Project Grant R03TR004017

EVALUATING THE IMPACT OF BASIC NEEDS ASSESSMENT AND SUPPORT TO IMPROVE COLPOSCOPY SHOW RATE: THE BASICS TRIAL - PROJECT SUMMARY/ABSTRACT EACH YEAR, APPROXIMATELY 3.5 MILLION INDIVIDUALS HAVE AN ABNORMAL CERVICAL SCREENING RESULT AND ARE RECOMMENDED FOR MEDICAL FOLLOW-UP, MOST COMMONLY COLPOSCOPY. COLPOSCOPY ALLOWS HEALTH PROVIDERS TO DETECT PRE-CANCERS AND OFFER THERAPEUTIC INTERVENTIONS THAT MAY PREVENT CERVICAL CANCER. UNFORTUNATELY, BETWEEN 37% AND 77% OF PATIENTS ARE LOST TO FOLLOW-UP AFTER THEIR ABNORMAL SCREEN AND NEVER RECEIVE APPROPRIATE CARE. LOW ADHERENCE TO COLPOSCOPY IS ESPECIALLY PREVALENT AMONG BLACK PATIENTS, THOSE WITH LOW INCOME, AND INDIVIDUALS WHO ARE UNINSURED OR HAVE MEDICAID, LEADING TO SOCIOECONOMIC DISPARITIES IN CERVICAL CANCER INCIDENCE AND MORTALITY. OUR PRELIMINARY DATA FROM TWO UNIVERSITY-BASED COLPOSCOPY CLINICS THAT PROVIDE CARE TO THESE UNDERSERVED PATIENTS, SHOW THAT COLPOSCOPY ADHERENCE IMPROVED FROM 50% TO 83% AFTER IMPLEMENTATION OF A TAILORED PHONE CALL INTERVENTION REMINDING PATIENTS OF THEIR APPOINTMENT AND OFFERING NAVIGATOR ASSISTANCE WITH UNMET SOCIAL NEEDS (E.G. UTILITIES, TRANSPORTATION, FOOD, SHELTER, CLOTHING, SAFETY). THESE PILOT DATA SUGGEST THAT A SOCIAL NEEDS NAVIGATOR PROGRAM IMPROVES COLPOSCOPY ADHERENCE, BUT THE LACK OF RANDOMIZATION LIMITS THE STRENGTH OF OUR CONCLUSIONS. IN THIS PROPOSAL, OUR OBJECTIVE IS TO TEST, AND ASSESS THE READINESS FOR IMPLEMENTATION OF A COLPOSCOPY CLINIC-BASED SOCIAL NEEDS NAVIGATOR PROGRAM FOCUSED ON FIVE SOCIAL DETERMINANTS OF HEALTH: HOUSING/SHELTER, FOOD INSECURITY, PERSONAL AND NEIGHBORHOOD SAFETY, FINANCIAL NEEDS, AND DISTRESS. THIS PROJECT WILL TEST THE HYPOTHESIS THAT THIS EQUITY-FOCUSED, SOCIAL NEEDS NAVIGATOR PROGRAM CAN IMPROVE COLPOSCOPY ADHERENCE AMONG UNDERSERVED PATIENTS. WE WILL PERFORM A RANDOMIZED CONTROLLED TRIAL IN WHICH 72 ELIGIBLE PATIENTS (LOW-INCOME, UNINSURED, OR ON MEDICAID) WHO ARE REFERRED FOR COLPOSCOPY AT WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, ARE ENROLLED AND THEN SCREENED FOR UNMET SOCIAL NEEDS AND DISTRESS. THEY WILL THEN BE RANDOMIZED 1:1 INTO EITHER RECEIVE THE SOCIAL NEEDS NAVIGATOR PROGRAM (N=36) OR ENHANCED USUAL CARE (N=36). IN THE NAVIGATOR ARM, A COMMUNITY HEALTH WORKER WILL PROVIDE FOUR MONTHS OF ASSISTANCE TAILORED TO THEIR NEEDS. IN THE ENHANCED USUAL CARE ARM, PATIENTS WILL BE OFFERED INFORMATION AND REFERRAL TO UNITED WAY 2-1-1, A FREE, 24-HR NATIONAL HELPLINE THAT CONNECTS CALLERS WITH LOCAL RESOURCES. IN SPECIFIC AIM 1 WE WILL DETERMINE THE EFFICACY OF OUR SOCIAL NEEDS NAVIGATOR PROGRAM TO IMPROVE COLPOSCOPY ADHERENCE. AIM 2 WILL ASSESS THE ABILITY OF OUR NAVIGATOR PROGRAM TO REDUCE UNMET SOCIAL NEEDS AND DISTRESS. AIM 3 WILL USE THE RE-AIM FRAMEWORK TO EVALUATE METRICS OF IMPLEMENTATION AND POTENTIAL FOR DISSEMINATION. THE PROPOSED WORK WILL PROVIDE KEY DATA TO LAUNCH A LARGE, PRAGMATIC, MULTISITE RANDOMIZED CONTROLLED TRIAL TO RIGOROUSLY TEST THE EFFECTIVENESS, IMPLEMENTATION, AND MAINTENANCE OF OUR SOCIAL NEEDS NAVIGATOR PROGRAM ACROSS DIFFERENT PATIENT POPULATIONS, COMMUNITY SETTINGS, AND HEALTHCARE ORGANIZATIONS. IF SUCH A TRIAL SHOWS THAT OUR NAVIGATOR PROGRAM IS EFFECTIVE, COST-EFFECTIVE, FEASIBLE, AND ACCEPTABLE, IT CAN BE WIDELY IMPLEMENTED TO IMPROVE COLPOSCOPY ADHERENCE AND EQUITY IN CERVICAL CANCER PREVENTION, INCIDENCE, AND MORTALITY.