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

N/AActive Not RecruitingNCT06189807

University of Michigan70 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

CKD Chronic Kidney Diseases

Interventions

Decision aidBEHAVIORAL

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.

Standard handoutOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: Day 1- 7 (post appointment with provider)

Secondary Outcomes

Feasibility of delivering a reproductive health decision aid in an academic nephrology clinic measured by proportion of approached patients that consent during screening period

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 12 months

Feasibility of delivering a reproductive health decision aid in a nephrology clinic - nephrologists

Data from ClinicalTrials.gov

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