Primary Care eHealth Intervention for Improved Outcomes in Chronic Kidney Disease

Kidney Failure, Chronic Clinical Trial

— CKD eHealth  

Official title:

Primary Care eHealth Intervention for Improved Outcomes in Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097550
• Other study ID #: IRB-28341
• Secondary ID: 1K23DK097308-01A
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 3, 2018

Study information

• Verified date: March 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project seeks to improve the health of patients with chronic kidney disease (CKD) by developing and testing an electronic health intervention (that will combine secure e--mail, smartphone text message, and online video materials) to promote patient use of effective medications. The information we collect on the electronic health intervention will guide future research, including a larger trial and other studies among related patient groups (e.g., racial minorities) and diseases (e.g., type 2 diabetes mellitus). The project has the potential to improve health outcomes for the millions of patients with CKD who are not yet receiving effective medications.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 3, 2018
• Est. primary completion date: November 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Other:
• eHealth Intervention
Patients randomized to this arm will receive eHealth materials every 2-4 weeks over the 12-month intervention. However, the exact nature of timing, dose, and delivery channel will be informed by the formative research.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CKD metabolic control score	A "CKD score" will be assigned to each patient at baseline and 12-month follow-up, which will be the primary outcome of the trial. The clinical targets that comprise the CKD score consist of laboratory or clinical measurements that are routinely performed in primary care settings and, as such, are readily available in the EHR. While apparent face validity and convenience provide a good rationale for introducing the CKD score, we also recognize the need to validate the score, which we will do in stages in both Aims 1 and 2 of the study.	12 months
Secondary	New indicated med prescriptions	New prescriptions for indicated medications.	12 months
Secondary	Adherence proxy measures	Refills for prescriptions to prescribed medications.	12 months
Secondary	Patient and provider satisfaction	Patient and provider satisfaction will be derived from online questionnaires.	12 months
Secondary	Urine albumin	Urine albumin	6 months
Secondary	Systolic blood pressure	Systolic blood pressure	6 months
Secondary	Hemoglobin A1c	Hemoglobin A1c	6 months
Secondary	LDL cholesterol	LDL cholesterol	6 months
Secondary	CKD progression	CKD progression measured by eGFR	12 months
Secondary	Diastolic blood pressure	Diastolic blood pressure	12 months
Secondary	HDL cholesterol	HDL cholesterol	12 months
Secondary	Total cholesterol	Total cholesterol	12 months