Maximising the potential of type 2 diabetes remission: scale up and sustainability considerations from the DiRECT-Aus implementation trial
Nilakshi Gunatillaka
A , Jenny Advocat A , Lauren Ball B , Terry Haines A , Cylie Williams A , Tze Lin Chai A , Mitchell Bowden C , Melissa Savaglio C , Kate Gudorf D E Elizabeth Sturgiss A *
A
B
C
D
E
Abstract
Approximately 500 million people worldwide live with type 2 diabetes mellitus. The UK’s ‘Diabetes Remission Clinical Trial’ (DiRECT) is a potential novel method for care. An Australian trial of DiRECT (DiRECT-Aus) showed that 56% of participants achieved diabetes remission at 12 months. We explored the experiences of patients, clinicians and trial partners involved in DiRECT-Aus to ascertain the acceptability and feasibility of DiRECT-Aus, as well as factors influencing implementation, to inform recommendations for sustainable scale up into mainstream primary care.
This qualitative implementation research conducted within a constructivist paradigm involved semi-structured interviews with key stakeholders. Data analysis followed an inductive thematic approach, informed by the Consolidated Framework for Implementation Research.
Patients (n = 14), general practitioners (n = 3), practice nurses (n = 6), dietitians (n = 7) and DiRECT-Aus trial partners (n = 5) were interviewed. We identified four core components of DiRECT-Aus that are essential for implementation and scale up. They were: (1) access to very low-energy diet products; (2) high frequency of contact with the dietitian; (3) dietitian’s clinical knowledge and patient-centred practice; and (4) absence of financial costs to patients. Several additional factors that could support implementation and suggested funding models are described.
This study concludes that DiRECT-Aus was acceptable and feasible to patients and clinicians.
Keywords: chronic disease, general practice, implementation research, medical nutrition therapy, primary care, qualitative, type 2 diabetes, very low energy diet.
Introduction
Type 2 diabetes mellitus (T2DM) is a major contributor to illness and disability (Sun et al. 2022). Over 1 million Australian adults live with T2DM, and the condition contributes to 50,000 hospitalisations and 16,000 deaths each year (AIHW 2023). The management of T2DM has focused on controlling glycated haemoglobin, preventing complications and treating underlying metabolic dysfunction (Galindo et al. 2023). There has been a more recent focus on remission, defined as not requiring diabetes medications for 2 months and glycated haemoglobin of <6.5% (48 mmol/mol; Lean et al. 2018; Lean et al. 2019). In addition to improved patient outcomes, remission has the potential to deliver broader economic benefits too (Menon et al. 2021). It is unsurprising then that T2DM remission is a strategic national priority for the Australian Government (Australian Government Department of Health and Aged Care 2021; Australian Government Department of Health and Aged Care 2022). As the prevalence of T2DM grows (AIHW 2022), so does the imperative to find novel approaches to support patients towards diabetes remission.
One potential approach is the UK ‘Diabetes Remission Clinical Trial’ (DiRECT; Lean et al. 2018), which involves a 12-month nurse- or dietitian-led weight management program. The program begins with total meal replacement using very low-energy diet (VLED) products for 13–20 weeks, followed by structured food re-introduction over 2–8 weeks and long-term weight loss maintenance support from a multidisciplinary primary care team for the remainder of the 12-month period. The resulting reductions in bodyweight and body fat may contribute to diabetes remission. The UK study found that nearly half (n = 68, 46%) the participants were in remission at 12 months (Lean et al. 2018), with one-third (n = 53, 36%) maintaining remission after 2 years (Lean et al. 2019).
Several studies have evaluated the translatability of this intervention to the Australian primary care setting (Hocking et al. 2024; Chimoriya et al. 2024a, 2024b). Diabetes Australia – NSW and ACT (formerly Diabetes NSW and ACT) partnered with five primary health networks (PHNs) and the University of Sydney to replicate the DiRECT trial in parts of New South Wales (NSW; ACTRN12620001129976; Hocking et al. 2024). This trial, termed DiRECT-Aus, and its intervention protocol is presented below (Table 1). In DiRECT-Aus, 56% of patient participants achieved diabetes remission at 12 months, with a mean adjusted reduction in bodyweight of 8.1% (Hocking et al. 2024). This result is comparable to other studies of the DiRECT program (Lean et al. 2018; Chimoriya et al. 2024b).
| Brief overview and duration | Detailed description of activities | ||
|---|---|---|---|
| Phase 1 | 13 weeks of total diet replacement (maximum duration 20 weeks) | Total meal replacement with very low-energy diet (VLED) products (Optifast, Nestle Health Science) with dosage based on patient’s body mass index (BMI) at baseline. If BMI was ≤40 kg/m2, patients were prescribed three meal replacement products per day equivalent to 3400 kJ or 800 kcal. If BMI was >40 kg/m2, participants were prescribed four meal replacement products per day, equivalent to 4000 kJ/950 kcal. Patients were also encouraged to consume at least 2 L of low-energy fluids, two cups of low-starch vegetables and one teaspoon of oil per day. Total dietary composition was 59% carbohydrate, 26% protein, 13% fat and 2% fibre. Psyllium husk fibre could be added to manage constipation if needed. Fortnightly dietitian consultations for monitoring, education and management. Ongoing support and monitoring from usual primary care team. Patients were encouraged to increase physical activity to 15,000 steps/day and maintain this level of physical activity throughout the trial period. | |
| Phase 2 | 6 weeks of structured food reintroduction (minimum 2 weeks, maximum 8 weeks) | Dietitian led food re-introduction where meal replacements were gradually substituted with healthy, low-fat meals (~50% carbohydrate, ~26% protein, <30% fat) Fortnightly or monthly dietitian consultations. Ongoing support and monitoring from usual primary care team. | |
| Phase 3 | Consolidation and maintenance (Up to 24 weeks) | Monthly dietitian consultations to manage individual programs and prevent weight regain. Where weight gain occurred, patients were offered ‘rescue plans’ comprising of either a return to one meal replacement product per day for 4 weeks (2–4 kg weight gain) or total diet replacement for 4 weeks followed by up to 4 weeks of structured food re-introduction (>4 kg weight gain or diabetes re-emergence). Ongoing support and monitoring from usual primary care team. |
Existing qualitative studies on participant experiences of the DiRECT program offer valuable insights; however, small sample sizes and limited professional diversity may affect the generalisability of those findings (Chimoriya et al. 2024b). Although there have been calls to scale up both DiRECT and DiRECT-Aus, the trial conditions under which these programs were delivered cannot be replicated in mainstream primary care settings without substantial additional investment, which limits their potential for scale up. Our study sought to investigate if and how DiRECT could be incorporated into Australia’s existing primary care system and funding environment. We explored perspectives of multiple groups of stakeholders, including patients, healthcare workers and healthcare planners. We focused on the acceptability and feasibility of DiRECT-Aus, as well as factors influencing implementation based on an established framework. From this we make recommendations for scale up and sustainability that adds valuable new knowledge for policy makers, healthcare planners and clinicians considering making DiRECT available to patients with T2DM.
Methods
Study design
Our cross-sectional qualitative implementation study was conducted within a constructivist paradigm. It involved semi-structured interviews to explore the experiences of patients, clinicians (general practitioners (GPs), nurses and dietitians) and implementation partners in the DiRECT-Aus trial. A qualitative approach was chosen to complement an existing quantitative evaluation (Hocking et al. 2024) and offer insights that help explain those findings. The Consolidated Framework for Implementation Research (CFIR; Damschroder et al. 2022) was used to design interview questions to explore implementation factors across the inner and outer context within practices, as well as relationships with local primary health organisations, and national funding and policy environments. Data analysis followed an inductive thematic approach (Braun and Clarke 2012). Themes were then mapped to CFIR domains, and used to abstract the findings to inform policy and practice change.
Research setting
The DiRECT-Aus trial was conducted in general practices across NSW, Australia, between 2021 and 2022 (Hocking et al. 2024). Of 252 patients screened, 183 were eligible and 155 were included in the analysis. The outcomes of the trial were T2DM remission (defined as glycated haemoglobi <6.5% for at least 2 months and without glucose-lowering medication) and weight change. No cost-effectiveness studies were or will be conducted to the best of the authors’ knowledge. Our study included a subsample of these 155 patients (n = 14), plus dietitians (n = 7), primary care clinicians (n = 9) and trial partner organisation staff (n = 5).
Participant recruitment and screening
All patients, healthcare professionals and trial partner organisation staff currently or previously involved in DiRECT-Aus were eligible to participate. The research team did not contact potential participants directly, to preserve confidentiality. Instead, a staff member from Diabetes NSW and ACT (KG) who was coordinating the DiRECT-Aus study sent GPs, nurses, dietitians and trial partner staff recruitment materials. The Diabetes NSW and ACT staff member also sent patient recruitment materials to the study liaison at each practice with a request to forward them to all enrolled (including withdrawn) patients.
Interested participants from all groups were asked to complete a secure survey embedded in the recruitment email to indicate their interest in the study. Researchers then contacted interested participants to describe the study, obtain informed consent and conduct interviews.
Data collection and analysis
Interviews were conducted with participants between January and June 2022. The interview guides were tailored to each participant group and designed to explore implementation factors based on CFIR (Damschroder et al. 2022; Supplementary file). Researchers had no prior relationship with the participants. Clinician researchers (ES, TLC) were engaged to collect data from clinicians. An experienced researcher collected data from patients (NG). Interviews were 30–60 min in duration and conducted via telephone or videoconference per the participant’s preference. All interviews were audio-recorded and transcribed. Transcripts were analysed in NVivo version 20 (QSR International 2023). Inductive thematic analysis (Braun and Clarke 2012) was guided by CFIR (Damschroder et al. 2022). Transcripts from initial interviews were inductively coded. A coding tree was developed by coding early interviews. All members of the team used this coding tree to guide analysis of transcripts from subsequent interviews. Additional codes and subcodes were added by individual coders where needed. All transcripts were double coded by a team (NG, ES, TLC, MB, MS). The team met frequently to discuss coding and emergent themes. Following inductive coding, the team mapped identified themes to the CFIR domains of innovation, outer setting, inner setting, individual and implementation process. We sought to describe themes based on how essential participants felt these were for the success of the trial and any future scale up efforts. ‘Core components’ were those that participants considered essential to the success of DiRECT-Aus, whereas ‘adaptable components’ were those that participants believed contributed positively, but could be adapted based on funding, staffing and other contextual constraints. Data collection and analysis occurred simultaneously, with the analysis informing iterative data collection and discussions on the adequacy of the sample. Data collection ceased when all eligible and interested participants were interviewed. The analysis showed that we reached an understanding of the phenomenon of interest and thus had adequate data to answer our research questions.
Results
Participant characteristics
A total of 35 participants were interviewed for this study, including 14 patient participants (Table 2); 16 clinicians, including seven dietitians, six nurses and three GPs (Table 3); and five representatives of implementation partner organisations (Table 4). As the researchers were not directly involved in recruitment, response rates could not be calculated.
| Patient characteristics | Frequency | Percent | |
|---|---|---|---|
| Age | |||
| 45–54 years | 4 | 28.6 | |
| 55–64 years | 6 | 42.9 | |
| ≥65 years | 1 | 7.1 | |
| Missing | 3 | 21.4 | |
| Sex | |||
| Male | 8 | 57.1 | |
| Female | 5 | 35.7 | |
| Missing | 1 | 7.1 | |
| Residential postcode | |||
| Metropolitan | 8 | 57.1 | |
| Rural/regional | 5 | 35.7 | |
| Missing | 1 | 7.1 | |
| Cultural background | |||
| Australian | 6 | 42.9 | |
| Chinese | 1 | 7.1 | |
| Indigenous | 1 | 7.1 | |
| Indian | 1 | 7.1 | |
| Italian | 1 | 7.1 | |
| Missing | 4 | 28.6 | |
| Low-income household | |||
| Yes | 4 | 28.6 | |
| No | 7 | 50.0 | |
| Missing | 3 | 21.4 | |
| Stage of DiRECT-Aus trial participation | |||
| Completed | 9 | 64.2 | |
| Continuing | 3 | 21.4 | |
| Ceased | 1 | 7.1 | |
| Missing | 1 | 7.1 | |
| Weight loss as a result of trial participation | |||
| Yes | 11 | 78.5 | |
| No | 0 | 0 | |
| Missing | 3 | 21.4 | |
| Use of telehealth during trial | |||
| Yes | 11 | 78.5 | |
| No | 0 | 0 | |
| Missing | 3 | 21.4 | |
| Attendance at group sessions during trial | |||
| Yes | 6 | 42.9 | |
| No, not offered | 4 | 28.6 | |
| No, unavailable when offered | 1 | 7.1 | |
| Missing | 3 | 21.4 | |
| Clinician characteristics | Frequency | Percent | |
|---|---|---|---|
| Professional background | |||
| GP | 3 | 18.8 | |
| Practice nurse | 6 | 37.5 | |
| Dietitian | 7 | 43.8 | |
| Location of practice | |||
| Metropolitan | 10 | 62.5 | |
| Rural/regional | 6 | 37.5 | |
| Stage of DiRECT-Aus trial participation | |||
| Completed | 3 | 18.8 | |
| Continuing | 12 | 75.0 | |
| Ceased (early) | 1 | 6.3 | |
| Provision of services via telehealth during trial | |||
| Yes | 11 | 68.8 | |
| No | 5 | 31.3 | |
| Provision of group sessions during trial | |||
| Yes | 6 | 37.5 | |
| No | 10 | 62.5 | |
| Primary Health Network and other stakeholder characteristics | Frequency | Percent | |
|---|---|---|---|
| Age | |||
| 35–44 years | 1 | 20.0 | |
| 55–64 years | 2 | 40.0 | |
| Missing | 2 | 40.0 | |
| Sex | |||
| Male | 1 | 20.0 | |
| Female | 4 | 80.0 | |
| PHN catchment | |||
| Metropolitan | 2 | 40.0 | |
| Rural/regional | 2 | 40.0 | |
| Missing/not applicable | 1 | 20.0 | |
| Stage of DiRECT-Aus trial participation | |||
| Continuing | 2 | 40.0 | |
| Unsure | 1 | 20.0 | |
| Missing | 2 | 40.0 | |
Implementation factors
A total of 11 themes were identified and mapped to the domains described in CFIR. Five of the 11 themes were classified as core components, with the remaining six described as adaptable components. Each theme is described below, and any contrasting perspectives that emerged within and between participant groups are presented for each component.
Most participating patients reported initial weight loss from total diet replacement with VLED meal replacement products. Several reduced or stopped taking medications for their T2DM or other chronic diseases. These early positive impacts appeared to strengthen their resolve to continue with an otherwise challenging dietary intervention.
All of a sudden, I start the diet and like I say … 5 kg in what is it, 8 days. And then I kept losing on average well … another three kilos in a week. Three to four kilos every week after that. it just … just kept coming off. (Patient 14)
Almost all patients planned to use VLED meal replacement products to maintain weight loss. However, several patients reported experiencing side-effects, such as nausea, vomiting and lethargy. Others wanted access to a fuller range of meal replacement products to overcome monotony.
They should warn people (about) what happens when you first drop your carbohydrates. They call it … on the internet ‘keto flu’ … I had no energy; I couldn’t hardly move without puffing and panting. I thought I was going to fall over. (Patient 4)
Many participants felt that frequent contact with the same dietitian over an extended period of time (12 months) was important for building rapport and receiving support to persevere with challenging changes to their eating behaviours.
Even at Christmas time, I was fine. I spoke to the dietitian beforehand. You know, she gave me strategies … you can have a piece of pudding at Christmas, just don’t eat a massive, big slice with a plate of ice cream. (Patient 7)
It’s … very important like to have only one dietitian, and follow up with one dietitian, instead of like, you know, changing the dietitian in between, because the patient … is developing that relationship with the dietitian … then they lose the relationship again, and then they have to see the new dietitian. (Nurse 5)
The DiRECT-Aus trial offered participating patients free VLED products and 12 months of free dietetic consultations. Many participants considered this to be a key motivator for initial recruitment and subsequent retention.
But, you know, like, if it wasn’t paid for, I wouldn’t have been able to do it. Number one, because the stuff is so bloody expensive. (Patient 8)
Participants also spoke about how the no-cost nature of DiRECT-Aus increased equitable access to the program for people from rural communities and those with limited financial resources.
People being able to access the necessary shakes and things included in the trial because I mean, they’re very expensive for people in small rural communities to purchase … It was a huge benefit for them. Yeah, it was a huge cost saving there for people. (Implementation Partner (Primary Health Network) 1)
So, most of them (patients) don’t have money to pay for things like Optifast because it’s expensive … I think it’s a great opportunity for them to have something like (the DiRECT-Aus program). (Dietitian 1)
Group sessions were not regularly offered due to the COVID-19 pandemic, scheduling issues and patient preferences. Where group sessions were offered, some participants found them helpful for sharing experiences and learning from others.
There’s learning from each other and what the experience whether good or bad. I mean someone’s struggling … someone’s doing well. I think there’s just the sharing (of) information and experience. (Patient 11)
However, many others were reluctant to share their weight-related concerns for fear of judgement from their peers.
You know it’s one of those things that, it’s a very personal journey, you know, it’s a very personal thing that you go through and there’s not always something that you want to share with people you don’t know. (Patient 13)
Some participants viewed group sessions as an opportunity to help others adhere to DiRECT-Aus, which might have unintentionally elicited feelings of inadequacy among peers who felt they were less successful in the program.
Going through we had one group session through this trial. And talking to people you could tell, well, I could sort of read the ones that were going to succeed and the ones that weren’t just by talking to them, they just didn’t have the will. Like, they couldn’t give up alcohol, or they couldn’t give up (the) McDonald’s hamburger. (Patient 14)
The patient workbook comprised guidance for implementing the total diet replacement and food re-introduction phases (including recipes and menus), overall advice for lifestyle change, plus strategies for managing side-effects and triggers based on existing initiatives (Albright and Gregg 2013; NHMRC 2013). Participants generally found the workbook helpful, although a few dietitians thought their patients had difficulty using them. They suggested improving the workbook’s readability and adding sample meal plans in future.
I found the participant workbook really good and really easy to understand, and the participants did as well. (Dietitian 3)
The workbook is a little bit disjointed. It’s hard to follow. There’s no flow. (Dietitian 5)
PHN staff were generally enthusiastic about the DiRECT-Aus program. However, some had a limited understanding of general practice business models, such as the pressures of unused office space, and the clinical challenges of T2DM management, which may have affected implementation.
There were some practices that were very interested, but their business models were such that they charged room hire and things like that. So, a cost involved that, you know, wasn’t factored into the study. (Implementation Partner (Primary Health Network) 1)
General practice probably doesn’t have a lot of time to sit there and you know, have a dietitian sit with their patients and go through dietary options and I guess, healthy living. (Implementation Partner (Primary Health Network) 3)
Securing dietitians’ involvement in DiRECT-Aus was challenging. One remote site relied on practice nurses to take on the dietitian’s role.
We don’t have a dietitian here at <remote location> that could have run the trials. So, my colleague who left was asked if she was interested … and she was becoming a credentialed diabetes educator … so she said yes. And I have an interest in diabetes. So, I was happy to take over. (Dietitian 3 (practice nurse by profession))
Several dietitians expressed concerns about their ongoing business viability given the fee-for-service funding model. Dietitians proposed alternate funding models to support their involvement, such as salaried employment or Medicare Benefits Scheme (MBS)-subsidised consultations similar to the Eating Disorder Care Plan (Australian Government Department of Health and Aged Care 2019; Australian Government 2023).
My cash flow was then significantly impacted. I’ve got another role. Because I couldn’t continue financially. That wasn’t viable for me to continue. (Dietitian 4)
(F) or those (patients) who are eligible, there can be another type of care plan with 20 visits. Something like that, something like what we have for eating disorders. (Dietitian 7)
Most patients developed a strong therapeutic relationship with their dietitian during the trial. Dietitians were supportive of their patients’ progress, helped them stay motivated and held them accountable to their dietary intake and broader health goals.
The dietitian that I had she’s absolutely brilliant. … Without them, I probably wouldn’t be able to be successful in this program. (Patient 6)
So, I have some participants and they … explained they were about to withdraw from the study … but because I know about their background, medical history, I knew about their life to some extent. So, I could encourage them … to follow the diet and follow the trial. (Dietitian 7)
Patients spoke highly of their dietitian’s skill in providing personalised advice on food selection, portion sizes and healthy substitutions.
I’ve been singing the praises of dietitians, because since then, I sort of noticed so many people, friends of mine that are all overweight and they go and (say) ‘Oh, I know what I’m going to do, I’m … only going to eat fruit up till midday. And then after midday, I’m just gonna (sic) eat salad’ You know, they take so much time investigating stupid quick fixes and they don’t go and see a dietitian. So, I’m just like, just don’t worry. Just don’t try and fix this yourself. Just go and see a dietitian. That’s what I say. (Patient 5)
A nurse performing the dietitian’s role highlighted the difficulties they experienced in not having this nutrition knowledge to support patients, and their reliance on another dietitian not involved in the trial.
I just felt like I was behind the eight ball when I took over just because I didn’t have that (dietetic) qualification. Most of the time if I had a question I always rang (another dietitian involved in the trial) … and then I could ring the participant later. … Some of the participants had questions that were difficult from a diet point of view for me to answer. (Dietitian 3 (practice nurse by profession))
People who are highly motivated and with fewer work, study or caregiving responsibilities, and with more supportive families were more likely to be able to complete the program without bespoke support.
It was difficult for some of the families who some of the individuals who weren’t supported by their family … (a) patient actually said to me that her family wasn’t supportive of her doing the program. So, she found that very isolating, not having group support around her. (Nurse 2)
Ethnic communities where VLED meal replacement products are less common may find adopting DiRECT-Aus more difficult, indicating a need for greater adaptation to suit diverse diets.
In Chinese culture, for someone with a Chinese background to change the diet to a, you know, a supplement or shake … it’s a bit difficult. It’s usually, it’s because … they don’t like that kind of taste. I don’t know how to put it. So … the ones who adhere the most they were a little bit more westernised. The typical Chinese one, they find it pretty hard to adhere to that. (GP 3)
Most dietitians involved in the DiRECT-Aus trial were external to the general practice team, and relied on GPs, nurses and other practice staff to reach their full potential in their role. GPs were less involved than practice nurses in DiRECT-Aus, instead focusing on their usual clinical role. Practice nurses assisted with screening, recruitment, trial activities such as taking patient measurements, and in care coordination between the GP and dietitian. Some practice managers also assisted with patient recruitment, and some reception staff facilitated appointment booking. We found that strong collaboration between the dietitian and the nurse improved patient participants’ experiences of DiRECT-Aus.
I actually don’t have too much of a role. I was … those are, those were my regular patients, so I see them, really from time to time … I don’t have too much of a role in the trial itself. Like, every day, every time that the dietitian comes, they speak to me about the patients but that’s probably just that. (GP 3)
So, I was the practice nurse. And then when the patients were coming for the DiRECT study to see the dietitian. So, I was just helping the dietitian like, you know, checking their blood pressure, not their blood pressure only but the weight and the waist circumference, the dietitian used to do it. And also, if there was the contact between the dietitian and the patient and the doctor, so if there was any concern or any question regarding to the patient, I was the, I was in the middle to like contact between doctors to communicate between doctors and the dietitian. (Nurse 5)
Building on our findings, we proposed funding models that could support scale up of DiRECT-Aus (Table 5). We describe a fully funded model where DiRECT-Aus is made available at no cost to the patient, several partially funded models where patients bear some costs and a fully paid model where patients bear the full cost.
| Model | Cost | Access | |
|---|---|---|---|
| Fully subsidised as tested in current trial | No cost to patient | No cost is an incentive for participation | |
| Private funding by patient (VLED, dietitian time) | Full cost of VLED to patient Dietitian bills patient privately | Inaccessible to people on low incomes Could increase health inequity | |
| Partly funded through GP management plan (GPMP) | Full cost of VLED to patient GPMP only funds five allied health visits per year | Inaccessible to people on low incomes Potential to increase health inequity | |
| New MBS item for DiRECT-Aus | Precedent with MBS item for eating disorders with 20 sessions funded per year Many allied health providers may charge additional out-of-pocket fees to patients | Likely to be more accessible in line with the model tested in this trial Unlikely to have VLED funded in an MBS item and so cost of VLED is still a barrier Out-of-pocket costs to patients still expected but likely to vary | |
| PBS funding of VLED | PBAC submission could be attempted for cost subsidy of VLED under the PBS | Likely to require some payment by the patient, similar to a prescription PBAC process is complicated and would require resourcing from an organisation for the submission | |
| Group sessions only to deliver the dietitian input | Full cost of VLED to patient Under certain conditions, patients with T2DM can access eight group sessions per year under MBS | Possible reduced access for patients who are working or have career responsibilities Barrier to access for people who are uncomfortable in a group setting |
PBAC, Pharmaceutical Benefits Advisory Committee; VLED, very low energy diet; MBS, Medicare Benefits Scheme; PBS, Pharmaceutical Benefits Scheme.
Discussion
DiRECT-Aus is acceptable and feasible to most patients and clinicians for diabetes remission within Australian primary care. Appropriate resourcing would be needed to ensure reliable access to VLED meal replacement products and ongoing support from a dietitian without any additional costs to the patient. Other factors that were essential to implementation were the dietitians’ expertise and professional knowledge, and their ability to develop a strong therapeutic relationship with their patients. We have also described supportive factors that can be adapted to context and funding constraints in this work. Future scale up efforts should consider how these factors influenced the DiRECT-Aus implementation and how DiRECT-Aus could complement existing programs for diabetes care.
Our findings are consistent with recent studies that show at least 12 visits are needed for effective weight management in primary care settings (Madigan et al. 2022). Both DiRECT-UK and DiRECT-Aus highlighted the importance of leveraging dietitians’ knowledge and experience of delivering dietetic interventions for the trial. Contrary to the UK study, however, our work suggests that other healthcare professionals, such as practice nurses, may find it challenging to deliver dietetic interventions, even when extensive support is offered (Rehackova et al. 2022a). Our findings on patient perspectives are also aligned with the UK’s DiRECT trial and another DiRECT pilot in Australia, which showed that rapid weight loss and improvements to diabetes markers motivated patients to adhere to the difficult total diet replacement program, and that being able to personalise the program could improve uptake and retention (Rehackova et al. 2022b; Chimoriya et al. 2024a). Our work adds to the evidence base by identifying personal characteristics of patients that may affect program adherence and completion, such as working status and family support, and highlights adaptations that may be needed for the DiRECT-Aus program to be more acceptable to people from diverse backgrounds.
The principal consideration for sustainable scale up is funding to support dietitian involvement and minimisation of costs for patients. Although others have found that patients are willing to bear some of the costs of this program (Chimoriya et al. 2024a), there are significant equity considerations, as it is patients from lower socioeconomic backgrounds who are disproportionately affected by T2DM and are least able to pay for programs, such as DiRECT-Aus. We have shown the impact different funding models may have on equity and reach (Table 5). Any changes from the fully funded DiRECT-Aus trial that creates a cost to patients would put the success of the program and subsequent likelihood of remission at risk.
The current fee-for-service model for private allied health in Australia is not conducive to scale up of DiRECT-Aus. There could be an opportunity to advocate for changes to the MBS to greatly subsidise dietitian involvement and Pharmaceutical Benefits Scheme for VLED meal replacement products as part of future scale up efforts. The current MBS funding model for patients with eating disorders provides a precedent where a specific MBS item number has been used to increase allied health access (in the case of eating disorders, 20 dietitian visits and 40 psychology visits over a 12-month period; Australian Government 2023). However, even with MBS support, it is likely that allied health providers would need to charge additional payments to the Medicare rebate given that a recent Grattan Institute report stated that only 56% of allied health services were bulk-billed with an average AUD55 patient co-payment per consultation (Stobart and Meehan 2022). Similarly, a recent decision to recognise VLED meal replacement products as suitable for special medical purposes (Food Standard Australia and New Zealand 2022) supports an application to offer these products through the Pharmaceutical Benefits Scheme.
Any attempt to secure MBS or Pharmaceutical Benefits Scheme coverage is likely to be resource intensive, and require a coalition of organisations to lead the advocacy to the Department of Health and Aged Care. Therefore, creative solutions may be needed to scale up DiRECT-Aus in the shorter term following a horizontal scaling up model. For example, PHNs may allocate flexible funding towards local implementation of DiRECT-Aus. There may be a larger role for a consortium to advocate for a change in the national PHN performance and quality framework that is set by the federal Department of Health and Aged Care (Australian Government Department of Health 2018). The policy environment may be more conducive to change than previously, given that diabetes remission has been identified as a strategic national focus (Australian Government Department of Health and Aged Care 2021).
Limitations
Our findings may be influenced by participant bias, where patients who had a negative experience of the trial (including those who withdrew) chose not to participate in this study. Our inclusion of clinicians may have mitigated this effect to some extent, as they were able to provide insights into negative patient experiences. In addition, this work reflects on the implementation of DiRECT-Aus under trial conditions; therefore, it may have different outcomes in real-world primary care settings. We acknowledge that a cost-effectiveness analysis was not conducted within the original trial, and one may be required to further validate our findings. To the authors’ knowledge, no cost-effectiveness studies are underway or planned.
Conclusion
DiRECT-Aus is an acceptable and feasible approach to diabetes remission in Australian primary care settings, and could be offered to people living with T2DM as one of a suite of effective programs for diabetes care. Although DiRECT-Aus has the potential to change long-term health outcomes for adults living with obesity, an increase in the funding available via federal support schemes is necessary to ensure appropriate support from dietitians and availability of VLED products.
Data availability
The data that support the findings of this study are not available, as participants did not give written consent for secondary research.
Conflicts of interest
ES is an Editor-in-Chief of Australian Journal of Primary Health. To mitigate this potential conflict of interest they had no editor-level access to this manuscript during peer review. ES reports that financial support was provided by Diabetes Australia, Sydney North Health Network, Western Sydney Primary Health Network, Healthy North Coast, Western New South Wales Primary Health Network and Southwestern Sydney Primary Health Network for this work. LB holds board membership of Dietitians Association of Australia. KG was employed by Diabetes Australia at the time of this project and is currently employed by Western Sydney Primary Health Network. The other authors declare that they have no conflicts of interest.
Declaration of funding
This Implementation trial was funded by Diabetes Australia, Sydney North Health Network, Western Sydney Primary Health Network, Healthy North Coast (North Coast PHN), Western NSW Primary Health Network and Southwestern Sydney PHN. The DiRECT-Aus trial was also funded by the organisations listed above. VLED products (Optifast) were supplied to trial participants by the manufacturer, Nestle Australia.
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