Clinical trial NCT06843603: Barriers/Facilitators and Care Coordination of Native Hawaiians & Kidney Disease
Official title: Barriers/Facilitators and Care Coordination of Native Hawaiians & Kidney Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kidney Disease, Chronic
Keywords: kidney disease, chronic
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: National Kidney Foundation, United States
First posted: 2025-02-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We propose a mixed method design study with the goal to improve CKD rescreening among early stage high-risk NHs by aligning health equity with a culturally informed care coordination systems model. Guided by the CFIR 2.017, in Aim 1/Year 1 we will conduct a formative evaluation on the barriers and facilitators associated with increasing individual patient follow-up with their PCP after the initial NKFH KEDS screening and develop implementation strategies. Then in Aim 2/Year 2 we will examine the acceptability and feasibility of a selected culturally-informed care coordination intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Native Hawaiians (NH) are 9.5 times more likely to be on dialysis or need a kidney transplant compared to Whites. They have the highest end-stage kidney disease (ESKD) incidence rates in the nation, begin dialysis at younger ages (30-50 years), and one of the most under-studied racial/ethnic groups in chronic kidney disease (CKD) research. This project's outcome is to improve kidney disease follow-up among early stage NHs at high risk by aligning health equity with a culturally appropriate care coordination systems model.

Detailed description: SPECIFIC AIMS Native Hawaiians (NH) are 9.5 times more likely to be on dialysis or need a kidney transplant as compared to those who identify race as White. NH have the highest rates of end-stage kidney disease in the United States (US) and begin dialysis at younger ages (30-50 years). NHs are also at high risk for diabetes, hypertension, cardiovascular disease, stroke, \& obesity which intersects with kidney disease. NHs are also one of the most under-studied racial/ethnic groups in chronic kidney disease (CKD) research.4 Therefore, there is a is critical need to examine and address kidney health disparities and inequities in the NH population.

This multi-disciplinary scientific team has conducted cross-sectional epidemiological early CKD studies over a 10-year period of time among NHs who participated in the National Kidney Foundation of Hawaii (NKFH) Kidney Early Detection \& Screening (KEDS) Program. Our findings indicate NHs have a heightened risk of end stage kidney disease based on biological and clinical risk factors5 using CKD biomarkers (i.e. lab tests for estimated glomerular filtration rate (eGFR↓) and urinary albumin creatinine ratio (UACR↑). These tests are indicators of abnormal kidney function and damage. One of the US Healthy People 2030 goals is to increase the proportion of older adults with CKD to obtain recommended screening tests (eGFR, UACR) to identify CKD in the early stages. The NKFH KEDS program provides a comprehensive community early detection screening program where participants are sent their screening lab results and are asked to share these results with their primary care provider (PCP). Our previous research has highlighted significant gaps related to participant follow-up with their PCP. Therefore, using the NIMHD Framework adapted to reflect social and cultural influences of NH health focused on family and community support/resources, access to cultural institutions and practice, and access to services to optimal health and well-being, the overall goal of this study is to develop a culturally-informed care coordination model between NKFH KEDS NH participants and NKFH and PCP staff to improve screening follow-up. Our central hypothesis is that a theoretically-driven, culturally-informed, care coordination model will not improve follow-up for eGFR \& UACR. To address this gap, this innovative study aims to adapt the abridged version of the Consolidated Framework for Implementation Research 2.0 framework named pragmatic context assessment tool (pCAT) for screening (eGFR, UACR) follow-up among NH adults in early stages of CKD. Specific Aims include:

Aim 1: Understand barriers and facilitators associated with culturally informed care coordination and follow-up for eGFR \& UACR. First, we will conduct a formative evaluation on the barriers \& facilitators of NKFH KEDS NH participants (n=25) and NKFH (n=15) and PCP (n=10) staff) and reach consensus by all (NH participants, NKFH and PCP staff, and a NH advisory group) of a feasible intervention - (1) NKFH KEDS NH participants, using the pCAT survey and interview and (2) NKFH and PCP staff, using the same pCAT18 survey and interview. NH participants (n=25) will be: (1) aged 18 years and older, (2) with eGFR \< 60 ml/min/1.73m2 (Stage 3a-3b CKD) and/or ≥30 UACR, (3) have participated in the NKFH KEDS Program within 3 months, and (4) able to read, write, and speak English. NKFH (n=15) and PCP (n=10) staff's inclusion criteria include: (1) able to read, write \& speak English and (2) aged 18 years and older. Three PCP sites will be selected due to high enrollment of NH patients in their practice. Consensus of key barriers/facilitators and contextual factors that will drive the intervention selection will be completed based on the evaluation results. The research team will summarize the literature on the implementation strategies, suggest strategies and reach consensus for a selected intervention by the end of study year 1. The advisory group will be made up of members from 3 NH non-profit organizations. Quantitative and qualitative analysis for the evaluation will be completed.

Aim 2: Examine the acceptability and feasibility of a culturally-informed care coordination intervention. Second, we will evaluate our intervention by selecting one PCP site to receive usual care and other PCP site will receive the culturally informed care coordination intervention. The NKFH KEDS NH participants (n=25) and NKFH (n=5) and PCP (n=5) staff (for each, control and intervention group) will be interviewed using the pCAT18 individual survey and interview evaluation and outcomes20 of our intervention in the first 6 months of study year 2. Finally, both quantitative and qualitative analysis will be used to examine the acceptability and feasibility of the intervention in the second half of year 2.

The long-term goal of this project is to improve CKD rescreening among early stage high-risk NHs by aligning health equity with a culturally appropriate care coordination systems model. To reach this goal, results from this NIH R21 project will provide the foundation for a pilot study for an NIH R34 IRINAH. This project has the potential for dissemination to other primary care provider offices and organizations - federally qualified community centers, and hospital clinics to increase re-screening rates among high risk NHs in the early stages of CKD between community and primary care provider follow-up.

Eligibility criteria: AIM 1 and AIM 2: Inclusion Criteria: Native Hawaiian (NH) participants from the NKFH KEDS program are:

* greater or equal to 18 years
* self-reported as Native Hawaiian
* eGFR less than 60 ml/min/1.73m2 (Stage 3a-3b CKD) and/or greater or equal to 30 mg/g UACR
* have participated in the NKFH KEDS Program within 3 months
* able to read, write, and speak English.

AIM 1 and AIM 2: Inclusion Criteria: NKFH and PCP staff are :

* able to read, write, and speak English,
* greater or equal to 18 years.

Exclusion Criteria: None

Primary outcomes:
measure: Acceptability to Intervention
timeFrame: 9 months
measure: Adoption of the Intervention
timeFrame: 9 months
measure: Feasibility of the Intervention
timeFrame: 9 months
Secondary outcomes:
measure: Beliefs to Change of the Intervention
timeFrame: 9 months
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: National Kidney Foundation of Hawaii
state: Hawaii
Study officials:
affiliation: University of Hawaii at Manoa
name: Merle R Kataoka-Yahiro, DrPH., MPH., MS.
role: PRINCIPAL_INVESTIGATOR
References: