Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404307
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-04-09
Brief Title:
Self-administration in Outpatient Parenteral Antimicrobial Therapy Service
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Self-administration in Outpatient Parenteral Antimicriobial Therapy Service
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SELF-OPAT
Brief 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 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
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 patients 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 andor 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 patients 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 patientcaregiver 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
OPAT can be performed in a variety of models Infusion in the patients 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 andor 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 patients 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 patientcaregiver 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None