Clinical trial NCT06189807: Pregnancy and Contraception Education in Chronic Kidney Disease (PACE-CKD)
Official title: Pregnancy and Contraception Education in Chronic Kidney Disease (PACE-CKD): A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CKD
Chronic Kidney Diseases
Keywords: Pregnancy and Contraception education
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-01-05
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group assignment will be randomized at the clinic level to intervention decision aid (N=2 clinics) or control (N=2 clinics). Nephrologists will be trained to deliver the intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Preparation for Decision Making (PrepDM) score at post-intervention
timeFrame: Day 1- 7 (post appointment with provider)
Secondary outcomes:
measure: Feasibility of delivering a reproductive health decision aid in an academic nephrology clinic measured by proportion of approached patients that consent during screening period
timeFrame: 12 months (after recruitment starts)
measure: 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
timeFrame: Day 1 (Visit at the clinic)
measure: Acceptability of delivering a reproductive health decision aid in a nephrology clinic -participants
timeFrame: Day 1- 7 (post appointment with provider)
measure: Acceptability of delivering a reproductive health decision aid in a nephrology clinic- nephrologists
timeFrame: 12 months
measure: Feasibility of delivering a reproductive health decision aid in a nephrology clinic - nephrologists
timeFrame: 12 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Andrea Oliverio, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: