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

Ingebjørg Irgens, Jana M Hoff, Hilde Sørli, Hanne Haugland, Johan K Stanghelle, Tiina Rekand, Ingebjørg Irgens, Jana M Hoff, Hilde Sørli, Hanne Haugland, Johan K Stanghelle, Tiina Rekand

Abstract

Background: 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.

Method/design: The first part of this research project aims to investigate the prevalence of PU among persons with SCI based on an epidemiological design. The study will identify possible risk factors for acquiring PU. A questionnaire focusing on previous and present PUs will be sent to persons who suffered SCIs between January 2004 and January 2014. In the second part we will compare two different treatment regimens of PU through a randomized controlled pilot trial (RCT) where we will compare outpatient SCI follow-up in a hospital versus outpatient follow-up from the patient's home, using telemedicine (teleSCI) interventions. We will compare the healing of the PU in the two groups (usual care versus teleSCI). The Tissue, Infection, Moisture Edge (TIME) registration form, the Photographic Wound Assessment Tool (PWAT) and the change in the ulcer size will be used to monitor the healing. Changes in health-related quality of life (HRQoL) and the need for assistance will be assessed using the Five Dimensions European Quality of Life scale (EQ-5D), the generic Medical Outcomes Study 12-item Short Form Health Survey (SF-12) modified version, the International Spinal Cord Injury Quality of Life Data set (ISCI-QoL Data set), and the Spinal Cord Independence Measure scale, version III (SCIM III). In addition to primary outcome measures, a cost-benefit evaluation and an assessment of patient satisfaction and participation will be performed, using customized questionnaires.

Discussion: The first part of the 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. 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. Our research protocol allows comparing methods for interaction between medical specialists at hospitals, local caregivers in the community, next of kin, and persons with SCI and PU. The RCT should identify advantages as well as challenges in the management of PU in different follow-up settings. This study aims to 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.

Trial registration: 1. www.ClinicalTrials.gov , ID: NCT02800915 , last update 9 October 2017. 2. The National Regional Ethical Committee (REC) 2014/ 684/ REK-Nord. https://helseforskning.etikkom.no/prosjekterirek/prosjektregister/prosjekt?p_document_id=469163&p_parent_id=473640&_ikbLanguageCode=n 3. https://app.cristin.no/projects/show.jsf?id=545284 4. https://www.sunnaas.no/kliniske-studier/bruk-av-telemedisin-som-virkemiddel-til-samhandling-i-poliklinisk-oppfolging-av-pasienter-med-ryggmargsskade-og-trykksar.

Keywords: Interdisciplinary collaboration; Paraplegia; Pressure ulcer; Pressure wounds; Service innovation; Spinal cord injury; TeleSCI; Telemedicine; Tetraplegia; Videoconferencing.

Conflict of interest statement

Ethics approval and consent to participate

The study and the Informed Consent Form for participation received ethical approval by The Norwegian Regional Committee North for Medical and Health Research Ethics. Informed consent will be obtained by the main investigator from all participants in the study. Only the main investigator will have access to the final trial data set. All participants are insured trough the Norwegian health system and the hospital insurance program for adverse effects/those who suffer harm from trial participation.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests. The study will be performed independently and without any influence from the investigators or founders.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The flow diagram of the trial
Fig. 2
Fig. 2
Standard Protocol Items: Recommended Items for Interventional Trials (SPIRIT). Template of content for the schedule of enrollment, interventions, and assessments in study 2.*

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