Primary Care eHealth Intervention for Improved Outcomes in Chronic Kidney Disease

Specific Aims:

Chronic Kidney Disease (CKD) affects over 20 million American adults. Effective medications
for reducing progression remain vastly under-utilized due to well-known behavioral barriers
for patients and clinicians, including the affective barriers of denial, inertia, and
uncertainty. The health consequences of this poor level of medication adoption warrant
development of new strategies to facilitate their use.

Moderate CKD as a Critical Juncture for Intervention: Rates of CKD are likely only to
escalate as contributing conditions (e.g., type 2 diabetes, obesity) increase. With
progression, patients experience costly but preventable renal and cardiovascular disease
adverse outcomes (e.g., dialysis, myocardial infarction). CKD also imposes a
disproportionately heavy burden on racial/ethnic minorities and those of lower socioeconomic
status. There are an estimated 8 million U.S. adults with stage 3 or "moderate" CKD (defined
by an estimated glomerular filtration rate (eGFR) of 30-59 mL/min/1.73m2) offering a sizeable
target population for intervention. Patients with stage 3 CKD are often diagnosed at this
stage of disease through routine laboratory tests performed by their primary care providers
and at a time when disease progression can still be minimized. Evidence shows that use of
four categories of medications (for renal protection, hypertension, diabetes, and
hyperlipidemia) can slow or even halt CKD disease progression.

Underutilization of Effective Medications for CKD Exposes a Quality Gap: These effective
drugs remain vastly under-utilized despite their promotion through drug formularies, practice
guidelines, and clinician and patient educational campaigns, including the landmark 2002
Kidney Disease Outcomes Quality Initiative and related undertakings. National ambulatory data
indicate that even among patients with CKD who are diagnosed with cardiovascular disease
(CVD), only 57% are on an angiotensin converting enzyme inhibitor (ACE-I) or angiotensin
receptor blocker (ARB), only 35% have achieved the target blood pressure control, and only
52% are taking a lipid-lowering agent, despite their clear benefits in high-risk populations.
Those without a CVD diagnosis have comparable or even worse rates for these target measures.
After a system-wide quality improvement initiative, Southern California Kaiser patients
identified as having CKD still had notable quality gaps in care: though improved, 16% were
missing an ACE-I/ARB, 56% had poorly controlled blood pressure, 40% had LDL over the target,
and 50% of those with comorbid type 2 diabetes (diabetes) had hemoglobin A1c levels of 7% or
greater.

Aim 1: Formative research—Develop the eHealth intervention Challenge: There is good evidence
on how to target conscious processing for health behavior change but less on affective
processing. Approach: Using a theory-based approach, we will identify the promising content,
minimum dose, and delivery for an eHealth intervention to promote appropriate medication
adoption. We will use observational, systematic review, and qualitative methodologies for
this formative research with a special emphasis on targeting affective processing (in
addition to conscious processing). Impact: We will develop an e-Health intervention that is
anticipated to have an effective content, dose, and delivery.

Aim 2: Evaluative research—Pilot test the eHealth intervention in a small RCT Challenge: The
eHealth intervention must be piloted and refined prior to a definitive investigation of its
efficacy. Approach: We will test the eHealth intervention for feasibility in a 2-arm pilot
RCT (intervention vs. usual care controls) among patients with stage 3b CKD managed in
primary care and their clinicians, while also collecting data critical to designing a future
efficacy trial. Randomization: patients (50/arm) will be clustered by clinician (20/arm) with
targeted inclusion of 1-3/clinician. Primary outcome: 4-point "CKD score" assessing control
of risk factors for CKD progression (proteinuria, blood pressure, plasma glucose, cholesterol
level/calculated CVD risk). H1: the intervention group will achieve a better mean CKD score
than the usual care group. Secondary outcomes: new prescriptions for the promoted
medications, CKD progression, and feasibility and process data. Impact: A new intervention
specifically targeted at medication adoption that is ready for evaluation in a larger
efficacy RCT.

Inclusion Criteria:

- Stage 3a (eGFR 45-59) plus poorly controlled risk factors for CKD progression and/or
cardiovascular disease morbidity/mortality). Our intervention is appropriate for
patients with stage 3a CKD who are not yet optimized for kidney protection (in the
setting of proteinuria) with ACE-inhibitors/ARBS, hypertension, diabetes and
cardiovascular disease treatment. Our intervention messages promote medication classes
for the optimization of these conditions and thus are appropriate for patients with
stage 3a CKD who are not yet controlled for these conditions

- Stage 3b chronic kidney disease (defined as eGFR 30-44): The rationale for including
patients with stage 3b CKD (defined by eGFR 30-44) but not stage 3a (eGFR 45-59) is to
reduce the possibility of misclassification of those with higher eGFRs (who have
little or no underlying kidney dysfunction) and to respond to evidence that patients
with stage 3b CKD have much higher rates of progression to kidney failure than those
with stage 3a. We chose the following inclusion criteria to optimize the balance
between generalizability, participant safety, treatment adherence, and retention.

- Having a primary care provider (PCP) at UCSF, defined as an identified individual
provider or provider group from whom the participant receives ongoing medical care, if
needed;

- Not pregnant at study assessment.

- The ability to use a computer or smartphone

- The ability to understand English

Exclusion Criteria:

- Severe hypertriglyceridemia (TG>500 mg/dL)

- Hyperkalemia (K>5.0 mEq/L)

- Serious illness likely to preclude study completion

- Pregnancy

- Intolerance/allergy to all indicated CKD medications

- Medication management for CKD (i.e., with all of the medications/medication classes
targeted for promotion by the eHealth intervention) has already been optimized

- Has never used MyChart: because MyChart use indicates a minimum level of existing
familiarity with and use of eHealth materials

- Having no access to a computer or smartphone

- Plans to change primary care site.

- Family/household member of another study participant or of a study staff member;

- Already enrolled or planning to enroll in a research study that would limit full
participation in this trial or confound interpretation of its results;

- Investigator discretion for clinical safety or protocol adherence reasons.