Patients will comprise three groups: older (over 65 years); 18-65 years with chronic and/or complex conditions; and those aged less than 16 years with increased risk of hospitalisation. The funding model includes financial incentives to general practitioners (GPs) for providing longer consultations, same day access and timely follow-up after hospitalisation to enrolled patients. The payments are proportional to expected health system savings associated with improved quality of GP care. An outreach facilitator will work with practices to help incorporate the incentive model into usual work. The main outcome measure is relational continuity of care (Primary Care Assessment Tool short-form survey), with secondary outcomes including health-related quality of life and health service use (hospitalisations, emergency presentations, GP and specialist services in the community, medicine prescriptions and targeted pathology and imaging ordering). Outcomes will be initially evaluated over a period of 12 months, with ongoing data collection for 5 years. DISCUSSION: The trial will provide robust evidence on a novel approach to providing continuous incentives for improving quality of general practice care, which can be compared to block payment incentives awarded at target quality levels of pay-for-performance, both within Australia and also internationally. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618000105246. Registered on 23 January 2018.

General practitioners' views on the influence of cost on the prescribing of asthma preventer medicines: a qualitative study.

Objective Out-of-pocket costs strongly affect patient adherence with medicines. For asthma, guidelines recommend that most patients should be prescribed regular low-dose inhaled corticosteroids (ICS) alone, but in Australia most are prescribed combination ICS-long-acting ß2-agonists (LABA), which cost more to patients and government. The present qualitative study among general practitioners (GPs) explored the acceptability, and likely effect on prescribing, of lower patient copayments for ICS alone. Methods Semistructured telephone interviews were conducted with 15 GPs from the greater Sydney area; the interviews were transcribed and thematically analysed. Results GPs reported that their main criteria for selecting medicines were appropriateness and effectiveness. They did not usually discuss costs with patients, had low awareness of out-of-pocket costs and considered that these were seldom prohibitive for asthma patients. GPs strongly believed that patient care should not be compromised to reduce cost to government. They favoured ICS-LABA combinations over ICS alone because they perceived that ICS-LABA combinations enhanced adherence and reduced costs for patients. GPs did not consider that lower patient copayments for ICS alone would affect their prescribing. Conclusion The results suggest that financial incentives, such as lower patient copayments, would be unlikely to encourage GPs to preferentially prescribe ICS alone, unless accompanied by other strategies, including evidence for clinical effectiveness. GPs should be encouraged to discuss cost barriers to treatment with patients when considering treatment choices. What is known about the topic? Australian guidelines recommend that most patients with asthma should be treated with low-dose ICS alone to minimise symptom burden and risk of flare ups. However, most patients in Australian general practice are instead prescribed combination ICS-LABA preventers, which are indicated if asthma remains uncontrolled despite treatment with ICS alone. It is not known whether GPs are aware that the combination preventers have a higher patient copayment and a higher cost to government. What does this paper add? This qualitative study found that GPs favoured combination ICS-LABA inhalers over ICS alone because they perceived ICS-LABA combinations to have greater effectiveness and promote patient adherence. This aligned with GPs' views that their primary responsibility was patient care rather than generating cost savings for government. However, it emerged that GPs rarely discussed medicine costs with patients, had low knowledge of medicine costs to patients and the health system and reported that patients rarely volunteered cost concerns. GPs believed that lower patient copayments for asthma preventer medicines would have little effect on their prescribing practices. What are the implications for practitioners? This study suggests that, when considering asthma treatment choices, GPs should empathically explore with the patient whether cost-related medication underuse is an issue, and should be aware of the option of lower out-of-pocket costs with guideline-recommended ICS alone treatment. Policy makers must be aware that differential patient copayments for ICS preventer medicines are unlikely to act as an incentive for GPs to preferentially prescribe ICS alone preventers, unless the position of these preventers in guidelines and evidence for their clinical effectiveness are also reiterated.