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| Name | Class |
|---|---|
| Amphia Hospital | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-administration | Experimental | Trained patients that will self-administer their antimicrobials in the outpatient setting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-administration | Behavioral | patients will self administer their antimicrobial treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Visits | To investigate the number of scheduled and unscheduled S-OPAT related nurse visits to the patient | 30 days after discharge |
| Consultations | To investigate the number of OPAT related telephone consultations (to the nurse and the hospital) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of training | Duration of S-OPAT training | 30 days after discharge |
| Patient satisfaction with training | The patients or caregivers who followed the S-OPAT training will receive a questionnaire with questions about their experience with the training and how well they understood the training. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brenda de Winter | Contact | 0107033202 | b.dewinter@erasmusmc.nl | |
| Moska Hassanzai, PharmD | Contact | 0107033202 | m.hassanzai@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Brenda de Winter, PharmD | Erasmus MC University Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amphia hospital | Breda | North Brabant | 4818CK | Netherlands |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D012646 | Self Administration |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D012648 | Self Care |
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| 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 | 30 days after discharge |
| Time to discharge | To investigate the time to discharge after signing up for OPAT | 30 days after discharge |
| Training completion | The number of patients/caregivers who successfully complete S-OPAT training and are therefore qualified for self-administration. | 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. | 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. | 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:
| 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. | 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 | 30 days after discharge |
| Clinical outcomes: Duration of treatment in S-OPAT | To investigate the amount of time patients spend in S-OPAT treatment | 30 days after discharge |
| Clinical outcomes: Patient mortality as performing S-OPAT | To investigate how many patients die whilst performing S-OPAT | 30 days after discharge |
| Adverse events | To investigate the adverse events reported during the first 30 days after discharge. | 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 | 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. | 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. | 30 days after discharge |
| 30 days after discharge |
| Difference between S-OPAT carried out by patient or caregiver | The performance of self-administration in the S-OPAT services by patients and caregivers will be compared. | 30 days after discharge |
| Erasmus MC | Rotterdam | South Holland | 3000WB | Netherlands |
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