Diabetic foot ulcers - predictors of healing time and aspects of telemedicine

Background: A diabetic foot ulcer (DFU) is a feared complication of diabetes. Both duration and severity of ulcer before start of treatment in specialist health care are factors that can effect healing time for patient with DFUs. More research about duration and severity of DFUs before seeking care as predictors of healing time might contribute to knowledge of importance for clinical interventions. Treatment of DFUs puts pressure on the health care system in terms of utilization of available resources. Moreover, the prevalence of diabetes is increasing dramatically and, as a result, longterm diabetes-related complications are also likely to increase. Telemedicine can be one way to address these issues, because telemedicine follow up may enable more integrated care pathways across health care levels. Telemedicine has been used in different settings, but knowledge of telemedicine’s effect on clinical outcomes and patients’ experiences among patients with DFUs is limited. Aims: The overall aim of this study was to provide new knowledge about predictors of healing time in patients with a DFU and to assess the effect of and experience with a telemedicine intervention for patients with a DFU. To achieve the overall aim, three specific aims were established: 1) to investigate whether A) duration of ulcer before start of treatment in specialist health care, and B) severity of ulcer according to the University of Texas (UT) classification system at the start of treatment (baseline), are independent predictors of healing time; 2) to evaluate whether telemedicine follow up of patients with DFUs treated in primary health care, in collaboration with hospital outpatient specialist care, is noninferior to standard outpatient care in terms of ulcer healing time. Further, to assess for superior whether amputations, death, consultations and patient satisfaction are different from telemedicine follow up compared to standard outpatient care; and, 3) to explore the experiences of patients with DFUs receiving telemedicine compared to patients receiving standard outpatient care health care delivered in the context of a cluster randomised controlled trial. Methods: Three different study designs were used. Study I: A retrospective cohort study included data from electronic medical records system of 105 patients with new DFUs from two outpatient clinics in Western Norway during 2009-2011. Competing risk regression with adjustment for potential confounders was used to evaluate the associations of duration and severity of the ulcer with healing time. Study II: In this pragmatic cluster randomised controlled non-inferiority trial, 182 patients (94/88 in telemedicine/standard outpatient care; 42 clusters) with a new DFU were recruited from three hospital outpatient clinics in Western Norway (from September 2012 to June 2016). The primary endpoint was healing time and secondary endpoints included amputation, death, number of consultations per month, and patient satisfaction. Study III: In the qualitative study individual interviews were conducted with 24 adults recruited from the cluster randomised controlled non-inferiority trial (n=13/ n=11 from the telemedicine /standard outpatient care group) in the period March 2014-May 2015. Results: Study 1: Of the 105 adults, 48 (45.7%) achieved ulcer healing, 38 (36.2%) underwent amputations, 10 (9.5%) died before ulcer healing and 9 (8.5%) were lost to follow up. For those who healed, mean healing time was 3.8 months (113 days), measured from start of treatment in the specialist health care to end of follow up. Time from patient-reported ulcer onset to referral by general practitioner (GP) to specialist health care was found to be a strong predictor of healing time. Patients who were referred to specialist health care by a GP ≥ 52 days after ulcer onset had a 58% (Sub hazard ratio (SHR) 0.42, CI 0.18, 0.98) decreased healing rate compared with patients who were referred earlier. Ulcers with the highest severity i.e. ulcer penetrating to tendon or bone (grade 2/3) and peripheral arterial disease with and without infection (stage C/D) according to the UT classification system had an 86% (SHR 0.14, CI 0.05, 0.43) decreased healing rate compared with low severity i.e. superficial ulcer (grade 1) with infection (stage A/B) or ulcer penetration to tendon/capsula (grad 2) and clean ulcer (stage A). Study II: Of 182 patients, 142 (78.9%) achieved complete ulcer healing, and 75 (79.8%) healed in the telemedicine group and 67 (76.1%) in the standards outpatient care group. Mean healing including only those who healed was 3.4 months and 3.8 months in the telemedicine group and standard outpatient group, respectively. Telemedicine was non-inferior to standard outpatient care regarding healing time (mixed-effects regression analysis: (mean difference –0.43 months, 95% CI –1.50, 0.65). This finding persisted also after taking into account competing risk from death and amputation (SHR 1.16, 95% CI 0.85, 1.59). There were no significant differences between the telemedicine follow up and standard outpatient care related to the effect estimate of the secondary outcomes, except for significantly fewer amputations in the telemedicine group. Study III: Three themes emerged from the analysis: 1) competence of health care professionals, 2) continuity of care, and 3) easy access, i.e. to receive treatment and follow up near home or at their home. Group allocation seemed to have limited impact on the patients’ follow-up experiences. Competence of health care professionals and continuity of care were important, because they could either enhance or impair wound care. When telemedicine functioned as intended, it was an advantage in the treatment. Easy access was important for the participants, but the importance of accessibility appeared only when competence among health care professionals and continuity of care were present. Conclusions: Early referral to specialist health care if an ulcer occurs is crucial for optimal ulcer healing and has a clear implication for routine care. Grade and stage severity are also important predictors for healing time, and early screening to assess the severity and initiation of prompt treatment is important. Telemedicine can be an alternative but also a supplement to usual care for patients with DFUs, at least for patients with more superficial ulcers. As the number of outpatient clinic consultations in the telemedicine group did not differ from the standard care group, there is need to focus on organisational aspects to facilitate the use of telemedicine. Health care professionals’ competence, continuity of care and easy access to health care services were essential for patients with DFUs, and telemedicine may compensate for lack of these factors

Sykepleiers erfaring ved bruk av telemedisin i behandling av diabetiske fotsår

Innledning: Tema for denne oppgaven er diabetiske fotsår og telemedisin i hjemmesykepleien. Diabetiske fotsår er komplikasjoner av diabetes, som påvirker pasientens livskvalitet alvorlig. Det er derfor nødvendig å følge opp såret i henhold til nasjonale faglige retningslinjer. Nasjonal helse- og sykehusplan ønsker derfor å innføre telemedisinsk teknologi, da dette vil kunne bidra til en forbedret og presis helsehjelp. Hensikten med denne oppgaven er derfor å utforske hvilke erfaringer sykepleiere har, ved bruk av telemedisin hos mennesker med diabetiske fotsår i hjemmesykepleien. Metode: Denne oppgaven er en generell litteraturstudie, der data fra eksisterende fag- og forskningslitteratur er benyttet for å diskutere og besvare problemstillingen. Faglitteratur er basert på Lovisenberg Diakonale Høgskole sine pensumlister i sykepleie. Forskningslitteraturen er funnet ved hjelp av strukturerte søk i databasen CINAHL. Søkeordene som ble benyttet er: «telemedicine», AND «telehealth», AND «telemedical monitoring», OR «diabetic foot ulcer», AND «woundcare». Antall artikler i treff var 48, og basert på inklusjons- og eksklusjonskriterier ble 4 artikler inkludert i oppgaven. Resultat: Funnene indikerer at ved bruk av telemedisin i behandling av diabetiske fotsår, erfarer sykepleiere bedre kommunikasjon, økt kompetanse i sårbehandling, økt dokumentasjonskvalitet og økt kvalitet på tjenesten. Sykepleiere erfarte også utfordringer ved dokumentasjonsprosessen og ved bruk av telemedisin i hjemmet til pasienten. Videre viser funn til at organisatoriske faktorer spiller en rolle på opplevelsen av telemedisin. Diskusjon: Telemedisin vil kunne bidra til flere hensiktsmessige endringer i praksis, som kan være gunstig for helsevesenet. Erfaringene tilsier at telemedisin vil kunne gi gode samarbeid på tvers av sektorer, sykepleiere vil bli mer bevisst på egen kompetanse, og bidra til at sykepleier dokumenterer nødvendige opplysninger som totalt gir en kvalitetssikker tjeneste. Påfølgende bidrar telemedisin til en personsentrert tilnærming i utøvelsen av sykepleien. Derimot vil faktorer som tid og bemanning kunne påvirke hvordan telemedisin vil fungere i praksis

The potential role of sensors, wearables and telehealth in the remote management of diabetes-related foot disease

Diabetes-related foot disease (DFD), which includes foot ulcers, infection and gangrene,is a leading cause of the global disability burden. About half of people who develop DFD experience a recurrence within one year. Long-term medical management to reduce the risk of recurrence is therefore important to reduce the global DFD burden. This review describes research assessing the value of sensors, wearables and telehealth in preventing DFD. Sensors and wearables have been developed to monitor foot temperature, plantar pressures, glucose, blood pressure and lipids. The monitoring of these risk factors along with telehealth consultations has promise as a method for remotely managing people who are at risk of DFD. This approach can potentially avoid or reduce the need for face-to-face consultations. Home foot temperature monitoring, continuous glucose monitoring and telehealth consultations are the approaches for which the most highly developed and user-friendly technology has been developed. A number of clinical studies in people at risk of DFD have demonstrated benefits when using one of these remote monitoring methods. Further development and evidence are needed for some of the other approaches, such as home plantar pressure and footwear adherence monitoring. As yet, no composite remote management program incorporating remote monitoring and the management of all the key risk factors for DFD has been developed and implemented. Further research assessing the feasibility and value of combining these remote monitoring approaches as a holistic way of preventing DFD is needed

Telemedicine in diabetes foot care delivery: health care professionals’ experience

Background: Introducing new technology in health care is inevitably a challenge. More knowledge is needed to better plan future telemedicine interventions. Our aim was therefore to explore health care professionals’ experience in the initial phase of introducing telemedicine technology in caring for people with diabetic foot ulcers. Methods: Our methodological strategy was Interpretive Description. Data were collected between 2014 and 2015 using focus groups (n = 10). Participants from home-based care, primary care and outpatient hospital clinics were recruited from the intervention arm of an ongoing cluster randomized controlled trial (RCT) (Clinicaltrials.gov: NCT01710774). Most were nurses (n = 29), but the sample also included one nurse assistant, podiatrists (n = 2) and physicians (n = 2). Results: The participants reported experiencing meaningful changes to their practice arising from telemedicine, especially associated with increased wound assessment knowledge and skills and improved documentation quality. They also experienced more streamlined communication between primary health care and specialist health care. Despite obstacles associated with finding the documentation process time consuming, the participants’ attitudes to telemedicine were overwhelmingly positive and their general enthusiasm for the innovation was high. Conclusions: Our findings indicate that using a telemedicine intervention enabled the participating health care professionals to approach their patients with diabetic foot ulcer with more knowledge, better wound assessment skills and heightened confidence. Furthermore, it streamlined the communication between health care levels and helped seeing the patients in a more holistic way. Keywords: telemedicine, diabetic foot ulcer, focus groups, interpretive description, health care professional

The Model for Assessment of Telemedicine (MAST): a scoping review of empirical studies

The evaluation of telemedicine can be achieved using different evaluation models or theoretical frameworks. This paper presents a scoping review of published studies which have applied the Model for Assessment of Telemedicine (MAST). MAST includes pre-implementation assessment (e.g. by use of participatory design), followed by multidisciplinary assessment, including description of the patients and the application and assessment of safety, clinical effectiveness, patient perspectives, economic aspects organisational aspects and socio-cultural, legal and ethical aspects. Twenty-two studies met the inclusion criteria and were included in the review. In this article, research design and methods used in the multidisciplinary assessment are described, strengths and weaknesses are analysed, and recommendations for future research are presented

A cross‐sector systematic review and synthesis of knowledge on telemedicine interventions in chronic wound management—Implications from a system perspective

Based on initially identified needs for further telemedicine (TM) and chronic wound management research, the objective of this article is twofold: to conduct a systematic review of existing knowledge on TM interventions in chronic wound management—including barriers and opportunities—across the specialist and primary care sectors, and to incorporate the review findings into a system framework that can be further developed and validated through empirical data. We conclude that there is a pressing need for broader and more comprehensive empirical explorations into quality improvement and integration of TM in chronic wound management, including using system frameworks that can capture cross‐sector system perspectives and associated implications. Of practical consideration, we suggest that the design and execution of TM improvement interventions and associated research projects should be conducted in close cooperation with managers and practitioners knowledgeable about barriers and opportunities that can influence the implementation of important interventions within chronic wound management

Asiakaslähtöisten sähköisten terveyspalvelujen käyttöönotto – malli käyttöönotolle ja vaikuttavuuden arvioinnille

Sähköisiä terveyspalveluja on kehitetty viime vuosina aktiivisesti. Sähköisten terveyspalvelujen kehittämisen ja käyttöönoton apuna on käytetty erilaisia teorioita ja malleja. Viitekehyksenä on ollut usein sosiotekninen teoria. Kehittämishankkeen yhtenä tavoitteena oli luoda malli sähköisten terveyspalvelujen kehittämiseen ja käyttöönottoon. Mallin tavoitteena on yhdenmukaistaa uusien sähköisten palvelujen kehittämistä, helpottaa palvelujen käyttöönottoa sekä auttaa seuraamaan toimintaa ja arvioimaan vaikuttavuutta. Mallintamista varten koottiin tutkimus- ja teoriatietoa sekä kokemustietoa kehittämishankkeen moniammatilliselta kehittäjäryhmältä (n = 14). Kehittäjäryhmään kuului terveydenhuollon ammattilaisia eli sairaanhoitajia ja terveydenhoitajia perusterveydenhuollosta, työterveyshoitajia ja -lääkäri, terveydenhuollon opettajia ja tietojärjestelmäasiantuntija.  Aineisto kehittäjäryhmältä koottiin Learning café -menetelmällä ja analysoitiin sisällönanalyysillä.Asiakaslähtöisten sähköisten terveyspalvelujen käyttöönoton ja vaikuttavuuden arvioinnin malli koostuu viidestä ulottuvuudesta: ihminen, teknologia, palvelut, organisaatio ja vaikuttavuuden arviointi. Malli sisältää periaatteet: asiakaslähtöisyys, yhteisöllisyys, monitoimijuus ja monikanavaisuus. Sähköisten terveyspalvelujen kehittäminen etenee palvelumuotoilun menetelmällä ja ketterän kehittämisen periaatteen mukaisesti vaiheittain. Toiminnan tavoitteena on kansalaisen terveys ja hyvinvointi. Mallissa korostuvat asiakkaiden ja ammattilaisten yhteistyö, kouluttaminen ja ohjaaminen uusiin palveluihin. Sähköisten terveyspalvelujen käyttö muuttaa niin ammattilaisen kuin asiakkaankin toimintaa. Asiakkaan vastuu oman terveyden ja hyvinvoinnin ylläpitämisestä kasvaa. Sähköisten terveyspalvelujen käytön vaikuttavuutta arvioidaan monin menetelmin. Mallin jatkokehittämistä varten tarvitaan tietoa erityisesti vaikuttavuuden arvioinnin menetelmistä.The development of eHealth services has been active over the last few years. Various theories and models have been used to support the development and implementation of eHealth services. The socio-technical theory has often been used as the framework for this process. One aim of the development project was to create a model for developing and implementing eHealth services and evaluating its effectiveness. The model aims at standardising and simplifying the development of new eHealth services, facilitating the process of launching these services, and assisting in monitoring and evaluating the services. The data for the modelling was collected from studies and theories and also from the experiences of a multiprofessional developing group (n = 14). This group consisted of health care specialists such as nurses, public health nurses, occupational health nurses, company physicians, and nursing teachers, and of an information technology specialist. The data from the group was collected using the Learning Café method and it was analysed by the method of content analysis.The model for implementing customer-oriented eHealth services and evaluating its effectiveness consists of five dimensions: human being, technology, services, organisation, and evaluation of effectiveness. The model also includes the following principles: customer orientation, community spirit, multifunctionality, and multichannel work. The development of eHealth services proceeds step by step with the method of service design and the principle of agile development. The work aims at maintaining and improving the health and welfare of citizens. The model emphasises cooperation between health care customers and professionals, education, and counselling in the use of new services. The use of eHealth services changes the activities performed by both professionals and customers. The responsibility of the customer for his or her own health and welfare will increase. The effectiveness of eHealth services can be evaluated by various methods. Knowledge on the methods of evaluating effectiveness will be especially needed when further developing the model