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

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{3 4 6 11 12}

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).

Research Team

Shena Gazaway, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility 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.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Characterizing Approaches to Dialysis Decision Making with Older Adults: A Qualitative Study of Nephrologists. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Shared patient and provider values in end-stage renal disease decision making: Identifying the tensions. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Challenges to Shared Decision Making About Treatment of Advanced CKD: A Qualitative Study of Patients and Clinicians. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Value of patient decision aids for shared decision-making in kidney failure. [2023]

5. England pubmed.ncbi.nlm.nih.gov

The Prepare for Kidney Care Study: prepare for renal dialysis versus responsive management in advanced chronic kidney disease. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Preferences for and Experiences of Shared and Informed Decision Making Among Patients Choosing Kidney Replacement Therapies in Nephrology Care. [2022]

7. United States 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. [2022]

8. Canada 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. [2021]

10. England 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. [2018]

11. England 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. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Integrated Digital Health System Tools to Support Decision Making and Treatment Preparation in CKD: The PREPARE NOW Study. [2022]