The Congestive Heart Failure Adherence Redesign Trial

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.

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).

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.

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.

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.

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.

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.

The EQ-5D self-report questionnaire consists of a 5-item health state assessment (rated as 1=none, 2=some, 3=severe), to produce an index score. Responses to the health state items can be converted to a time trade-off (TTO) utility score, where 1 represents perfect health and 0 represents death (negative utilities are possible, representing states worse than death). A visual analog scale (VAS) can be applied, scored from 0 to 100, where higher scores are better. EQ-5D index score can be used to produce health utilities and to estimate quality-adjusted life-years (QALYs) gained or lost.

Two biomarkers are accessed via blood assays; High sensitivity C-reactive protein (hsCRP) and B-type natriuretic peptide (BNP). Plasma hs CRP, an inflammatory marker, is associated with worse heart failure outcomes. Heart failure treatment reduces hsCRP. B-type natriuretic peptide (BNP) is a biomarker of myocyte stress. Standard safety procedures are used in performing the participant blood draw required for this measure.

The PHQ9 is comprised of 9 self-reported items answered in "Not at all = 0; Several days = 1; More than half the days = 2; Nearly every day = 3" format summed to yield score between 0-27. Higher score indicates more severe depression symptoms.

: This 10-item questionnaire assesses a list of major stressful life events, focusing on several important domains: severe illness, death of a loved one, family conflict/divorce, financial problems, and exposure to neighborhood or workplace violence, including sexual abuse and rape, assessed as Yes/No/Refusal responses.

A 11-item questionnaire assesses a list of Traumatic Stress life events , including: Being in a natural disaster, a serious accident, being attacked with or without a weapon, military combat or in a war zone, sexual abuse and rape, and other situations extraordinarily stressful situations. Responses are Yes/No/Don't Know/Refusal. If a participant indicates an event occurred the frequency is assessed with 4 possible responses from never=0, 1 time=1, 2-3 times =3, and 4 or more times = 4.

This 6-item screen for post-traumatic stress disorder (PTSD) was derived empirically from the PCL-C Questionnaire for use in primary care settings. It contains 2 items from each of 3 subscales that correlated most highly with the overall subscale score. The 3 subscales are: Re-Experiencing, Avoidance, and Hyper-Arousal. Respondents rate items on a 5-point scale (ranging from 1 = "Not at all" to 5 = "Extremely"). The short scale has been found to have good reliability and validity and is used as an indication of symptoms of PTSD.

This physician adherence indicator is based on prescribing the three pharmacological classes of HF medications (ACEI/ARB, beta-blockers, and aldosterone antagonists). This endpoint is assessed by reviewing the most recent pertinent outpatient medical record at each time point for each participant. The modified Global Adherence indicator (mGAI) is computed for each participant by calculating the proportion of indicated care (across three therapeutic classes). The higher mGAI indicates better adherence.

For each enrolled PCP, the proportion of their patients participating in the study achieving blood pressure below 130/80 mm Hg during study assessments is computed.

Total number of heart failure hospitalizations and heart failure emergency room visits, separately and combined, overall and by subgroups indicated above.