Project Grant R01AG087104

Award Date 6/15/25
Completion Date 2/28/30
Dollars Obligated $852K
Federal Grant Program
93.866
Assistance Type
Project Grant
Place of Performance
New York, USA
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A PROSPECTIVE OBSERVATIONAL COHORT STUDY TO EVALUATE AND PREDICT OROPHARYNGEAL DYSPHAGIA (OD) IMPROVEMENT IN HOSPITALIZED PATIENTS WITH ALZHEIMER'S DISEASE AND RELATED DEMENTIAS (AD/ADRD) - PROJECT ABSTRACT. OROPHARYNGEAL DYSPHAGIA (OD) IS HIGHLY PREVALENT (UP TO 86%) IN HOSPITALIZED PATIENTS WITH ALZHEIMER'S DISEASE (AD) AND AD-RELATED DEMENTIAS (AD/ADRD), BECAUSE BASELINE FACTORS (E.G., AGE, FUNCTIONAL STATUS) ARE EXACERBATED BY ACUTE FACTORS (E.G., ACUTE ILLNESS, DELIRIUM). ALTHOUGH ACUTE FACTORS OFTEN IMPROVE OR EVEN RESOLVE PRIOR TO HOSPITAL DISCHARGE, NO STANDARD OF CARE EXISTS FOR REASSESSMENT PRIOR TO DISCHARGE. FURTHER, DYSPHAGIA DIETS, THE MAINSTAY HOSPITAL MANAGEMENT OF OD, ARE FREQUENTLY CONTINUED WITHOUT REASSESSMENT WHEN PATIENTS TRANSITION BACK TO THE COMMUNITY OR LONG-TERM CARE. THIS IS CONCERNING BECAUSE DYSPHAGIA DIETS, ALSO LEAD TO MALNUTRITION, DEHYDRATION, AND REDUCED QUALITY OF LIFE (QOL). IN OUR PILOT PROSPECTIVE OBSERVATIONAL STUDY OF HOSPITALIZED PATIENTS WITH AD/ADRD AND OD (N=62), ONLY 25.8% (N=16) HAD OD REASSESSMENT PRIOR TO DISCHARGE, YET, OF THOSE REASSESSED, 62.5% (N=10) HAD CLINICAL OD IMPROVEMENT, RESULTING IN DIET LIBERALIZATION. HOWEVER, IT IS NOT POSSIBLE TO REASSESS EVERY PATIENT IN THE REAL-WORLD SETTING. THUS, DEVELOPING A MACHINE-LEARNING (ML) MODEL THAT PREDICTS WHICH PATIENTS WITH AD/ADRD ARE LIKELY TO HAVE IMPROVEMENT IS A CRITICAL AND INNOVATIVE FIRST STEP TO DEVELOP A COST-EFFECTIVE TARGETED APPROACH TO OD REASSESSMENT (AIM 1). FURTHER, PREVIOUS RESEARCH USED PHYSIOLOGIC SWALLOW MEASURES TO ASSESS OD RECOVERY AND TREATMENT RESPONSE (E.G., SWALLOW REHABILITATION), WITHOUT EXAMINING ASSOCIATIONS WITH CLINICAL OD IMPROVEMENT, NAMELY DIET LIBERALIZATION. THIS WILL BE THE FIRST AD/ADRD STUDY TO PROSPECTIVELY EVALUATE OD IMPROVEMENT USING A REFERENCE STANDARD TEST (MODIFIED BARIUM SWALLOW STUDY, MBSS) TO DETERMINE ASSOCIATIONS BETWEEN PHYSIOLOGIC SWALLOW IMPROVEMENT AND CLINICAL OD IMPROVEMENT (AIM 2). OUR INTERDISCIPLINARY TEAM WITH EXPERTISE IN GERIATRICS, HOSPITAL MEDICINE, AD/ADRD AND OD RESEARCH, BIOSTATISTICS, AND ML METHODS IS WELL-POISED TO COMPLETE THIS RESEARCH. STUDY DESIGN: WE WILL PROSPECTIVELY RECRUIT (N=336) HOSPITALIZED PATIENTS WITH AD/ADRD AND A DIAGNOSIS OF OD ON A REFERENCE STANDARD ASSESSMENT (MBSS). ALL PATIENTS WILL UNDERGO A MBSS AT INITIAL ASSESSMENT AND AGAIN, PRIOR TO HOSPITAL DISCHARGE (REASSESSMENT). SPECIFIC AIMS: WE PROPOSE TO CONDUCT A PROSPECTIVE OBSERVATIONAL COHORT STUDY OF HOSPITALIZED PATIENTS WITH AD/ADRD, DIAGNOSED WITH OD, TO: AIM 1A) DEVELOP A ML MODEL TO PREDICT WHICH PATIENTS WILL HAVE CLINICAL OD IMPROVEMENT PRIOR TO HOSPITAL DISCHARGE; AIM 1B) PROSPECTIVELY, SILENTLY VALIDATE THE MODEL TO ACQUIRE REAL-TIME PRELIMINARY PERFORMANCE METRICS, IN PREPARATION FOR A FULL-SCALE PROSPECTIVE VALIDATION; AND AIM 2) DETERMINE THE ASSOCIATION BETWEEN IMPROVEMENT IN PHYSIOLOGIC SWALLOW IMPAIRMENT AND CLINICAL OD IMPROVEMENT. IMPACT: OUR FINDINGS WILL: 1) INFORM OD REASSESSMENT PRIOR TO HOSPITAL DISCHARGE, TO REDUCE UNNECESSARY USE OF DYSPHAGIA DIETS AND IMPROVE OUTCOMES (E.G., QOL) FOR PERSONS WITH AD/ADRD; AND 2) ADVANCE OD RESEARCH BY ASSOCIATING PHYSIOLOGIC SWALLOW IMPAIRMENT WITH CLINICAL OD IMPROVEMENT (I.E., DIET LIBERALIZATION), WHICH WILL STRENGTHEN CLINICAL SIGNIFICANCE FOR STUDIES EVALUATING OD RECOVERY AND TREATMENT.

Posted 6/2/25, 12:00 AM