Self-administration in Outpatient Parenteral Antimicriobial Therapy Service
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- To asses the capability of patients to self-administer antibiotics in the outpatient setting in the Dutch medical system.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/line 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
排除标准
- •Former participation in this study
- •Pregnancy
- •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 drugs required
- •More than one intravenous administration device required (e.g. elastomeric pump and medication cassette)
结局指标
主要结局
To asses the capability of patients to self-administer antibiotics in the outpatient setting in the Dutch medical system.
时间窗: 30 days after discharge
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.
次要结局
- Visits(30 days after discharge)
- Consultations(30 days after discharge)
- Devices(30 days after discharge)
- Time to discharge(30 days after discharge)
- The number of patients/caregivers who finish their complete assigned S-OPAT trajectory(30 days after discharge)
- The costs associated with performing and organizing S-OPAT in de Dutch medical system(30 days after discharge)
- Clinical outcomes: The outcomes of the infection in S-OPAT treatment(30 days after discharge)
- Clinical outcomes: Duration of treatment in S-OPAT(30 days after discharge)
- Adverse events(30 days after discharge)
- Readmission rate(30 days after discharge)
- Satisfaction outcomes(30 days after discharge)
- Patient/caregiver characteristics(30 days after discharge)
- Training completion(30 days after discharge)
- Clinical outcomes: Amount of patients experiencing reinfection in S-OPAT treatment(30 days after discharge)
- Clinical outcomes: Patient mortality as performing S-OPAT(30 days after discharge)
- Health outcomes(30 days after discharge)
研究者
Dr. B.C.M. (Brenda) de Winter
Assistent professor
Erasmus Medical Center