Healthpartners Institute

METRO-MINNESOTA COMMUNITY CLINICAL ONCOLOGY PROGRAM (MM-CCOP)

HOME USE OF MD-LOGIC AUTOMATED INSULIN DELIVERY SYSTEM: SAFETY AND EFFICACY

A TECHNOLOGY-DRIVEN INTERVENTION TO IMPROVE EARLY DETECTION AND MANAGEMENT OF COGNITIVE IMPAIRMENT - PROJECT SUMMARY THE PREVALENCE OF ALZHEIMER’S DISEASE (AD) AND AD-RELATED DEMENTIAS (ADRD) IS EXPECTED TO TRIPLE BY 2050, CONTRIBUTING TO DECREASED QUALITY OF LIFE, INCREASED MEDICAL CARE UTILIZATION, AND ADDITIONAL BURDEN ON AN ALREADY STRESSED PRIMARY CARE SYSTEM. MANY CLINICIANS LACK CONFIDENCE TO ASSESS, DIAGNOSE AND MANAGE COGNITIVE IMPAIRMENT (CI), AND MORE THAN 50% OF PATIENTS WITH CI ARE UNDIAGNOSED. UNFORTUNATELY, STUDIES SHOW THAT EVEN IN SETTINGS WITH HIGH RATES OF STANDARDIZED CI SCREENING, VERY FEW PATIENTS WHO SCREEN POSITIVE HAVE DOCUMENTATION OF ANY CLINICIAN FOLLOW-UP ACTION. TO ADDRESS THESE IMPORTANT PROBLEMS, IN PHASE 1 (R61) OF THIS PROJECT, WE WILL DEVELOP AND VALIDATE A MACHINE LEARNING MODEL (CALLED MC-PLUS) USING RESULTS FROM BRIEF MINI- COG (MC) SCREENS COMPLETED ROUTINELY AT ANNUAL MEDICARE WELLNESS EXAMS AND ELECTRONIC HEALTH RECORD (EHR) DATA TO IDENTIFY PATIENTS AT ELEVATED RISK OF A FUTURE DEMENTIA DIAGNOSIS (AD/ADRD). WE WILL ALSO DEVELOP AND VALIDATE A WEB-BASED AND EHR-INTEGRATED CI CLINICAL DECISION SUPPORT (CI-CDS) SYSTEM TO ENGAGE PATIENTS AND CLINICIANS IN CONVERSATION ABOUT ELEVATED DEMENTIA RISK, AND TO GIVE CLINICIANS THE CONFIDENCE AND TOOLS THEY NEED TO DIAGNOSE AND MANAGE CI. BOTH MC-PLUS AND THE CI-CDS SYSTEM WILL BE ADDED INTO AN EXISTING WEB-BASED CDS PLATFORM THAT HAS HIGH USE RATES AND PRIMARY CARE CLINICIAN SATISFACTION, AND IS ALREADY SEAMLESSLY INTEGRATED WITHIN THE EHR. THIS CDS PLATFORM IMPROVES OUTCOMES FOR PATIENTS WITH CHRONIC DISEASES SUCH AS DIABETES AND HIGH CARDIOVASCULAR RISK AS SHOWN IN PUBLISHED STUDIES. WE WILL SYSTEMATICALLY VALIDATE THE CI-CDS SYSTEM WITH EXPERT CHAMPIONS PRIOR TO CONDUCTING A PILOT TEST AT ONE PRIMARY CARE CLINIC. AFTER MILESTONES FOR SUCCESS ARE DEMONSTRATED, WE WILL BEGIN PHASE 2 (R33), A LARGE PRAGMATIC TRIAL WITH 30 PRIMARY CARE CLINICS RANDOMIZED TO RECEIVE CI-CDS OR USUAL CARE (UC). WE WILL EVALUATE CHANGE IN CLINICIAN CONFIDENCE IN CI DETECTION AND CARE MANAGEMENT IN CI-CDS COMPARED TO UC CLINICS. IF SUCCESSFUL, THE CI-CDS SYSTEM WILL IMPROVE RATES OF NEW CI DIAGNOSIS AND NARROW EXISTING SOCIODEMOGRAPHIC DISPARITIES IN ADULTS WITH ELEVATED DEMENTIA RISK IDENTIFIED BY MC-PLUS AT INDEX VISIT IN CI-CDS COMPARED TO UC CLINICS. WE WILL EVALUATE THE IMPACT OF THE INTERVENTION ON CARE MANAGEMENT AND CARE PLANS USING EHR DATA AND CHART AUDITS. WE WILL ASSESS DETERMINANTS OF CLINICIAN ACTIONS IN RESPONSE TO THE CDS SYSTEM USING BEHAVIOR CHANGE THEORY AND TECHNOLOGY ACCEPTANCE CONSTRUCTS, AND CONDUCT PHONE SURVEYS OF PATIENT AND CAREGIVER DYADS TO EVALUATE INTERVENTION EFFECTS ON FEELINGS OF PREPAREDNESS FOR DECISION MAKING AND DISTRESS. THE CI-CDS SYSTEM IS IMMEDIATELY SCALABLE TO LARGE NUMBERS OF PATIENTS THROUGH THE EXISTING NON-COMMERCIALIZED CDS PLATFORM ALREADY IN USE FOR MILLIONS OF PATIENTS IN CARE SYSTEMS SPANNING 14 STATES. THE CDS SYSTEM IMPLEMENTED AS DESCRIBED COULD MAXIMIZE RETURN ON MASSIVE INVESTMENTS THAT HAVE BEEN MADE IN EHR SYSTEMS, AND PROVIDE A PROTOTYPE TO RAPIDLY AND CONSISTENTLY TRANSLATE EVOLVING EVIDENCE-BASED CI GUIDELINES INTO PERSONALIZED CI CARE AND GUIDANCE WITHIN PRIMARY CARE.

MITIGATING DIABETIC KETOACIDOSIS IN PEOPLE WITH T1D AND CHRONIC KIDNEY DISEASE ON AN SGLT1&2 INHIBITOR: KETOSIS RISK FACTOR DETERMINATION AND INCORPORATION INTO AN ENHANCED GLUCOSE KETONE REPORT - PROJECT SUMMARY IT IS ESTIMATED THAT 1.8 MILLION PEOPLE IN THE U.S. HAVE TYPE 1 DIABETES (T1D) AND OF THESE, AT LEAST 20% HAVE CHRONIC KIDNEY DISEASE (CKD). SODIUM-GLUCOSE COTRANSPORTER INHIBITORS (SGLT2I) AND SIMILAR MEDICATIONS IMPROVE GLYCEMIC CONTROL AND ARE CARDIOPROTECTIVE AND KIDNEY PROTECTIVE. HOWEVER, IN TRIALS OF SGLT2I AS AN ADJUNCT TO INSULIN IN PATIENTS WITH T1D, POTENTIAL BENEFITS WERE NOT FULLY REALIZED DUE TO INCREASED INCIDENCE OF DIABETIC KETOACIDOSIS (DKA). FUTURE APPROVAL OF SGLT2I FOR T1D WILL DEPEND ON A MORE COMPREHENSIVE UNDERSTANDING OF KETOSIS RISKS AND FEASIBLE STRATEGIES FOR PREVENTION OF DKA. USE OF CONTINUOUS KETONE MONITORING (CKM) MAY ALLOW FOR THE SAFE USE OF SGLT2I IN PATIENTS WITH T1D, BUT PATIENT USE OF THE KETONE DATA IN REAL-TIME AND PATIENT AND PROVIDER USE OF A RETROSPECTIVE COMBINED CGM/CKM REPORT WILL BOTH BE CRITICAL COMPONENTS OF HOW CKM DATA MAY HELP FACILITATE THE SAFE USE OF SGLT2I THERAPY TO IMPROVE HEALTH OUTCOMES. THE HEALTHPARTNERS INTERNATIONAL DIABETES CENTER (IDC) PROVIDES COMPREHENSIVE CARE FOR OVER 7000 PATIENTS WITH T1D IN MINNESOTA AND CONDUCTS EXTENSIVE CONTINUOUS GLUCOSE MONITORING (CGM), INSULIN MANAGEMENT, AND DIETARY MANAGEMENT RESEARCH IN THIS POPULATION. OVER THE LAST 40 YEARS, IDC HAS PLAYED A CRITICAL ROLE IN THE EVALUATION AND IMPLEMENTATION OF NEW DIABETES THERAPIES INTO PRACTICE. WE HAVE DEVELOPED THE CONSENSUS STANDARD CGM DATA REPORT (AMBULATORY GLUCOSE PROFILE: AGP) USED BY ALL MAJOR CGM MANUFACTURERS, CLINICIANS, AND RESEARCHERS GLOBALLY. WE HAVE LED OR CONTRIBUTED AS A PARTICIPATING SITE IN CLINICAL TRIALS EVALUATING THE SAFETY AND EFFICACY OF MOST NEW DIABETES MEDICATION CLASSES IN USE, INCLUDING SGLT2I THERAPY. THE OVERALL GOALS OF THIS PROPOSAL ARE TO DEVELOP AND EVALUATE A NOVEL DKA RISK MITIGATION STRATEGY IN ORDER TO SUPPORT THE SAFE USE OF SGLT2I THERAPY IN PATIENTS WITH T1D. WE PROPOSE STUDYING SGLT2I MEDICATIONS WITH A FOCUS ON PATIENTS WITH T1D AND MILD TO MODERATE CKD; THIS GROUP IS THE MOST LIKELY TO BENEFIT FROM THE SGLT2I KIDNEY PROTECTIVE EFFECTS AND, ONCE APPROVED FOR USE IN T1D, PATIENTS AT RISK FOR KIDNEY DISEASE MAY BE PRIORITIZED FOR TREATMENT WITH SGLT2I THERAPY. THE DKA RISK MITIGATION STRATEGY WE PROPOSE WILL LEVERAGE EARLY DETECTION OF RISK FOR DKA THROUGH CKM TECHNOLOGY AND OUR TEAM'S EXPERTISE IN DEVELOPING AND IMPLEMENTING STANDARDIZED, COMPREHENSIVE, AND CLINICALLY RELEVANT REPORTS FOR CGM DATA. THE COMBINED CGM/CKM REPORT THAT WE PROPOSE, IN ADDITION TO CONTINUOUS GLUCOSE AND KETONE DATA, WILL INCORPORATE PATIENT DATA ON POTENTIALLY MODIFIABLE KETOSIS RISK FACTORS. THE CGM/CKM REPORT WILL BE REFINED TAKING INTO ACCOUNT THE PREFERENCES OF PATIENTS AND PROVIDERS, ENSURING AN ACCESSIBLE AND INTERPRETABLE USER INTERFACE AND SUPPORTING SUSTAINED BEHAVIOR CHANGES TO PREVENT EPISODES OF KETOSIS AND TO ENSURE THAT WHEN EPISODES OF KETOSIS DO OCCUR, THEY DO NOT PROGRESS TO DKA. THIS PROPOSAL BUILDS ON OUR EXTENSIVE CLINICAL AND RESEARCH EXPERTISE IN DIABETES CARE, QUALITATIVE AND QUANTITATIVE ANALYSES, AND LEADERSHIP IN OPTIMIZATION OF CGM REPORTS TO IMPROVE GLYCEMIC CONTROL AND LONG-TERM CLINICAL OUTCOMES WHILE PREVENTING DKA IN PATIENTS WITH T1D AND CKD PROGRESSION.

HEALTHY HOMES/HEALTHY KIDS: PEDIATRIC PRIMARY CARE-BASED OBESITY PREVENTION

REDUCING CV RISK IN PREDIABETES PATIENTS USING EHR-BASED DECISION SUPPORT

PRIORITIZED CLINICAL DECISION SUPPORT TO REDUCE CARDIOVASCULAR RISK

A TEAM-BASED AND TECHNOLOGY DRIVEN ADHERENCE INTERVENTION TO IMPROVE CHRONIC DISEASE OUTCOMES

REDUCING CLINICAL INERTIA IN OBESITY MANAGEMENT OF DIABETES IN PRIMARY CARE: CLUSTER-RANDOMIZED TRIAL - PROJECT SUMMARY OBESITY HAS BEEN STEADILY INCREASING IN PREVALENCE AND NOW AFFECTS MORE THAN 4 IN 10 U.S. ADULTS, LEADING TO MANY ADVERSE HEALTH OUTCOMES INCLUDING MYOCARDIAL INFARCTION, STROKE, TYPE 2 DIABETES (T2DM), HYPERTENSION, SLEEP APNEA, ARTHRITIS, AND OTHERS. EFFECTIVE SURGICAL, PHARMACEUTICAL, AND BEHAVIORAL TREATMENTS FOR OBESITY ARE AVAILABLE, AND THE EVIDENCE TO SUPPORT THE BROAD USE OF THESE TREATMENTS FOR OBESITY IS VERY WELL ESTABLISHED. HOWEVER, ACTIVE MANAGEMENT OF OBESITY DEFINED AS PRESCRIBING OR REFERRING ADULTS WITH OBESITY FOR LIFESTYLE, PHARMACEUTICAL, OR SURGICAL TREATMENT OF OBESITY, IS GREATLY UNDERUSED. MAJOR UNDERLYING REASONS FOR UNDERUTILIZATION OF EFFECTIVE OBESITY TREATMENTS INCLUDE: (A) BOTH PATIENTS AND PRIMARY CARE CLINICIANS (PCCS) FREQUENTLY UNDERESTIMATE THE EFFECTIVENESS AND POTENTIAL BENEFITS OF OBESITY TREATMENTS; AND (B) BOTH PATIENTS AND CLINICIANS TYPICALLY LACK ACCESS TO EVIDENCE-BASED, PATIENT-SPECIFIC ESTIMATES OF THE POTENTIAL BENEFITS AND RISKS OF APPROPRIATE PATIENT-SPECIFIC OBESITY TREATMENT OPTIONS. TO ADDRESS THIS PROBLEM, WE INTEGRATE EXTERNALLY VALIDATED PREDICTION EQUATIONS THAT ESTIMATE BENEFITS AND RISK OF VARIOUS OBESITY TREATMENT OPTIONS IN ADULTS WITH T2DM INTO A WIDELY-USED AND SUCCESSFUL CLINICAL DECISION SUPPORT SYSTEM IN ORDER TO DELIVER APPROPRIATE PATIENT-SPECIFIC OBESITY TREATMENT SUGGESTIONS AT THE POINT OF CARE. WE IMPLEMENT A SCALABLE, WEB-BASED POINT-OF-CARE DECISION-SUPPORT INTERVENTION IN A RANDOMIZED TRIAL IN 40 PRIMARY CARE CLINICS WITH 15,814 ELIGIBLE PATIENTS, AND ASSESS INTERVENTION IMPACT ON THE FOLLOWING PRIMARY OUTCOMES: (A) APPROPRIATE REFERRAL OF ELIGIBLE PATIENTS FOR EVALUATION FOR METABOLIC BARIATRIC SURGERY (MBS); (B) APPROPRIATE INITIATION OF FDA-APPROVED MEDICATIONS FOR WEIGHT LOSS; (C) WEIGHT TRAJECTORIES; AND (D) PATIENT- REPORTED CONVERSATIONS WITH THEIR PCC ABOUT WEIGHT LOSS AND INTENTIONS TO ENGAGE IN WEIGHT LOSS. IN ADDITION, WE COLLECT AND ANALYZE CLINICIAN-REPORTED AND PATIENT-REPORTED DATA TO IDENTIFY FACTORS THAT MAY IMPEDE OR FACILITATE BROAD DISSEMINATION OF THIS INTERVENTION STRATEGY TO OTHER CARE DELIVERY SETTINGS. THIS INNOVATIVE PROJECT WILL (A) PROVIDE STATE-OF-THE-ART SCIENTIFIC EVIDENCE ON OBESITY TREATMENT TO LARGE NUMBERS OF OBESE AMERICAN ADULTS WITH T2DM AND THEIR PCCS AT THE POINT OF CARE; (B) HELP PCCS IDENTIFY APPROPRIATE PATIENT-SPECIFIC OBESITY TREATMENT OPTIONS; (C) IMPLEMENT IN PRIMARY CARE A WEB-BASED EHR-LINKED OBESITY TREATMENT CLINICAL DECISION SUPPORT MODEL THAT USES STATE-OF-THE-ART HIT STANDARDS, IS BROADLY SCALABLE, EASY TO UPDATE AS EVIDENCE CHANGES, AND OPTIMIZED FOR CLEAR COMMUNICATION OF INFORMATION TO PATIENTS AND PCCS; AND (D) IMPROVE THE CLINICAL RETURN ON ONGOING MASSIVE PRIVATE AND PUBLIC INVESTMENTS IN OUTPATIENT HEALTH INFORMATION SYSTEMS.

HOME BLOOD PRESSURE TELEMONITORING AND CASE MANAGEMENT TO CONTROL HYPERTENSION

DE-IMPLEMENTING OPIOID USE AND IMPLEMENTING OPTIMAL PAIN MANAGEMENT FOLLOWING DENTAL EXTRACTIONS

EHR-BASED DECISION SUPPORT FOR PEDIATRIC ACUTE ABDOMINAL PAIN IN EMERGENCY CARE

TREATMENT INITIATION FOR NEW EPISODES OF DEPRESSION IN PREGNANT WOMEN - PROJECT SUMMARY UP TO 12% OF PREGNANT WOMEN HAVE A NEW EPISODE OF DEPRESSION, IE, AN INCIDENT OR RECURRENT DEPRESSIVE EPISODE WITH SYMPTOM ONSET DURING PREGNANCY. EFFECTS OF UNTREATED ANTENATAL DEPRESSION INCLUDE UNHEALTHY MATERNAL BEHAVIORS (EG, DIMINISHED SELF-CARE, SMOKING, SUBSTANCE USE, SELF-HARM) AND EMOTIONAL AND BEHAVIORAL PROBLEMS IN OFFSPRING. ANTENATAL DEPRESSION OR ELEVATED DEPRESSION SCORES, IDENTIFIED BY SCREENING INSTRUMENTS, INCREASE THE RISK OF PRETERM BIRTH (PTB), LOW BIRTH WEIGHT (LBW), AND SMALL FOR GESTATIONAL AGE (SGA) BIRTH, AND ARE ASSOCIATED WITH BREASTFEEDING DISCONTINUATION BEFORE 3 MONTHS POSTPARTUM. IN-PERSON PSYCHOTHERAPY AND ANTIDEPRESSANT MEDICATION IMPROVE DEPRESSION SYMPTOMS IN MANY WITH DEPRESSION, YET <50% OF PREGNANT WOMEN WITH NEW EPISODES OF DEPRESSION INITIATE THESE TREATMENTS. ALTHOUGH SOME BARRIERS TO INITIATING ANTIDEPRESSANTS AND PSYCHOTHERAPY ARE KNOWN, OTHER FACTORS HAVE NOT BEEN WELL DESCRIBED, ESPECIALLY AFTER ACCOUNTING FOR DEPRESSION SEVERITY. FURTHERMORE, THE IMPACT OF ANTIDEPRESSANTS AND PSYCHOTHERAPY ON PERINATAL OUTCOMES, INCLUDING PTB, LBW, SGA, AND BREASTFEEDING CONTINUATION AMONG PREGNANT WOMEN WITH NEW EPISODES OF DEPRESSION AFTER ACCOUNTING FOR CONFOUNDING BY DEPRESSION SEVERITY IS UNKNOWN. GIVEN THE IMPORTANCE OF FACTORS INFLUENCING THE DECISION TO INITIATE ANTIDEPRESSANT OR PSYCHOTHERAPY TREATMENT DURING PREGNANCY AND THE NEED FOR FURTHER EVIDENCE ON THE PERINATAL RISKS AND BENEFITS ASSOCIATED WITH ANTIDEPRESSANT USE AND PSYCHOTHERAPY IN PREGNANT WOMEN, THE GOAL OF THIS STUDY IS TO IDENTIFY PREDICTORS AND PERINATAL EFFECTS OF PSYCHOTHERAPY AND ANTIDEPRESSANT USE FOR NEW EPISODES OF DEPRESSION DURING PREGNANCY WHILE ACCOUNTING FOR DEPRESSION SEVERITY. WE WILL CONDUCT THIS STUDY IN A RACIALLY AND ETHNICALLY DIVERSE MULTI- SITE POPULATION USING ELECTRONIC HEALTH DATA, ENRICHED WITH SURVEY DATA FROM A SUBSET OF WOMEN. AMONG PREGNANT WOMEN WITH NEW EPISODES OF DEPRESSION, WE WILL EVALUATE FACTORS THAT INFLUENCE THE PROPENSITY TO INITIATE PSYCHOTHERAPY OR ANTIDEPRESSANTS; ACCOUNTING FOR THESE IS CRUCIAL WHEN STUDYING TREATMENT EFFECTS. WE WILL DESCRIBE PATTERNS OF USE OF ALTERNATIVE DEPRESSION MANAGEMENT APPROACHES (EG, INTERNET- BASED PSYCHOTHERAPY, PEER SUPPORT GROUPS, AND COMPLEMENTARY AND ALTERNATIVE MEDICINE) AND WILL EVALUATE WHETHER INITIATION OF PSYCHOTHERAPY OR ANTIDEPRESSANTS IS ASSOCIATED WITH THESE PRACTICES WHILE ACCOUNTING FOR DEPRESSION SEVERITY. WE WILL QUANTIFY THE IMPACT OF PSYCHOTHERAPY AND ANTIDEPRESSANTS (INCLUDING DOSE, TIMING, AND DURATION OF USE) ON PTB, LBW, SGA, AND BREASTFEEDING CONTINUATION ACCOUNTING FOR THE PROPENSITY TO INITIATE PSYCHOTHERAPY OR ANTIDEPRESSANTS AND DEPRESSION SEVERITY. WE ARE UNIQUELY POSITIONED TO OVERCOME LIMITATIONS OF CONFOUNDING AND SMALL SIZE IN PRIOR STUDIES GIVEN OUR DATA ON DEPRESSION SEVERITY AND MATERNAL COMORBIDITY FOR MORE THAN 8,000 PREGNANT WOMEN. OUR STUDY WILL BE INFORMATIVE FOR UNDERSTANDING THE MENTAL HEALTH INTERVENTIONS UTILIZED BY PREGNANT WOMEN WITH DEPRESSION AND WILL INFORM DECISION MAKING ON OPTIMAL DEPRESSION MANAGEMENT DURING PREGNANCY.

USING SYSTEMS SCIENCE METHODS TO STUDY CARDIAC RISK IN THE SOMALI COMMUNITY

AN ARTIFICIAL INTELLIGENCE APPROACH TO UNDERSTANDING TRADE-OFFS IN EMERGENCY DEPARTMENT DECISION-MAKING - PROJECT SUMMARY EMERGENCY DEPARTMENT (ED) DECISION-MAKING IS INHERENTLY COMPLEX, INFLUENCED BY UNCERTAINTY, TIME PRESSURE, AND HIGH-STAKES CONSEQUENCES. ED CROWDING EXACERBATES THESE CHALLENGES BY INCREASING DISTRACTIONS AND COGNITIVE LOAD, OFTEN LEADING TO SUBOPTIMAL DECISIONS AND ADVERSE OUTCOMES. TRIAGE NURSES ARE TYPICALLY THE FIRST POINT OF CONTACT FOR MEDICAL NEEDS ASSESSMENT. FOR EXAMPLE, THEIR ROLE IN PRIORITIZING PATIENTS IS ONE OF THE MOST CONSEQUENTIAL DECISIONS, YET CURRENT TRIAGE ACCURACY IS ONLY ABOUT 60% COMPARED TO EXPERT BENCHMARKS. THIS PERFORMANCE GAP STEMS FROM THE COMPLEXITY OF ED SCENARIOS, WHICH OFTEN EXCEED HUMAN COGNITIVE LIMITS. ARTIFICIAL INTELLIGENCE (AI), INCLUDING LARGE LANGUAGE MODELS (LLMS), OFFER THE POTENTIAL TO SUPPORT TRIAGE NURSES AND ALL MEMBERS OF THE ED TEAM BY IMPROVING DECISION-MAKING ON MANY ED TASKS, ESPECIALLY DURING CROWDING. ADVANTAGES OF SUCH TOOLS INCLUDE RAPID PROCESSING OF LARGE VOLUMES OF DATA, OPERATING WITHOUT FATIGUE, AND BEING DEPLOYABLE ON DEMAND – ALL WHILE RIVALING HUMAN DECISION-MAKING ON A WIDE VARIETY OF TASKS. WITH RECENT ADVANCES IN AI, THERE IS A TIMELY OPPORTUNITY TO INVESTIGATE ITS UTILITY IN SUPPORTING ED DECISION-MAKING. WHILE AI/LLMS COULD BE VITAL SUPPORT FOR ED DECISION-MAKING, THERE IS NO GOLD STANDARD (EXPERT ANNOTATED LABELED DATA) BY WHICH TO EVALUATE THE QUALITY OR ACCURACY ED DECISIONS, AND NO STANDARDIZED TASKS OR METRICS. WE PROPOSE TO DEVELOP A SET OF GOLD-STANDARD ED DECISIONS DERIVED BY EXPERT ANNOTATION ON PATIENT CASES FOR A SET OF DECISION-MAKING TASKS, AND ESTABLISH A SET OF METRICS FOR ASSESSING DECISION-MAKING PERFORMANCE. IN ADDITION, WE WILL FINE-TUNE AND VALIDATE FINE-TUNED LLMS, WITH THE BEST-PERFORMING MODEL TERMED “AI-TRIAGE+”. WE WILL THEN TEST THE PERFORMANCE OF AI-TRIAGE+ ON ED DECISION-MAKING-TASKS VS. STATUS QUO (HUMAN DECISIONS) AND EXISTING PRE-TRAINED (GENERALIST) AI MODELS. AIM 1: COMPARE THE PERFORMANCE OF AI MODELS TO A GOLD STANDARD ON FIVE ED DECISION-MAKING TASKS: ESI (EMERGENCY SEVERITY INDEX) LEVEL RECOMMENDATION, PATIENT-FACING DIAGNOSTIC QUESTION GENERATION, ACCEPTABLE SAFE WAIT TIME VALUES FOR EACH PATIENT, RECOMMEND DIAGNOSTIC TESTS AND ED PROCEDURES FOR THE PATIENT, AND RECOMMEND ED RESOURCE LEVEL BASED ON THE PATIENT'S NEEDS (AKA PATIENT DISPOSITION). WE WILL ASSESS OVERALL MODEL PERFORMANCE AND PERFORMANCE ON SPECIFIC SUBSETS OF CASES, E.G., BY DIAGNOSES, AGE GROUP, ED WORKLOAD (OVERCROWDING SCORE). AIM 2: ESTIMATE THE IMPACT OF AI MODELS' DECISIONS ON CLINICAL OUTCOMES. USING EXISTING RISK EQUATIONS, WE WILL ESTIMATE HOW DIFFERENT ED DECISIONS BY AI MODELS WILL IMPACT ICU ADMISSIONS OR DEATH IN ED, HOSPITAL ADMISSIONS, AND LENGTH OF HOSPITAL STAY. WE WILL ALSO EXPLORE THE POTENTIAL OF AI-TRIAGE+ TO IMPROVE ED EFFICIENCY AT A SYSTEM LEVEL. THIS WORK DIRECTLY SUPPORTS THE NINR FOCUS ON SYSTEMS AND MODELS OF CARE, OFFERING FOUNDATIONAL TOOLS AND INSIGHTS TO GUIDE AI INTEGRATION INTO ED PRACTICE.

IMPLEMENTING CANCER PREVENTION USING PATIENT - PROVIDER CLINICAL DECISION SUPPORT

CV BENEFITS AND SAFETY OF GLUCOSE-LOWERING THERAPIES IN ADULTS WITH DIABETES

CHILDHOOD HYPERTENSION AND OBESITY: DIAGNOSIS, CARE, AND COSTS

EHR-BASED CLINICAL DECISION SUPPORT TO IMPROVE BP MANAGEMENT IN ADOLESCENTS

EVALUATING OPTIONS FOR NON-RESPONDERS: A SMART APPROACH TO ENHANCING WEIGHT LOSS

THE INTERPLAY OF ENDS AND TOBACCO CONTROL POLICY: IMPACT ON THE POPULATION HARMS OF TOBACCO - PROJECT SUMMARY THIS PROJECT WILL CLARIFY THE VALUE AND IMPACT OF POLICY OPTIONS INTENDED TO REDUCE THE POPULATION HARMS OF TOBACCO. THE RISE IN POPULARITY OF ELECTRONIC NICOTINE DELIVERY SYSTEMS (ENDS) SUCH AS E-CIGARETTES POSES BOTH OPPORTUNITIES AND CHALLENGES FOR REDUCING THE POPULATION HARMS OF TOBACCO. ENDS MIGHT REDUCE POPULATION HARM IF SUBSTITUTED FOR A SIGNIFICANT PROPORTION OF COMBUSTIBLE CIGARETTES (C-CIGS), BUT SUCH BENEFITS MUST BE WEIGHED AGAINST THE FACT THAT ENDS POSE A RISK TO INDIVIDUALS WHO, IN THEIR ABSENCE, WOULD NOT USE TOBACCO. SIMULATION STUDIES CAN AND HAVE BEEN USED TO ASSESS THE TRADE-OFFS ASSOCIATED WITH ENDS. TO DATE, EFFECTS HAVE BEEN SIMULATED IN THE CONTEXT OF TOBACCO CONTROL POLICY THAT WAS IN PLACE AT THE TIME THE MODEL WAS BUILT AND REFLECT THE AVERAGE OF STATE POLICIES IN PLACE. YET, THE EFFECTS OF ENDS MAY VARY ACCORDING TO THE INTENSITY OF THE TOBACCO CONTROL POLICIES IN PLACE. FOR THE PROPOSED STUDY, WE DEFINE INTENSIFIED TOBACCO CONTROL POLICIES (I-TCP) AS EVIDENCE-BASED POLICIES THAT PRIMARILY TARGET C-CIG USE AND ARE CAPABLE OF SUBSTANTIALLY REDUCING THE POPULATION HARMS FROM TOBACCO WHEN SCALED TO LEVELS RECOMMENDED BY PUBLIC HEALTH AGENCIES, I.E., C-CIG TAXES, INCREASED TOBACCO CONTROL EXPENDITURES THAT FUND COMPREHENSIVE TOBACCO CONTROL PROGRAMS, AND COMPREHENSIVE INDOOR SMOKING BANS. BECAUSE I-TCP CAN SUBSTANTIALLY REDUCE THE POPULATION HARMS OF TOBACCO, THE POTENTIAL FOR ENDS TO FURTHER REDUCE THESE HARMS MAY BE ATTENUATED WHEN I-TCP ARE IN EFFECT. MOREOVER, OUR CURRENT KNOWLEDGE OF THE HEALTH AND ECONOMIC IMPACT OF I-TCP WAS, FOR THE MOST PART, AMASSED DURING A TIME WHEN ENDS DID NOT EXIST. IF THE PRESENCE OF ENDS IN THE MARKETPLACE LEADS TO SUBSTITUTION OF LESS HARMFUL FORMS OF NICOTINE (SUCH AS ENDS) FOR MORE TOXIC COMBUSTIBLE PRODUCTS, THEN, GIVEN THE WIDESPREAD AVAILABILITY OF ENDS, I-TCPS MAY NOT LOWER POPULATION HEALTH AND ECONOMIC HARMS OF TOBACCO AS MUCH AS AVAILABLE ESTIMATES INDICATE. I-TCP MAY ALSO INFLUENCE USE PATTERNS OF ENDS, CREATING DYNAMICS THAT COULD LEAD TO UNANTICIPATED LEVELS OF HEALTH IMPACT FOR BOTH ENDS AND I-TCP. THUS, THE INTRODUCTION OF ENDS TO THE MARKETPLACE HAS CREATED GAPS IN OUR KNOWLEDGE OF POLICY EFFECTS, WHICH COULD PRECIPITATE POLICY MISSTEPS THAT INCREASE, NOT DECREASE, POPULATION LEVEL TOBACCO HARM. THE INTERTWINED EFFECTS OF TOBACCO PRODUCTS AND POLICIES CANNOT MEANINGFULLY BE EXPLORED THROUGH ANY REAL-WORLD EXPERIMENT. THEREFORE, WE WILL CONDUCT A SIMULATION STUDY TO CLOSE THESE KNOWLEDGE GAPS. ALTHOUGH NO STATE IS IMPLEMENTING ALL TOBACCO POLICIES AT RECOMMENDED LEVELS, EXISTING VARIATION IN STATE POLICIES CAN BE EXPLOITED TO REVEAL THE LIKELY IMPACT OF INDIVIDUAL STATE POLICIES. LEVERAGING EXISTING DATA SETS THAT CAPTURE VARIATION IN STATE POLICY TIMING AND INTENSITY, WE WILL BUILD A SIMULATION MODEL TO ESTIMATE THE COMBINED EFFECTS OF POLICIES AND ENDS. MODEL SIMULATIONS WILL PRODUCE BOTH NATIONAL- AND STATE-LEVEL ESTIMATES TO INFORM POLICY AIMED AT REDUCING TOBACCO POPULATION HARMS, WHILE ACCOUNTING FOR: THE EFFECTS OF ENDS IN THE PRESENCE OR ABSENCE OF I-TCP, AND THE EFFECTS OF I-TCP IN THE PRESENCE OR ABSENCE OF ENDS. THE RESULTS WILL CLARIFY THE PLAUSIBLE RANGE OF IMPACTS OF BOTH ENDS AND I-TCP.

EVALUATION OF A NATURAL EXPERIMENT TO IMPROVE STATEWIDE DEPRESSION CARE IN MN

A CLINIC-RANDOMIZED TRIAL OF A CLINICAL DECISION SUPPORT SYSTEM TO IMPROVE DENTAL PROVIDER DELIVERY OF BRIEF TOBACCO INTERVENTIONS AND QUITLINE REFER

PERSONALIZED PHYSICIAN LEARNING INTERVENTION TO IMPROVE HYPERTENSION CONTROL

MACHINE GUARDING: TRANSLATION INTO PRACTICE

NEONATAL, LACTATION, AND CHILD HEALTH OUTCOMES FOLLOWING RSV VACCINATION DURING PREGNANCY - PROJECT SUMMARY RESPIRATORY SYNCYTIAL VIRUS (RSV) CAN CAUSE SEVERE ILLNESS IN YOUNG CHILDREN AND IS THE LEADING CAUSE OF INFANT HOSPITALIZATION IN THE UNITED STATES. PRENATAL RSV PREFUSION F PROTEIN−BASED (RSVPREF) VACCINE EFFICACY IS 69% FOR SEVERE RSV-ASSOCIATED LOWER RESPIRATORY TRACT ILLNESS IN INFANTS THROUGH 6 MONTHS. IN AUGUST 2023, THE FOOD AND DRUG ADMINISTRATION APPROVED THE VACCINE FOR USE AT 32 THROUGH 36 GESTATIONAL WEEKS WITH A PRESCRIBING INFORMATION WARNING ABOUT PRETERM BIRTH GIVEN AN IMBALANCE IN PRETERM BIRTH RISK OBSERVED BETWEEN THE VACCINE AND PLACEBO GROUPS IN THE CLINICAL TRIAL. HOWEVER, PREGNANT PEOPLE AT HIGH RISK FOR PRETERM BIRTH WERE EXCLUDED FROM THE TRIAL, THE TRIAL DID NOT ASSESS THE EFFECT OF THE VACCINATION ON LACTATION-RELATED OUTCOMES, AND THERE ARE LIMITED SAFETY DATA ON NEONATAL OUTCOMES AND LONGER-TERM INFANT AND CHILD OUTCOMES INCLUDING GROWTH, NEURODEVELOPMENT, AND ALLERGIC CONDITIONS. ON SEPTEMBER 22, 2023, THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) RECOMMENDED SEASONAL ADMINISTRATION OF EITHER PRENATAL RSVPREF VACCINE OR NIRSEVIMAB, A LONG-ACTING MONOCLONAL ANTIBODY ADMINISTERED TO INFANTS, TO PREVENT SEVERE RSV INFECTION. LACK OF SAFETY DATA DECREASES VACCINE CONFIDENCE AND COULD CONTRIBUTE TO POOR UPTAKE OF RSVPREF DURING PREGNANCY. THOUGH THERE IS LITTLE BIOLOGIC PLAUSIBILITY OF HARMFUL EFFECTS OF PRENATAL RSVPREF VACCINATION ON NEONATAL, LACTATION, AND CHILD HEALTH OUTCOMES, RIGOROUS REAL-WORLD SAFETY DATA ARE NEEDED TO GUIDE INFORMED DECISION-MAKING. TO ADDRESS THE NEED FOR COMPREHENSIVE SAFETY DATA ON PRENATAL RSVPREF, WE PROPOSE TO STUDY THE EFFECTS OF RSVPREF VACCINATION ON NEONATAL, LACTATION, AND CHILD HEALTH OUTCOMES IN UP TO 20,000 MOTHER-INFANT DYADS USING ELECTRONIC HEALTH RECORD DATA SUPPLEMENTED WITH VACCINATIONS FROM STATE IMMUNIZATION INFORMATION SYSTEMS ACROSS FOUR LARGE HEALTH SYSTEMS IN HAWAII, OREGON, WASHINGTON, MINNESOTA, AND WISCONSIN. WE WILL USE RIGOROUS EPIDEMIOLOGIC METHODS, INCLUDING PROPENSITY SCORES TO ADDRESS CONFOUNDING, INVERSE PROBABILITY OF CENSORING WEIGHTING (IPCW) TO ADDRESS SELECTION BIAS, AND TARGET TRIAL EMULATION TO ADDRESS IMMORTAL TIME BIAS. FOR ASSOCIATIONS SUGGESTING HARM, WE WILL EXPLORE THE DIRECT EFFECTS OF RSVPREF INDEPENDENT OF PRETERM BIRTH AND INFANT NIRSEVIMAB EXPOSURE. THE EXPLORATORY MEDIATION ANALYSIS WILL USE A CAUSAL INFERENCE APPROACH. WE WILL BUILD ON THE DATA STRUCTURE AND METHODS THAT WE DEVELOPED THROUGH A NATIONAL INSTITUTES OF HEALTH (NIH)-FUNDED STUDY OF COVID-19 VACCINATION AND LACTATION OUTCOMES AND EXPERTISE DEVELOPED THROUGH CENTERS FOR DISEASE CONTROL AND PREVENTION-FUNDED RESEARCH ON ANTENATAL VACCINATION SAFETY. WE ARE UNIQUELY POSITIONED TO STUDY LACTATION AND CHILD HEALTH OUTCOMES AND OVERCOME REPORTING AND VOLUNTEER BIAS IN OTHER STUDIES BY USING ROUTINELY COLLECTED INFORMATION ON BREASTFEEDING, GROWTH, AND DEVELOPMENTAL SCREENING AT WELL- CHILD VISITS FOR A DEFINED POPULATION AS WE HAVE DONE IN PRIOR NIH-FUNDED RESEARCH. THE STUDY WILL PROVIDE TIMELY REAL-WORLD EVIDENCE TO INFORM CLINICAL GUIDELINES AND DECISION MAKING REGARDING PRENATAL RSV VACCINATION.

HOTSPOTTING CARDIOMETABOLIC DISPARITIES FOR SIMULATED ADVANCES IN POPULATION CARE

SIMULATED DIABETES TRAINING FOR RESIDENT PHYSICIANS

MATERNAL COVID-19 VACCINATION AND LACTATION OUTCOMES - THE EFFICACY OF CORONAVIRUS DISEASE (COVID-19) VACCINES AVAILABLE IN THE US IS UP TO 95% AGAINST SYMPTOMATIC COVID-19. HOWEVER, PREGNANT AND LACTATING INDIVIDUALS WERE EXCLUDED FROM INITIAL CLINICAL TRIALS. COVID-19 VACCINE TRIALS ARE NOW UNDERWAY IN PREGNANT WOMEN IN THEIR SECOND OR THIRD TRIMESTER BUT ARE NOT EXPECTED TO CONCLUDE UNTIL 2022 OR 2023, AND EVALUATION OF LACTATION OUTCOMES IS NOT PLANNED. COVID-19 VACCINES ARE HIGHLY EFFECTIVE, AND MOUNTING EVIDENCE SUGGESTS IMMUNOGENIC PROTECTION FOR BREASTFED INFANTS OF MOTHERS RECEIVING COVID-19 VACCINES. TO DATE, THERE ARE NO PUBLISHED STUDIES ON COVID-19 VACCINE SAFETY DURING PREGNANCY OR LACTATION FOR BREASTFED INFANTS, MILK PRODUCTION AND EXCRETION, OR OTHER LACTATION-RELATED OUTCOMES. THIS LACK OF SAFETY DATA THREATENS TO UNDERMINE VACCINATION EFFORTS IN PREGNANT AND LACTATING WOMEN. TRADITIONAL DATA SOURCES USED FOR POST-LICENSURE SURVEILLANCE HAVE LIMITED RELEVANCE FOR LACTATION OUTCOMES . SPONTANEOUS REPORTING SYSTEMS SUFFER FROM REPORTING BIAS DUE TO THEIR VOLUNTARY NATURE; THEIR LACK OF A DENOMINATOR OF VACCINATED LACTATING WOMEN PRECLUDES RISK ESTIMATES. THE CDC'S V-SAFE PROGRAM, SMART PHONE-BASED MONITORING FOR VACCINE SIDE EFFECTS, DOES NOT CAPTURE LACTATION STATUS. ONGOING HEALTH CARE CLAIMS-BASED SURVEILLANCE STUDIES ALSO DO NOT ROUTINELY CAPTURE LACTATION. OBSERVATIONAL STUDIES ENROLLING COVID-VACCINATED LACTATING WOMEN RELY PRIMARILY ON SELF-REPORTED OUTCOMES AND HAVE LIMITED GENERALIZABILITY. TO ADDRESS THE NEED FOR COMPREHENSIVE SAFETY DATA, WE PROPOSE A NOVEL STUDY OF ANTENATAL AND POSTPARTUM COVID-19 VACCINATION AND LACTATION-RELATED OUTCOMES IN MOTHER-INFANT PAIRS, INCLUDING MORE THAN 11,000 BREASTFEEDING DYADS. WE WILL USE ELECTRONIC HEALTH RECORD DATA LINKED WITH STATE IMMUNIZATION DATA ACROSS FOUR LARGE HEALTH SYSTEMS TO STUDY INFANT GROWTH, INFANT HEATH CARE UTILIZATION, MATERNAL MASTITIS, AND BREASTFEEDING STATUS UP TO 7 MONTHS AFTER DELIVERY FOLLOWING MATERNAL COVID-19 VACCINATION. ALSO, WE WILL EXPLORE ACUTE INFANT OUTCOMES AND ABNORMAL INFANT DEVELOPMENTAL SCREENS FOLLOWING MATERNAL COVID-19 VACCINATION. WE ARE UNIQUELY POSITIONED TO OVERCOME LACK OF INFORMATION ON LACTATION STATUS AND REPORTING AND VOLUNTEER BIAS USING ROUTINELY COLLECTED INFORMATION ON BREASTFEEDING AT WELL-CHILD VISITS FOR A DEFINED POPULATION. WE WILL APPLY RIGOROUS EPIDEMIOLOGIC METHODS, INCLUDING PROPENSITY SCORE ADJUSTMENT, TO ADDRESS CONFOUNDING. WITH A FOCUS ON LACTATION, OUR STUDY WILL COMPLEMENT OTHER STUDIES OF COVID-19 VACCINATION IN PREGNANCY AND STUDIES COLLECTING MILK SAMPLES FROM COVID-19-VACCINATED VOLUNTEERS. IT WILL PROVIDE ESSENTIAL AND CURRENTLY UNAVAILABLE EVIDENCE REGARDING LACTATION-RELATED OUTCOMES FOLLOWING PERINATAL COVID-19 VACCINATION. FINDINGS SUPPORTING SAFETY CAN REDUCE VACCINE HESITANCY, WHEREAS RESULTS IDENTIFYING A POTENTIAL HARM WILL BE IMPORTANT FOR INFORMING PATIENT DECISION MAKING. FURTHERMORE, THE NOVEL APPROACH AND METHODS FOR STUDYING LACTATION­ RELATED OUTCOMES DEVELOPED THROUGH THE PROPOSED STUDY CAN BE ADAPTED TO EFFICIENTLY EVALUATE THE SAFETY OF DRUGS AND VACCINES CURRENTLY RECOMMENDED OR BEING INVESTIGATED FOR USE IN PREGNANT OR POSTPARTUM WOMEN.

IMPROVING RECOGNITION AND MANAGEMENT OF HYPERTENSION IN YOUTH: COMPARING APPROACHES FOR EXTENDING EFFECTIVE CDS FOR USE IN A LARGE RURAL HEALTH SYSTEM

RANDOMIZED TRIAL TO IMPROVE CARE OF PATIENTS WITH HEREDITARY CANCER SYNDROMES - PROJECT SUMMARY AMONG THE ESTIMATED ONE MILLION AMERICANS WHO HAVE SCREENED POSITIVE FOR SPECIFIC GENETIC VARIANTS RELATED TO HEREDITARY BREAST AND OVARIAN CANCER SYNDROME (HBOC) OR LYNCH SYNDROME (LS), LESS THAN HALF ARE UP TO DATE ON EVIDENCE-BASED CANCER PREVENTION MEASURES THAT MAY INCREASE EARLY DETECTION OF SYNDROME-RELATED CANCERS OR PREVENT THESE CANCERS ALTOGETHER. MOST PATIENTS NEWLY DIAGNOSED WITH HEREDITARY CANCER SYNDROMES RECEIVE EXTENSIVE INITIAL CARE FROM GENETIC COUNSELORS OR ONCOLOGY TEAMS BUT FOR MANY PATIENTS WITHOUT A CANCER DIAGNOSIS AT THE TIME OF SYNDROME IDENTIFICATION, ACCESS TO REGULAR FOLLOW-UP CARE FROM ONCOLOGISTS AND GENETIC COUNSELORS IS LIMITED. PILOT DATA SHOW THAT THE MOST FREQUENT SOURCE OF CARE FOR PATIENTS WITH HBOC OR LS IS THE PRIMARY CARE SETTING, BUT MANY PRIMARY CARE CLINICIANS ARE UNFAMILIAR WITH RAPIDLY EVOLVING CANCER PREVENTION GUIDELINES FOR PATIENTS WITH HBOC OR LS. ALTHOUGH PRIMARY CARE CLINICIANS ARE IDEALLY POSITIONED TO MAKE TIMELY REFERRALS TO SUBSPECIALISTS FOR INDICATED CANCER PREVENTION CARE AND PROCEDURES, ACCESS TO EVIDENCE-BASED CLINICAL DECISION SUPPORT TO OPTIMIZE CARE FOR PATIENTS WITH THESE HEREDITARY CANCER SYNDROMES DOES NOT EXIST. WE POSIT THAT USING PRIMARY CARE CLINICAL ENCOUNTERS TO PROMOTE APPROPRIATE SUBSPECIALIST REFERRAL AND TESTING OF THESE HIGH-RISK PATIENTS WILL IMPROVE QUALITY OF CARE AND CLINICAL OUTCOMES FOR PATIENTS WITH THESE HEREDITARY CANCER SYNDROMES. TO ACHIEVE THIS GOAL, WE EXPAND AN EFFECTIVE PATIENT-CENTERED PRIMARY CARE CLINICAL DECISION SUPPORT (PC-CDS) SYSTEM TO GUIDE EVIDENCE-BASED CARE OF THESE HIGH-RISK PATIENTS, AND ASSESS INTERVENTION IMPACT ON UP-TO-DATE CANCER PREVENTION CARE, SHARED DECISION MAKING, AND PATIENT SELF-EFFICACY IN MANAGING HEREDITARY CANCER RISKS. THE WEB-BASED NATURE OF THE PROPOSED PC-CDS SYSTEM, ITS PRIOR SUCCESS IN IMPROVING PRIMARY CARE FOR A WIDE RANGE OF OTHER CHRONIC CONDITIONS, AND ITS HIGH USE RATES IN PRIMARY CARE SETTINGS SUGGEST THAT THIS APPROACH TO CARE IMPROVEMENT MAY BE AN EFFECTIVE STRATEGY TO INCREASE APPROPRIATE REFERRALS AND EVIDENCE-BASED PREVENTIVE CARE OF ADULTS WITH THESE HEREDITARY CANCER SYNDROMES. TO ASSESS INTERVENTION IMPACT ON CARE OF ADULTS WITH SPECIFIC PATHOGENIC OR LIKELY PATHOGENIC GENE VARIANTS RELATED TO HBOC OR LS, WE RANDOMLY ASSIGN 30 PRIMARY CARE CLINICS WITH AN ESTIMATED 2488 STUDY-ELIGIBLE PATIENTS WITH LABORATORY OR ELECTRONIC HEALTH RECORD (EHR)-DOCUMENTED HBOC OR LS TO USUAL CARE (N=15 CLINICS) OR TO THE PC-CDS INTERVENTION (N=15 CLINICS) AND ASSESS INTERVENTION IMPACT ON (I) UP TO DATE EVIDENCE-BASED CANCER PREVENTION CARE, (II) PATIENT AND CLINICIAN ASSESSMENTS OF SHARED DECISION MAKING RELATED TO CANCER PREVENTION CARE, AND (III) PATIENT SELF-EFFICACY IN MANAGING THEIR HEREDITARY CANCER RISKS. THE PROJECT DELIVERS A SCALABLE AND ADAPTIVE WEB-BASED CDS SYSTEM THAT INFORMS PATIENTS WITH SPECIFIC GENETIC VARIANTS AND THEIR PCCS OF EVOLVING STANDARDS OF CARE, FACILITATES TIMELY ACCESS TO APPROPRIATE SUBSPECIALTY CARE, AND CAN BE EXTENDED TO GUIDE DELIVERY OF EVIDENCE-BASED CARE TO THOSE WITH OTHER GENETIC VARIANTS LIKELY TO REACH CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) OFFICE OF PUBLIC HEALTH GENOMICS (OPHG) TIER 1 STATUS IN COMING YEARS.

AN INNOVATIVE APPROACH TO DISSEMINATE DENTAL RESEARCH

OPTIMIZING THE VALUE OF PROMS IN IMPROVING CARE DELIVERY THROUGH HEALTH INFORMATION TECHNOLOGY

TECHNICAL EDUCATION: BRIDGING THE GAP IN HEALTH AND SAFETY IN SMALL BUSINESSES

A NURSE-LED PHYSICIAN-DIRECTED SYSTEM FOR PROVIDING OPTIMAL CARDIAC CARE

A TECHNOLOGY-DRIVEN INTERVENTION TO IMPROVE IDENTIFICATION AND MANAGEMENT OF CHRONIC KIDNEY DISEASE IN PRIMARY CARE

A TECHNOLOGY-DRIVEN INTERVENTION TO IMPROVE EARLY DETECTION AND MANAGEMENT OF COGNITIVE IMPAIRMENT

DECISION SUPPORT TO IMPROVE DENTAL CARE FOR MEDICALLY COMPROMISED PATIENTS

VALIDITY OF SELF-REPORTED ADULT VACCINATION STATUS

SCISIPBIO: CONSTRUCTING HETEROGENEOUS SCHOLARLY GRAPHS TO EXAMINE SOCIAL CAPITAL DURING MENTORED K AWARDEES TRANSITION TO RESEARCH INDEPENDENCE: EXPLICATING A MATTHEW MECHANISM

TAILORED SELF-MANAGEMENT OF TMD PAIN USING HEALTH INFORMATION TECHNOLOGY

COMPUTER-ASSISTED GUIDANCE FOR TOBACCO DEPENDENCE INTERVENTIONS IN DENTAL OFFICES

NOVEL APPROACHES TO WEIGHT LOSS MAINTENANCE

AN OPTIMIZATION TRIAL OF A MEANING AND THEORY-BASED DIGITAL INTERVENTION TO INCREASE PHYSICAL ACTIVITY (MAP TO HEALTH) - PROJECT SUMMARY PHYSICAL ACTIVITY (PA) PLAYS A KEY ROLE IN HEALTHY AGING AND OVERALL WELL-BEING, YET MORE THAN HALF OF ADULTS DO NOT ACHIEVE THE RECOMMENDED 150 MINUTES OF PA PER WEEK. ALTHOUGH MANY PROGRAMS AIM TO HELP PEOPLE BECOME MORE ACTIVE, THEIR EFFECTS ARE OFTEN MODEST AND TEND TO FADE OVER TIME. ONE PROMISING APPROACH IS TO DEVELOP PA PROGRAMS THAT FOCUS ON THE UNDERLYING PSYCHOLOGICAL PROCESSES THAT SUPPORT LONG-TERM BEHAVIOR CHANGE. OUR TEAM PREVIOUSLY IDENTIFIED TWO KEY BEHAVIOR CHANGE MECHANISMS THAT MAY HELP PEOPLE STAY ACTIVE: AWARENESS OF PERSONAL MEANING (MEANING SALIENCE) AND MOTIVATION SUPPORTED BY SELF-DETERMINATION THEORY (SDT), WHICH EMPHASIZES THE BASIC PSYCHOLOGICAL NEEDS OF FEELING AUTONOMOUS, COMPETENT, AND CONNECTED TO OTHERS (RELATEDNESS). WE SYSTEMATICALLY INCORPORATED THESE PRINCIPLES INTO A DIGITAL BEHAVIOR CHANGE INTERVENTION CALLED MAP TO HEALTH. THE PROGRAM DELIVERS PERSONALIZED, TIMELY MESSAGES THAT REMIND USERS OF THEIR PERSONAL REASONS FOR BEING ACTIVE AND SUPPORT THEIR MOTIVATION THROUGH DIFFERENT BEHAVIORAL STRATEGIES. INITIAL TESTING SHOWED PROMISE BUT ALSO SUGGESTED THAT THE PROGRAM NEEDED REFINEMENT BEFORE LAUNCHING A LARGER TRIAL. USING THE OBESITY-RELATED BEHAVIORAL INTERVENTION TRIALS (ORBIT) FRAMEWORK FOR DEVELOPING BEHAVIORAL TREATMENTS, THIS PROJECT AIMS TO OPTIMIZE MAP TO HEALTH TO BETTER SUPPORT ADULTS IN MIDLIFE ACHIEVE PA GOALS. IN A 4-WAY FACTORIAL OPTIMIZATION TRIAL, 368 PARTICIPANTS WILL BE RANDOMIZED TO ONE OF 16 EXPERIMENTAL CONDITIONS REPRESENTING ALL POSSIBLE COMBINATIONS OF FOUR BEHAVIORAL INTERVENTION STRATEGIES (2 [MEANING-BASED, YES V. NO] X 2 [ACTION PLANNING WITH JUST-IN-TIME MESSAGES V. RANDOMLY TIMED MESSAGES] X 2 [PA CHOICE V. WALKING] X 2 [BUDDY, YES V. NO]) THAT TARGET FOUR HYPOTHESIZED MECHANISMS OF CHANGE (MEANING SALIENCE, COMPETENCE, AUTONOMY, AND RELATEDNESS). THE 3-MONTH ACTIVE INTERVENTION PHASE WILL BE FOLLOWED BY A 3-MONTH MAINTENANCE PHASE AND A 6 MONTH NO-INTERVENTION FOLLOW-UP TO ASSESS DURABILITY OF INTERVENTION EFFECTS. SURVEY AND ACCELEROMETER OUTCOMES WILL BE MEASURED AT BASELINE (0 MONTHS), MID-ACTIVE INTERVENTION (1.5 MONTHS), POST-ACTIVE INTERVENTION (3 MONTHS), POST-MAINTENANCE INTERVENTION (6 MONTHS), AND AT FOLLOW-UP (9 AND 12 MONTHS). THE STUDY HAS THREE AIMS: (1) COMPARE ACCELEROMETER-MEASURED MVPA BETWEEN PARTICIPANTS RANDOMIZED TO EACH OF FOUR THEORY-BASED INTERVENTION STRATEGIES; (2) ASSESS WHETHER EACH OF THE FOUR BEHAVIORAL INTERVENTION STRATEGIES IS ASSOCIATED WITH GREATER INCREASES IN THE ASSOCIATED MECHANISM OF CHANGE; AND (3) USE SEMI-STRUCTURED QUALITATIVE INTERVIEWS (UP TO N=48) TO FACILITATE A DEEPER UNDERSTANDING OF WHETHER AND HOW PARTICIPANTS EXPERIENCE MAP TO HEALTH INTERVENTION STRATEGIES AS ACTING ON TARGET MECHANISMS. MAP TO HEALTH AIMS BE BOTH EFFICIENT AND ENGAGING, WITH THE POTENTIAL TO SUPPORT LARGE-SCALE IMPROVEMENTS IN THE HEALTH AND WELL-BEING OF INSUFFICIENTLY ACTIVE ADULTS IN MIDLIFE.

INVESTIGATING BEHAVIORAL MECHANISMS AND EFFICACY OF A PROVIDER-DIRECTED INTERVENTION FOR HPV VACCINE PROMOTION IN REAL-WORLD DENTAL SETTINGS - PROJECT SUMMARY HUMAN PAPILLOMAVIRUS (HPV) IS THE LEADING CAUSE OF OROPHARYNGEAL CANCERS IN THE US. DESPITE THE SAFETY AND EFFECTIVENESS OF THE HPV VACCINE (HPV-V), COVERAGE IS FAR BELOW THAT FOR OTHER ROUTINE ADOLESCENT VACCINES AND THE HEALTHY PEOPLE 2030 GOAL OF 80%. HPV-V PROMOTION AT DENTAL VISITS IS SEEN AS A PRIME OPPORTUNITY TO PREVENT OROPHARYNGEAL AND OTHER CANCERS, YET MANY DENTAL PROVIDERS ARE NOT COMFORTABLE DOING SO DUE TO LACK OF KNOWLEDGE AND SELF-EFFICACY, AND FEAR OF HARMING THE PATIENT-PROVIDER RELATIONSHIP. USING THE NIH STAGE MODEL OF BEHAVIORAL INTERVENTION DEVELOPMENT AS OUR GUIDE, WE PROPOSE TO DEVELOP A THEORY-BASED INTERVENTION TO ADDRESS DENTAL PROVIDER BARRIERS TO HPV-V PROMOTION, ELUCIDATE THE INTERVENTION'S BEHAVIORAL MECHANISMS, AND TEST THE REAL-WORLD EFFICACY OF THE INTERVENTION IN CATALYZING PROVIDER HPV-V PROMOTION. THE INTERVENTION WILL CONSIST OF 1) PROVIDER TRAINING ABOUT HPV/HPV-V; 2) TAILORED SCRIPTS TO AID PROVIDERS IN RESPONDING TO PATIENT/PARENT/GUARDIAN CONCERNS ABOUT HPV-V. DURING THE UG3 PHASE, WE WILL RANDOMIZE 21 HEALTHPARTNERS DENTAL GROUP CLINICS TO INTERVENTION VS. USUAL CARE (UC; N=~131 PROVIDERS). UG3 AIMS ARE TO: DEVELOP SURVEY MEASURES AND PILOT-TEST PROVIDER HPV-V PROMOTION TRAINING (AIM 1) AND TAILORED SCRIPTS (AIM 2); DEVELOP MEASURES AND METHODS FOR MONITORING PROVIDER FIDELITY TO THE TRAINING AND INTERVENTION ACTIVITIES (AIM 3); AND DRAFT COMPLIANCE/STUDY DOCUMENTS AND OBTAIN IRB/NIDCR APPROVALS (AIM 4). DURING THE UH3 PHASE, WE WILL CONDUCT A CLUSTER (CLINIC)-RANDOMIZED CLINICAL TRIAL (INTERVENTION VS. UC) TO TEST THE REAL-WORLD EFFICACY OF THE INTERVENTION TO INCREASE HPV-V PROMOTION ACTIVITY (AIM 5). WE WILL ASSESS WHETHER THE INTERVENTION IMPACTED THE THREE INTENDED BEHAVIORAL MECHANISM TARGETS: INCREASED KNOWLEDGE OF HPV/HPV-V; INCREASED SELF-EFFICACY FOR HPV-V PROMOTION; AND REDUCED FEAR OF HPV-V PROMOTION NEGATIVELY AFFECTING THE PATIENT- PROVIDER RELATIONSHIP (AIM 6). FOR EACH TARGET, WE WILL ALSO ASSESS WHETHER THE INTERVENTION'S EFFECTS FOLLOWED THE FULL MECHANISTIC PATHWAY TO THE ENDPOINT BEHAVIOR, HPV-V PROMOTION (AIM 7). BEYOND OUR AIMS, WE WILL CONDUCT EXPLORATORY WORK EXAMINING TWO ADDITIONAL CANDIDATE BEHAVIORAL MECHANISMS: ADEQUACY OF MATERIAL RESOURCES TO SUPPORT DENTAL PROVIDERS IN PROMOTING HPV-V, AND PROVIDERS' PERCEPTION THAT HPV-V PROMOTION COMPORTS WITH THEIR PROFESSIONAL IDENTITY. WE WILL ALSO CONDUCT AN EXPLORATORY ANALYSIS OF THE INTERVENTION'S EFFICACY IN INCREASING HPV-V UPTAKE (30-DAY POST-VISIT PATIENT VACCINATION RATES). OUR LONG-TERM GOAL IS TO REDUCE HPV AND OROPHARYNGEAL CANCER PREVALENCE THROUGH HPV-V PROMOTION BY DENTAL PROVIDERS. SIGNIFICANT IMPACT OF THE PROJECT INCLUDES: 1) DEVELOPING THE FIRST THEORY-BASED BEHAVIORAL INTERVENTION FOR HPV-V PROMOTION AIMED AT DENTAL PROVIDERS; 2) DELIVERING THE FIRST EVIDENCE OF REAL-WORLD EFFICACY OF SUCH AN INTERVENTION; 3) ILLUMINATING BEHAVIORAL MECHANISMS PURPORTED TO UNDERLIE PROVIDER BEHAVIOR CHANGE; 4) PRODUCING FUNDAMENTAL KNOWLEDGE TO GUIDE FUTURE HPV-V PROMOTION INTERVENTION DEVELOPMENT; AND 5) ADVANCING THE SCIENCE OF BEHAVIOR CHANGE BY REVEALING BEHAVIORAL PRINCIPLES UNDERLYING PROVIDER BEHAVIOR CHANGE.

EXPLORING MECHANISMS OF HEPATITIS C VIRUS-ASSOCIATED XEROSTOMIA - PROJECT SUMMARY/ABSTRACT CHRONIC HEPATITIS C VIRUS (HCV) INFECTION REMAINS ONE OF THE MAJOR CAUSES OF CHRONIC LIVER DISEASE, CIRRHOSIS AND LIVER CANCER, AND IS A MAJOR PUBLIC HEALTH ISSUE WORLDWIDE, WITH AN ESTIMATED PREVALENCE OF 170 MILLION PEOPLE GLOBALLY. WITH NO PROPHYLACTIC HCV VACCINE AVAILABLE, HCV REMAINS DIFFICULT TO ERADICATE. NEWER GENERATIONS OF DIRECT-ACTING ANTIVIRALS (DAA) ARE EFFECTIVE IN ELIMINATING THE VIRUS IN UP TO 95% OF THE PATIENTS, HOWEVER, THIS TREATMENT REMAINS OUT OF REACH FOR MANY INDIVIDUALS. MULTIPLE HCV EXTRAHEPATIC MANIFESTATIONS (EHM) HAVE BEEN REPORTED IN PATIENTS WITH CHRONIC HCV INFECTION INCLUDING CHRONIC LYMPHOCYTIC SIALADENITIS, AND SICCA SYNDROME INDISTINGUISHABLE FROM SJÖGREN’S SYNDROME (SS). YET, THE MECHANISMS OF THE XEROSTOMIA AND SALIVARY GLAND (SG) HYPOFUNCTION REMAIN CONTROVERSIAL. THUS, UNDERSTANDING THE CLINICAL ASPECTS OF HCV-ASSOCIATED XEROSTOMIA IS OF INTEREST TO BETTER ASSESS AND MANAGE THIS SYMPTOM. THE OBJECTIVES OF THIS PROJECT ARE TO DETERMINE THE PATHOPHYSIOLOGIC CHANGES IN THE MINOR SALIVARY GLANDS (MSG) AND CHANGES IN SALIVA COMPOSITION ASSOCIATED WITH CHRONIC HCV INFECTION AND CORRELATE THESE CHANGES WITH CLINICAL FEATURES OF SG HYPOFUNCTION (MENTORED PHASE) AND TO MECHANISTICALLY DESCRIBE THE HCV-ASSOCIATED XEROSTOMIA (INDEPENDENT PHASE). TO ACHIEVE THIS GOAL, DR. JOSÉ MALDONADO-ORTIZ WILL WORK WITH A MENTORING TEAM INCLUDING DR. JOHN CHIORINI (PRIMARY MENTOR), DR. BLAKE WARNER (CO-MENTOR), DR. RAJ GOPALAKRISHNAN (COLLABORATOR), DR. VALERIA DE GIORGI (COLLABORATOR), AND NOBEL LAUREATE DR. HARVEY ALTER (COLLABORATOR). IN AIM 1, THE PATHOPHYSIOLOGIC CHANGES IN THE MSG OF PATIENTS WITH CHRONIC HCV INFECTION WILL BE DETERMINED AND CORRELATED TO XEROSTOMIA AND CLINICAL FEATURES OF SALIVARY DYSFUNCTION IN PATIENTS WITH AND WITHOUT COMPLAINTS OF XEROSTOMIA. IN AIM 2, THE EFFECTS OF HCV DAA THERAPY IN SALIVARY PHYSIOLOGY WILL BE DETERMINED AND CORRELATED TO CLINICAL FEATURES OF XEROSTOMIA. TO UNDERSTAND THE PATHOPHYSIOLOGY OF CHRONIC HCV-ASSOCIATED SG DYSFUNCTION (AIM 1), AND THE EFFECTS OF DAA THERAPY IN SG FUNCTION, MSG BIOPSIES WILL BE COLLECTED AND USED TO PROVIDE HISTOPATHOLOGICAL EVIDENCE OF SG DAMAGE/CHANGES AND RESEARCH TISSUES TO PERFORM RNASEQ AND SCRNASEQ, IN ADDITION TO SIALOMETRY, SIALOCHEMISTRY, AND ULTRASONOGRAPHY OF THE MAJOR SG. DRY MOUTH AND ORAL HEALTH RELATED QUALITY OF LIFE INSTRUMENTS WILL BE COMPLETED. IN AIM 3, THE MECHANISMS OF HCV INDUCED SALIVARY GLAND DYSFUNCTION WILL BE DETERMINED IN VIVO. TO THIS END, AN ADENO-ASSOCIATED VIRUS (AAV) VECTOR EXPRESSING THE ANTIGENIC HCV ENVELOPE PROTEINS E1 AND E2 WILL BE TRANSFERRED INTO THE SUBMANDIBULAR SG OF MICE TO 1) BETTER UNDERSTAND THE HCV/HOST IMMUNE CELL INTERACTIONS AND 2) TISSUE CHANGES THAT MAY RESULT IN SG DYSFUNCTION. IN COMBINATION, THESE STUDIES WILL REVEAL NEW INFORMATION ABOUT VIRAL INFECTIONS AND THE TRIGGERING OR INITIATION OF SG DISEASES SUCH AS SS. HCV INFECTION OFFERS A UNIQUE OPPORTUNITY TO STUDY VIRAL INDUCED SG DYSFUNCTION AND CAN PROVIDE MECHANISTIC DATA ON THE ROLE OF VIRUSES IN DRIVING INFLAMMATION, DYSFUNCTION, AND DAMAGE IN THE SG.

ORAL CORTICOSTEROID USE DURING PREGNANCY AND RISK FOR PRETERM BIRTH

EHEALTH RECORDS TO IMPROVE DENTAL CARE FOR PATIENTS WITH CHRONIC ILLNESSES

TREATMENT OF HYPERTENSION IN ADULTS WITH THIAZIDES: PRAGMATIC TRIAL PILOT STUDY

USE OF COMPLEMENTARY AND ALTERNATIVE MEDICINE IN PATIENT MANAGEMENT OF DIABETES