Pregnancy and Contraception Education for Chronic Kidney Disease
(PACE-CKD Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Michigan
Disqualifiers: Dialysis, Kidney transplant, Surgically sterile, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Pregnancy and Contraception Education Decision Aid for chronic kidney disease?
Research shows that decision aids, which help patients understand their treatment options, can lead to better decision-making and outcomes. These aids help patients choose the right treatment for them, which can improve their adherence to the treatment and their overall health.
12345Is the Pregnancy and Contraception Education Decision Aid safe for people with chronic kidney disease?
The research does not provide specific safety data for the Pregnancy and Contraception Education Decision Aid, but it emphasizes the importance of personalized and safe contraception options for women with chronic kidney disease.
23678How is the treatment in the Pregnancy and Contraception Education for Chronic Kidney Disease trial different from other treatments for CKD?
This treatment is unique because it focuses on providing comprehensive reproductive counseling for women with chronic kidney disease (CKD), addressing the lack of consistent and adequate information about pregnancy and contraception. Unlike other treatments that may focus solely on medical management of CKD, this approach emphasizes informed decision-making and patient-centered care regarding reproductive health.
267910Eligibility Criteria
This trial is for patients with chronic kidney disease who are interested in making informed decisions about their reproductive health. Specific eligibility criteria have not been provided, but typically such trials require participants to be adults capable of consent and without conditions that might interfere with the study.Inclusion Criteria
Able to speak and read English
I have been diagnosed with chronic kidney disease.
I have kidney problems for more than 3 months.
Exclusion Criteria
I have had a kidney transplant.
Patients that have significant cognitive or visual impairment that limits interaction with the decision aid (DA)
I am either surgically sterile or currently pregnant.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants receive either a novel decision aid about pregnancy and contraception in chronic kidney disease or currently available educational materials
1 day
1 visit (in-person)
Follow-up
Participants complete a survey about pregnancy and contraception decision making and the acceptability and feasibility of the educational materials
1 week
1 visit (virtual)
Long-term Follow-up
Nephrologists are anonymously surveyed after all patients have completed measures to assess acceptability and feasibility
12 months
Participant Groups
The study is testing a special decision aid designed to help kidney disease patients understand their options regarding pregnancy and contraception. This will be compared to standard informational handouts. The goal is to see if the decision aid improves understanding and decision-making.
2Treatment groups
Experimental Treatment
Group I: Intervention Group - Decision aidExperimental Treatment1 Intervention
Group II: Control Group -Experimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MichiganAnn Arbor, MI
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Who Is Running the Clinical Trial?
University of MichiganLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
How to select among dialysis options. [2019]End-stage renal disease is an almost unique disease area in which patients not only choose their treatment modality but can also change their mind and their treatment as time goes by. The way that information about treatment options is presented to patients is critical in influencing how they process this information, and it is possible to present information to patients in different ways so that patients can make better decisions about the treatment they receive. It is important to recognize that simply giving more information to patients does not necessarily improve their ability to make decisions. Instead, a series of simple principles should be used when giving information to help patients to choose between dialysis options, and it is possible to put this together into 'patient decision aid' which will reduce bias and increase the likelihood of a patient choosing the treatment which is right for them. If a patient does do this, it is more likely that they will comply with the treatment better, tolerate complications of the treatment better, and experience better outcomes.
Supporting Patient-Centered Pregnancy Counseling in Nephrology Care: A Semistructured Interview Study of Patients and Nephrologists. [2023]Individuals with chronic kidney disease (CKD) are at increased risk of adverse pregnancy outcomes and are susceptible to disempowerment and decisional burden when receiving reproductive counseling and considering pregnancy. Nephrologists do not frequently counsel about reproductive health, and no tools exist to support patient-centered reproductive counseling for those with CKD.
Development of a decision aid to inform patients' and families' renal replacement therapy selection decisions. [2021]Few educational resources have been developed to inform patients' renal replacement therapy (RRT) selection decisions. Patients progressing toward end stage renal disease (ESRD) must decide among multiple treatment options with varying characteristics. Complex information about treatments must be adequately conveyed to patients with different educational backgrounds and informational needs. Decisions about treatment options also require family input, as families often participate in patients' treatment and support patients' decisions. We describe the development, design, and preliminary evaluation of an informational, evidence-based, and patient-and family-centered decision aid for patients with ESRD and varying levels of health literacy, health numeracy, and cognitive function.
Use of a Supportive Kidney Care Video Decision Aid in Older Patients: A Randomized Controlled Trial. [2021]There are few studies of patient-facing decision aids that include supportive kidney care as an option. We tested the efficacy of a video decision aid on knowledge of supportive kidney care among older patients with advanced CKD.
Value of patient decision aids for shared decision-making in kidney failure. [2023]It is unknown how often Dutch patient decision aids are used during kidney failure treatment modality education and what their impact is on shared decision-making.
The patient experience of kidney disease and pregnancy. [2020]Achieving parenthood is often a priority and goal for women with chronic kidney disease (CKD). It can be challenging due to medical and emotional complexities around pregnancy planning and care, increased risk of adverse maternal and fetal outcomes, fears about medications such as immunosuppressants and fetal harm, and concerns regarding the impact of pregnancy on women's kidney health. Navigating the pathways for shared decision-making regarding parenthood requires an understanding of the patient's experiences, values, priorities, and needs. In this review, we describe the patient perspective of high-risk pregnancies including those complicated by CKD and outline recommendations for counseling that incorporate these perspectives to improve the patient experience.
Ignorance is Not Bliss: The Case for Comprehensive Reproductive Counseling for Women with Chronic Kidney Disease. [2023]The bioethics literature has paid little attention to matters of informed reproductive decision-making among women of childbearing age who have chronic kidney disease (CKD), including women who are on dialysis or women who have had a kidney transplant. Women with CKD receive inconsistent and, sometimes, inadequate reproductive counseling, particularly with respect to information about pursuing pregnancy. We identify four factors that might contribute to inadequate and inconsistent reproductive counseling. We argue that women with CKD should receive comprehensive reproductive counseling, including information about the possibility of pursuing pregnancy, and that more rigorous research on pregnancy in women with CKD, including women on dialysis or who have received a kidney transplant, is warranted to improve informed reproductive decision making in this population.
Contraception in chronic kidney disease: a best practice position statement by the Kidney and Pregnancy Group of the Italian Society of Nephrology. [2022]Even though fertility is reduced, conception and delivery are possible in all stages of CKD. While successful planned pregnancies are increasing, an unwanted pregnancy may have long-lasting deleterious effects, hence the importance of birth control, an issue often disregarded in clinical practice. The evidence summarized in this position statement is mainly derived from the overall population, or other patient categories, in the lack of guidelines specifically addressed to CKD. Oestroprogestagents can be used in early, non-proteinuric CKD, excluding SLE and immunologic disorders, at high risk of thromboembolism and hypertension. Conversely, progestin only is generally safe and its main side effect is intramestrual spotting. Non-medicated intrauterine devices are a good alternative; their use needs to be carefully evaluated in patients at a high risk of pelvic infection, even though the degree of risk remains controversial. Barrier methods, relatively efficacious when correctly used, have few risks, and condoms are the only contraceptives that protect against sexually transmitted diseases. Surgical sterilization is rarely used also because of the risks surgery involves; it is not definitely contraindicated, and may be considered in selected cases. Emergency contraception with high-dose progestins or intrauterine devices is not contraindicated but should be avoided whenever possible, even if far preferable to abortion. Surgical abortion is invasive, but experience with medical abortion in CKD is still limited, especially in the late stages of the disease. In summary, personalized contraception is feasible, safe and should be offered to all CKD women of childbearing age who do not want to get pregnant.
Feminizing care pathways: Mixed-methods study of reproductive options, decision making, pregnancy, post-natal care and parenting amongst women with kidney disease. [2023]To identify the needs, experiences and preferences of women with kidney disease in relation to their reproductive health to inform development of shared decision-making interventions.
Pregnancy and contraceptive counseling of women with chronic kidney disease and kidney transplants. [2022]Women with kidney disease of childbearing age should expect proactive counseling regarding pregnancy and contraception. Discussions should include the impact of pregnancy on their kidney disease and the impact of kidney disease on maternal and fetal outcomes. However, nephrologists rarely discuss sexual dysfunction, infertility, menstrual irregularities, and contraception with their premenopausal women patients. This review will consider pregnancy-related issues to discuss when counseling women with all stages of chronic kidney disease. Issues related to contraception in women on dialysis, women with functioning kidney transplants, and those with chronic kidney disease will also be reviewed.