ImPart for Chronic Kidney Disease

(ImPart Trial)

Overseen By Alicia Cole, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Dialysis, Hospice, Severe mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist people with stage 4 chronic kidney disease (CKD) and their caregivers in improving health care decision-making. It tests various support methods for caregivers, such as coaching in decision-making and communication skills, and educating patients on obtaining effective social support. The trial includes several groups, each receiving a combination of training sessions to enhance teamwork between patients and caregivers. Individuals with stage 4 CKD who can communicate in English, along with their chosen caregiver, may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity for patients to enhance their healthcare experience through innovative support strategies.

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 prior data suggests that this methodology is safe for participants?

Research has shown that the ImPart treatment for chronic kidney disease aims to enhance decision-making between patients and caregivers. As this treatment involves training rather than a new drug or procedure, specific safety data is not available. Participants will not experience typical side effects associated with new medications.

The treatment includes various levels of social support and communication training for both caregivers and patients. These activities are generally safe, with no evidence indicating serious risks or negative effects. For those considering participation, the main focus will be on learning and practicing new skills in a supportive environment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ImPart program for chronic kidney disease (CKD) because it focuses on improving communication and support between patients and caregivers, which is a fresh approach compared to the usual medication or dialysis treatments. Unlike traditional treatments that primarily address the physical symptoms of CKD, ImPart aims to enhance decision-making and relationships, helping patients and caregivers navigate the emotional and practical challenges of the disease. This trial explores various combinations of social support, communication skills, and patient education to find the most effective way to empower and support individuals dealing with CKD. The hope is that by strengthening these interpersonal dynamics, patients will experience better overall outcomes and quality of life.

What evidence suggests that this trial's treatments could be effective for chronic kidney disease?

Research has shown that when patients and doctors make decisions together, patient involvement and satisfaction increase. This approach might enhance the effectiveness of the ImPart program for individuals with chronic kidney disease (CKD). In this trial, participants will join various treatment arms, each offering different combinations of social support, communication tips, and patient psychoeducation. Patients and caregivers who have participated in similar community programs have found them helpful for making health decisions. Collaborating in this way helps patients and their families manage health choices better, potentially leading to improved health outcomes. Programs focusing on both patients and caregivers have shown promise in supporting effective decision-making in CKD care. Overall, these findings suggest that ImPart could be a valuable tool for improving decision-making in CKD treatment. ^{1 2 6 7 8}

Who Is on the Research Team?

Shena Gazaway, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.

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!

You can speak and read English and fill out initial questionnaires.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• ImPart - Improving Chronic Kidney Disease Decisional Partnerships

Trial Overview 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.

How Is the Trial Designed?

Group I: Basic social support + patient psychoeducation Experimental Treatment 1 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 psychoeducation Experimental Treatment 1 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 + communication Experimental Treatment 1 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 support Experimental Treatment 1 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 psychoeducation Experimental Treatment 1 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 psychoeducation Experimental Treatment 1 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 + communication Experimental Treatment 1 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 support Experimental Treatment 1 Intervention

3 in-person/telephone weekly sessions on providing social support for caregiver participants and a single monthly follow-up call for caregiver participant

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A qualitative study involving 29 patients aged 65 and older with advanced chronic kidney disease (CKD) revealed significant differences in priorities between patients and clinicians regarding treatment decisions, highlighting the need for better alignment in shared decision-making.

Patients often felt that clinicians applied a standardized approach to CKD treatment, which did not fully consider their individual experiences and values, indicating a need for more personalized care strategies to enhance patient engagement and satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges to Shared Decision Making About Treatment of Advanced CKD: A Qualitative Study of Patients and Clinicians. House, TR., Wightman, A., Rosenberg, AR., et al.[2023]

The study involved 305 kidney patients in Phase 1 and 187 in Phase 2, assessing their involvement in decision-making about renal replacement therapy (RRT) within the last 90 to 180 days, showing that routine measurement of patient involvement is feasible in chronic disease management.

Most participants reported a collaborative decision-making style (73% in Phase 1 and 69% in Phase 2) and low decisional conflict (85% in Phase 1 and 76% in Phase 2), indicating that patients generally feel involved and confident in their treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can we routinely measure patient involvement in treatment decision-making in chronic kidney care? A service evaluation in 27 renal units in the UK. Durand, MA., Bekker, HL., Casula, A., et al.[2022]

A survey of 1,029 chronic kidney disease (CKD) patients revealed that many are willing to accept risks associated with preventative medications, especially as they approach late-stage disease, highlighting the importance of risk-benefit discussions in treatment decisions.

Clinician recommendations and support in managing side effects significantly influence patients' willingness to start and continue new medications, indicating the need for effective communication between patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Damron, KC., Friedman, R., Inker, LA., et al.[2022]

In a study of 267 predialysis patients with chronic kidney disease (CKD), 69.3% experienced at least one adverse safety event, highlighting the high risk of complications in this population.

The most common adverse events reported were hypoglycemia in diabetic patients and hyperkalemia (high potassium levels), with significant co-occurrences of these events, indicating a need for better safety monitoring in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. Ginsberg, JS., Zhan, M., Diamantidis, CJ., et al.[2021]

A study involving 34 stakeholders (17 hemodialysis patients, 9 nephrologists, and 8 non-physician providers) revealed shared values in communication and information that emphasize patient involvement and safety in decision-making for end-stage renal disease treatment.

Tensions were identified between personalized and routinized communication, highlighting the need for individualized information delivery to patients, which could improve self-care behaviors related to diet and medication adherence in a busy clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared patient and provider values in end-stage renal disease decision making: Identifying the tensions. Vandenberg, AE., Bowling, CB., Adisa, O., et al.[2020]

A study of 447 adults with chronic kidney disease found that while 72% preferred shared decision-making regarding kidney treatment, only 35% had discussions about dialysis or transplantation with their healthcare teams.

Patients who had longer-term nephrology care and more frequent visits were more likely to engage in treatment discussions, highlighting the importance of ongoing care in facilitating informed decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preferences for and Experiences of Shared and Informed Decision Making Among Patients Choosing Kidney Replacement Therapies in Nephrology Care. Barrett, TM., Green, JA., Greer, RC., et al.[2022]

Only 56% of healthcare professionals used patient decision aids like 'Three Good Questions' and the Dutch Kidney Guide during kidney failure treatment education, indicating limited implementation of these tools.

Patients reported higher satisfaction with their education in hospitals that utilized these decision aids, but their experience of shared decision-making did not improve after healthcare professionals received training on these aids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of patient decision aids for shared decision-making in kidney failure. van Eck van der Sluijs, A., Vonk, S., Bonenkamp, AA., et al.[2023]

The implementation of digital health tools in four chronic kidney disease clinics successfully identified 1,032 patients, with 24% classified as high-risk for kidney failure, demonstrating the efficacy of these tools in patient management.

The digital tools improved shared decision-making, as evidenced by 91% of patients completing a values clarification tool and 87% having their treatment preferences documented in the electronic health record, indicating high acceptability and usability among patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Digital Health System Tools to Support Decision Making and Treatment Preparation in CKD: The PREPARE NOW Study. Green, JA., Ephraim, PL., Hill-Briggs, F., et al.[2022]

The Conservative Kidney Management Assessment of Practice Patterns Study aims to provide unbiased information on survival and patient-centered outcomes in advanced chronic kidney disease, addressing the variability in care and decision-making across different renal units in the UK.

The Prepare for Kidney Care study is a randomized controlled trial designed to compare preparation for dialysis versus conservative care, focusing on quality-adjusted life years and incorporating qualitative research to enhance understanding of patient experiences and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Prepare for Kidney Care Study: prepare for renal dialysis versus responsive management in advanced chronic kidney disease. Murphy, E., Burns, A., Murtagh, FEM., et al.[2021]

In a 6-month study involving 52 Stage III-V CKD patients, the interactive voice-inquiry dial-response system (IVRDS) detected significantly more adverse safety events (54% of participants) compared to a paper diary (15%), highlighting its effectiveness in monitoring patient-reported outcomes.

The IVRDS not only identified a higher rate of clinically significant events, such as hypoglycemia, but also received positive feedback from participants, suggesting it could enhance patient safety in chronic kidney disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Safety Events in Chronic Kidney Disease Recorded With an Interactive Voice-Inquiry Dial-Response System: Monthly Report Analysis. Fink, JC., Doerfler, RM., Yoffe, MR., et al.[2023]

Patients with stage 3 and 4 chronic kidney disease (CKD) are at high risk for adverse drug events (ADEs) due to the kidneys' role in medication clearance, highlighting the need for effective monitoring systems.

Interviews with clinics revealed significant differences in electronic decision support practices and organizational culture, which are crucial factors to consider when implementing electronic drug-disease alerts to reduce ADEs in outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Lin, CP., Guirguis-Blake, J., Keppel, GA., et al.[2018]

A qualitative study involving 35 nephrologists revealed four distinct decision-making approaches regarding conservative management for kidney replacement therapy: paternalist, informative, interpretive, and institutionalist, with the interpretive model being the most effective for achieving shared decision making.

Only one third of nephrologists discussed conservative management options with patients, indicating a significant gap in patient engagement and information sharing, particularly among those who viewed dialysis initiation as a primary measure of success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Approaches to Dialysis Decision Making with Older Adults: A Qualitative Study of Nephrologists. Ladin, K., Pandya, R., Perrone, RD., et al.[2023]

Citations

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Partnering With Chronic Kidney Disease Dyads This presentation outlines the process of collaborative intervention development with a Community Advisory Board (CAB) to address health-related decision-making ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11226109/

Exploring the acceptability of a community-enhanced ... A community-enhanced intervention to improve decision support partnership between patients with chronic kidney disease and their family caregivers.

3. withpower.com withpower.com/trial/phase-chronic-kidney-disease-ckd-2-2024-98890

ImPart for Chronic Kidney Disease Studies show that shared decision making can improve patient engagement and satisfaction, which may indirectly support the effectiveness of ImPart in helping ...

4. jpsmjournal.com jpsmjournal.com/article/S0885-3924(25)00251-9/pdf

Partnering With Chronic Kidney Disease Dyads Developing effective interventions for chronic kidney disease (CKD) focused on dyadic health- related decision-making (treatment choice) requires a.

5. data.qdr.syr.edu data.qdr.syr.edu/dataset.xhtml?persistentId=doi:10.5064/F6UXQABW

Palliative Care Research Cooperative QDR This deposit provides the interview data from the Phase 2 acceptability interviews with CKD patients-caregivers dyads to describe their health- ...

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RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03522740

Decision Aid for Renal Therapy (DART) This randomized clinical trial targeting 400 older adults with advanced kidney disease and as many as 400 of their care-partners compares the effectiveness of ...

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0305291

PLOS One - Research journals Patients with advanced chronic kidney disease (CKD) often rely on unpaid family caregivers to help cope and make health-related decisions [1–3].