Pregnancy and Contraception Education in Chronic Kidney Disease (PACE-CKD)
- Conditions
- Chronic Kidney DiseasesCKD
- Interventions
- Behavioral: Decision aidOther: Standard handout
- Registration Number
- NCT06189807
- Lead Sponsor
- University of Michigan
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 70
-
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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group - Decision aid Decision aid - Control Group - Standard handout -
- Primary Outcome Measures
Name Time Method Preparation for Decision Making (PrepDM) score at post-intervention 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.
- Secondary Outcome Measures
Name Time Method 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) Acceptability of using the shared decision aid will be assessed by 8 questions and analyzed descriptively.
Feasibility of delivering a reproductive health decision aid in a nephrology clinic - nephrologists 12 months Feasibility of using the shared decision aid will be assessed by 2 questions and analyzed descriptively.
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 Acceptability of using the shared decision aid will be assessed by 2 questions and analyzed descriptively.
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States