Hospital based care at home; study protocol for a mixed epidemiological and randomized controlled trial

Trials, 2019 · DOI: https://doi.org/10.1186/s13063-019-3185-y · Published: January 8, 2019

Spinal Cord Injury Telehealth & Digital Health Dermatology

Simple Explanation

Individuals with spinal cord injuries (SCI) are prone to pressure ulcers (PUs) because of the loss of sensorimotor function involved as well as increased skin moisture. Treatment of PU after SCI is complicated, involving different specialties and with need for long-lasting follow-up. This study should identify risk factors for PU after SCI, and find an effective and less time-consuming treatment for the condition among different available methods for follow-up. The first part of this research project will reveal the epidemiology of PU after SCI, and explore the risk factors. This part enables further prevention of PU after SCI and this information will be used in the follow-up RCT.

Study Duration

Study 1: January 2017 to May 2018. Study 2: June 2015 to July 2019.

Participants

Study 1: Persons with SCI between January 2004 and January 2014. Study 2: Sixty persons with SCIs and ongoing PUs

Evidence Level

Level 1: Randomized controlled pilot trial (RCT) and Epidemiological study

Key Findings

1
Epidemiological knowledge of persons with SCI and PUs will provide insight of this complication
2
Compared to other methods, PU treatment and healing will be more optimal by using teleSCI for follow-up at home measured in terms of healing, user interaction, and satisfaction
3
teleSCI enables specialized interdisciplinary health care workers to interact with, and empower, the primary health care workers

Research Summary

This research project consists of an epidemiological analysis, called study 1, and a randomized controlled pilot trial (RCT), called study 2. In study 1, the aim is to analyze the epidemiology of persons with SCI and past or present PUs; such an approach helps to specify the extent of this complication. The RCT aims to investigate clinical and economic aspects of follow-up by teleSCI compared to other methods. This part will assess the interaction between the specialized health care service, the users, and the caregivers using different approaches to follow-up. This article describes a RCT that could make an important contribution to the field of PU healing, patients’ QoL and opinions about the quality of interaction and knowledge sharing between the specialized health care services and those involved in the primary health care.

Practical Implications

Future Guidelines

The results of study 2 will have implications on, and will potentially influence future guidelines for, services innovated, interdisciplinary outpatient treatment of patients with PUs or other time-consuming follow-up conditions.

Clinical Routines

Videoconferencing in the outpatient follow-up of persons with SCI and PU will change clinical routines and facilitate interdisciplinary collaboration, communication and competence exchange among participants of the health care services.

Cost-Benefit

By conducting an economic evaluation, we will be able to determine whether teleSCI has economical benefits compared to more traditional methods

Study Limitations

1
Participation is voluntary, and withdrawal is possible at any time.
2
it will not be possible to blind the participants.
3
As usual, as care services vary in type and frequency, the follow-up provided for each participant will depend on the local resources available.

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