The Congestive Heart Failure Adherence Redesign Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure, Congestive Cardiovascular Diseases Heart Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Enhanced Training

The Enhanced Training intervention follows a multi-level strategy in which both the patient and their PCP are intervened upon concurrently. Randomization occurs at the PCP-level, that is, patients are assigned to the Enhanced Training group only if their PCP has been enrolled and randomized to this group. Descriptions of the intervention on the PCP-level and patient-level are provided in the intervention section.

Group Type EXPERIMENTAL

Enhanced Training

Intervention Type BEHAVIORAL

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 Education

The Enhanced Education intervention follows a multi-level strategy in which both the patient and their PCP are intervened upon concurrently. The intervention strategy revolves around providing nominal information through the mail. Randomization occurs at the PCP-level; that is, patients are assigned to the Enhanced Education group only if their PCP already has been enrolled and randomized to this group. Description of the intervention on the PCP-level and patient-level is provided in the intervention section.

Group Type ACTIVE_COMPARATOR

Enhanced Education

Intervention Type BEHAVIORAL

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.

Interventions

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Enhanced Training

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).

Intervention Type BEHAVIORAL

Enhanced Education

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

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.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No