To assess feasibility of self-administration of intravenous antimicrobial therapy in the Dutch context.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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 events reported during the first 30 days after
discharge.
Adverse events are categorized into line-related events and adverse drug events
(ADEs). Line-related events included mechanical complications (dislodgement,
occlusion/clotting, malfunction, leakage) or infectious complications
(catheter-related bloodstream infections, site irritation/infection
(phlebitis)). Adverse events reported by health care professionals as well as
self-reported adverse events by the patient were included.Ook nog ADE
specificatie?
- To investigate the 30 day all-cause readmission rate after the end of the
S-OPAT trajectory. Unexpected hospital admission post-discharge is defined as
any readmission except for the scheduled admissions, such as elective surgeries
or chemotherapies.
- To investigate the 30 day OPAT/infection related readmission rate of the
S-OPAT trajectory
Satisfaction outcomes
- To investigate the patient satisfaction of S-OPATacceptability with S-OPAT
- To investigate the health-related quality of life (EQ-5D-5L questionnaire)
Background summary
The OPAT (Outpatient Parenteral Antimicrobial Therapy) service consists of
providing antimicrobial therapy by parenteral infusion without hospitalization.
The current practice is that a nurse visits the patient*s home daily to
administer the antimicrobial therapy (healthcare professional, H-OPAT).
However, OPAT can also be performed by the patient or caregiver. In this model
the patient/caregiver administrates the intravenous antimicrobial
(self-administration, S-OPAT). Internationally, S-OPAT is a well-established
practice, however research in the Netherlands on S-OPAT is lacking.
Study objective
To assess feasibility of self-administration of intravenous antimicrobial
therapy in the Dutch context.
Study design
Prospective observational feasibility study
Study burden and risks
All patients will receive standard of care treatment. The only difference is
that the patient/caregiver will be self-administering after qualification
instead of a nurse visiting the patient for administration daily.
Patient/caregiver will be thoroughly trained according to a standardized
training and competency form. There is 24/7 supervision available in case the
patient/caregiver is experiencing complications or has questions or concerns.
In the case that the patient/caregiver is failing self-administration (after
qualification), the patient will be deferred to the regular OPAT program
(H-OPAT). All patients will be asked to fill out questionnaires. Patients may
benefit from this study as they can administer the antimicrobial therapy when
it is convenient for them, instead of waiting for the nurse to arrive and
administer. Caregivers do not benefit from this study. Participation in this
study is extra time investment for the caregiver (for training and daily
administration)
Dr.Molewaterplein 40
Rotterdam 3015 GD
NL
Dr.Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85913.078.24 |