Journal of Foot and Ankle Research
Neuropathy and vasculopathy can lead to costly and debilitating complications in people with diabetes. The purpose of this study was to evaluate, at an organizational level, uptake of practices included in a diabetic foot care clinical pathway and associated resources. This research focused on patients at low and moderate risk in Alberta, Canada between 2014 to 2019.
Serial surveys (2014, 2019) of practices related to screening and care of the feet of people with diabetes. Surveys were administered using a combination of targeted and snowball sampling in order to assess the impact of the clinical pathway first implemented in 2015. The pathway focused on screening, assessment and referral of patients from primary care. High-risk foot teams (HRFT) were established at six sites to provide increased access to specialty care. Comparative statistics were performed to assess differences in footcare practices between 2014 and 2019 using two-tailed Fisher’s exact test or Chi-square test.
Respondents (n = 104, 2014 and n = 75, 2019) included personnel from primary health care, home care and long-term care, acute and emergency care, specialty clinics, diabetes-specific programs and private contractors. The proportion of primary care and home care/long-term care (HC/LTC) sites providing screening increased significantly (p < 0.05). A significant increase in the proportion of sites providing assessment for patients designated as moderate risk also increased from 35% (34 out of 96 sites) to 55% (36 out of 65 sites) (p < 0.05), particularly with respect to vascular assessment, and the proportion of sites reporting appropriate follow-up intervals according to the pathway recommendation was also improved.
Provision of a clinical pathway for diabetic foot care along with education and resources led to increased screening in primary care and HC/LTC settings in Alberta, Canada. HRFT provided primary healthcare providers with an important option for referral and also provided increased expertise for procedures such as vascular assessment for patients with moderate risk of ulceration. This comprehensive model has the potential to reduce progression of foot problems and overall health services utilization. Further analyses of outcomes such as incident lower limb amputation and long-term cost-effectiveness of pathway implementation are underway.
Peer Review reports
Diabetic foot ulcer (DFU) is a severe diabetes complication often leading to lower limb amputations. In Canada in 2011, more than 25,000 prevalent cases resulted in 6036 amputations with a cost per prevalent case of $21,371 CAD [ 1 ]. International studies have found the 5-year mortality rate after new-onset ulceration to be 43–55%, and as high as 74% for people with diabetes who had a lower limb amputation [ 2 ]. DFU and lower limb amputations in people with diabetes are potentially preventable in 75% [ 3 ] and 50–85% of cases, respectively, through screening, early treatment and better self-care practices [ 4 ]. Clinical pathway development, clinician training and education, and provision of procedural support tools are all shown to increase foot screening and improve treatment [ 5 , 6 ]. Patient education is also recommended as important to reduce risk of diabetic foot complications [ 7 ]. Efforts to prevent DFU in patients identified at moderate to high risk, have a strong possibility of cost-effectiveness [ 8 ] probably through reduction of emergency department or inpatient admissions, which are increased by 3-fold in patients with DFU compared with other ambulatory clinic cases [ 9 ]. Provision of care by multi-disciplinary teams to prevent and manage foot wounds is recommended [ 10 , 11 , 12 ], as is having a structured approach to assessing clinical and metabolic parameters and assigning risk categories to patients [ 13 ]. In Queensland, Australia, implementation of state-wide protocols for diabetic foot care reduced major amputation by 45% [ 14 ].
In the jurisdiction of Alberta, Canada, diabetic foot disease was identified in 2013 as a priority for action by the Diabetes, Obesity and Nutrition (DON) Strategic Clinical Network™ (SCN) of Alberta Health Services (AHS) [ 15 ]. As part of the pathway development process, the DON SCN™ conducted a survey with both quantitative and qualitative elements in order to understand existing foot care services across Alberta. The unpublished survey results identified low screening capacity, barriers to referral, and lack of standardized approaches were supported by self-reported data from people with diabetes. This showed that self-care practices and screening frequencies [ 16 ] were not in accordance with Diabetes Canada 2013 guidelines for foot care [ 4 ], a problem also reported for Canada as a whole [ 17 ]. In 2014, the DON SCN™ began the process of implementing a new care pathway for diabetic foot care focusing on DFU prevention through screening and creation of multidisciplinary High Risk Foot Teams (HRFT) to facilitate referrals.
The literature shows that integrated care models for secondary prevention of DFU or LLA are medically and cost-effective [ 8 , 18 ]. However, there is a paucity of literature on efficacious and cost-effective integrated care models for primary prevention of DFU [ 3 , 19 ]. Approaches using multi-disciplinary teams appear to be efficacious but overall quality of the studies is not optimal [ 10 ]. Based on guidelines of Diabetes Canada [ 4 ], Wounds Canada [ 20 ] and the Registered Nurses Association of Ontario (RNAO) [ 21 ], the Alberta Health Services (AHS) diabetes foot care pathway was developed. It encompasses elements of assessment, planning, implementation and evaluation of foot care strategies for patients using a patient-centred approach and addressing appropriate treatment of comorbidities [ 22 ]. The pathway also acted upon RNAO recommendations to include professional education and guidelines to cover policy and organizational considerations. It also provided resources to monitor and support quality improvement, develop an effective referral strategy, advocate for client services that promote offloading of pressure to prevent re-ulceration [ 21 ].
In 2015, the DON SCN™ conducted a pilot project at three sites followed by scale and spread across Alberta. The pathway utilizes HRFT that provide a foot protection service and support primary care. The primary care service performs the initial screening, care for low risk patients, and continued care for patients with healed ulcers once released from specialty care. A screening instrument and modules to support patient education have also been made available along with education on their utilization. HRFT also provide referral to surgeons, providers of specialty footwear and offloading devices, and other supports for patients [ 23 ].
The aim of current study was to assess the impact of implementing a diabetes foot care clinical pathway and associated resources and training on organizational changes in diabetic foot care practices in 2019 compared with the baseline state in 2014 in Alberta, Canada. This research focused on organizational capacity for foot screening and care of low-moderate risk patients. In comparison with responses in 2014 we predict enhanced diabetic foot care practices, particularly at sites with access to HRFT.
Serial cross-sectional assessments of organizational practices related to foot care of people with diabetes.
Health care sites that play a role in the care of diabetic foot screening and treatment across the continuum in Alberta were identified. These were primary health care, home care and long-term care, acute and emergency care, specialty clinics, diabetes-specific programs and private contractors. Sites that actively participated in implementation of the diabetes foot care pathway, as well as those that did not were included in the survey. The 2019 survey was conducted between February and April. The 2014 survey was conducted in September.
A convenience sample of representatives of the identified health care sites were recruited, including physicians, nurse practitioners, registered nurses, licensed practical nurses, foot care nurses, orthopedic surgeons, physio- or occupational therapists, dietitians or pharmacists, diabetes educators, clinic managers or any practitioner who had contacted the DON SCN™ about foot care, including private service providers (e.g., foot care nurses, podiatrists). In 2014, the extent of sites and individuals participating in care of patients with diabetic foot disease was less well known; thus snowball sampling initiated with a small number of key contacts was used to distribute the survey as widely as possible. The total number of sites approached to participate was undetermined. In 2019, a list of potential participants were developed based on the previous respondents to the survey in 2014. In addition, we invited attendees at four AHS-sponsored foot care symposia held in 2017 and 2018, and utilized personal knowledge to invite other individuals involved in diabetic foot care as well . This greatly expanded the potential participant list compared with 2014. In both 2014 and 2019, potential participants were contacted by email with an invitation, the study information and a hyperlink to the survey. Potential participants received two email reminders to complete the survey following the initial invitation. Waiver of consent was granted for the 2014 survey by the Research Ethics Board of the University of Alberta. In 2019, informed consent was implied by completion of the survey.
A literature review to identify best practice, informed the process of developing the intervention, including the care pathway and ancillary resources. In addition, the Project Lead (author KD) consulted experts in the United Kingdom (UK) regarding their pathway development process and implementation of foot protection teams, which assess and treat patients at risk of, or presenting with DFU [ 24 ]. The Canadian Agency for Drugs and Technology and Health organized and facilitated a meeting between four provinces, including Alberta, to discuss current foot and wound care practices. Following this, Alberta and New Brunswick teams embarked on pathway development and the implementation of “high risk foot teams” (foot protection teams) similar to what had been implemented in the UK. The New Brunswick team allowed the DON SCN™ to leverage the work they had started in the development of a diabetes foot care clinical pathway. The DON SCN™ struck a working group composed of diabetes educators, primary care physicians and nurses, home care, wound care nurses and nurse practitioners and foot care nurses (licensed practical nurses (LPNs)), including authors KD and ML. The working group developed The Alberta Diabetes Foot Care Clinical Pathway tools and resource toolkit ( Supplementary Materials ). It was guided by the tools and resources developed by New Brunswick (diabetic foot screening tool, health provider guide, referral guidelines, patient handouts on low, moderate and high risk foot problems) and Canadian guidelines [ 20 , 21 , 25 ]. All tools and resources in the toolkit were vetted with and approved by a provincial steering committee. Members of the steering committee consisted of podiatric surgeons, orthopedic surgeons, dermatologist, physiatrists, endocrinologist, primary care physician, wound care nurses and nurse practitioners, and foot care nurses.
The diabetes foot care pathway focussed on three key elements: screening, assessment and referral pathways that could be customized depending on site characteristics. Implementation in primary care and home care/long-term care (HC/LTC) settings focused on screening and assessment supported by a novel screening tool, a risk assessment triage referral form, training from a nurse with specialized wound care training, videos and other supports. Goals for screening and assessment included increased competency of primary care providers to accurately categorize a person with diabetes as low, moderate, high or urgent risk for foot ulceration and amputation, to increase screening rates, and to provide patient education using resources developed by the DON SCN™. Within primary health care, appropriate actions taken on patients with moderate risk feet (i.e., having conditions such as callus, structural deformities or loss of protective sensation) have the potential to reduce risk of future ulceration. This included educating patients on the importance of routine self-care activities. Moderate risk assessment included inspection for skin and nail abnormalities, assessment of structural deformities (e.g., bunions, hammertoes), assessing whether special footwear was necessary, and evaluating vascular and peripheral nervous function.
To address barriers to timely referrals of high or urgent risk patients, in part related to Alberta’s large rural and remote population, HRFT were constituted in strategic locations. Depending on the site, HRFT were led by physicians, nurse practitioners, nurses, licensed practical nurses, or occupational therapists and included at least one other provider, preferably one member holding prescribing privileges for medications, diagnostic testing and referral to specialty care. Such multidisciplinary teams are recommended in various guidelines and are often known as foot protection teams [ 4 , 11 , 21 , 26 , 27 ]. In the Alberta model, HRFT assess and treat patients at risk of a DFU and those with an ulcer present. HRFTs have wound management and debridement expertise, lower leg vascular assessment training, can prescribe footwear through a provincially funded resource for medical aids, Alberta Aids to Daily Living (AADL). AADL is funded by Alberta Health and is mandated to help Albertans with a long-term disability, chronic or terminal illness to pay for basic medical equipment and supplies. However, only specified healthcare professional may prescribe AADL services. Skilled deployment of more complex testing and treatment modalities (e.g. debridement) is essential in preventing ulcers from progressing. Some HRFTs have the ability to perform skin and nail care (nail trimming/callus management) as an adjunct service. Other HRFTs do not provide this service; patients can be referred to a community podiatrist, foot care nurse, or other medically trained provider in the community. HRFT make formal linkages with other referral services such as diabetes clinics, vascular laboratories, occupational therapists or orthotists. HRFT could refer to specialists such as community podiatrists (private practitioners) or podiatric surgeons (focusing on wound management and limb preservation) as outlined in the pathway. In addition to the DON SCN™-sponsored sites, other sites throughout Alberta have developed similar multidisciplinary models of care in primary care or outpatient settings.
In addition to the specific pathway intervention, the DON SCN™ also created a number of tools to support screening, assessment and HRFT, which were freely available via a website [ 23 ] ( Supplemental Materials ). Awareness of the pathway was achieved through newsletters, word of mouth, symposiums, and presentations at meetings and conferences.
For purposes of comparative analyses, 2014 data were considered as “usual care” controls compared with 2019 post-intervention data as a whole. The 2019 data was also stratified by whether sites accessed HRFT and their practices compared to each other.
Between 2014 and 2019, 8 sites (2 North Zone, 2 Edmonton Zone, 2 Central Zone, 1 Calgary Zone, 2 South Zone) received training from the DON SCN™ personnel in all elements of the intervention including use of the clinical pathway and associated resources (toolkit) and established HRFT. Additional education consisted of training in performing a diabetes foot screen, using the pathway tools to navigate the patient to the most appropriate resource and follow-up timelines depending on risk level. This training was provided to anyone requesting it, mainly in primary care settings but also community pharmacists and indigenous healthcare providers. Of 41 Primary Care Networks in Alberta, 14 received in person training while education was provided to personnel in most First Nations health centres in Alberta via videoconference. The wound care nurse provided in-person training, with education on how to use the pathway and perform a foot screen, backed up by videos and a user guide for the tools. Implementation support was provided by the DON SCN™ project team, which included authors KD and PO. More than 1300 healthcare providers attended DON SCN™ sponsored continuing education conferences provided in 2017 and 2018. In addition, the clinical pathway and associated resources were freely available via the internet and a series of e-learning modules was created. Of 390 individuals who enrolled, 62% (n = 242) completed the e-learning courses.
A customized cross-sectional computer-based survey study was conducted in 2014 and again in 2019, prior to, and following widespread implementation of the diabetes foot care pathway in order to assess its uptake and changes in practice. The data collected compared screening practices, assessment of feet at moderate or high risk for ulceration, and protocols for dealing with urgent cases. The survey items were organized into sections by risk levels (low, moderate, high, urgent) and offered multiple options of care models. Respondents selected options, with more than one option being available for most questions. Respondents could also provide responses to an open-ended question to comment more fully on issues relevant to each risk section (Table 1 ). The 2014 survey was developed to determine what the current state of foot and wound care was in the province and how currently the different risk levels were being managed. The 2019 survey was a follow-up to determine how the landscape had changed with the implementation of the pathway and HRFT. The 2014 and 2019 surveys were similar with the 2019 version modified to include HRFT as a referral option. In this report the focus was on screening and assessment of individuals with low and moderate risk of foot ulcer.
Table 1 Definition of variables
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Figure 1 a and Table 2 shows that the proportion of all respondents providing basic foot screening increased from 2014 to 2019 (p < 0.05), and this increase was still significant when non-respondents were included in the group not providing screening. An analysis by geographically organized health zones, showed the main increases were in North (p < 0.05) and Central (p = 0.056) zones, which are primarily rural (Table 3 ). The main contributors to increased foot screening practices were primary care and HC/LTC sites (Fig. 1 b, Table 3 ), with none of the other areas of practices changing significantly. In 2019 compared with 2014, 5% (n = 1) versus 30% (n = 6) of primary care sites did not provide basic screening (p < 0.01). Similarly 40% (n = 7) versus 53% (n = 19) of HC/LTC sites did not provide basic screening in 2019 compared with 2014 (p < 0.05) (Table 3 ). In 2019, one-third of respondents had adopted the screening tool developed as part of the DON SCN™ resource toolkit (Table 3 ).
a – Proportion of all respondents performing foot screening, or assessing moderate or high risk patients with diabetes. b – Proportion of respondents providing primary health care or HC/LTC services that reported providing foot screening for patients with diabetes. *p < 0.05, **p < 0.01 with Fisher’s Exact Test
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In total, 35% (n = 34 out of 96 sites) and 55% (n = 36 out of 65 sites) respondents indicated that their site provided assessment of moderate risk patients in 2014 and 2019, respectively (Fig. 1 a, Table 2 ), a significant increase (p < 0.05). Of the respondents, the main providers of moderate risk assessment were primary care and HC/LTC, together accounting for 43% (n = 18) and 39% (n = 22) of the sites providing this service in 2014 and 2019, respectively, which was not significantly different. However, more outpatient (p < 0.05) and wound clinics (p < 0.01) reported provision of care for moderate risk patients in 2019 than 2014 (Table 4 ). The service model utilized for moderate risk assessment, in 2014, was most often a hospital or clinic team. In 2019, there were 13 sites reporting utilization of HRFT, which did not exist in 2014.
Table 4 Assessment of Moderate Risk – Characteristics of Sites
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With regard to the services provided, between 2014 and 2019, there were significant increases in the proportion of sites providing patients with lists of foot/nail care providers in the community (p < 0.001) and sites providing referrals to podiatrists or footcare nurses (p < 0.001) (Fig. 2 a, Table 4 ). Similarly, for practices related to structural deformities, an increased proportion of sites provided relevant education (p < 0.01) and provided referrals to podiatrists or orthopedic specialists (p < 0.01) (Fig. 2 b, Table 4 ). However, no differences in education about footwear or referral to providers of specialty footwear were detected (Fig. 2 c), with the exception that referral to HRFT was a new option available in 2019. In 2019 a significantly (p < 0.01) bigger proportion of respondents reported that their sites performed assessment of vascular problems than in 2014 (Fig. 2 d, Table 4 ). These included referral to general practitioners (p < 0.05) along with HRFT and vascular laboratories. Finally, services provided for loss of sensation and neuropathic pain were found to be similar between service models, with referral to a physician or nurse practitioner predominating but HRFT referred to by nearly half of the sites in 2019 (Table 4 ). Frequency of reassessing patients with moderate risk changed, with a smaller proportion of clinics not having a formalized schedule (p < 0.001) and more clinics reassessing at 4–6 months in 2019 vs 2014 (p < 0.05) (Table 4 ).
Provision of service to patients with moderate risk feet. a – Nail and skin care services provided. b – Services for structural deformities provided. c – Services for specialty footwear provided. d – Performance of vascular assessment and related referrals for peripheral artery disease. Comparing 2014 to 2019, *p < 0.05, **p < 0.01, *** p < 0.001 by Fisher’s exact test. Data were analysed using raw counts and transformed to % respondents for presentation
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We compared practices in assessing and caring for moderate risk patients reported by sites utilizing specified HRFT (n = 13) compared with those utilizing other models of care delivery (other types of clinical teams) (n = 20) using 2019 data. The areas of practice represented in the two care models were not significantly different (p > 0.05) (Table 5 ). The sites reporting HRFT were located more in urban areas than the clinic/hospital teams (p < 0.05). More clinic/hospital teams than HRFT provided skin and nail care (75% versus 63%, (n = 15 versus n = 5, p < 0.1). Referral to podiatrists and assessment of structural deformities was similar between care models. HRFT were more likely to hold AADL authorization than other sites (p < 0.1), meaning that patients could be referred and have a portion of costs covered by Alberta’s publically-funded insurance plan. With regard to assessment of vascular problems, all sites provided this service but clinic/hospital teams were more likely to refer patients to their general practitioner (p < 0.05). HRFT were more likely to assess pedal pulses than clinic/hospital teams (p < 0.1) but no differences were detected in use of other diagnostic modalities. Finally, with regard to assessing loss of protective sensation, practices were similar between the care models (Table 5 ).
Table 5 Comparison between sites utilizing HRFT vs other care models for assessing moderate risk patients