The Effect of Telemedicine Follow-up Care on Diabetes-Related Foot Ulcers: A Cluster-Randomized Controlled Noninferiority Trial.

OBJECTIVE: To evaluate whether telemedicine (TM) follow-up of patients with diabetes-related foot ulcers (DFUs) in primary health care in collaboration with specialist health care was noninferior to standard outpatient care (SOC) for ulcer healing time. Further, we sought to evaluate whether the proportion of amputations, deaths, number of consultations per month, and patient satisfaction differed between the two groups. RESEARCH DESIGN AND METHODS: Patients with DFUs were recruited from three clinical sites in western Norway (2012-2016). The cluster-randomized controlled noninferiority trial included 182 adults (94/88 in the TM/SOC groups) in 42 municipalities/districts. The intervention group received TM follow-up care in the community; the control group received SOC. The primary end point was healing time. Secondary end points were amputation, death, number of consultations per month, and patient satisfaction. RESULTS: Using mixed-effects regression analysis, we found that TM was noninferior to SOC regarding healing time (mean difference -0.43 months, 95% CI -1.50, 0.65). When competing risk from death and amputation were taken into account, there was no significant difference in healing time between the groups (subhazard ratio 1.16, 95% CI 0.85, 1.59). The TM group had a significantly lower proportion of amputations (mean difference -8.3%, 95% CI -16.3%, -0.5%), and there were no significant differences in the proportion of deaths, number of consultations, or patient satisfaction between groups, although the direction of the effect estimates for these clinical outcomes favored the TM group. CONCLUSIONS: The results suggest that use of TM technology can be a relevant alternative and supplement to usual care, at least for patients with more superficial ulcers.

Shared Electronic Health Record Systems: Key Legal and Security Challenges.

Use of shared electronic health records opens a whole range of new possibilities for flexible and fruitful cooperation among health personnel in different health institutions, to the benefit of the patients. There are, however, unsolved legal and security challenges. The overall aim of this article is to highlight legal and security challenges that should be considered before using shared electronic cooperation platforms and health record systems to avoid legal and security "surprises" subsequent to the implementation. Practical lessons learned from the use of a web-based ulcer record system involving patients, community nurses, GPs, and hospital nurses and doctors in specialist health care are used to illustrate challenges we faced. Discussion of possible legal and security challenges is critical for successful implementation of shared electronic collaboration systems. Key challenges include (1) allocation of responsibility, (2) documentation routines, (3) and integrated or federated access control. We discuss and suggest how challenges of legal and security aspects can be handled. This discussion may be useful for both current and future users, as well as policy makers.

Telemedicine Versus Standard Follow-Up Care for Diabetes-Related Foot Ulcers: Protocol for a Cluster Randomized Controlled Noninferiority Trial (DiaFOTo).

BACKGROUND: This paper presents the protocol for an ongoing study to evaluate a telemedicine follow-up intervention for patients with diabetes-related foot ulcers. Diabetes-related foot ulcers represent challenges for patients and the health services. The large increase in the prevalence of diabetes, combined with the aging population, means that the absolute number of patients with diabetes-related foot ulcers is likely to continue to increase. Health care services therefore need to provide close clinical follow-up care for people with diabetes both in primary and specialist care. Information and communication technologies may enable more integrated treatment and care pathways across organizational boundaries. However, we lack knowledge about the effect of telemedicine follow-up and how such services can be optimally organized. OBJECTIVE: To present the design and methods of a study evaluating a telemedicine follow-up intervention for patients with diabetes-related foot ulcers. METHODS: The study is designed as a cluster randomized controlled trial (noninferiority trial) involving municipalities or municipality districts (clusters) belonging to one clinical site in Western Norway. The study includes patients with type 1 and type 2 diabetes presenting with a new foot ulcer at the initial visit to the clinic. Patients in the intervention group receive telemedicine follow-up care in the community. The key ingredient in the intervention is the close integration between health care levels. The intervention is facilitated by the use of an interactive wound platform consisting of a Web-based ulcer record combined with a mobile phone, enabling counseling and communication between nurses in the community and specialist health care. Patients in the control group receive standard hospital outpatient care. The primary endpoint in the trial is healing time; secondary outcomes include amputation and death, patient-reported outcome measures, and follow-up data on the recurrence of foot ulcers. In addition, qualitative substudies are being performed to provide a more comprehensive evaluation of the ongoing processes during the trial with the patients in the intervention and control groups and those health care professionals either working in primary care or in specialist care delivering the intervention. RESULTS: The project has been funded. The inclusion of patients started in September 2012. Because recruitment goals were not met in the initial period, two more clinical sites have been included to meet sample size requirements. Patient recruitment will continue until June 2016. Data collection in the qualitative substudies has been completed. CONCLUSIONS: This telemedicine trial operates in a novel setting and targets patients with diabetes-related foot ulcers during a 12-month follow-up period. The trial addresses whether integrated care using telemedicine between primary and specialist health care can be an equivalent alternative to standard outpatient care. TRIAL REGISTRATION: ClinicalTrials.gov NCT01710774; https://clinicaltrials.gov/ct2/show/NCT01710774 (Archived by WebCite at http://www.webcitation.org/6im6KfFov).