Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 31, 2023
Date Accepted: Dec 16, 2023
Clinical Remote Monitoring of Individuals with SCI at Risk for Pressure Injury Recurrence utilizing mHealth: Protocol of a Pilot Pragmatic Hybrid Implementation Trial
ABSTRACT
Background:
Pressure injuries are one of the most challenging secondary conditions for individuals with spinal cord injuries and related disorders (SCI/D) due to inherent life-long risk factors that include a lack of sensory and motor function below the level of injury and reliance on a wheelchair for daily mobility resulting in prolonged periods of sitting. While many factors contribute to the development of pressure injuries, the pressure between the skin and a surface is always a factor and depends on magnitude of pressure and duration. Broad recommendations for relieving pressure are used because we know very little about the unique day-to-day life patterns of the individual wheelchair user. If a patient returns to their therapist after the occurrence of a pressure injury, the therapist can check equipment fit and effectiveness of pressure offloading, and they can ask about other surfaces they sit on in their home and community. This time-lapsed, largely self-reported data is fraught with recall bias and inaccuracies that the therapist does their best to incorporate into an effective care plan.
Objective:
Our objective for this application is to pilot test the clinical effectiveness of a telehealth model of care combined with our mobile health (mHealth) AW-Shift© device for remote monitoring of factors related to maintaining skin health and wheelchair setup. Our overall hypothesis is that an enhanced connected model of care utilizing remote monitoring of pressure management will result in improved clinical outcomes (wound recurrence, early identification of wounds, and wound healing) for adults with SCI at high risk for pressure injury recurrence.
Methods:
Across all AIMS, we will use a mixed-method design using an exploratory sequential approach to include the strengths of both qualitative and quantitative data. In AIMS 1 and 2 of the study, in an iterative fashion, we will collect qualitative data from therapists, patients with SCI/D, and other stakeholders. In AIM 3, utilizing both qualitative and quantitative data, we will perform a randomized, controlled, hybrid, effectiveness/implementation design to pilot test the intervention.
Results:
In this ongoing study, the initial focus group guides and implementation strategies have been developed.
Conclusions:
We hypothesize that an enhanced connected model of care utilizing remote monitoring of pressure management will result in improved clinical outcomes (wound recurrence, early identification of wounds, and wound healing) for adults with SCI at high risk for pressure injury recurrence. This application will expand upon our prior work to move the AW-Shift© system into routine clinical care which was a high desire of adults with SCI/D for improved individualized care plans to prevent pressure injuries. Clinical Trial: In Process
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