To investigate if dried blood spot sampling of vancomycin and creatinine leads to less outpatient visits regarding vancomycin therapy compared to conventional sampling in OPAT service.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the amount of outpatient visits regarding
vancomycin therapy.
Secondary outcome
Outcomes regarding outpatient visits
- To compare the amount of outpatient visits with the sole purpose of
vancomycin TDM in the control group versus intervention group (phlebotomy
visits)
- To compare the amount of outpatient visits with the sole purpose of
laboratory sampling (with and without TDM) in the control group versus
intervention group
- To compare the amount of outpatient visits regarding vancomycin therapy
without laboratory sampling in the control group versus intervention group
- To compare the amount of outpatient visits regarding vancomycin therapy
including laboratory sampling (with and without TDM) in the control group
versus intervention group
- To compare the amount of VNC therapy related telephone consultations in the
control group versus intervention group
Sampling outcomes
- To compare the amount of correct blood sampling in the control group versus
intervention group
- To investigate the DBS sampling quality
- To investigate how many patients are failing DBS (and are subsequently
switched to conventional blood sampling)
- To explore the facilitators and barriers for (in)correct DBS sampling
- Amount of patients unable to perform fingerprick after training in the
hospital
- To explore potential determinants for patients who are failing or passing DBS
sampling under supervision after training (determinants taken into account are
e.g. demographic factors (age, sex, weight), use of anticoagulans, sampling by
patient or by family member/caregiver)
Satisfaction and quality of life outcomes
- To investigate if dried blood spot sampling of vancomycin leads to a higher
patient satisfaction compared with conventional sampling in OPAT service.
- To explore potential determinants for patient satisfaction; determinants
taken into account are e.g. demographic factors (age, sex, weight), geographic
factors (distance to sampling facility, mode of transportation to sampling
facility), medical factors (treatment infection, comorbidities, duration of
antibiotic treatment, outpatient visits, time to discharge), sampling factors
(DBS sampling by patient or by family member/caregiver, conventional sampling
by venepuncture or by drawing blood from line), patient costs and costs related
to loss of productivity.
- To investigate if dried blood spot sampling of vancomycin leads to a higher
quality of life compared with conventional sampling in OPAT service.
Cost outcomes
- To compare patient costs in the control group versus intervention group
- To compare costs related to loss of productivity in the control group versus
intervention group
- To compare health care costs in the control group versus intervention group
- To compare societal costs (total of all costs) in the control group versus
intervention group
Clinical outcomes
- To compare clinical outcomes (e.g. reinfection, readmission, complications,
duration of treatment, mortality) in the control group versus intervention
group
- To compare the relative amount of nephrotoxicity occurrence (defined as in
the RIFLE criteria) in the control group versus intervention group
- To compare the time to discharge after signing up for OPAT in the control
group versus intervention group
- To compare the duration of hospital stay in the control group versus
intervention group
TDM outcomes
- To compare the relative amount of creatinine measurements in the control
group versus intervention group
- To compare the relative amount of vancomycin measurements in the control
group versus intervention group
- To compare the relative time of vancomycin levels in the therapeutic range in
the control group versus intervention group
- To compare the amount of dosage changes of vancomycin therapy in the control
group versus intervention group
- To compare the time to achieving the therapeutic range of vancomycin levels
after dosage changes in the control group versus intervention group
Logistical outcomes
- To compare the time of vancomycin blood sample arrival at the lab after
sampling in the control group versus intervention group
Background summary
The OPAT service consists of providing antimicrobial therapy by parenteral
infusion without hospitalization. A widely used antibiotic in OPAT is
vancomycin. To ensure adequate exposure to vancomycin, drug doses are adjusted
based on blood concentration measurements, a practice known as therapeutic drug
monitoring (TDM). A drawback of vancomycin use in OPAT is the need TDM which
requires patients to travel to a blood sampling facility for blood sampling. An
alternative sampling method for TDM is the dried blood spot (DBS) method (i.e.
a finger prick). OPAT is provided for patients who are stable and healthy
enough to leave the hospital and clinical monitoring of these patient
population is minimal. However, clinical monitoring of vancomycin therapy
during OPAT is intensive due to TDM of vancomycin. By implementing DBS sampling
the amount of clinical consultations regarding vancomycin therapy in OPAT
services can be reduced. Furthermore, this effectiveness may increase when a
biochemical parameter such as renal function parameter (i.e. creatinine) are
measured along with drug concentrations (leading to even less outpatient
visits); the benefit of this has not been investigated yet
Study objective
To investigate if dried blood spot sampling of vancomycin and creatinine leads
to less outpatient visits regarding vancomycin therapy compared to conventional
sampling in OPAT service.
Study design
Open label randomized controlled parallel study.
Study burden and risks
All patients in both arms will receive standard of care treatment with
vancomycin and perform therapeutic drug monitoring of vancomycin as usual. The
only difference in the intervention arm is that blood sampling is performed by
dried blood spot sampling at home after being trained in the hospital. If dried
blood spot sampling fails, patients will be asked to go to a phlebotomy
facility for blood drawing (traditional sampling). Some patients in the
intervention group will be interviewed. All patients will be asked to fill out
questionnaires about medical consumption, work, satisfaction and quality of
life. Patients in the intervention arm may benefit from this study as the need
for travelling to a blood drawing facility is no longer required.
's Gravendijkwal 230
Rotterdam 3000 CA
NL
's Gravendijkwal 230
Rotterdam 3000 CA
NL
Listed location countries
Age
Inclusion criteria
- Aged 18 and over
- Able to understand written information and able to give informed consent
- Hospitalized
- Treated with intravenous vancomycin and to be discharged with vancomycin OPAT
service with minimal 1 planned outpatient vancomycin TDM order
- Able and willing to perform finger pricks for dried blood spot sampling, or
able and willing to undergo finger pricks performed by family members or other
caregivers
- Able and willing to fill in questionnaires
Exclusion criteria
- Former participation in this trial
- Cognitive dysfunction or other dysfunctionalities which makes the patient
unable to draw blood by a fingerprick or fill out questionnaires
- Unable to sample an adequate DBS after training in the hospital (this is also
applicable for family members or other caregivers who are failing to perform
adequate DBS sampling for the patient)
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 | NL83813.078.23 |