Pregnancy and Contraception Education in Chronic Kidney Disease (PACE-CKD): A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Preparation for Decision Making (PrepDM) score at post-intervention
研究概览
简要总结
This pilot study will assess the efficacy of a pregnancy and contraception education decision aid (DA) for patients with chronic kidney disease to support decisions about reproductive health, and will assess feasibility and acceptability of the intervention to inform future Research Project Grant (R01) level studies.
详细描述
60 patient participants will receive either a novel DA about pregnancy and contraception in chronic kidney disease delivered by patient's nephrologist or will receive currently available educational materials based on clinic-level randomization. Nephrologists will be trained to deliver the novel decision aid or will provide usual care. Patients will complete a survey about pregnancy and contraception decision making and the acceptability and feasibility of the educational materials after the clinical visit. Intervention nephrologists will be anonymously surveyed after all patients have completed measures, to assess acceptability and feasibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any Chronic Kidney Disease (CKD) diagnosis
- •CKD defined as abnormality in kidney structure or function for >3 months and may be manifested by having any one of the following:
- •i. Glomerular filtration rate (GFR)<60 milliliter/Minute (ml/min)/1.73m2, or
- •ii. A marker of kidney damage (albuminuria >30 milligrams per gram (mg/g), abnormal kidney histology by biopsy, hematuria, structural abnormalities by imaging (e.g. polycystic kidney disease, horseshoe kidney) or electrolyte abnormalities due to tubular disorders)
- •- Able to speak and read English
排除标准
- •Patients receiving dialysis
- •Patients who have a kidney transplant
- •Patients that are surgically sterile (tubal ligation or hysterectomy) or currently pregnant
- •Patients that have significant cognitive or visual impairment that limits interaction with the decision aid (DA)
结局指标
主要结局
Preparation for Decision Making (PrepDM) score at post-intervention
时间窗: Day 1- 7 (post appointment with provider)
This is a 10-item survey that participants answer not at all (1) to a great deal (5). PrepDM is scored on a 0-100 scale, where higher score indicates better preparation for decision making. A score of \>75 is a clinically significant cut off that indicates participants being well prepared to make decisions after reviewing a DA.The PrepDM scale was adapted slightly to meet the needs of the target population and the developed novel decision aid.
次要结局
- Feasibility of delivering a reproductive health decision aid in an academic nephrology clinic measured by the percentage of enrolled patients in the intervention clinics that providers reviewed contraception or pregnancy planning with participants during(Day 1 (Visit at the clinic))
- Acceptability of delivering a reproductive health decision aid in a nephrology clinic -participants(Day 1- 7 (post appointment with provider))
- Feasibility of delivering a reproductive health decision aid in a nephrology clinic - nephrologists(12 months)
- Feasibility of delivering a reproductive health decision aid in an academic nephrology clinic measured by proportion of approached patients that consent during screening period(12 months (after recruitment starts))
- Acceptability of delivering a reproductive health decision aid in a nephrology clinic- nephrologists(12 months)
研究者
Andrea Oliverio
Assistant Professor
University of Michigan