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Self-administration in Outpatient Parenteral Antimicrobial Therapy service

Self-administration in Outpatient Parenteral Antimicrobial Therapy service - SELF-OPAT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56984
Enrollment
70
Registered
2024-09-02
Start date
2024-10-01
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

selfadministration of intravenous antimicrobial therapy

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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 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 Instead of the patient, a caregiver can also be eligible to perform self-administration. A caregiver is eligible if: - Aged 18 and over - Able to understand written information and able to give informed consent - Able and willing to perform daily administration of intravenous therapy after following a training - Patient is willing to get self-administered by this caregiver

Exclusion criteria

Exclusion criteria: - Former participation in this study - 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 antimicrobial therapy required - More than one intravenous administration device required (e.g. elastomeric pump and medication cassette)

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
S-OPAT outcomes - To investigate the number of scheduled and unscheduled S-OPAT related nurse visits to the patient - To investigate the number of OPAT related (telephone) consultations (to the nurse and the hospital) - 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 - To investigate the time to discharge after signing up for OPAT - The number of patients/caregivers who successfully complete S-OPAT training and are therefore qualified for self-administration. Successful completion of S-OPAT training is defined as the completion of the training for S-OPAT and the subsequent qualification (knowledge check and return demonstration) for S-OPAT trajectory by the nurse. - To describe characteristics of patients/caregivers who successfully completed S-OPAT training versus patients who did not qualify for self-administration. Determinants taken into account are e.g. demographic factors (age, sex), medical factors (indication, treatment duration, comorbidities), infusion factors (type of device). - The number of patients/caregivers who finish their complete assigned S-OPAT trajectory. - 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. Determinants taken into account are e.g. demographic factors (age, sex), medical factors (indication, treatment duration, comorbidities), infusion factors (type of device). Cost outcomes - To investigate the healthcare costs of S-OPAT Clinical outcomes - To investigate the clinical outcomes at day 30 after discharge. The following clinical outcomes are taken into account: o Cure (defined as patients who completed S-OPAT and do not require IV antimicrobial therapy after the end of S-OPAT). o Reinfection o Duration of S-OPAT treatment o Mortality - To investigate the adverse event

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 27, 2026