In the United States, the burden of chronic kidney disease rests disproportionately on rural communities. This study evaluates the implementation and effectiveness of CommunityRx-Chronic Kidney Disease (CRx-CKD); this health information technology intervention integrates medical, social, and self-care resources to improve CKD management in rural eastern North Carolina. Through a partnership among local primary care centers, community organizations, and researchers, CRx-CKD will strengthen rural care networks, improve CKD management, and enhance the well-being of rural communities.
Approximately one in seven adults in the United States lives with chronic kidney disease. Chronic kidney disease typically worsens with time and, in its final stage, can result in kidney failure. Contextual factors in rural, eastern North Carolina communities impede optimal management of chronic kidney disease multimorbidity. In these communities, geographical barriers to medical care, dwindling resources, and underdeveloped health infrastructure have worsened chronic kidney disease outcomes. CommunityRx-CKD (CRx-CKD) is an evidence-based, low-intensity, health information technology-driven intervention designed to support chronic kidney disease management in rural eastern North Carolina. CRx-CKD integrates medical (e.g., blood pressure and glucose monitoring, eye and foot care), social (food, housing, transportation), and self-care (weight and stress management, exercise) resources. CRx-CKD comprises three components: brief education on integrated chronic kidney disease needs, a chronic kidney disease care plan that includes integrated care referrals, and clinic navigator-led, longitudinal support (12 months) for chronic kidney disease patients in our trial. Our multidisciplinary, community-engaged research team will test the effects of CRx-CKD through three related aims. This pragmatic individual-randomized, two-arm, single-blind trial in 25 rural primary care clinics in 12 rural eastern North Carolina counties (n=634 adults with CKD) assesses the effect of CRx-CKD on acute healthcare utilization (primary outcome), self-efficacy for finding resources, knowledge and sharing of integrated care resources, resource use, number of unmet needs over time, ambulatory care utilization, and health-related quality of life. The researchers hypothesize that 12-month acute healthcare utilization will differ between participants receiving CRx-CKD and those receiving usual care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
CommunityRx-Chronic Kidney Disease (CRx-CKD) is an evidence-based, low-intensity, health information technology-driven intervention designed to support chronic kidney disease management in rural eastern North Carolina. CRx-CKD integrates medical (e.g., blood pressure and glucose monitoring, eye and foot care), social (food, housing, transportation), and self-care (weight and stress management, exercise) resources. CRx-CKD comprises three components: brief education on integrated chronic kidney disease needs, a chronic kidney disease care plan that includes integrated care referrals, and clinic navigator-led, longitudinal support (12 months) for chronic kidney disease patients.
Goshen Medical Center
Beulaville, North Carolina, United States
Mean number of 911 calls
Number of 911 calls is self-reported with a look-back period of 3 months in response to an item originally used in the DIAMOND RCT: "How many times has 911 been called (either by yourself or someone acting on your behalf)?"
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Mean number of emergency room visits
Number of emergency room visits is the sum of two self-reported items with a look-back period of 3 months, originally used in the DIAMOND RCT: 1. "How many times did the ambulance take you to the emergency room?" 2. "How many times did you go to the emergency room without an ambulance?"
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Mean number of after-hours or urgent care clinic visits
Number of after-hours of urgent care clinic visits is self-reported with a look-back period of 3 months in response to an item originally used in the DIAMOND RCT: "How many times did you go to the after-hours medical clinic?"
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Mean number of hospital admissions
Number of hospital admissions is self-reported with a look-back period of 3 months in response to an item originally used in the DIAMOND RCT: "How many times were you admitted to the hospital?"
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Self-efficacy to find community-based resources
Self-efficacy to find community-based resources is measured using an item developed from Bandura's self-efficacy theory and used in prior CommunityRx trials: "How confident are you in your ability to find resources in your community that help you manage your health?" Responses will be assessed on a 5-point Likert scale ranging from '1' (not at all confident) to '5' (completely confident).
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Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
634
Time frame: Baseline, 6 months, 12 months
Number of participants reporting knowledge community-based resources
Knowledge of community-based resources is measured using 10 self-reported items adapted and tested in prior CommunityRx studies: "Do you know of places in your community that offer \[specific resources\]?" We will report the number of participants endorsing knowledge of 0, 1, 2, 3 or 4+ resource types.
Time frame: Baseline, 6 months, 12 months
Mean attitude about community-based resources
Attitude about community-based resources is measured using a self-report Likert item adapted and tested in prior CommunityRx studies: "Your community has the resources you need to manage your health." Response range from '1' (strongly agree) to '5' (strongly disagree).
Time frame: Baseline, 6 months, 12 months
Number of participants reporting use of community-based resources
Use of community resources is measured using 10 self-reported survey items adapted and tested in prior CommunityRx studies: "Have you received services from places like this for you or your household in the last 6 months?" We will report the number of participants endorsing utilization of 0, 1, 2, 3 or 4+ resource types.
Time frame: Baseline, 6 months, 12 months
Number of participants sharing community-based resources
Sharing of community resources is measured using 10 self-reported survey items adapted and tested in prior CommunityRx studies: "Have you told anyone about places like this in the past 6 months?" We will report the number of participants endorsing sharing 0, 1, 2, 3 or 4+ resource types.
Time frame: Baseline, 6 months, 12 months
Mean number of physician office visits
Number of physician office visits is self-reported with a look-back period of 3 months in response to an item originally used in the DIAMOND RCT: "How many times have you seen a physician for an office visit?"
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Number of health-related social needs
Health-related social needs are measured via the Accountable Health Communities Health-Related Social Needs Screener. This measure includes ten items evaluating participant needs across the domains of: housing, food, transportation, utilities, and interpersonal violence. Higher scores indicate greater needs.
Time frame: Baseline, 6 months, 12 months
Mean Patient-Reported Outcome Measurement Information System (PROMIS) Global-10 score
The PROMIS Global-10 measures general health-related quality-of-life. Response options are presented as nine 5-point and one 11-point Likert scales. Higher scores indicate greater health-related quality-of-life.
Time frame: Baseline, 6 months, 12 months