NIH U54MD008620

Patient NAVIgation to Reduce Readmissions among Black Men with Heart Failure

(NAVI-HF)

Raegan W. Durant, MD, MPHAssociate Professor of MedicineDivision of Preventive Medicine

University of Alabama at Birmingham

Sub-Project 1, Center for Healthy African American Men Through Partnerships (CHAAMPS), 5U54MD008620 (NIMHD)

March 23, 2016

NIH U54MD008620

Overall Study Objective and

Specific Aims• Compare the efficacy of heart failure self-care education plus a patient navigator-

delivered self-care plan (Education + PN arm) with heart failure self-care education alone (Educational Control arm) in a randomized control trial among African American men with heart failure

• Specific Aims

1. To assess the 30-day all-cause readmission rates among male African American HF patients receiving HF self-care education plus a patient navigator-delivered self-care plan versus HF self-care education alone

2. To assess the HF self-efficacy and heart failure self-care adherence among male African American HF patients receiving HF self-care education plus a patient navigator-delivered self-care plan versus HF self-care education alone

3. To evaluate the cost-effectiveness of HF self-care education plus a patient navigator-delivered self-care plan versus HF self-care education alone

NIH U54MD008620

NAVI-HF –Study Population

Inclusion Criteria1. African American2. Male3. Age > 404. Inpatient admission at UAB Hospital or UAB Medical

West for HF according to ICD-9 or DRG codes 5. Residence in Jefferson or Shelby County, Alabama6. English-speaking7. Physically and cognitively able to listen to 30-minute

video and undergo a home visit and telephone contacts over several weeks.

Exclusion Criteria1. Heart transplant or awaiting heart transplant 2. Currently participating in another clinical research

study3. Current or anticipated long-term (> 2 weeks)

residence in a skilled nursing facility4. Patients who indicated that they were unwilling to

make lifestyle changes now or in the near future5. Patients whose symptoms may be eliminated by

surgery or who had undergone surgery in the monthbefore or after enrollment

Study Population = 416 African American men with heart failure

NAVI-HF – Protocol OverviewEducation + Patient Navigation

208 patients randomized to self-care education

+ Patient navigator-delivered self-care plan

During inpatient stay, Study Coordinator (SC):

1. Administers baseline questionnaire

2. Views HF self-care video with patient

Brief telephone contact -Within 24-48 hours of

discharge to check patient status

Home Visit - PN counsels patient on self-care

plan using Motivational Interviewing (MI)

with patient during Post-Discharge Week 1

Scheduled weekly telephone contacts (4) by

PN to monitor progress on tailored self-care

plan during Post-Discharge Weeks 5-8

Once weekly telephone contacts PN to review

self-care plan with patient during Post-

Discharge Weeks 3 and 4

Two telephone contacts - PN counsels patient

on self-care plan using MI twice via telephone

during Post-Discharge Week 2

Educational Control208 patients randomized to

self-care education alone

Weekly mailing (8) of

NHLBI heart disease

educational materials

Post-Discharge

Weeks 1-8

During inpatient stay, SC:

1. Administers baseline

questionnaire

2. Views HF self-care video

with patient

HF

ho

sp

italiz

atio

nP

D W

eek 1

PD

Week 2

-4

Tim

e

PD

Week

5-8

*In Education + Patient Navigation arm only, Patient Navigator will introduce himself to patient during

inpatient stay and schedules home visit. NIH U54MD008620

NIH U54MD008620

Educational Video

• Overview of heart failure and symptoms

• 4 chapters based on target heart failure self-care behaviors1. Daily weights and symptom monitoring2. Taking medicines appropriately (medication

adherence)3. Low-salt diet4. Exercise

• Culturally tailored for African American men

NAVI-HF - Outcomes

Baseline 30 days 60 days 6 months

Demographics

HF Self-care adherence

Knowledge of HF self-

care

Self-efficacy

Social Support

QOL

Functional status

Rx adherence

Comorbidities

Discharge medications

Stress

Satisfaction with

chronic illness care

All-cause Hospitalizations All-cause Hospitalizations

HF Self-care adherence

Self-efficacy

QOL

Knowledge of HF self-

care

Social Support

Functional status

Rx adherence

Comorbidities

Discharge medications

Stress

Satisfaction with

chronic illness care

All-cause Hospitalizations

HF Self-care adherence

Self-efficacy

QOL

Knowledge of HF self-

care

Social Support

Functional status

Rx adherence

Comorbidities

Discharge medications

Stress

Satisfaction with

chronic illness care

NIH U54MD008620

Selected Study Measures

• Medical Outcomes Study Social Support Scale• Scored 0-100, higher score=higher social support

• Riegel Self-Care of Heart Failure Index• Comprised of 3 subscales: Maintenance, Management,

and Confidence• Subscale scores > 70 represent adequate HF self-care

• 4-item Morisky Adherence Scale• 0 = worst adherence and 4 = best (perfect) adherence

• Atlanta Knowledge of Heart Failure Scale• Scored 0-26 with 1 pt. for each correct answer

NIH U54MD008620

NIH U54MD008620

Recruitment Progress-to-Date

• Recruitment began 4/15

• 47 participants enrolled as of 3/18/16

• 5 non-randomized pilot participants

• 42 randomized to either study arm

NIH U54MD008620

Preliminary Results (n=35)Characteristics % or mean

Age (mean + SD) 55.9 + 8.5

EducationDid not finish high school.Graduated high school.Some collegeGraduated collegeSome professional/graduate school or higher

6 (17.6)13 (38.2)11 (32.44 (11.8)0 (0)

Annual household incomeLess than $20,000$20,000 to $39,000$40,000 to $59,000$60,000 to $79,000$80,000 or More

24 (70.6)5 (14.7)3 (8.8)2 (5.9)0 (0)

InsuranceMedicarePrivate Health InsuranceVeterans Administration (VA) Benefits or TRICAREMedicaidNo Health InsuranceOther

9 (25.7)8 (22.8)2 (5.7)15 42.9)7 (20.0)5 (14.3)

Married 9 (25.7)

NIH U54MD008620

Preliminary Results

Characteristics % or mean

Self-reported health statusExcellent Very Good GoodFairPoor

0 (0)2 (5.7)10 (28.6)19 (54.3)4 (11.4)

Knowledge of Heart Failure 19.3 + 3.6

Social Support 89.1 + 14.9

Adequate Self-Care of Heart FailureSelf-Care MaintenanceSelf-Care ManagementSelf-Care Confidence

9 (25.7)14 (40.0)19 (54.3)

Medication Adherence 2.77 + 1.3

Steps to Increase Recruitment Pace

• Added second site (UAB Medical West) for recruitment

• Initially case workers to send referrals

• Will implement process for direct review of daily

inpatient census for potentially eligible patients

• Will review patient identification processes with Data

Resources at UAB Hospital to ensure that all potential

patients are identified on daily review

• Consideration of 3rd site, but limited by staff resources to

actually reach out to patients at 3 geographically

disparate locations.

NIH U54MD008620

NAVI-HF Team

• Principal Investigator – Raegan Durant, MD, MPH

• Co-Investigator - Isabel Scarinci, PhD

• Co-Investigator - Alexander Lo, MD, PHD

• Co-Investigator – Maria Pisu, PhD

• Biostatistician - Young-il Kim, PhD

• Study Coordinator - Billy Alexander, BSN, RN

• Patient Navigator - James Mapson

• Research Assistant – Sital Patel

Questions?