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

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.

Intermittent mild negative pressure applied to the lower limb in patients with spinal cord injury and chronic lower limb ulcers: a crossover pilot study.

STUDY DESIGN: Randomized, assessor-blinded crossover pilot study. OBJECTIVES: To explore the use of an intermittent negative pressure (INP) device for home use in addition to standard wound care (SWC) for patients with spinal cord injury (SCI) and chronic leg and foot ulcers before conducting a superiority trial. SETTING: Patient homes and outpatient clinic. METHODS: A 16-week crossover trial on 9 SCI patients (median age: 57 years, interquartile range [IQR] 52-66), with leg ulcers for 52 of weeks (IQR: 12-82) duration. At baseline, patients were allocated to treatment with INP + SWC or SWC alone. After 8 weeks, the ulcers were evaluated. To assess protocol adherence, the patients were then crossed over to the other group and were evaluated again after another 8 weeks. Lower limb INP treatment consisted of an airtight pressure chamber connected to an INP generator (alternating 10 s -40mmHg/7 s atmospheric pressure) used 2 h/day at home. Ulcer healing was assessed using a photographic wound assessment tool (PWAT) and by measuring changes in wound surface area (WSA). RESULTS: Seven of nine recruited patients adhered to a median of 90% (IQR: 80-96) of the prescribed 8-week INP-protocol, and completed the study without side effects. PWAT improvement was observed in 4/4 patients for INP + SWC vs. 2/5 patients for SWC alone (P = 0.13). WSA improved in 3/4 patients allocated to INP + SWC vs. 3/5 patients in SWC alone (P = 0.72). CONCLUSIONS: INP can be used as a home-based treatment for patients with SCI, and its efficacy should be tested in an adequately sized, preferably multicenter randomized trial.

Intermittent negative pressure applied to the lower limb increases foot macrocirculatory and microcirculatory blood flow pulsatility in people with spinal cord injury.

STUDY DESIGN: Experimental prestudy and poststudy. OBJECTIVES: Examine the acute effects of intermittent negative pressure (INP) applied to the lower limb on foot circulation in people with spinal cord injuries (SCIs). SETTING: Vascular laboratory, Oslo University Hospital. METHODS: Twenty-four people with SCI (median age 59 years, range 29-74) were exposed to lower leg INP (-40 mm Hg) using an air-tight pressure chamber connected to an INP generator. The contralateral leg was placed outside the pressure chamber. We continuously measured arterial blood flow velocity (ultrasound Doppler), skin blood flow (laser Doppler), skin temperature of the dorsum of the foot, heart rate (ECG) and systemic blood pressure (Finometer) during 5-min baseline (atmospheric pressure), followed by 10-min INP (alternating 10 s -40 mm Hg and 7 s atmospheric pressure), and 5-min post-INP (atmospheric pressure). Skin blood flow was measured on the foot placed outside the pressure chamber. A mixed effects regression model was applied to estimate the effect of INP on blood flow. To quantify flow fluctuations, we calculated cumulative up-and-down changes in arterial blood flow velocity per minute. RESULTS: Flow fluctuations increased during INP compared to baseline [32.3 cm/s/min (95% CI 26.9 to 37.7) vs. 15.2 cm/s/min (95% CI 9.8 to 20.6), P < 0.001]. Peak blood flow velocity and skin blood flow was reached 2-3 s after the onset of negative pressure and increased 33% (95% CI 16 to 46, P < 0.001) and 11% (95% CI -4.1 to 60, P = 0.14) above baseline, respectively. CONCLUSIONS: INP induced increased foot arterial blood flow fluctuations compared to baseline. SPONSORSHIPS: The Norwegian Research Council provided funding to Otivio (grant: 241589).