Process evaluation of a practice nurse-led smoking cessation trial in Australian general practice: views of general practitioners and practice nurses.

BACKGROUND: Support in primary care can assist smokers to quit successfully, but there are barriers to general practitioners (GPs) providing this support routinely. Practice nurses (PNs) may be able to effectively take on this role. OBJECTIVES: The aim of this study was to perform a process evaluation of a PN-led smoking cessation intervention being tested in a randomized controlled trial in Australian general practice. METHODS: Process evaluation was conducted by means of semi-structured telephone interviews with GPs and PNs allocated in the intervention arm (Quit with PN) of the Quit in General Practice trial. Interviews focussed on nurse training, content and implementation of the intervention. RESULTS: Twenty-two PNs and 15 GPs participated in the interviews. The Quit with PN intervention was viewed positively. Most PNs were satisfied with the training and the materials provided. Some challenges in managing patient data and follow-up were identified. CONCLUSION: The Quit with PN intervention was acceptable to participating PNs and GPs. Issues to be addressed in the planning and wider implementation of future trials of nurse-led intervention in general practice include providing ongoing mentoring support, integration into practice management systems and strategies to promote greater collaboration in GPs and PN teams in general practice. The ongoing feasibility of the intervention was impacted by the funding model supporting PN employment and the competing demands on the PNs time.

Quit in general practice: a cluster randomized trial of enhanced in-practice support for smoking cessation.

OBJECTIVES: To evaluate the uptake and effectiveness of tailored smoking cessation support, provided primarily by the practice nurse (PN), and compare this to other forms of cessation support. METHODS: Three arm cluster randomized controlled trial conducted in 101 general practices in Sydney and Melbourne involving 2390 smokers. The Quit with PN intervention was compared to Quitline referral and a usual care control group. Smoking cessation pharmacotherapy was recommended to all groups. Outcomes were assessed by self-report at 3- and 12-month follow-up. Uptake of the interventions is also reported. RESULTS: The three groups were similar at baseline. Follow-up at 12 months was 82%. The sustained and point prevalence abstinence rates, respectively, at 3 months by group were: PN intervention 13.1% and 16.3%; Quitline referral 10.8% and 14.2%; Usual GP care 11.4% and 15.0%. At 12 months, the rates were: PN intervention 5.4% and 17.1%; Quitline referral 4.4% and 18.8%; Usual GP care 2.9% and 16.4%. Only 43% of patients in the PN intervention group attended to see the nurse. Multilevel regression analysis showed no effect of the intervention overall, but patients who received partial or complete PN support were more likely to report sustained abstinence [partial support odds ratio (OR) 2.27; complete support OR 5.34]. CONCLUSION: The results show no difference by group on intention to treat analysis. Those patients who received more intensive PN intervention were more likely to quit. This may have been related to patient motivation or an effect of PN led cessation support.

Stepping up: a nurse-led model of care for insulin initiation for people with type 2 diabetes.

BACKGROUND: Most people with type 2 diabetes (T2D) have glycaemic levels outside of target. Insulin is effective in improving glycaemia and most people with T2D eventually need this. Despite this, transition to insulin therapy is often delayed in primary care. OBJECTIVE: To develop a model of care (Stepping Up) for insulin initiation in routine diabetes care in Australian general practice. To evaluate the model for feasibility of integration within routine general practice care. METHODS: Drawing on qualitative work and normalisation process theory, we developed a model of care that included clarification of roles, in-practice systems and simple clinical tools. The model was introduced in an educational and practice system change intervention for general practitioners (GPs) and practice nurses (PNs). Five practices (seven GPs and five PNs) and 18 patients formed the feasibility study. Evaluation at 3 and 12 months explored experiences of GPs, PNs and patients. RESULTS: Fourteen patients commenced insulin, with average HbA1c falling from 8.4% (68.3 mmol/mol) to 7.5% (58.5 mmol/mol) at 3 months. Qualitative evaluation highlighted how the model of care supported integration of the technical work of insulin initiation within ongoing generalist GP care. Ensuring peer support for patients and issues of clinical accountability and flexibility, managing time and resources were highlighted as important. CONCLUSIONS: The Stepping Up model allowed technical care to be embedded within generalist whole-person care, supported clinicians and practice system to overcome clinical inertia and supported patients to make the timely transition to insulin. Testing of the model's effectiveness is now underway.

An exploratory trial of insulin initiation and titration among patients with type 2 diabetes in the primary care setting with retrospective continuous glucose monitoring as an adjunct: INITIATION study protocol.

BACKGROUND: Insulin initiation and titration in primary care is necessary to respond to the growing epidemic of type 2 diabetes (T2D). The INITIATION study aims to evaluate the impact of implementing a new model of care with Primary Care Physician and Practice Nurse (PN) teams supported by a Credentialed Diabetes Educator-Registered Nurse (CDE-RN) and endocrinologist in initiating and titrating basal and prandial insulin for T2D patients in the Australian healthcare system over 24 weeks. This study also explores the feasibility and efficacy of retrospective continuous glucose monitoring (r-CGM) in comparison with self-monitoring of blood glucose (SMBG) among people with T2D in primary care. METHODS/DESIGN: The study employs a before and after design with a nested exploratory trial of SMBG and r-CGM. A total of 102 insulin naïve T2D patients with a glycated haemoglobin (HbA1c) level of >7.5% in the previous 6 months while treated with maximal oral therapy will be recruited and screened from 22 primary care practices in Melbourne, Australia. All patients will be commenced on a basal insulin regimen following randomization into one of the two blood glucose monitoring arms, with intensification to a "basal plus" regimen if required. The outcomes of the new model of care will be benchmarked with data collected over the same period from a specialist setting in Melbourne, Australia. DISCUSSION: This article describes the study protocol and insulin treatment algorithm employed in the first study to explore r-CGM use among T2D in primary care. Findings from the INITIATION study will inform development of a larger randomized controlled trial. TRIAL REGISTRATION: ACTRN12610000797077.

An exploratory trial of basal and prandial insulin initiation and titration for type 2 diabetes in primary care with adjunct retrospective continuous glucose monitoring: INITIATION study.

AIMS: To evaluate basal and prandial insulin initiation and titration in people with type 2 diabetes mellitus (T2DM) in primary care and to explore the feasibility of retrospective-continuous glucose monitoring (r-CGM) in guiding insulin dosing. The new model of care features General Practitioners (GPs) and Practice Nurses (PNs) working in an expanded role, with Credentialed Diabetes Educator - Registered Nurse (CDE-RN) support. METHODS: Insulin-naïve T2DM patients (HbA1c >7.5% [>58 mmol/mol] despite maximal oral therapy) from 22 general practices in Victoria, Australia commenced insulin glargine, with glulisine added as required. Each was randomised to receive r-CGM or self-monitoring of blood glucose (SMBG). Glycaemic control (HbA1c) was benchmarked against specialist ambulatory patients referred for insulin initiation. RESULTS: Ninety-two patients mean age (range) 59 (28-77) years; 40% female; mean (SD) diabetes duration 10.5 (6.1) years participated. HbA1c decreased from (median (IQR)) 9.9 (8.8, 11.2)%; 85 (73, 99) mmol/mol to 7.3 (6.9, 7.8)%; 56 (52, 62) mmol/mol at 24 weeks (p < 0.0001). Comparing r-CGM (n = 46) with SMBG (n = 42), there were no differences in major hypoglycaemia (p=0.17) or ΔHbA1c (p = 0.31). More r-CGM than SMBG participants commenced glulisine (26/48 vs. 7/44; p < 0.001). Results were comparable to 82 benchmark patients, with similar low rates of major hypoglycaemia (2/89 vs. 0/82; p = 0.17) and less loss to follow up in the INITIATION group (3/92 vs. 14/82; p = 0.002). CONCLUSIONS: Insulin initiation and titration for T2DM patients in primary care was safe and improved HbA1c with low rates of major hypoglycaemia. CDE-RNs were effective in a new consultant role. r-CGM use in primary care was feasible and enhanced post-prandial hyperglycaemia recognition. Trial registration ACTRN12610000797077.

Can primary care team-based transition to insulin improve outcomes in adults with type 2 diabetes: the stepping up to insulin cluster randomized controlled trial protocol.

BACKGROUND: Type 2 diabetes (T2D) brings significant human and healthcare costs. Its progressive nature means achieving normoglycaemia is increasingly difficult, yet critical to avoiding long term vascular complications. Nearly one-half of people with T2D have glycaemic levels out of target. Insulin is effective in achieving glycaemic targets, yet initiation of insulin is often delayed, particularly in primary care. Given limited access to specialist resources and the size of the diabetes epidemic, primary care is where insulin initiation must become part of routine practice. This would also support integrated holistic care for people with diabetes. Our Stepping Up Program is based on a general practitioner (GP) and practice nurse (PN) model of care supported appropriately by endocrinologists and credentialed diabetes educator-registered nurses. Pilot work suggests the model facilitates integration of the technical work of insulin initiation within ongoing generalist care. METHODS: This protocol is for a cluster randomized controlled trial to examine the effectiveness of the Stepping Up Program to enhance the role of the GP-PN team in initiating insulin and improving glycaemic outcomes for people with T2D. 224 patients between the ages of 18 and 80 years with T2D, on two or more oral hypoglycaemic agents and with an HbA1c ≥7.5% in the last six months will be recruited from 74 general practices. The unit of randomization is the practice.Primary outcome is change in glycated haemoglobin HbA1c (measured as a continuous variable). We hypothesize that the intervention arm will achieve an absolute HbA1c mean difference of 0.5% lower than control group at 12 months follow up. Secondary outcomes include the number of participants who successfully transfer to insulin and the proportion who achieve HbA1c measurement of <7.0%. We will also collect data on patient psychosocial outcomes and healthcare utilization and costs. DISCUSSION: The study is a pragmatic translational study with important potential implications for people with T2D, healthcare professionals and funders of healthcare though making better use of scarce healthcare resources, improving timely access to therapy that can improve disease outcomes. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12612001028897.

Effectiveness of general practice based, practice nurse led telephone coaching on glycaemic control of type 2 diabetes: the Patient Engagement and Coaching for Health (PEACH) pragmatic cluster randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness of goal focused telephone coaching by practice nurses in improving glycaemic control in patients with type 2 diabetes in Australia. DESIGN: Prospective, cluster randomised controlled trial, with general practices as the unit of randomisation. SETTING: General practices in Victoria, Australia. PARTICIPANTS: 59 of 69 general practices that agreed to participate recruited sufficient patients and were randomised. Of 829 patients with type 2 diabetes (glycated haemoglobin (HbA1c) >7.5% in the past 12 months) who were assessed for eligibility, 473 (236 from 30 intervention practices and 237 from 29 control practices) agreed to participate. INTERVENTION: Practice nurses from intervention practices received two days of training in a telephone coaching programme, which aimed to deliver eight telephone and one face to face coaching episodes per patient. MAIN OUTCOME MEASURES: The primary end point was mean absolute change in HbA1c between baseline and 18 months in the intervention group compared with the control group. RESULTS: The intervention and control patients were similar at baseline. None of the practices dropped out over the study period; however, patient attrition rates were 5% in each group (11/236 and 11/237 in the intervention and control group, respectively). The median number of coaching sessions received by the 236 intervention patients was 3 (interquartile range 1-5), of which 25% (58/236) did not receive any coaching sessions. At 18 months' follow-up the effect on glycaemic control did not differ significantly (mean difference 0.02, 95% confidence interval -0.20 to 0.24, P=0.84) between the intervention and control groups, adjusted for HbA1c measured at baseline and the clustering. Other biochemical and clinical outcomes were similar in both groups. CONCLUSIONS: A practice nurse led telephone coaching intervention implemented in the real world primary care setting produced comparable outcomes to usual primary care in Australia. The addition of a goal focused coaching role onto the ongoing generalist role of a practice nurse without prescribing rights was found to be ineffective. TRIAL REGISTRATION: Current Controlled Trials ISRCTN50662837.

What does it cost to establish a practice-nurses-led clinical trial in general practice?

OBJECTIVE: To describe the processes and costs of engaging practice nurses (PNs) to establish a cluster randomised controlled trial (RCT) to study type 2 diabetes in general practice. DESIGN, SETTING AND PARTICIPANTS: Descriptive study of the processes and costs of engaging PNs from 59 general practices in Victoria that were participating in the Patient Engagement And Coaching for Health (PEACH) study, prior to practices being randomly assigned in the cluster RCT. MAIN OUTCOME MEASURES: Estimated direct research costs and personnel costs for establishing a general practice-based research project involving PNs (eg, costs for approaching Victorian Divisions of General Practice and the Australian Practice Nurses Association; practice and patient recruitment; research project establishment at general practices; and PNs' training, support and engagement during the study establishment period). RESULTS: The estimated cost to establish our PN-led general practice-based cluster RCT was over $110 000, with an average cost of $2000 per practice. Direct research and personnel costs were considerably higher than anticipated. Lack of research skills among PNs required intensive hands-on support from the research team. CONCLUSIONS: It is feasible to undertake a PN-led, general practice-based clinical trial in diabetes care. Future research funding needs to account for recruitment costs, including the need to build PN research capacity, and to overcome the inherent difficulties of engaging practices in complex intervention trials in primary care. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number Register ISRCTN50662837.