A new randomized controlled trial (RCT) has found that telehealth systems perform just as well as specialist diabetic foot clinics in healing people with diabetic foot ulcers (DFU). This RCT published in Diabetes Care by researchers from Norway found that patients managed in primary care with telehealth support from specialist DFU clinics had the same DFU healing times, patient satisfaction and even death rates compared to those managed in the DFU clinics alone. However, is that the fully story?
What do we know about telehealth in DFU?
Telehealth has long been thought to be beneficial to delivering DFU care to patients living long distances from DFU clinics. Yet, historically studies investigating telehealth systems in DFU care have varied considerably in methodology and findings. For example, a 2004 Australian study found a decrease in amputation rates in remote regions that accessed wound care specialist advice using telehealth. While a 2015 Danish RCT found similar DFU healing times and amputation rates when comparing the outcomes of DFU clinics only with telehealth services that replaced 2 out of every 3 DFU clinic consults. Conversely, a 2017 Australian study found using telehealth images alone to diagnose DFU characteristics had very low accuracy casting doubt on using telehealth alone without extensive support.
What did this new study do then?
First, this new non-inferiority cluster-RCT was designed to test if outcomes were similar rather than different between two groups, i.e. non-inferior. Second, it randomized 42 districts (and all patients within) in a region of Norway to receive the telehealth or control care, i.e. clusters. Third, it only included new patients with DFUs in those clusters. Fourth, it collected and reported the demographics, comorbidities, living arrangements, diabetes treatments and DFU locations in both groups.
Finally, the telehealth care group received a specialist DFU clinic consult every 6 weeks with care delivered in between times by community nurses under the telehealth supervision of the specialist DFU clinic. This telehealth supervision was defined as community nurses uploading DFU images and up-to-date medical record details to a web-based platform and then discussing the patient’s progress with the specialist DFU clinic at least weekly. The control care group received only specialist DFU clinic consults at least fortnightly. Both groups were then followed for 12 months to see who healed, had an amputation, died, how many consultations they had, and how they rated their experience.
What did they find?
They recruited 182 patients (94 telehealth; 88 control). The demographics, co-morbidities, diabetes treatments, living arrangements and DFU locations were pretty much the same between groups. After 12 months they found similar DFUs healed (80% telehealth; 76% control), healing times (3.4 months; 3.8 months), deaths (5%; 6%), consultations (8.7 per month; 8.4) and patient satisfaction (4.4/5; 4.4/5). And the telehealth group had significantly fewer amputations (6%; 15%). They also looked at subgroups of different DFU locations (on foot) and distance patients lived from the clinic and still found little difference, except people living >25km away had far fewer consultations.
However, whilst this study had many strengths – it was a good-quality RCT, recruited only patients with a new DFU and had improved data collection and intervention detail – it also had limitations. These included: i) even though they reported some DFU location data they did not report DFU classification data so we don’t know what types of DFUs were included ii) they didn’t report what DFU treatment was provided in each arm, such as how they debrided, offloaded, dressed DFUs; iii) they didn’t report the make-up of the specialist DFU clinic, such as what discipline/s were involved; and iv) they didn’t recruit the numbers of patients they originally calculated they needed, but, this should all somewhat be negated by the randomization and all outcomes descriptively favoring the telehealth intervention.
What does that all mean?
In conclusion, the authors accurately state there were “no differences regarding time to healing, death, and patient satisfaction as well as significant fewer amputations in the (telehealth) group suggest(ing) that use of (telehealth) technology can be an alternative and supplement to usual care”. But, they caution this by saying most of their patients anecdotally had superficial DFUs and these findings may apply more to less-severe DFU. On the flip side, they also suggest that anecdotally their outcomes were better when community nurses and the specialist DFU clinics became more familiar with the telehealth equipment and communicating with each other.
So in short, we now have two good quality RCTs (from Denmark 2015 and Norway 2018) finding patients with less-complex DFU receiving part of their care under telehealth supervision from specialist DFU clinics had similar outcomes as those only receiving care from specialist DFU clinics. This suggests if a DFU clinic decided to replace two thirds of its clinic consults with consults provided by community nurses under their clinic’s close telehealth supervision, that patient outcomes should not be affected.
However, it should also be noted, that nearly all these telehealth studies also show that to produce these outcomes, services need extensive integrated telehealth communications platforms consisting of a range of available images, up-to-date medical histories and regular communications between trained local clinicians and specialist DFU clinics. Thus, services cannot simply implement telehealth technology alone (such as sending a photo to an expert) and expect to have equivalent patient outcomes.
Overall, these findings show services willing to invest in the telehealth technology, training and integrated communication between clinicians on the ground and specialist DFD clinics should “virtually” heal DFUs. If that can happen in geographically small European nations, imagine what could happen in Australia. Specialist DFU clinics providing integrated telehealth support to local clinicians can only improve access to best practice care for the 50,000 Australians with diabetic foot disease and bring us one step closer to our goal of ending avoidable amputations in a generation.