The PARTNER cluster RCT

The PARTNER study is an investigator-initiated pragmatic RCT. A detailed explanation of the background, theoretical development and protocol for the broader PARTNER study (2016/959) has been described previously,7 11 and the trial prospectively registered with the Australia New Zealand Clinical Trials Registry (ACTRN12617001595303). The process and feasibility evaluations will be reported in accordance with the Standards for Reporting Implementation Studies, and the Consolidated Criteria for Reporting Qualitative Research guidelines.12 13

Briefly, the RCT is comparing the new PARTNER model of service delivery to usual care.7 We will recruit 44 general practices and 572 patients with knee OA in urban and regional practices in Victoria and New South Wales, Australia. The patients will be 45 years of age or older, and have had knee pain (≥4/10) for a minimum of 3 months. The model has interventions for both the person with OA, and their GP. The GP intervention will provide professional development and training opportunities on the most current conservative, non-surgical management options available for OA, as recommended by national and international clinical guidelines.3–5 This will include audit/feedback activities, online learning modules and the Integrated Care electronic desktop IT support tool (previously named cdmNET). All GPs in the study regardless of group allocation will be asked to provide an initial evidence-based consultation for their participating patients. If allocated to the intervention arm, patients will be referred to the PARTNER CST. The CST is a centralised, multidisciplinary team of health professionals trained in best-practice OA management, and with skills in health behaviour change. The CST will support patient participants to manage their knee OA for a period of 12 months. The CST will provide the patients with education, advice and ongoing support for behaviour change on the key OA treatments, including leg strengthening exercises, general physical activity, weight loss and appropriate use of pain medications as agreed with the patient. Patients with a body mass index ≥27 will have the option of completing the Commonwealth Scientific and Industrial Research Organisation’s online ‘Total Wellbeing Diet’ (TWD) program.14 15 The TWD program is based on an evidence-based, structured, nutritionally balanced eating plan designed to be delivered as part of a balanced lifestyle programme.16 Patient participants may also be directed to one or more secondary interventions or additional healthcare services if they meet the referral criteria and/or have identified it as a personal priority. These treatment options may include online cognitive behavioural therapy (CBT) programme for mood, pain coping and sleep or referrals to healthcare professionals (eg, physiotherapists or dieticians) for face-to-face sessions. The primary outcomes of the PARTNER study are change in self-reported pain and function at 12 months. We will also assess a range of secondary patient-level outcomes at 6 and 12 months, and including the cost-effectiveness of the model.7

Patient and public involvement

One of the strengths of this process and feasibility evaluation is that it has been incorporated into the overall study design from conception. Both the main protocol and this evaluation and feasibility subprotocol are underpinned by existing theoretical frameworks.17–21 It has built on considerable background work undertaken by our team, and with input from a broad range of stakeholders, GPs and consumers who participated in our five working groups: (1) scientific methods, (2) data, (3) GP model of service delivery, (4) consumer engagement and (5) policy and marketing. Each working group was chaired by an appropriate representative from either an industry partner, consumer group or other stakeholder organisation. This process and feasibility evaluation protocol has had further input from colleagues with expertise in implementing and assessing health interventions, and its content has evolved after findings from our pilot work. We send 6 monthly updates on the study’s progress to our stakeholders and participants via an online newsletter.

Theoretical frameworks for the process evaluation

Figure 1 outlines the PARTNER logic model, which summarises the key questions, target behaviours, interventions, mediators and outcomes for both GPs and patients recruited to the study. The development of the model used Wagner’s theoretical framework for the management of chronic disease,17 the Behaviour Change Wheel and the Theoretical Domains Framework18 to identify key intervention components and propose a causal pathway between the study intervention and the main outcomes.

Our methods for the process and feasibility evaluations are based on the recommendations from the UK Medical Research Council framework for undertaking a process evaluation of complex interventions.19 The RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework has further guided the development of our evaluation questions.20 21 RE-AIM is recommended by the Osteoarthritis Research Society International for conducting implementation trials on OA.9 RE-AIM emphases the need to look into the proportion and representativeness of the participants’ involved in the trial, the impact of the intervention, the fidelity and dose of the implementation and identify issues impacting on long-term scaling of the model. It covers five domains, briefly:

• Reach: did the intervention reach who we intended?

• Effectiveness: was the intervention effective and cost-effective? (this question is primarily addressed by the RCT)7

• Adoption: who do we need to target to develop institutional support for the intervention? Did the practices recruited to our study adopt the changes at an organisational level, how representative were these sites compared with other Australian settings and what needs to be undertaken to have it adopted more widely? Will actual change in the way OA is managed in primary care be achievable with our model, and how well do the end users (clinicians, patients and other service providers) accept the intervention and processes?9

• Implementation: was the intervention delivered correctly and consistently (fidelity) as intended at the trial outset?

• Maintenance: can the intervention be delivered sustainably in different healthcare contexts and more broadly?

Data sources for the PARTNER study

We will use a mixed-methods approach that uses both quantitative and qualitative methods to capture process data for analysis (table 1, figure 1), all of which involve informed consent and have been approved by an ethics committee. Detailed descriptions of the quantitative data collection instruments and analysis have been described previously in the main protocol,7 with details relevant to this protocol outlined below. The type and timing of data collected to address each aim of the process evaluation, including the details of the qualitative data collection are described in the following sections. Figure 2 illustrates the integration of the process and feasibility evaluations with the main RCT. Briefly, the data collection methods and time points relevant to these evaluations include:

1. Study administration records: include participant tracking, screening, training, withdrawal and serious adverse event logs; and training logs for the GPs, CST and other trial staff. Data are collected for the duration of the trial.

2. Electronic survey data from patients and GP surveys. GPs complete surveys at baseline and after the study team has confirmed all their patients have attended their first GP consultation. Patients complete surveys at baseline, post GP visit, 3, 6 and 12 months.

3. Electronic consultation detailed records of each of the CSTs’ consultations with the intervention patients over the 12-month period.

4. Service provider records will be collected from external providers delivering the weight-loss intervention, and the online CBT programme offered to the intervention group (ie, painTrainer and ThisWayUp).

5. Recorded consultation phone calls between the patient and the CST: all patient consultations for the duration of the patient’s involvement with the CST will be audio-recorded. For the first 18 weeks patients will be contacted once a fortnight on average (nine calls), and then monthly for the next 6 months (six calls). The actual number and timing of these calls will be agreed between the patient and the CST.

6. Semistructured qualitative interviews: these will be undertaken with a selection of GPs, patients and the CST personnel. GP interviews will be undertaken after all their enrolled patients have had their initial GP visit. Patient interviews will be undertaken after they have completed their 12-month survey. The CST interviews will be undertaken after all patients have finished their last consultation.

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Figure 2

Indicative timing of the data collection processes for GPs and patients. This schematic illustrates the integration of the process and feasibility evaluations with the main RCT. Open boxes are quantitative data collection, filled boxes are qualitative data (interviews or phone call recordings). The patient intervention is for 12 months. *Data are collected for GPs in the intervention group only. CST, Care Support Team; GPs, general practitioners; Pt, patients; Q, online survey questionnaires.

Quantitative data analysis to address the aims of the process evaluation

We will use a wide selection of the quantitative data to explain the study’s effectiveness results in terms of fidelity and engagement with the intervention, particularly around the consistency of the study’s implementation as per the primary protocol (figure 1) and the trial procedures manuals (Aim 1.1). This will include the study administration records, the electronic survey data collected from both patients and GPs, the electronic consultation records from the CST and any changes required to the protocol over the duration of the study. For the GPs in the intervention group, we will also examine how many completed the required professional development training modules, the optional capacity building training modules and the number of intervention patients who were ultimately referred to the CST with OA (ie, if there were any patients who were not diagnosed with OA). We will further examine if patients have reported receiving information on, or discussed with their GP, any of the four key topics (OA education, physical activity, muscle strengthening and weight loss), and whether OA management plans were prepared for each patient. To determine what usual care entailed for our control cohort (Aim 1.2), we will analyse the electronic survey data from both the GPs and patients, including if there were any unanticipated treatments prescribed or activities undertaken that may need to be addressed in a future roll-out of the model.

For the CST, we will analyse the study records and survey data to determine the amount of time spent with each patient, and whether the key interventions or secondary interventions (mood, pain and sleep management) were discussed in the consultations. Electronic patient survey data, the CST electronic consultation records and a selection of the recorded patient consultations will be further examined to establish what issues or topics were typically discussed during the consultations (Aim 1.3), including any additional issues that may need to be incorporated into the intervention long-term (also see the Qualitative data collection methods section). We will examine the nature of the support and advice provided to patients by both the GPs and the CST, map the frequency and accuracy of each treatment component to the international care standards for OA (OA Quality Indicators)22 23 and identify any conflicting advice that may need to be addressed when designing future training or educational materials.

We will also use the quantitative datasets to determine the feasibility and acceptability of having the model adopted broadly in an Australian healthcare context. We will explore healthcare providers’ and patients’ experience of the intervention and its perceived impact (Aim 2.2 and 2.3) and examine any issues that arose during the trial that would affect broader implementation (Aim 2.1). We will undertake an audit of the inclusion and exclusion criteria, and the screening logs for general practices, GPs and patients to identify any reasons for not choosing to participate and for any loss to follow-up. These data will be compared with the general population to give an indication of the representativeness and generalisability of the results to other patients, healthcare service providers and other Australian states/territories. Collectively, these data will provide some insight into the generalisability of the efficacy results, and any amendments that may need to be incorporated into the current model. This information will also be used to determine the cost effectiveness of the PARTNER model compared with usual care.7

Qualitative data collection

In addition to the quantitative datasets, we will collect and analyse qualitative data that will address many of the process and feasibility aims of this study (see table 1). First, we will analyse a sample of the telephone interactions that have been recorded between the patients in the intervention group and the CST. After the final patient is recruited, we will purposively select 20 patients to conduct a detailed analysis of their telephone consultations. We aim to ensure maximum heterogeneity of sampling, based on clinical and demographic characteristics, and gain the perspectives of patients and GPs in both urban and regional/rural general practices and smaller versus larger practices. To capture the change in the perspectives over the 12 months, three phone calls will be analysed per person, covering the initial consultation—one randomly selected call from the first 18 weeks of the intervention (intensive phase), and one randomly selected call from the last 6 months of the CST intervention (maintenance phase). The phone recordings will be transcribed and analysed using predesigned checklists. The first checklist will be used to determine how much time is spent on the key priority topics and the targeted secondary interventions (mood, pain coping and sleep; figure 1). A tally will be made of the different types of issues discussed during the calls and the type of information given (Aim 1.1, 1.3, 1.5). We will also assess if the components of care delivered by the CST are accompanied by the appropriate behaviour change methods to support self-management as per the PARTNER protocol. We will use a checklist based on the methodology developed by our partner ‘HealthChange Australia’ to train the CST in behaviour change techniques to examine the fidelity of the delivery of the behaviour change component of the intervention. This analysis will be undertaken by a member of the study team involved with the intervention, and an independent person not involved with running the trial. Data will be compiled and compared, and if required adjudicated by a third party.

Second, we will undertake semistructured qualitative interviews with a selection of patients, GPs and the CST. These results will also address a range of the aims of these process and feasibility evaluations (table 1), and a primary focus on contextual factors affecting delivery and implementation, and thus those that influence rolling-out and long-term sustainability of the PARTNER model (Aims 2.1, 2.2 and 2.3). The interviews will be conducted over the telephone or face-to-face, by dedicated researcher/s not involved with delivering the RCT and with experience in qualitative data collection. Our multidisciplinary research team will develop the semistructured interviews to explore issues around patients’, GPs’ and CST personnel’s perspectives on how, why and for whom the interventions did or did not work, positive and negative (unintentional) outcomes, possible barriers and facilitators to rolling-out the intervention, including any adoption considerations at the setting or organisational (meso) level, if the new model of care is valued by the users, and if they found any aspects burdensome (ie, the number of appointments for patients or the amount of training for GPs).

Similar to the selection of recorded CST phone consultations, we will use purposive sampling to gain perspectives from patients and GPs from different regional and practice-related contexts. This will include around 30 patients (15 control and 15 intervention) and 14 GPs (7 from each group), or until redundancy is observed. We will also interview all willing members of the CST. Patients will be different from those used in the examination of the telephone consultations with the CST and will have finished their involvement with the trial. The interviews will be conducted one-to-one and will take approximately 1 hour each. Participants will be consented by the interviewer over the phone. The interviews will follow an interview guide which outlines the broad discussion topics. The draft interview schedule will be tested with patients and healthcare professional volunteers prior to use.