Telemedicine Improves Chronic Ulcer Outcomes

Chronic ulcers greatly add to the clinical, economic, and patient burden on health care, increasing visits that challenge patients and strain overworked clinical centers. Telemedicine (TM) facilitates interprofessional collaboration and patient education and enables specialist bedside consults for clients without adding to their transfer and travel risks.^1,2 Evidence supports improved postoperative monitoring, access to experts, and cost savings for TM-managed patients with acute or chronic wounds in a variety of settings.^1,3 Despite its limitations, including likely overdiagnosis and dependence on functioning technology, TM has been validated for surgical site infection (SSI) surveillance, reducing post vascular surgery SSI-related readmissions,⁴ and was at least as safe and effective as in-person consults during postoperative wound care in general.² The 2 following studies illustrate the value of TM in managing patients with diabetic foot ulcers (DFUs),^5,6 pressure ulcers,⁶ and a variety of leg ulcers.⁶

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Reference: Smith-Strøm H, Igland J, Østbye T, Tell GS, Hausken MF, Graue M, Skeie S, Cooper JG, Iversen MM. The effect of telemedicine follow-up care on diabetes-related foot ulcers: a cluster-randomized controlled noninferiority trial [published online November 29, 2017]. Diabetes Care. 2018;41(1):96–103.

Rationale: Qualitative studies suggest TM follow-up reduced specialist follow-up consults in wound care, but randomized clinical trials (RCTs) are needed to support the quantitative healing effects of TM compared with standard of care (SOC) for DFU treatment.

Objective: Conduct a RCT evaluating whether patients with DFUs receiving TM follow-up by primary health care professionals collaborating with specialist hospital outpatient care achieved healing, amputation, and mortality outcomes that were not inferior to those achieved by patients attending the clinic every 2 weeks as SOC. 

Methods: A multicenter, controlled, parallel cluster, randomized trial assigned patients from 21 pairs of matched municipal clusters of patients in western Norway to receive up to 12 months of unblinded follow-up care for a new DFU. All consenting patients in 1 cluster from each pair received either TM (n = 94) or SOC (n = 88). Patients were at least 20 years of age with type 1 or 2 diabetes mellitus. Those with an ulcer on the same foot during the preceding 6 months, incapable of understanding or completing the questionnaires or adhering to study protocols, or with a life expectancy < 1 year were excluded. Follow-up with TM was conducted by a trained nursing staff using a mobile phone application for web-based assessment, documentation, and treatment with a clinic visit every 6 weeks to verify healing. Follow-up with SOC recording the same data and using the same care plans was conducted every 2 weeks by similarly trained nurses with optional interim home care visits as needed. Time from diagnosis to complete healing of the whole foot skin with no amputation was the primary outcome. Noninferiority was defined as a mean difference in healing time between TM–SOC of < 1.5 months. Secondary outcomes included the number of visits per month, amputation of the study limb, death, or patient experiences reported at the study end on the Generic Short Patient Experiences Questionnaire. Intent-to-treat analysis used linear regression to determine healing time differences and Fine and Gray competing risk regression that used amputation and death as events competing with healing. Results were reported as subhazard ratios with a 95% confidence interval. A generalized linear model adjusted for clusters was used to test differences between TM and SOC amputations and mortality.

Results: The 2 groups were well matched at baseline except for a higher percentage of toe ulcers in the TM group (60.6%) as compared with the SOC group (38.6%; P < .009) and more patients with type 2 diabetes mellitus in TM (86.2%) compared with SOC (71.6%; P < .016). Adjusting analyses for these differences did not affect significance of study outcomes. The 182 patients who completed the study experienced similar satisfaction levels, visit frequencies, mortality (5 deaths/group), and healing outcomes in both groups: 79.8% in the TM group healed in a mean of 3.4 months, and 76.1% in the SOC group healed in a mean of 3.8 months. More amputations were experienced before healing during the 12-month study by patients receiving SOC (13) than TM (6) (P < .05). Of the 5 major amputations, 4 were in the SOC group.

Authors’ Conclusions: Diabetic foot ulcer healing outcomes using TM follow-up for 12 months were not inferior to those using SOC, but use of TM was associated with significantly fewer amputations.

Reference: Wickström HL, Öien RF, Fagerström C, Anderberg P, Jakobsson U, Midlöv PJ. Comparing video consultation with in-person assessment for Swedish patients with hard-to-heal ulcers: registry-based studies of healing time and of waiting time. BMJ Open. 2018;8(2):e017623. doi: 10.1136/bmjopen-2017-01762.

Rationale: Video communications are widely used in different medical specialties and considered ideal for wound management but are underused for chronic ulcers.

Objective: Compare the effects of video consults with in-person assessment on healing and waiting time for those with hard-to-heal ulcers.

Methods: Two studies were performed from October 2014 through September 2016 at a dedicated wound care center that treated 25% of all Swedish patients with hard-to-heal ulcers according to structured, evidence-based wound assessment and treatment principles and recorded outcomes in a standardized Registry of Ulcer Treatment (RUT). Hard-to–heal ulcers were defined as a break in the skin of any etiology, severity, size, and duration (days from onset to baseline diagnosis) that had not healed in at least 4 weeks. One study analyzed clinically confirmed healing times of consecutive patients with hard-to-heal ulcers diagnosed using Skype (TM; N = 100) compared with control patients diagnosed in the same time frame using in-person assessment (N = 1888). A second study compared diagnosis waiting times for the same 100 TM-managed patients and 100 similar control patients diagnosed in person at a clinic in the same health care system. All ulcer areas were measured at baseline before randomized group assignment using planimetry or longest length multiplied by width to estimate area. Healing time was defined as the interval between baseline diagnosis and complete ulcer epithelial coverage. Waiting time was defined as days from referral to the time when the patient was diagnosed. Healing time was analyzed as Kaplan-Meier survival time and tested for group differences using the log rank test. Student’s t test evaluated the significance (P < .05) of differences between the 2 groups on normally distributed variables. The Mann-Whitney U statistic was used to test for group differences on non-normally distributed variables. Cox regression analyses were used to explore the effects of patient age, gender, diabetes, ulcer baseline area, and duration on healing time, followed up to ulcer healing or end of study, whichever came first. 

Results: Patients were comparable at baseline for all variables except for a longer prestudy ulcer duration in the TM group (mean, 124 days) compared with controls (mean, 84 days; P = .001). Most of the TM group (82%) healed significantly faster (median healing time, 59 days) than the 52% of 1888 control patients who healed in a median of 82 days. This difference was consistent (P < .001) with or without adjustments for amputations, deaths, patient age, gender, diabetes, ulcer baseline area, or duration effects on healing time. The TM group experienced shorter waiting times between referral and diagnosis (median, 25 days; range, 1–83 days) compared with controls (median, 32 days; range, 3–294 days; P = .017).

Authors’ Conclusions: Using TM consults as a complement to in-person assessment for patients with hard-to-heal ulcers improved healing times and waiting times between initial patient referral and definitive diagnosis.

The 2 studies reviewed here suggest TM and standardized evidence-based care can complement in-person assessment, improving time to diagnosis and healing for a wide variety of hard-to-heal chronic ulcers^5,6 or reducing the likelihood of amputations⁵ during the first year of DFU management. Telemedicine can protect patients from difficult transfers and journeys to clinical care centers that interrupt daily living and increase the potential for injury or breakdown of existing wounds. Home wound care professionals can use TM to reduce valuable time spent travelling and improve access to specialist consults that could resolve developing complications before they become serious. Telemedicine can support earlier or more consistent referral of patients to expert specialists, improving patient benefits.⁶ Combining TM with the use of a standard registry magnified the power to observe improved healing outcomes significant in the RUT study,⁶ but this was not so in the smaller DFU RCT.⁵ As the authors noted, nonblind wound evaluation in these studies may have biased results.^5,6 Future blind-evaluated studies are needed to confirm these effects and to assess the effects of TM on costs of care, patient quality of life, and staff perceptions. Nonetheless, these studies highlight the potential of TM to improve outcomes and resource use in overburdened health care systems around the world.