Targeting Social Determinants to Improve Chronic Kidney Disease Care

Study Overview
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Brief Summary
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The primary research goals of this application are to characterize social factors including health literacy and numeracy skills of CKD patients and examine associations with knowledge, self-efficacy, self-care behaviors, and clinical outcomes, and to examine the impact of an efficient interactive educational intervention to facilitate patient-provider communication. The investigators will accomplish these goals by executing a cluster-randomized controlled trial and performing detailed analysis of baseline measures. The specific aims of this study are: Specific Aim 1: Determine the association of social factors with patient kidney knowledge, self-efficacy, participation in self-care behaviors, and clinical outcomes in moderate to advanced CKD. Hypothesis: In patients with CKD, low health literacy and numeracy is common and associated with older age, non-white race, fewer years of education, lower socioeconomic (income) status, less kidney knowledge, lower self-efficacy of self-care, and less adherence with medication and diet self-care recommendations. Low literacy/numeracy is also associated with higher blood pressures, more proteinuria, and more severe dysfunction of renal clearance. Specific Aim 2: Evaluate the impact of a tailored literacy-sensitive educational tool used cooperatively by physicians and patients to improve self-care and outcomes in CKD. Hypothesis: Utilization of a concise literacy-sensitive physician-delivered educational tool will be feasible and associated with higher patient kidney knowledge, self-efficacy of self-care and greater adherence to medication and nutrition recommendations compared to usual care.

Official Title
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Targeting Social Determinants to Improve Chronic Kidney Disease Care

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Behavioral: interactive educational intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receiving care in the Vanderbilt General Nephrology Clinic for at least 1 prior visit past 12 months; Serum creatinine available in the medical record in the last 12 months demonstrating Chronic Kidney Disease (eGFR<60mls/min); Age 18-80 years; English-speaking. Exclusion Criteria: Pre-existing diagnosis of significant dementia or psychosis as determined by primary provider and documented in the medical record; Corrected visual Acuity >60/20 using a Rosenbaum Pocket Vision Screen; Patient receives dialysis or has a functional kidney transplant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: interactive educational intervention<br>Physicians will use an interactive educational worksheet during the standard-of-care clinic visit. | Behavioral: interactive educational intervention<br>* Use of a concise, literacy-sensitive, physician-led, educational interaction with the patient.<br>|
| No Intervention: control group<br>Physicians will conduct the standard-of-care clinic visit as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-care of Chronic Kidney Disease | Change from baseline in the following surveys/questionaires at 6 months Morisky 8-Item Survey Frequent Food Questionaire | baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient understanding of kidney disease and their disease status | Change from baseline in the following surveys/questionaires at 6 months Kidney Awareness & Knowledge Survey Perceived Kidney Self-Management Scale Kidney Disease Self-Management Behaviors | baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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health literacy, health numeracy