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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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
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.
- Conditions
- Infections, Bacterial Infections
- 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 group | Role | What they receive |
|---|---|---|
| Self-administration | Experimental | Trained 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.
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)
Visits
To investigate the number of scheduled and unscheduled S-OPAT related nurse visits to the patient
Measured: 30 days after discharge
Consultations
To investigate the number of OPAT related telephone consultations (to the nurse and the hospital)
Measured: 30 days after discharge
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
Time to discharge
To investigate the time to discharge after signing up for OPAT
Measured: 30 days after discharge
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
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
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
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
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
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
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
Clinical outcomes: Patient mortality as performing S-OPAT
To investigate how many patients die whilst performing S-OPAT
Measured: 30 days after discharge
Adverse events
To investigate the adverse events reported during the first 30 days after discharge.
Measured: 30 days after discharge
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
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
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.
- First posted8 May 2024
- Study startMay 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amphia Hospital
- Responsible party
- Principal investigator, Dr. B.C.M. (Brenda) de Winter, Erasmus Medical Center
- Investigators
- Brenda de Winter, PharmD, Principal investigator, Erasmus MC University Medical Centre
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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-administration in Outpatient Parenteral Antimicriobial Therapy Service
- ClinicalTrials.gov ID
- NCT06404307
- Acronym / sponsor ID
- SELF-OPAT / ABR NL85913.078.24
- Conditions
- Infections, Bacterial Infections
- Keywords
- Outpatient, Antimicrobials, Outpatient Parenteral Antimicrobial Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Amphia Hospital
- Study start
- May 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-administration | Experimental | Behavioral: Self-administrationTrained patients that will self-administer their antimicrobials in the outpatient setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-administrationpatients will self administer their antimicrobial treatment | Behavioural | Self-administration |
Primary outcome
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
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.
16 secondary outcomes
Visits
Time frame: 30 days after discharge
Consultations
Time frame: 30 days after discharge
Devices
Time frame: 30 days after discharge
Time to discharge
Time frame: 30 days after discharge
Training completion
Time frame: 30 days after discharge
Patient/caregiver characteristics
Time frame: 30 days after discharge
The number of patients/caregivers who finish their complete assigned S-OPAT trajectory
Time frame: 30 days after discharge
The costs associated with performing and organizing S-OPAT in de Dutch medical system
Time frame: 30 days after discharge
Clinical outcomes: The outcomes of the infection in S-OPAT treatment
Time frame: 30 days after discharge
Clinical outcomes: Amount of patients experiencing reinfection in S-OPAT treatment
Time frame: 30 days after discharge
Clinical outcomes: Duration of treatment in S-OPAT
Time frame: 30 days after discharge
Clinical outcomes: Patient mortality as performing S-OPAT
Time frame: 30 days after discharge
Adverse events
Time frame: 30 days after discharge
Readmission rate
Time frame: 30 days after discharge
Satisfaction outcomes
Time frame: 30 days after discharge
Health outcomes
Time frame: 30 days after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brenda de Winter, PharmD principal investigator
Erasmus MC University Medical Centre
2 sites in 1 country: see every site and its status.
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.