A Phase II RCT of Stroke Navigators to Improve Compliance with Secondary Stroke Prevention: PROTECT DC

Transcription

1 A Phase II RCT of Stroke Navigators to Improve Compliance with Secondary Stroke Prevention: PROTECT DC Alexander W. Dromerick, MD National Rehabilitation Hospital Georgetown University Departments of Neurology & Rehabilitation Medicine Washington, D.C. Chelsea S. Kidwell, MD (Co-PI) Georgetown University Department of Neurology Washington, D.C. Abstract 4416

2 Financial Disclosures AW Dromerick, none MC Gibbons, none DF Edwards, none D Farr, none A Jayam-Trouth, none N Shara, none BN Sanchez, none S Fernandez, none R Coles, none J Richardson, none B Ovbiagele, none CS Kidwell, none Trial Name: Preventing Recurrence of Thromboembolic Events through Coordinated Treatment in the District of Columbia Trial Abbreviation: PROTECT DC Trial Registry Number or ID: NCT PI/Coordinator Name(s): Alexander W. Dromerick MD/Chelsea S. Kidwell MD/ Deeonna Farr MPH PI/Coord. Affiliation(s): Georgetown University/National Rehabilitation Hospital Trial Sponsor(s): NINDS U Trial Deeonna.E.Farr@Medstar.net Web Site: Trial Contact Information: Deeonna Farr MPH, Deeonna.E.Farr@Medstar.net This work was supported by Award Number U54NS from the National Institute of Neurological Disorders And Stroke (NINDS) and National Institute on Minority Health and Health Disparities (NIMHD) (U54NS057405). PI: Chelsea S. Kidwell, MD

3 Introduction The initiation of effective secondary prevention strategies is most effective when implemented early (before another potentially disabling stroke occurs), monitored frequently, and maintained long-term. PROTECT DC facilitates the initiation of secondary prevention behaviors in an attempt to prevent the recurrence of stroke among participants. The program trains lay people, called stroke navigators, to provide participants with education on secondary prevention behaviors and to navigate the health and human service system, which will assist participants in obtaining the necessary services and programs to engage in secondary prevention behaviors.

4 Health Behavior Change Increasing adherence involves changing longstanding healthrelated behaviors. Among the most influential models is the Theory of Reasoned Action (TRA) and the closely associated Theory of Planned Behavior (TPB), which address an individual s motivation to perform a specific health-related behavior. This theory incorporates concepts of beliefs (behavioral and normative), attitudes, intentions, and behavior, and is based on findings that attitudes toward a specific behavior predicts the participant s behavior better than the attitude towards the target disease. TPB predicts that if PROTECT DC is to reduce stroke by increasing the effectiveness of secondary stroke prevention, it must increase participants behavioral intention towards taking medications, not simply towards avoiding stroke.

5 Health Care Navigation Navigators are lay community health workers who assist patients with accessing existing health care resources. First widely used in the US by Freeman, Muth & Kerner (1995) for breast cancer at Harlem Hospital. Navigators do not provide care, but assist participants in overcoming barriers to accessing existing resources to adhere to secondary stroke prevention behaviors. Using concepts from TRA/TRB, they attempt to reshape participant beliefs, intentions and actions regarding secondary stroke prevention behaviors. PROTECT DC navigators are supervised by physicians, social workers, health educators, and nurses.

6 Methods Objective: 1. To determine whether stroke navigation can improve compliance with secondary stroke prevention measures in an urban underserved population with atherogenic ischemic stroke. 2. To assess the contribution of health status, depression, cognition, socio-economic status, race and other factors to the incidence of barriers and the rate of response to the study interventions. Study Design: Design: Phase II, single-blind, randomized controlled trial Analysis: Intention to treat Sample: n = 250 Sites: Washington Hospital Center, Georgetown University Hospital, Howard University Hospital, National Rehabilitation Hospital Interventions: Experimental: Stroke navigation for a one year. Control: Usual and customary care (meeting Get With the Guidelines criteria) for one year. Outcome Measures: Primary: Systolic blood pressure, HbA1c, LDL, INR at one year after stroke onset. Secondary: Stroke knowledge, exercise, dietary modification, smoking cessation at one year.

7 Methods Inclusion Criteria: 1. Age 18 years 2. Hospitalized due to ischemic stroke or intercurrent ischemic stroke event within the past 30 days 3. Large vessel, small vessel, or cryptogenic with stroke risk factors etiologies as defined by TOAST criteria, or cardioembolic stroke due to atherogenic causes 4. Community dwelling prior to stroke 5. Resides within the District of Columbia or closely nearby 6. Expected to reside after hospital discharge within the District of Columbia or closely nearby 7. Caregiver or interested party available, if moderately or severely disabled (not required to actually reside with participant) 8. Sufficient number of collateral contacts to assure follow-up. 9. NIHSS <20 Participant Schedule

8 Participant Accrual Accrual: N= 230 Age: Mean (SD) = 61.4 (12); Range (29 90) Sex: Male (n= 110, 48%); Female (n= 120, 52%) Intention to Treat 4/1/ /16/2011 Race: AA (n= 204, 89%) Cauc (n= 19, 8%) Asian (n= 5, 2%) Other (n= 2, 1%) Intervention: Navigation (n= 116) Control (n= 114) Participants Enrolled Actual Grant Projection NIHSS: Median = 2; Range (0 20) 0 Discharge Status: Home (n= 134, 58%) Acute Rehab/Other (n= 96, 42%)

9 Blinded Rating & Retention Completed (as of 1/13/2012): 20% NIHSS Distribution (Enrollment) 3-month assessment: n=194 1-year assessment: n=137 2-year phone call: n=11 Percentage (%) 18% 16% 14% 12% 10% 8% 6% 4% 2% 0% Score