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

NCT06905119 | Recruiting

• 1 other identifier: 38_NAV2
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

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"\[Mesh\] )

Conditions

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

Keywords

Catheterization, Peripheral; Vascular Access Devices; Patient Education as Topic; Telemedicine; Mobile Applications

Outcome Measures

Primary Outcomes (7)

• 1. Patients who use computerized applications are more involved in their care and have fewer complications with the PICC

  Number of phlebitis episodes

  At the end of intervention: Time from PICC placement to removal.

• 1. Patients who use computerized applications are more involved in their care and have fewer complications with the PICC.

  Number of episodes of catheter removal by reason for removal: pain

  At the end of intervention: Time from PICC placement to removal.

• 1. Patients who use computerized applications are more involved in their care and have fewer complications with the PICC.

  Number of infection episodes

  At the end of intervention: Time from PICC placement to removal.

• 1. Patients who use computerized applications are more involved in their care and have fewer complications with the PICC.

  Number of episodes of withdrawal reason due to accidental exit

  At the end of the intervention: Time from PICC placement to removal.

• 1. Patients who use computerized applications are more involved in their care and have fewer complications with the PICC.

  Number of episodes of skin lesions

  At the end of intervention: Time from PICC placement to removal.

• 1. Patients who use computerized applications are more involved in their care and have fewer complications with the PICC.

  Number of thrombosis episodes

  At the end of intervention: Time from PICC placement to removal.

• 1. Patients who use computerized applications are more involved in their care and have fewer complications with the PICC.

  Number of episodes of catheter breakage as a reason for removal

  At the end of intervention: Time from PICC placement to removal.

Secondary Outcomes (3)

• Patient experience

  At the end of using the application: Time from PICC placement to removal.

• Patient experience

  At the end of using the application: Time from PICC placement to removal.

• Patient Satisfaction

  At the end of using the application: Time from PICC placement to removal.

Study Arms (2)

Smart phone APP

EXPERIMENTAL

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.

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

Control arm

NO INTERVENTION

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.

Interventions

Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters OTHER

The application is offered to all patients at the time of PICC placement. If they accept, they go to the intervention group. If they do not accept, they go to the control group.

Also known as: SpadCare Experience

Smart phone APP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundacion Miguel Servet: lead
• Universidad Pública de Navarra: collaborator

Study Sites (1)

Hospital Universitario de Navarra

Pamplona, Navarre, 31003, Spain

RECRUITING

MeSH Terms

Conditions

Hyperphagia; Patient Participation; Catheter-Related Infections

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Infections

Central Study Contacts

María Inés Corcuera Martínez MI Corcuera Martínez, RN-PhD(c)

CONTACT

+34 687609658; mi.corcuera.martinez@navarra.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: April 1, 2025
• Study Start: May 4, 2023
• Primary Completion: April 1, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)