Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters: SpadCare Experience

Fundacion Miguel Servet

Status: Active, not recruiting

Conditions: Infusions, Intravenous; Administration, Intravenous; Home Nursing; Computers, Handheld; Care Givers; Digital Health; Nursing; Patient Participation; Central Venous Catheters; Mobile Applications; Delivery of Health Care; Catheterization, Peripheral; Home Infusion Therapy; Patient Education As Topic; Adverse Effects; Vascular Access Devices; User-Computer Interface; Parenteral Nutrition, Home; Self Administration; Telemedicine; Smartphone; Catheterization, Central Venous; Catheter-Related Infections

Treatments: Other: Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters

Study type: Interventional

Funder types: Other

Identifiers

NCT06905119

38_NAV2

Details and patient eligibility

About

The study focuses on patients who require outpatient infusion of therapy ("Infusions, Intravenous"[Mesh]) "Administration, Intravenous"[Mesh] ("Home Infusion Therapy"[Mesh]) "Parenteral Nutrition, Home"[Mesh] via a peripherally inserted central catheter (PICC) ("Central Venous Catheters"[MeSH] "Catheterization, Central Venous"[MeSH] "Catheterization, Peripheral" [MeSH] "Vascular Access Devices"[Mesh] )

Full description

The patients, who receive training ("Patient Education as Topic"[Mesh] "patient participation"[MeSH Terms] ) via an app on their personal mobile phone ("User-Computer Interface"[Mesh] "Smartphone"[MeSH] "Mobile Applications"[MeSH] "Computers, Handheld"[Mesh] "Digital Health"[Mesh] are able to perform specialized care ("Nursing"[Mesh]) Care"[MeSH] "Delivery of Health Care"[Mesh:NoExp] "Home Nursing"[MeSH] "Self Administration"[Mesh] to reduce complications ("adverse effects"[MeSH Subheading] "Catheter-Related Infections"[Mesh] ) so that they are monitored in real time by those responsible for the catheter. ("Telemedicine"[Mesh]

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients >18 years.
• Sign the informed consent form.
• Have a Smartphone and accept the use of the APP.
• Patient with a PICC inserted by the Infusion and Vascular Access Team of the University Hospital of Navarra and with a planned use of at least one month.

Exclusion criteria

• Patients with limitations in the use of digital resources or lack of Smartphone.
• Patients who do not want to install the APP on their Smartphone
• Patients who do not authorize access to their Computerized Medical Record (HCI).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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201 participants in 2 patient groups

Smart phone APP

Experimental group

Description:

Patients who agree to participate in the study, once the PICC is placed, download the app to their personal Smartphone or that of a family member. The app contains all the information about the catheter, including the insertion date, gauge, number of lumens, batch number, and more. The weekly catheter care is performed at home, at the health center, or in the hospital and can be performed by nursing professionals or properly trained family members or caregivers of the patient. The patient reports any incidents that may occur each week. If an incident occurs, the responsible professional contacts the patient by phone and, if necessary, makes an appointment for an in-person consultation to review the catheter. The patient records the care performed in the app and a reminder is automatically recorded in the phone calendar. The app has documentation prepared by expert personnel along with video procedures for the care, and the "step-by-step" feature that allows the care to be performed.

Treatment:

Other: Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters

Control arm

No Intervention group

Description:

Usual care description: Patients in the intervention group only have information about their catheter (placement date, catheter reference and batch) on a paper card; they do not have documentary or audiovisual resources. The treatment is carried out exclusively by nursing professionals at the hospital or health centre, and the latter are the ones who contact the hospital professionals who placed it in the event of an incident. The professionals who inserted the catheter are aware of the information about the catheter removal and whether there has been any significant complication when reviewing the catheters they have inserted at the end of the year, and are not aware of the incidents until the annual review. The under-registration in computer applications means that information on a high number of inserted catheters is not available.