The Congestive Heart Failure Adherence Redesign Trial

Lynda Powell, PhD, MEd320 enrolled

Overview

The purpose of this study is to test whether a culturally sensitive self-management (SM) intervention, compared to an education only control, will reduce all-cause hospital days in patients with mild to moderate heart failure and household income less than $30,000 per year.

The purpose of the CHART research study is to assess the value of a novel multi-level intervention for low-income patients recently hospitalized with heart failure relative to providing education alone (both strategies are described in detail in the Intervention section below). The investigators refer to their novel intervention strategy as 'Enhanced Training' and their education-only strategy the investigators refer to as 'Enhanced Education'. These two strategies of participant follow-up will be assessed and compared by analyzing patient's all-cause hospital days over a 2.5-year follow-up period (the investigators note that, for patients with heart failure, the average number of such all-cause hospital days over a 2.5-year period has tripled over the past 25 years). The Enhanced Training strategy aims to improve patient receipt of evidence-based therapy by: 1) activating patients using a culturally sensitive approach that might better resonate with the investigators predominantly urban, African-American and Hispanic, target population; 2) providing timely and useful information to the primary care provider; and 3) promoting effective communication between patients and their primary care provider. The Enhanced Education strategy is less intrusive and aims to provide patients and primary care providers with appropriate educational materials via mail. The primary aims of this research study are to determine if Enhanced Training and/or Enhanced Education will improve: patient adherence to drug therapy and salt restriction, health care provider adherence to evidence-based guidelines, and patient functional capacity and quality of life. Secondary aims will include assessing impact of the interventions on CRP and BNP, which are two key biomarkers of heart failure progression.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

320

Conditions

Heart Failure, Congestive Cardiovascular Diseases Heart Diseases

Interventions

Enhanced TrainingBEHAVIORAL

PCP-Level: A PCP randomized to the Enhanced Training (ET) group will receive: 1) a full and pocket sized copy of the current AHA Heart Failure (HF) Guidelines; 2) a summary of their patient's data collected at baseline, 6-month, and 30-month in-person study visits; and 3) an invitation to complete the CHART-designed online course in HF management for CME credit. Patient Level: The ET patient-level intervention uses Community Health Workers (CHWs) to assist the patient in learning self-management behaviors to reduce the risk of hospitalization. The key objectives are to: improve heart failure knowledge; encourage use of HF management tools; and facilitate development of self-management skills. Each participant receives at least: six AHA educational mailings, six monthly home visits, and 18 phone calls by CHWs within the first six months of the intervention. The CHW then conducts monthly telephone visits for the subsequent two years (for a total of 30 months of follow-up).

Enhanced EducationBEHAVIORAL

The Enhanced Education (EE) intervention follows a multi-level strategy in which both the patient and their PCP are intervened upon concurrently. The intervention provides nominal information through the mail. Randomization occurs at the PCP-level; patients are assigned to the EE group only if their PCP already has been randomized to this group. PCP Level: Upon randomization to the EE group each PCP will receive a full-sized copy of the current American Heart Association (AHA) Heart Failure Guidelines within thirty days after randomization. Patient Level: Upon their assignment to the EE group, patients will receive: Six AHA Tip-Sheet mailings (one Tip-Sheet to be mailed each of the first six months following group assignment); a telephone call, made by the CHART Research Assistant (RA), completed once during each of the first six months following group assignment and only to confirm that the patient received the Tip-Sheet mailing for that month.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Inclusion Criteria (PCP) 1. Provider must be the health professional who is managing the potential patient enrollee's heart failure medication(s). Inclusion Criteria (Patients) 1. Participant has been diagnosed with Heart Failure (HF), 2. Self reported family income is less than $30,000/year, 3. Has experienced at least one hospitalization for acute, decompensated, HF within the previous 6 months based upon: 1. Being admitted for symptoms of HF (ex: peripheral edema, shortness of breath and fatigue), and 2. responding to anti-failure therapy such as diuretics and other anti-failure therapy such as ACE Inhibitors, ARBs, or Beta blockers. 4. Has evidence of systolic dysfunction, defined by an ejection \<50 by 1 of 3 methods: echocardiography, radiographic contrast ventriculography, or nuclear ventriculography; done within the last year. 5. Age ≥ 18 years 6. Currently resides in Cook County, Illinois. 7. Speaks English or Spanish. 8. The primary care provider (PCP) has consented and has no more than 12 patients enrolled. 9. Completed the informed consent process. 10. Successfully completed the 30-day run-in period and study baseline visit Exclusion Criteria: Exclusion Criteria (PCP) Health providers will be excluded from enrollment if they are: 1. Still in their residency or training period, 2. A member of the CHART research staff. Exclusion Criteria (Patients) Patients will be excluded from enrollment if they have: 1\. An uncertain 12-month prognosis. 1. Listed for imminent cardiac transplant. 2. Has an advanced directive of "Do not resuscitate". 3. Has uncertain 12-Month Prognosis, as adjudicated by the Principal Investigator

Locations (1)

Rush University Medical Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Total number of all cause hospitalization days

Participant's are queried quarterly concerning any hospitalizations occuring since the previous contact. These self-reported events are then confirmed via study adjudication of pertinent acquired hospital medical records. Analysis of the primary outcome will consist of comparing mean total number of all-cause hospitalization days between the two intervention groups. Analyses will also be performed with respect to the following pre-determined subgroups: (Primary Healthcare Provider subgroups) medical specialty, academic rank, "adherent" to evidence-based guidelines at baseline, and number of years since certification; (Patient Participant subgroups) age, gender, ethnicity, insurance status, years of education, health literacy, number of comorbidities, medication adherence at baseline, heart failure functional capacity, baseline BNP, presence of major stress and/or psychological trauma, perceived social support, number of years since first heart failure diagnosis, and self-efficacy

Time frame: Measured over the 30 month patient participant follow-up period

Secondary Outcomes

Total number of heart failure related hospitalization days

Participants are queried quarterly during the 30-month study follow-up period as to any hospitalizations that occurred since the previous study contact. These self-reported events are then determined to be heart failure related via study adjudication of pertinent acquired hospital medical records.

Time frame: measured over the 30 month patient participant follow-up period

Health Care Costs

Participant's are queried quarterly during study follow-up as to any hospitalizations, nursing home stays, or home health care episodes since the previous study contact. The costs of these self-reported events are then determined via study adjudication of collected hospital medical record. (costs of emergency room visits will be considered separately).

Time frame: Measured over the 30 monthstudy follow-up period

Distance traveled during th Six-Minute Walk test

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

The Six-Minute Walk test is a supervised patient performance measure used in heart failure assessment. Standard six-minute walk safety procedures are used to ensure participant safety during conduct of this test.

Time frame: This test is administered during in-person participant assessment visits conducted at baseline and at 6 and 30 months following treatment assignmentMeasured over/after 30 months

The Kansas City Cardiomyopathy Questionnaire

This questionnaire is a 23-item, self-administered questionnaire that quantifies physical function, symptoms, social function, self-efficacy, and quality of life for patients with heart failure. Scores range from 0 to 100 where higher scores indicate better function.

Time frame: This questionnaire is administered during participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.

Patient Medication Adherence

Medication adherence will be assessed by tracking a single heart failure medication (an ACE, ARB, Beta-Blocker, or diuretic typically). Tracking will be done using a MEMS™ electronic pill monitoring cap from AARDEX and comparing the medication regimen observed to the regimen prescribed by their health care provider. To ensure participant safety, we have instituted a study protocol to help ensure participants' routine medication-taking behavior is not compromised by the use of an electronic pill cap device.

Time frame: Adherence is measured at baseline and at 6 and 30 months following treatment assignment

CALS Food Frequency Questionnaire (Salt Intake)

To determine salt intake over the past week, the CALS Food Frequency Questionnaire will be used. This questionnaire has been specially developed to focus on dietary items that are main sources of sodium. It is computer-scored and provides data on total sodium consumed and can track changes in sodium intake over time.

Time frame: This questionnaire is administered during participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.

Self-Efficacy of Heart Failure Self-Management

The Self-Efficacy at Self-Management Scale directly assesses confidence in the use of the 5 specific self-management skills that are a target of the Enhanced Training intervention.