Patients Navigation to Reduce Readmissions among Black Men with Heart Failure (NAVI-HF)
- 1. NIH U54MD008620 Patient NAVIgation to Reduce Readmissions among Black Men with Heart Failure (NAVI-HF) Raegan W. Durant, MD, MPH Associate Professor of Medicine Division 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
- 2. 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
- 3. NIH U54MD008620 NAVI-HF –Study Population Inclusion Criteria 1. African American 2. Male 3. Age > 40 4. 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, Alabama 6. English-speaking 7. Physically and cognitively able to listen to 30-minute video and undergo a home visit and telephone contacts over several weeks. Exclusion Criteria 1. Heart transplant or awaiting heart transplant 2. Currently participating in another clinical research study 3. Current or anticipated long-term (> 2 weeks) residence in a skilled nursing facility 4. Patients who indicated that they were unwilling to make lifestyle changes now or in the near future 5. Patients whose symptoms may be eliminated by surgery or who had undergone surgery in the month before or after enrollment Study Population = 416 African American men with heart failure
- 4. 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 Control 208 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 HFhospitalizationPDWeek1PDWeek2-4 Time PDWeek 5-8 *In Education + Patient Navigation arm only, Patient Navigator will introduce himself to patient during inpatient stay and schedules home visit. NIH U54MD008620
- 5. NIH U54MD008620 Educational Video • Overview of heart failure and symptoms • 4 chapters based on target heart failure self-care behaviors 1. Daily weights and symptom monitoring 2. Taking medicines appropriately (medication adherence) 3. Low-salt diet 4. Exercise • Culturally tailored for African American men
- 6. 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
- 7. 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
- 8. 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
- 9. NIH U54MD008620 Preliminary Results (n=35) Characteristics % or mean Age (mean + SD) 55.9 + 8.5 Education Did not finish high school. Graduated high school. Some college Graduated college Some professional/graduate school or higher 6 (17.6) 13 (38.2) 11 (32.4 4 (11.8) 0 (0) Annual household income Less 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) Insurance Medicare Private Health Insurance Veterans Administration (VA) Benefits or TRICARE Medicaid No Health Insurance Other 9 (25.7) 8 (22.8) 2 (5.7) 15 42.9) 7 (20.0) 5 (14.3) Married 9 (25.7)
- 10. NIH U54MD008620 Preliminary Results Characteristics % or mean Self-reported health status Excellent Very Good Good Fair Poor 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 Failure Self-Care Maintenance Self-Care Management Self-Care Confidence 9 (25.7) 14 (40.0) 19 (54.3) Medication Adherence 2.77 + 1.3
- 11. 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.
- 12. 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
- 13. Questions?