Self-administration in Outpatient Parenteral Antimicrobial Therapy Service

NCT06404307 | Not Yet Recruiting

• 1 other identifier: ABR NL85913.078.24
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Home Outpatient Parenteral Antimicrobial Treatment (Home-OPAT) is a service provided to patients that receive antibiotics via infusion but are clinically well enough to go home. A nurse will visit the patient daily to administer the antibiotics. However, the patient or a caregiver can also administer the antibiotics without the help of a nurse. This is called Self-OPAT. The Self-OPAT service is already in practice internationally but not yet in the Netherlands. The goal of this observational study is to assess the possibility to implement Self-OPAT in the Dutch context. The main questions it aims to answer are: Which patients are suitable for Self-OPAT services? How can patients be trained adequately for performing Self-OPAT? What are the experiences of patients with Self-OPAT? How much nurse engagement is needed during Self-OPAT? Is the outcome of treatment with Self-OPAT comparable to Home-OPAT? How do the costs of Self-OPAT differ from the costs of Home-OPAT? How can you implement an Self-OPAT program in the hospital? Participants will be trained by a nurse to administer the infusion antibiotics. They will then administer the antibiotics themselves for as long as the duration of treatment. Every week a nurse will visit to check the progression of the treatment and check the functioning and hygiene of the infusion materials. After a month participants will fill-out a questionnaire about their experience with Self-OPAT.

Conditions

Infections; Bacterial Infections

Keywords

Outpatient; Antimicrobials; Outpatient Parenteral Antimicrobial Treatment

Outcome Measures

Primary Outcomes (1)

• To asses the capability of patients to self-administer antibiotics in the outpatient setting in the Dutch medical system.

  To assess the feasibility of self-administration of intravenous antimicrobial therapy in the Dutch context. Feasibility is defined as adherence to the study protocol, which is defined as qualification for S-OPAT after training and completing an S-OPAT trajectory with a weekly scheduled nurse visit.

  30 days after discharge

Secondary Outcomes (16)

• Visits

  30 days after discharge

• Consultations

  30 days after discharge

• Devices

  30 days after discharge

• Time to discharge

  30 days after discharge

• Training completion

  30 days after discharge

Other Outcomes (3)

• Duration of training

  30 days after discharge

• Patient satisfaction with training

  30 days after discharge

• Difference between S-OPAT carried out by patient or caregiver

  30 days after discharge

Study Arms (1)

Self-administration

EXPERIMENTAL

Trained patients that will self-administer their antimicrobials in the outpatient setting

Behavioral: Self-administration

Interventions

Self-administration BEHAVIORAL

patients will self administer their antimicrobial treatment

Self-administration

Eligibility Criteria

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

You may qualify if:

• Aged 18 and over
• Hospitalized
• Treated with intravenous antimicrobial therapy and to be discharged with OPAT service
• To be discharged with OPAT service for a minimum of 5 days
• Central intravenous access/line in place
• Has a safe home environment (water, telephone, refrigerator available) and access to transport to hospital
• Able to understand written information and able to give informed consent
• Able and willing to perform self-administration, or able and willing to be self-administered by family members or other caregivers
• Able and willing to fill in questionnaires

You may not qualify if:

• Former participation in this study
• Pregnancy
• Discharge to a rehabilitation centre or nursing care centre (i.e. no discharge to home)
• Concomitant nursing care, if the patient requires other nursing care the patient will be placed on nursing care and the nurses administer the medication during the concomitant nursing care
• More than two intravenous drugs required
• More than one intravenous administration device required (e.g. elastomeric pump and medication cassette)

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Amphia Hospital: collaborator

Study Sites (2)

Amphia hospital

Breda, North Brabant, 4818CK, Netherlands

Location

Erasmus MC

Rotterdam, South Holland, 3000WB, Netherlands

Location

MeSH Terms

Conditions

Infections; Bacterial Infections

Interventions

Self Administration

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Self Care

Study Officials

• Brenda de Winter, PharmD

  Erasmus MC University Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brenda de Winter

CONTACT

0107033202; b.dewinter@erasmusmc.nl

Moska Hassanzai, PharmD

CONTACT

0107033202; m.hassanzai@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistent professor

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: May 8, 2024
• Study Start: May 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

NL (2)