Self-administration in Outpatient Parenteral Antimicrobial Therapy Service — SELF-OPAT  

Bacterial Infections Clinical Trial

Official title: Self-administration in Outpatient Parenteral Antimicriobial Therapy Service

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Outpatient parenteral antimicrobial therapy (OPAT) is defined as 'the administration of parenteral antimicrobial therapy in at least 2 doses on different days without intervening hospitalization. It can be provided for patients who need parenteral therapy for severe or deeply seated infections, under the condition that they are stable and healthy enough to leave the hospital. Nowadays, OPAT is considered regular care in many countries across Europe, Asia, North America, and Oceania. It is a safe, effective, and cost-saving practice.

OPAT can be performed in a variety of models. Infusion in the patient's home with active intervention of nursing personnel is called 'Healthcare Professional Outpatient Parenteral Antimicrobial Therapy (H-OPAT). In the Netherlands, the H-OPAT model is common practice. A disadvantage of H-OPAT is the need to arrange a nurse (from a home care organization) for visiting the patient at home to administer the intravenous antimicrobial.

Home-based H-OPAT can also be performed by the patient or a caregiver, introducing another model called self-administration OPAT (S-OPAT). In this model, healthcare personnel initially trains the patient and/or their caregivers to administer antimicrobials. After training, the patient or the caregiver administrates the intravenous antimicrobial instead of a visiting nurse. Internationally, S-OPAT is a well-established practice and it is known that it is a safe and effective practice and leads to increased patient satisfaction and reduced healthcare costs.

This is a prospective observational feasibility study to assess the feasibility of self-administration of intravenous antimicrobial therapy in the Dutch context.

Due to research lacking on S-OPAT in the Netherlands and the limited experience with S-OPAT in the Netherlands the following questions are still to be answered:

• Which patients are suitable for S-OPAT?

• How can patients be trained adequately for performing S-OPAT?

• What are the experiences of patients with S-OPAT?

• How much nurse engagement is needed during S-OPAT?

• Are the clinical outcomes with S-OPAT comparable to H-OPAT?

• What is the cost benefit of S-OPAT?

• How can you implement an S-OPAT program in the hospital?

After inclusion into the study the patient or a caregiver will be trained to perform S-OPAT by a nurse. The nurse will then sign a qualification form. If a patient is deemed unsuitable they will be deferred to the regular OPAT program. In the study there will be a weekly mandatory visit from the nurse of the home care organization for line dressing change and line care. The weekly home visits provide opportunities to assess patient condition and adherence to the self-administration. The patient's ongoing ability to perform self-administration and care partner fatigue are also evaluated. For this assessment, the nurse will fill out a short check-list every week. If during the S-OPAT trajectory, the patient is deemed unsuitable to perform self-administration according to the visiting nurse, the patient/caregiver will stop self-administration and will be deferred to the regular OPAT program. At day 30 after discharge, patients will be asked to fill out questionnaires regarding: health-related quality of life, acceptability and satisfaction with the S-OPAT service. ;

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infections

• NCT number: NCT06404307
• Study type: Interventional
• Source: Erasmus Medical Center
• Contact: Brenda de Winter
• Phone: 0107033202
• Email: b.dewinter@erasmusmc.nl
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Completion date: March 31, 2025