Cost Effectiveness of Two Different Strategies to Implement the NVOG Guideline Programme on Subfertility
试验速览
- 阶段
- 不适用
- 入组人数
- 5,200
- 试验地点
- 16
- 主要终点
- Extent of guideline adherence after approximately one year (measured by a specific set of guideline-derived indicators, formulated beforehand by the research group)
研究概览
简要总结
The purpose of this study is to compare two different strategies to implement the existing Guideline programme on Subfertility, as issued by the Dutch Society of Obstetrics and Gynaecology (NVOG). Therefore, an innovative patient-directed strategy will be compared to a control strategy and effectiveness, costs and feasibility of both strategies will be assessed.
详细描述
The Dutch Society of Obstetrics and Gynaecology (NVOG) has developed a guideline programme on Subfertility, including 9 guidelines concerning diagnosis and treatment of subfertility and a national IVF protocol.
However, guidelines in general do not implement themselves; large gaps consists between best evidence (as described in the guidelines) and practice, resulting in a large variation between professionals.
Our study will compare an innovative patient-directed strategy with a (minimal intervention) control strategy, and effectiveness, costs and feasibility of both will be assessed. We eventually aim at the most cost-effective strategy to implement the existing subfertility guideline programme.
Please Note: In our protocol, we consider only 'couples' undergoing fertility treatment; therefore, we aim at gathering information from approximately 5200 records, of both male and female participants. When reporting eventually on their treatment, we will consider them only as couples, resulting in reported numbers of approximately 2600 participating couples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •each patient, male or female, visiting the OPD for a subfertility related problem or treatment
- •each patient admitted to the hospital with complications of an infertility treatment
排除标准
- •patients receiving insemination with donor sperm
- •patients receiving ICSI treatment
- •patients who are non-Dutch speaking or understand too little Dutch to fill out the questionnaires
研究组 & 干预措施
minimal intervention
professional audit and feedback on current practice
干预措施: professional audit and feedback (guideline adherence) (Behavioral)
maximal intervention
multi-faceted intervention consisting of professional and patient elements
干预措施: patient education (Behavioral)
maximal intervention
multi-faceted intervention consisting of professional and patient elements
干预措施: professional audit and feedback (guideline adherence) (Behavioral)
maximal intervention
multi-faceted intervention consisting of professional and patient elements
干预措施: professional education (communication/shared decision making) (Behavioral)
maximal intervention
multi-faceted intervention consisting of professional and patient elements
干预措施: information tools (Other)
结局指标
主要结局
Extent of guideline adherence after approximately one year (measured by a specific set of guideline-derived indicators, formulated beforehand by the research group)
时间窗: half year after intervention
Costs of both Implementation strategies
时间窗: half year after intervention
次要结局
- Psychosocial patient characteristics after one year: fear, depression, satisfaction(half year after intervention)