Chronic Kidney Diseases, CKD
Conditions
Keywords
Pregnancy and Contraception education
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.
Interventions
BEHAVIORALDecision 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.
OTHERStandard 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 1- 7 (post appointment with provider) | Acceptability of using the shared decision aid will be assessed by 8 questions and analyzed descriptively. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed