Clinical trial NCT06404307: Self-administration in Outpatient Parenteral Antimicrobial Therapy Service
Official title: Self-administration in Outpatient Parenteral Antimicriobial Therapy Service
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infections
Bacterial Infections
Keywords: Outpatient
Antimicrobials
Outpatient Parenteral Antimicrobial Treatment
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Amphia Hospital
First posted: 2024-05-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: To asses the capability of patients to self-administer antibiotics in the outpatient setting in the Dutch medical system.
timeFrame: 30 days after discharge
Secondary outcomes:
measure: Visits
timeFrame: 30 days after discharge
measure: Consultations
timeFrame: 30 days after discharge
measure: Devices
timeFrame: 30 days after discharge
measure: Time to discharge
timeFrame: 30 days after discharge
measure: Training completion
timeFrame: 30 days after discharge
measure: Patient/caregiver characteristics
timeFrame: 30 days after discharge
measure: The number of patients/caregivers who finish their complete assigned S-OPAT trajectory
timeFrame: 30 days after discharge
measure: The costs associated with performing and organizing S-OPAT in de Dutch medical system
timeFrame: 30 days after discharge
measure: Clinical outcomes: The outcomes of the infection in S-OPAT treatment
timeFrame: 30 days after discharge
measure: Clinical outcomes: Amount of patients experiencing reinfection in S-OPAT treatment
timeFrame: 30 days after discharge
measure: Clinical outcomes: Duration of treatment in S-OPAT
timeFrame: 30 days after discharge
measure: Clinical outcomes: Patient mortality as performing S-OPAT
timeFrame: 30 days after discharge
measure: Adverse events
timeFrame: 30 days after discharge
measure: Readmission rate
timeFrame: 30 days after discharge
measure: Satisfaction outcomes
timeFrame: 30 days after discharge
measure: Health outcomes
timeFrame: 30 days after discharge
Other outcomes:
measure: Duration of training
timeFrame: 30 days after discharge
measure: Patient satisfaction with training
timeFrame: 30 days after discharge
measure: Difference between S-OPAT carried out by patient or caregiver
timeFrame: 30 days after discharge
Locations:
city: Breda
country: Netherlands
facility: Amphia hospital
state: Noord-Brabant
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
affiliation: Erasmus MC University Medical Centre
name: Brenda de Winter, PharmD
role: PRINCIPAL_INVESTIGATOR
References: