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InfectionsSELF-OPATNCT06404307

Self-administration in Outpatient Parenteral Antimicrobial Therapy Service

A study testing Self-administration in people with Infections and Bacterial Infections, run by Erasmus Medical Center at 2 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Infections, Bacterial Infections
What is being tested?
Self-administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesNetherlands
Study dates
May 2024to 31 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

Brenda de Winter contact

0107033202

b.dewinter@erasmusmc.nl

Moska Hassanzai, PharmD contact

0107033202

m.hassanzai@erasmusmc.nl

Netherlands2 sites
  • Amphia hospital

    Breda, North Brabant, 4818CK

    Jeroen Diepstraten, PharmD, jdiepstraten@amphia.nl

  • Erasmus MC

    Rotterdam, South Holland, 3000WB

    Moska KochHassanzai, PharmD, 0107033202, m.hassanzai@erasmusmc.nl

    Brenda de Winter, PharmD, 0107033202, b.dewinter@erasmusmc.nl

Other trials in Netherlands

About this study

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

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:

Read more

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.

Read the 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.

Being tested
Self-administration
Keywords
Outpatient, Antimicrobials, Outpatient Parenteral Antimicrobial Treatment
Medical subject headings
Infections, Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-administrationBehavioural

    patients will self administer their antimicrobial treatment

Study groups in NCT06404307
Study groupRoleWhat they receive
Self-administrationExperimentalTrained patients that will self-administer their antimicrobials in the outpatient setting
Receives: Behavioral: Self-administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 days after discharge

Secondary outcomes (16)
  1. Visits

    To investigate the number of scheduled and unscheduled S-OPAT related nurse visits to the patient

    Measured: 30 days after discharge

  2. Consultations

    To investigate the number of OPAT related telephone consultations (to the nurse and the hospital)

    Measured: 30 days after discharge

  3. Devices

    To investigate the number of the different infusion devices (i.e. elastomeric pumps, infusion bags, infusion cassettes) used for S-OPAT patients in this study

    Measured: 30 days after discharge

  4. Time to discharge

    To investigate the time to discharge after signing up for OPAT

    Measured: 30 days after discharge

  5. Training completion

    The number of patients/caregivers who successfully complete S-OPAT training and are therefore qualified for self-administration.

    Measured: 30 days after discharge

  6. Patient/caregiver characteristics

    To describe characteristics of patients/caregivers who successfully completed S-OPAT training versus patients who did not qualify for self-administration.

    To describe characteristics of patients/caregivers who successfully completed their S-OPAT trajectory (with only a weekly scheduled nurse visit) versus patients who did not.

    Measured: 30 days after discharge

  7. The number of patients/caregivers who finish their complete assigned S-OPAT trajectory

    The total amount of patients or caregivers that succesfully complete their assigned S-OPAT trajectory.

    Measured: 30 days after discharge

  8. The costs associated with performing and organizing S-OPAT in de Dutch medical system

    To investigate the healthcare costs of S-OPAT by investigating the costs attributed to:

    • loss of productive hours by the patient
    • requirement of nursing staff
    • travel costs
    • cost of materials

    Measured: 30 days after discharge

  9. Clinical outcomes: The outcomes of the infection in S-OPAT treatment

    To investigate the progression of the infection in the patients when in S-OPAT treatment.

    Measured: 30 days after discharge

  10. Clinical outcomes: Amount of patients experiencing reinfection in S-OPAT treatment

    To investigate the amount of patients that experience reinfection when treated in S-OPAT setting

    Measured: 30 days after discharge

  11. Clinical outcomes: Duration of treatment in S-OPAT

    To investigate the amount of time patients spend in S-OPAT treatment

    Measured: 30 days after discharge

  12. Clinical outcomes: Patient mortality as performing S-OPAT

    To investigate how many patients die whilst performing S-OPAT

    Measured: 30 days after discharge

  13. Adverse events

    To investigate the adverse events reported during the first 30 days after discharge.

    Measured: 30 days after discharge

  14. Readmission rate

    To investigate the 30 day all-cause readmission rate after the end of the S-OPAT trajectory.

    To investigate the 30 day OPAT/infection related readmission rate of the S-OPAT trajectory

    Measured: 30 days after discharge

  15. Satisfaction outcomes

    To investigate the patient acceptability with S-OPAT by handing them a questionnaire about their experience with S-OPAT.

    Measured: 30 days after discharge

  16. Health outcomes

    The patients will fill out a EQ-5D-5L questionnaire both at discharge and after 30 days of S-OPAT treatment. These will be compared to each other and to other patients.

    Measured: 30 days after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2024
  2. Study startMay 2024 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06404307
Sponsor's protocol ID
ABR NL85913.078.24
Acronym
SELF-OPAT
Status last verified
May 2024
First submitted
9 Apr 2024
Last updated
8 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Self-administration in people with Infections and Bacterial Infections, run by Erasmus Medical Center at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Brenda de Winter (0107033202, b.dewinter@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To asses the capability of patients to self-administer antibiotics in the outpatient setting in the Dutch medical system. (time frame: 30 days after discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.

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