ImPart for Chronic Kidney Disease
(ImPart Trial)
Recruiting in Palo Alto (17 mi)
Overseen byShena Gazaway, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
Disqualifiers: Dialysis, Hospice, Severe mental illness, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this study is to pilot test, an optimization trial approach to develop and refine the decision partnering skills of persons with stage 4 chronic kidney disease and their caregivers. Using a 2x2x2 full factorial design, 64 dyads (patients and one identified caregiver) will be randomized to receive one or more lay coach-delivered decision partnering training components, based on Pearlin's Stress-Health Model of Family Caregiving and Rini's Social Support Effectiveness theory. The components include: 1) caregiver coaching on effective decision support (1 vs. 3 sessions); 2) caregiver decision support communication training (1 session vs. none); and 3) patient social support effectiveness psychoeducation (yes vs. no).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment ImPart for Chronic Kidney Disease?
The research highlights the importance of shared decision making in managing chronic kidney disease, which is a key component of the ImPart treatment. Studies show that shared decision making can improve patient engagement and satisfaction, which may indirectly support the effectiveness of ImPart in helping patients make informed choices about their care.
12345Is the ImPart treatment for Chronic Kidney Disease safe for humans?
The research articles do not provide specific safety data for the ImPart treatment for Chronic Kidney Disease. They focus on decision-making processes and general safety concerns in CKD care, but not on the safety of this specific treatment.
678910How is the ImPart treatment for chronic kidney disease different from other treatments?
ImPart focuses on improving shared decision-making between patients and healthcare providers, which is a unique approach compared to traditional treatments that primarily focus on medical interventions. This treatment emphasizes patient involvement in decision-making, helping them to be better prepared and informed about their treatment options.
3461112Eligibility Criteria
This trial is for pairs of patients with stage 4 chronic kidney disease and their caregivers. Participants must be adults, able to speak and read English, and complete questionnaires. Each patient needs a confirmed diagnosis (with specific test results) and an enrolled caregiver willing to join the study.Inclusion Criteria
My kidney function is severely reduced.
I am 18 years old or older.
It seems like the criterion you provided is incomplete. If you have a specific criterion you'd like me to summarize, please provide the details and I'd be happy to help!
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants receive telehealth decision support training, including caregiver coaching and patient psychoeducation, over a 24-week period using a 2x2x2 factorial design.
24 weeks
Weekly sessions (in-person/telephone) and monthly follow-up calls
Follow-up
Participants are monitored for feasibility, acceptability, and preliminary efficacy of intervention components.
4 weeks
2 visits (in-person)
Participant Groups
The IMPART study tests how well different training programs help patients with chronic kidney disease and their caregivers make decisions together. It uses a special design where dyads get varying amounts of coaching on decision support, communication training, or social support psychoeducation.
8Treatment groups
Experimental Treatment
Group I: Basic social support + patient psychoeducationExperimental Treatment1 Intervention
1 in-person/telephone weekly sessions on providing social support for caregiver participants and 2 sessions of social support, decision aids, and tips for good communication for patient participants and a single monthly follow-up call for both participants.
Group II: Basic social support + communication + patient psychoeducationExperimental Treatment1 Intervention
2 in-person/telephone weekly sessions on providing social support and tips for good communication for caregiver participants and 2 sessions of social support, decision aids, and tips for good communication for patient participants and a single monthly follow-up call for both participants.
Group III: Basic social support + communicationExperimental Treatment1 Intervention
2 in-person/telephone weekly sessions on providing social support and tips for good communication for caregiver participants and a single monthly follow-up call for caregiver participant
Group IV: Basic social supportExperimental Treatment1 Intervention
1 in-person/telephone weekly sessions on providing social support for caregiver participants a single monthly follow-up call for the caregiver participant.
Group V: Advanced social support + patient psychoeducationExperimental Treatment1 Intervention
3 in-person/telephone weekly sessions on providing social support for caregiver participants and 2 sessions of social support, decision aids, and tips for good communication for patient participants and a single monthly follow-up call for both participants.
Group VI: Advanced social support + communication+ patient psychoeducationExperimental Treatment1 Intervention
4 in-person/telephone weekly sessions on providing social support and tips for good communication for caregiver participants and 2 sessions of social support, decision aids, and tips for good communication for patient participants and a single monthly follow-up call for both participants.
Group VII: Advanced social support + communicationExperimental Treatment1 Intervention
4 in-person/telephone weekly sessions on providing social support and tips for good communication for caregiver participants and a single monthly follow-up call for caregiver participant
Group VIII: Advanced social supportExperimental Treatment1 Intervention
3 in-person/telephone weekly sessions on providing social support for caregiver participants and a single monthly follow-up call for caregiver participant
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Shena GazawayBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Characterizing Approaches to Dialysis Decision Making with Older Adults: A Qualitative Study of Nephrologists. [2023]Despite guidelines recommending shared decision making, nephrologists vary significantly in their approaches to discussing conservative management for kidney replacement therapy with older patients. Many older patients do not perceive dialysis initiation as a choice or receive sufficient information about conservative management for reasons incompletely understood. We examined how nephrologists' perceptions of key outcomes and successful versus failed treatment discussions shape their approach and characterized different models of decision making, patient engagement, and conservative management discussion.
Shared patient and provider values in end-stage renal disease decision making: Identifying the tensions. [2020]To examine concordance and tensions in values among stakeholder groups across the shared decision making process for end-stage renal disease patients treated with hemodialysis.
Challenges to Shared Decision Making About Treatment of Advanced CKD: A Qualitative Study of Patients and Clinicians. [2023]Greater understanding of the challenges to shared decision making about treatment of advanced chronic kidney disease (CKD) is needed to support implementation of shared decision making in clinical practice.
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 Prepare for Kidney Care Study: prepare for renal dialysis versus responsive management in advanced chronic kidney disease. [2021]Shared decision making in advanced chronic kidney disease (CKD) requires unbiased information on survival and person-centred outcomes known to matter to patients: quality of life, symptom burden and support from family and healthcare professionals. To date, when deciding between dialysis and conservative care, patients have had to rely on evidence from small observational studies. Clinicians recognize that like is not being compared with like in these studies, and interpret the results differently. Furthermore, support differs considerably between renal units. What patients choose therefore depends on which renal unit they attend. To address this, a programme of work has been underway in the UK. After reports on survival and symptoms from a small number of renal units, a national, mixed-methods study-the Conservative Kidney Management Assessment of Practice Patterns Study-mapped out conservative care practices and attitudes in the UK. This led to the Prepare for Kidney Care study, a randomized controlled trial comparing preparation for dialysis versus preparation for conservative care. Although powered to detect a positivist 0.345 difference in quality-adjusted life years between the two treatments, this trial also takes a realist approach with a range of person-centred secondary outcomes and embedded qualitative research. To understand generalizability, it is nested in an observational cohort study, which is nested in a CKD registry. Challenges to recruitment and retention have been rapidly identified and addressed using an established embedded mixed methods approach-the QuinteT recruitment intervention. This review considers the background to and progress with recruitment to the trial.
Preferences for and Experiences of Shared and Informed Decision Making Among Patients Choosing Kidney Replacement Therapies in Nephrology Care. [2022]Chronic kidney disease (CKD) can progress rapidly, and patients are often unprepared to make kidney failure treatment decisions. We aimed to better understand patients' preferences for and experiences of shared and informed decision making (SDM) regarding kidney replacement therapy before kidney failure.
Treating Early-Stage CKD With New Medication Therapies: Results of a CKD Patient Survey Informing the 2020 NKF-FDA Scientific Workshop on Clinical Trial Considerations for Developing Treatments for Early Stages of Common, Chronic Kidney Diseases. [2022]With a growing number of medications and therapies available to treat chronic kidney disease (CKD), risk-versus-benefit discussions are increasingly critical. Balancing risks and benefits requires assessing patients' understanding of these, as well as incorporating patient preferences and tolerance for side effects into shared decision making.
Patient-Reported Safety Events in Chronic Kidney Disease Recorded With an Interactive Voice-Inquiry Dial-Response System: Monthly Report Analysis. [2023]Monitoring patient-reported outcomes (PROs) may improve safety of chronic kidney disease (CKD) patients.
Patient-reported and actionable safety events in CKD. [2021]Patients with CKD are at high risk for adverse safety events because of the complexity of their care and impaired renal function. Using data from our observational study of predialysis patients with CKD enrolled in the Safe Kidney Care study, we estimated the baseline frequency of adverse safety events and determined to what extent these events co-occur. We examined patient-reported adverse safety incidents (class I) and actionable safety findings (class II), conditioned on participant use of drugs that might cause such an event, and we used association analysis as a data-mining technique to identify co-occurrences of these events. Of 267 participants, 185 (69.3%) had at least one class I or II event, 102 (38.2%) had more than one event, and 48 (18.0%) had at least one event from both classes. The adjusted conditional rates of class I and class II events ranged from 2.9 to 57.6 per 100 patients and from 2.2 to 8.3 per 100 patients, respectively. The most common conditional class I and II events were patient-reported hypoglycemia and hyperkalemia (serum potassium>5.5 mEq/L), respectively. Reporting of hypoglycemia (in patients with diabetes) and falling or severe dizziness (in patients without diabetes) were most frequently paired with other adverse safety events. We conclude that adverse safety events are common and varied in CKD, with frequent association between disparate events. Further work is needed to define the CKD "safety phenotype" and identify patients at highest risk for adverse safety events.
Using the diffusion of innovations theory to assess socio-technical factors in planning the implementation of an electronic health record alert across multiple primary care clinics. [2018]Adverse drug events (ADEs) are a leading cause of death in the United States. Patients with stage 3 and 4 chronic kidney disease (CKD) are at particular risk because many medications are cleared by the kidneys. Alerts in the electronic health record (EHR) about drug appropriateness and dosing at the time of prescription have been shown to reduce ADEs for patients with stage 3 and 4 CKD in inpatient settings, but more research is needed about the implementation and effectiveness of such alerts in outpatient settings.
Can we routinely measure patient involvement in treatment decision-making in chronic kidney care? A service evaluation in 27 renal units in the UK. [2022]Shared decision making is considered an important aspect of chronic disease management. We explored the feasibility of routinely measuring kidney patients' involvement in making decisions about renal replacement therapy (RRT) in National Health Service settings.
Integrated Digital Health System Tools to Support Decision Making and Treatment Preparation in CKD: The PREPARE NOW Study. [2022]Digital health system tools to support shared decision making and preparation for kidney replacement treatments for patients with chronic kidney disease (CKD) are needed.