Pregnancy and Contraception Education in Chronic Kidney Disease (PACE-CKD) (PACE-CKD)

Pregnancy and Contraception Education in Chronic Kidney Disease (PACE-CKD): A Pilot Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Kidney Diseases; CKD
• Intervention / Treatment: Other: Standard handout; Behavioral: Decision aid

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control Group -	Other: Standard handout; Enrolled participants will be sent the standard information about pregnancy, birth control, and kidney disease and asked to read that information prior to a standard of care appointment with participants nephrologist. Prior to the appointment study staff will provide participants with a paper version of the materials that had previously been sent. During the appointment, the participant's nephrologist may review the materials with the participant and answer any questions. Following the appointment, participants will be asked to complete a short survey about: the experience using the materials, experience about being counseled about pregnancy and birth control during visit, willingness to use such materials in the future, and information about participants kidney disease diagnosis.
Experimental: Intervention Group - Decision aid	Behavioral: Decision aid; Enrolled participants will be sent the novel educational decision aid about pregnancy, birth control, and kidney disease and asked to read that information prior to a standard of care appointment with participants nephrologist. Prior to the appointment, study staff will provide participants with a paper version of the materials that had previously been sent. During the appointment participant's nephrologist may review the materials with the participant and answer any questions. Following the appointment, participants will be asked to complete a short survey about: the experience using the materials, experience about being counseled about pregnancy and birth control during visit, willingness to use such materials in the future, and information about participants kidney disease diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preparation for Decision Making (PrepDM) score at post-intervention	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.	Day 1- 7 (post appointment with provider)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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	Acceptability of using the shared decision aid will be assessed by 8 questions and analyzed descriptively.	Day 1- 7 (post appointment with provider)
Acceptability of delivering a reproductive health decision aid in a nephrology clinic- nephrologists	Acceptability of using the shared decision aid will be assessed by 2 questions and analyzed descriptively.	12 months
Feasibility of delivering a reproductive health decision aid in a nephrology clinic - nephrologists	Feasibility of using the shared decision aid will be assessed by 2 questions and analyzed descriptively.	12 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Andrea Oliverio, MD, MSc, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2024
• Primary Completion (Actual): September 24, 2025
• Study Completion (Estimated): September 25, 2026

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 10, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Pregnancy and Contraception education
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Investigative Techniques; Decision Support Techniques
• Other Study ID Numbers: HUM00233787; 1K23DK123413-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No