Kidney DiseaseNCT07794631
Strategies to Transform Kidney Care and Improve Pursuit of Transplant
A study testing Digital Health Integration, Training for Early Transplant Access and Support and Kidney Health Mobile Health (mHealth) Application in people with Kidney Disease and Kidney Transplant, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
Approximately 15% of the U.S. population has chronic kidney disease, and ~700,000 patients are in full kidney failure also called end-stage kidney disease (ESKD). The optimal treatment for ESKD is living donor kidney transplantation (LDKT), followed by deceased donor kidney transplantation (DDKT); however, the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Disease, Kidney Transplant, Deceased Donor Kidney Transplant
- What is being tested?
- Digital Health Integration, Training for Early Transplant Access and Support and Kidney Health Mobile Health (mHealth) Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18 years or older
- Patients in CKD Stage 3b, 4 or ESKD
- English or Spanish-speaking
Who cannot join
- Contraindications to transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Southern California
Pasadena, California, 91101
About this study
Official title: Multilevel Intervention Strategies to Transform Kidney Care and Improve Pursuit of Transplant in an Integrated Healthcare Delivery System
Approximately 15% of the U.S. population has chronic kidney disease, and ~700,000 patients are in full kidney failure also called end-stage kidney disease (ESKD). The optimal treatment for ESKD is living donor kidney transplantation (LDKT), followed by deceased donor kidney transplantation (DDKT); however, the standard of care continues to be ongoing dialysis, which has poor clinical outcomes in comparison to LDKT and DDKT. Best practices to transform kidney care recommended by the Centers for Medicare and Medicaid Services (CMS), the American Society of Nephrology (ASN) and the 2019 Executive Order Advancing American Kidney Health Initiative include earlier detection of patients whose kidneys are deteriorating rapidly, introducing transplant as a potential treatment option earlier, optimally before their kidneys fail, improved dissemination of health literate transplant education tools, often through digital technology or mHealth, and increasing LDKT rates by helping patients locate living donors or motivating others to donate. Barriers at the patient-, support network-, clinician- and system-levels of the Socio-Ecological Model persist, including poor identification of high-risk patients, insufficient clinician time to discuss transplant, poor transplant knowledge, reluctance or insufficient support to ask living donors to donate, and disengaged friends and relatives, some of whom who might become living donors.
While extensive policy and intervention efforts are underway, none have achieved significant increases in pursuit and receipt of transplant, especially LDKT rates. In 2017, Kaiser Permanente Southern California (KPSC), an integrated care system serving 24,000 CKD patients, partnered with the Transplant Research and Education Center (TREC) at Houston Methodist Research Institute (HMRI) and J.C. Walter Jr. Transplant Center Houston Methodist Hospital (HMH) to launch a multi-year plan for transforming CKD and ESKD care.
Investigators now propose to conduct a pragmatic stepped wedge cluster randomized trial of a novel multilevel intervention to improve CKD and ESKD care, improve transplant rates and reduce disparities. One innovative component of the multilevel intervention is a state-of-the-art technology-supported mHealth application, developed in partnership with patients, to engage patients, family members, and potential living donors to improve their CKD knowledge, view transplant success stories, and seek kidney-related support to pursue transplant, including learning how to find living donors. Investigators also seek to identify moderators at various socio-ecological levels, especially factors influencing variations in effectiveness across different settings and among underserved patient subgroups known to have reduced access to transplant and build implementation tools to increase access to and pursuit of transplant within large integrated health systems including comparable systems (commercial, academic, safety net) across the U.S.
Read the detailed description
This study will evaluate an innovative multilevel transplant intervention delivered within KPSC, an integrated CKD healthcare delivery system, for earlier stage patients not yet in kidney failure (Stage 3b and 4) as well as for patients whose kidneys have failed. The intervention will target patients, their support networks, potential donors, KPSC clinicians, and the KPSC system as a whole. It will integrate an innovative mHealth CKD education application with updated KPSC CKD care process to educate, empower, and engage patients, potential living donors, and family members in learning more about and pursuing transplant and living donation.
The intervention will be activated across the system by KPSC CKD clinical leadership, with all research and educational components led by the study PIs. Investigators will assess effects of the multilevel intervention on the primary outcome, referral for transplant, and on secondary outcomes including attendance at KPSC education classes, KPSC nephrology visits, level of patient transplant knowledge, wait-listing rates, and DDKT/LDKT rates. Investigators will further analyze trial results, examining heterogeneity of treatment effects and mechanisms of effect.
This study operates under a reliance agreement, with KPSC being the reviewing IRB of record.
- Conditions
- Kidney Disease, Kidney Transplant, Deceased Donor Kidney Transplant, Living Donor Kidney Transplantation, Chronic Kidney Disease (Stages 3b-5)
- Being tested
- Digital Health Integration, Training for Early Transplant Access and Support, Kidney Health Mobile Health (mHealth) Application
- Medical subject headings
- Kidney Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Health IntegrationBehavioural
Enhance practice-based performance reports and dashboards to continuously monitor, incorporate and track changes in transplant metrics.
Training for Early Transplant Access and SupportBehavioural
Teach providers how to support transplant referral earlier with patients and how to find living donors. Increase referrals to and patients' use of mHealth technology, transplant education sessions, and kidney support networks.
Kidney Health Mobile Health (mHealth) ApplicationBehavioural
Adapt the mHealth app in order to: Educate and engage CKD patients and their support networks in learning about and taking transplant actions and becoming living donor advocates; Use video technology to capture and view real-life transplant and living donor success stories; Teach patients how to find living donors; Refine KPSC transplant education sessions to align with mHealth technology to support the intended audience; Strengthen Kaiser kidney peer support networks and living donor advocates to synergize mentoring with mHealth.
*Note: mHealth is a generic name for the actual application
| Study group | Role | What they receive |
|---|---|---|
| System Level | Other | Interventions at the health system level include expanding use of telehealth, mHealth, and health information technology to increase opportunities for enhanced care and education and enhancing practice-based performance reports and dashboards detecting high risk patients, flagging missing test results, and tracking key transplant metrics. Receives: Behavioral: Digital Health Integration |
| Provider Level | Other | Intervention activities include teaching providers how to support transplant referral earlier and increasing referring patients and families to transplant educational resources including KPSC transplant classes, the mHealth application, and peer support networks. Additional clinician-targeted activities will include educational programs, training on use of key CKD tools (e.g., the Tangri risk score) and training in patient and donor support activities and brief interventions. Receives: Behavioral: Training for Early Transplant Access and Support |
| Patient and Support System Level | Other | A kidney health-specific mHealth mobile application, is being designed to educate, empower, and engage CKD patients, their support networks, and potential living donors. It allows patients and their support to choose to learn about educational topics most interesting to them and to answer follow-up questions to show mastery of content (e.g., the basics of CKD care, all renal replacement options, the transplant and living donor evaluation processes). To empower patients, the mHealth application incorporates in-app support groups and messaging to foster peer support and create a community of encouragement. It also includes video stories of patients and living donors receiving transplants and donating a kidney through the Living Donation Storytelling Project and allows users the opportunity to film their own stories about their need for a living donor. The app will provide decision aids and tools to help patients find a living kidney donor and refers them to financial resources. Receives: Behavioral: Kidney Health Mobile Health (mHealth) Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Referral to Transplant
The primary clinical outcome is any referral to transplant within the study period. The chi-square test will be used to compare the primary outcome between the treatment arms. Next, GLMM models will be constructed to test whether the treatment effect is significant between the two arms, using a logit link function for equation 1. The model will allow investigators to include relevant patient characteristics, as well as provider- and site-level random effects to account for correlation within clinicians or sites, because individual visits within a provider/site are often more similar in their outcomes than others. The level and difference-in-difference parameters will be interpreted and reported as odds ratios, with corresponding 95% confidence limits. Investigators will apply a similar methodology for secondary outcomes.
Measured: Baseline to 12-months
Secondary outcomes (5)
Level of transplant knowledge
At the level of patient and support-network, knowledge gaps related to kidney transplant will be addressed by providing access to educational topics (CKD care basics, renal replacement options available, transplant and living donor evaluation processes, etc.) via the mHealth application.
For continuous outcomes, GLMM with the covariates and the site-level random-effects described above for the primary outcome will be used to estimate the pre- vs. post-implementation level differences. Depending on the probability distribution of the outcome variables, investigators will use identity or log link functions as appropriate.
Measured: Baseline to 12-months
Attendance at KPSC Education Classes
For the binary outcomes, such as attendance at education classes, the same analytic scheme as described above for the primary outcome will be used to evaluate the intervention effects.
Measured: Baseline to 12 months
Deceased or Living Donor Kidney Transplant Rates
Measured: Baseline to 12-months
Wait-listing Rates
Measured: Baseline to 12-months
Number of KPSC Nephrology Visits
Measured: Baseline to 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start15 Aug 2022
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The stepped wedge cluster randomized controlled trial will be conducted in 12 KPSC medical centers with 660 CKD patients each (CKD Stages 3b (high risk) - ESKD) to be sequentially rolled out in three groups of four KPSC centers at a time until all centers receive the multilevel intervention. Prior to randomization, facilities will be matched to create four groups of three similar facilities based on key facility characteristics hypothesized to be associated with intervention effectiveness and implementation success186, such as patient volume, staffing patterns and other CFIR Internal Setting variables; geographic region and service area type (urban, suburban, rural), and other External Context variables. Matching and creation of groups will be conducted using an SAS algorithm.186 Within each group of three closely-matched facilities, each facility will be randomly assigned to either cluster (step) 1, 2 or 3 to determine when each facility will begin the implementation phase.
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794631
- Sponsor's protocol ID
- PRO00035370
- Other IDs
- 1R01HS028655-01A1
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multilevel Intervention Strategies to Transform Kidney Care and Improve Pursuit of Transplant in an Integrated Healthcare Delivery System
- ClinicalTrials.gov ID
- NCT07794631
- Acronym / sponsor ID
- PRO00035370
- Conditions
- Kidney Disease, Kidney Transplant, Deceased Donor Kidney Transplant, Living Donor Kidney Transplantation, Chronic Kidney Disease (Stages 3b-5)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Kaiser Permanente
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 15% of the U.S. population has chronic kidney disease, and ~700,000 patients are in full kidney failure also called end-stage kidney disease (ESKD). The optimal treatment for ESKD is living donor kidney transplantation (LDKT), followed by deceased donor kidney transplantation (DDKT); however, the standard of care continues to be ongoing dialysis, which has poor clinical outcomes in comparison to LDKT and DDKT. Best practices to transform kidney care recommended by the Centers for Medicare and Medicaid Services (CMS), the American Society of Nephrology (ASN) and the 2019 Executive Order Advancing American Kidney Health Initiative include earlier detection of patients whose kidneys are deteriorating rapidly, introducing transplant as a potential treatment option earlier, optimally before their kidneys fail, improved dissemination of health literate transplant education tools, often through digital technology or mHealth, and increasing LDKT rates by helping patients locate living donors or motivating others to donate. Barriers at the patient-, support network-, clinician- and system-levels of the Socio-Ecological Model persist, including poor identification of high-risk patients, insufficient clinician time to discuss transplant, poor transplant knowledge, reluctance or insufficient support to ask living donors to donate, and disengaged friends and relatives, some of whom who might become living donors.
While extensive policy and intervention efforts are underway, none have achieved significant increases in pursuit and receipt of transplant, especially LDKT rates. In 2017, Kaiser Permanente Southern California (KPSC), an integrated care system serving 24,000 CKD patients, partnered with the Transplant Research and Education Center (TREC) at Houston Methodist Research Institute (HMRI) and J.C. Walter Jr. Transplant Center Houston Methodist Hospital (HMH) to launch a multi-year plan for transforming CKD and ESKD care.
Investigators now propose to conduct a pragmatic stepped wedge cluster randomized trial of a novel multilevel intervention to improve CKD and ESKD care, improve transplant rates and reduce disparities. One innovative component of the multilevel intervention is a state-of-the-art technology-supported mHealth application, developed in partnership with patients, to engage patients, family members, and potential living donors to improve their CKD knowledge, view transplant success stories, and seek kidney-related support to pursue transplant, including learning how to find living donors. Investigators also seek to identify moderators at various socio-ecological levels, especially factors influencing variations in effectiveness across different settings and among underserved patient subgroups known to have reduced access to transplant and build implementation tools to increase access to and pursuit of transplant within large integrated health systems including comparable systems (commercial, academic, safety net) across the U.S.
Detailed description
This study will evaluate an innovative multilevel transplant intervention delivered within KPSC, an integrated CKD healthcare delivery system, for earlier stage patients not yet in kidney failure (Stage 3b and 4) as well as for patients whose kidneys have failed. The intervention will target patients, their support networks, potential donors, KPSC clinicians, and the KPSC system as a whole. It will integrate an innovative mHealth CKD education application with updated KPSC CKD care process to educate, empower, and engage patients, potential living donors, and family members in learning more about and pursuing transplant and living donation.
The intervention will be activated across the system by KPSC CKD clinical leadership, with all research and educational components led by the study PIs. Investigators will assess effects of the multilevel intervention on the primary outcome, referral for transplant, and on secondary outcomes including attendance at KPSC education classes, KPSC nephrology visits, level of patient transplant knowledge, wait-listing rates, and DDKT/LDKT rates. Investigators will further analyze trial results, examining heterogeneity of treatment effects and mechanisms of effect.
This study operates under a reliance agreement, with KPSC being the reviewing IRB of record.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The stepped wedge cluster randomized controlled trial will be conducted in 12 KPSC medical centers with 660 CKD patients each (CKD Stages 3b (high risk) - ESKD) to be sequentially rolled out in three groups of four KPSC centers at a time until all centers receive the multilevel intervention. Prior to randomization, facilities will be matched to create four groups of three similar facilities based on key facility characteristics hypothesized to be associated with intervention effectiveness and implementation success186, such as patient volume, staffing patterns and other CFIR Internal Setting variables; geographic region and service area type (urban, suburban, rural), and other External Context variables. Matching and creation of groups will be conducted using an SAS algorithm.186 Within each group of three closely-matched facilities, each facility will be randomly assigned to either cluster (step) 1, 2 or 3 to determine when each facility will begin the implementation phase.
| Arm | Type | Receives |
|---|---|---|
| System Level | Other | Behavioral: Digital Health IntegrationInterventions at the health system level include expanding use of telehealth, mHealth, and health information technology to increase opportunities for enhanced care and education and enhancing practice-based performance reports and dashboards detecting high risk patients, flagging missing test results, and tracking key transplant metrics. |
| Provider Level | Other | Behavioral: Training for Early Transplant Access and SupportIntervention activities include teaching providers how to support transplant referral earlier and increasing referring patients and families to transplant educational resources including KPSC transplant classes, the mHealth application, and peer support networks. Additional clinician-targeted activities will include educational programs, training on use of key CKD tools (e.g., the Tangri risk score) and training in patient and donor support activities and brief interventions. |
| Patient and Support System Level | Other | Behavioral: Kidney Health Mobile Health (mHealth) ApplicationA kidney health-specific mHealth mobile application, is being designed to educate, empower, and engage CKD patients, their support networks, and potential living donors. It allows patients and their support to choose to learn about educational topics most interesting to them and to answer follow-up questions to show mastery of content (e.g., the basics of CKD care, all renal replacement options, the transplant and living donor evaluation processes). To empower patients, the mHealth application incorporates in-app support groups and messaging to foster peer support and create a community of encouragement. It also includes video stories of patients and living donors receiving transplants and donating a kidney through the Living Donation Storytelling Project and allows users the opportunity to film their own stories about their need for a living donor. The app will provide decision aids and tools to help patients find a living kidney donor and refers them to financial resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 years or older
- Patients in CKD Stage 3b, 4 or ESKD
- English or Spanish-speaking
Key exclusion criteria (1 listed)
- Contraindications to transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Health IntegrationEnhance practice-based performance reports and dashboards to continuously monitor, incorporate and track changes in transplant metrics. | Behavioural | System Level |
| Training for Early Transplant Access and SupportTeach providers how to support transplant referral earlier with patients and how to find living donors. Increase referrals to and patients' use of mHealth technology, transplant education sessions, and kidney support networks. | Behavioural | Provider Level |
| Kidney Health Mobile Health (mHealth) ApplicationAdapt the mHealth app in order to: Educate and engage CKD patients and their support networks in learning about and taking transplant actions and becoming living donor advocates; Use video technology to capture and view real-life transplant and living donor success stories; Teach patients how to find living donors; Refine KPSC transplant education sessions to align with mHealth technology to support the intended audience; Strengthen Kaiser kidney peer support networks and living donor advocates to synergize mentoring with mHealth. *Note: mHealth is a generic name for the actual application | Behavioural | Patient and Support System Level |
Primary outcome
Referral to Transplant
Time frame: Baseline to 12-months
The primary clinical outcome is any referral to transplant within the study period. The chi-square test will be used to compare the primary outcome between the treatment arms. Next, GLMM models will be constructed to test whether the treatment effect is significant between the two arms, using a logit link function for equation 1. The model will allow investigators to include relevant patient characteristics, as well as provider- and site-level random effects to account for correlation within clinicians or sites, because individual visits within a provider/site are often more similar in their outcomes than others. The level and difference-in-difference parameters will be interpreted and reported as odds ratios, with corresponding 95% confidence limits. Investigators will apply a similar methodology for secondary outcomes.
5 secondary outcomes
Level of transplant knowledge
Time frame: Baseline to 12-months
Attendance at KPSC Education Classes
Time frame: Baseline to 12 months
Deceased or Living Donor Kidney Transplant Rates
Time frame: Baseline to 12-months
Wait-listing Rates
Time frame: Baseline to 12-months
Number of KPSC Nephrology Visits
Time frame: Baseline to 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Health Integration, Training for Early Transplant Access and Support and Kidney Health Mobile Health (mHealth) Application in people with Kidney Disease and Kidney Transplant, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Referral to Transplant (time frame: Baseline to 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.