Programs

  • Transitional Care Model Study

    DR. ELIZABETH FINE SMILOVICH, GERIATRICIAN AT THE CLEVELAND VA RECEIVED A SUBAWARD FROM THE ARNOLD FOUNDATION THROUGH UNIVERSITY OF PENNSYLVANIA TO STUDY THE REPLICATION OF THE TRANSITIONAL CARE MODEL (TCM) VIA A RANDOMIZED CONTROL TRIAL CONDUCTED ACROSS FOUR HEALTH SYSTEMS WITH A TOTAL OF 1,600 ENROLLED PATIENTS. THIS STUDY WAS ALSO SUPPORTED IN PART BY THE VA HEALTH SERVICES RESEARCH AND DEVELOPMENT SERVICE. THE PURPOSE OF THE TRANSITIONAL CARE MODEL IS TO EXPLORE THE ADVANCED PRACTICE REGISTERED NURSES (APRNS) ROLE WITH PATIENTS AND THEIR FAMILY CAREGIVERS AFTER DISCHARGE FROM THE HOSPITAL, AND TO SEE IF THEIR INVOLVEMENT IN POST-DISCHARGE MEDICAL MANAGEMENT MAY IMPROVE THE PATIENTS' EXPERIENCE AND ENHANCE THEIR HEALTH OUTCOMES. THE STUDY ENROLLED PARTICIPANTS 65 YEARS AND OLDER AND WHO HAD BEEN ADMITTED TO THE HOSPITAL WITH PNEUMONIA OR A HISTORY OF HEART FAILURE AND COPD OR WHOSE SYMPTOMS SUGGESTED A NEW HEART FAILURE OR COPD DIAGNOSIS. ONCE A PARTICIPANT SIGNED THE CONSENT FORM, THEY WERE RANDOMLY ASSIGNED INTO THE CONTROL GROUP OR INTERVENTION GROUP. THE CONTROL GROUP WAS GIVEN A QUESTIONNAIRE WHILE IN THE HOSPITAL AND 90-DAYS POST HOSPITAL DISCHARGE. PARTICIPANTS IN THE INTERVENTION GROUP WERE GIVEN THE SAME QUESTIONNAIRE BUT ALSO ASSIGNED AN APRN TO COORDINATE THEIR CARE FOR 60-90 DAYS AFTER DISCHARGE. THE APRN WORKED WITH THE PARTICIPANTS VA HEALTH CARE TEAM TO ASSESS THEIR MEDICAL NEEDS, COORDINATE SERVICES, AND ASSIST IN DESIGNING AND IMPLEMENTING THE PLAN OF CARE. THE APRN ALSO ATTENDED THE PARTICIPANTS FIRST AND SOMETIMES SUBSEQUENT FOLLOW-UP APPOINTMENTS POST-DISCHARGE. DR. FINE SMILOVICH AND HER TEAM ENROLLED 194 SUBJECTS INTO THIS STUDY OVER A TWO-YEAR PERIOD. INITIAL ANALYSIS IS SHOWING PROMISING RESULTS FROM THE APRN INVOLVEMENT. PRELIMINARY DATA SHOWS THAT ONLY ABOUT 16% OF PARTICIPANTS IN THE INTERVENTION GROUP HAD REHOSPITALIZATIONS 30-DAYS POST DISCHARGE COMPARED TO THE CONTROL GROUP AT ABOUT 22% REHOSPITALIZATION RATE.
    Geographies
    Not indicated
    Dates
    Jan 1, 2022 – Dec 31, 2022
    Source
    990
    No causes provided
    No populations provided
    –
    $215K

  • Nonendoscopic Screening for Esophageal Cancer

    DR. KATARINA GREER, GASTROENTEROLOGIST AT THE CLEVELAND VA, RECEIVED A DOD PEER REVIEWED CANCER RESEARCH PROGRAM (PRCRP) IMPACT AWARD IN 2021. THE GRANT ENTITLED "NONENDOSCOPIC SCREENING TO IMPACT ESOPHAGEAL CANCER IN VETERANS" IS A THREE-YEAR GRANT THAT STARTED IN EARLY 2022. THIS IS THE FOUNDATION'S FIRST CLINICAL DOD AWARD. BACKGROUND: ESOPHAGEAL ADENOCARCINOMA (EAC) HAS INCREASED MORE THAN 6-FOLD IN THE PAST FOUR DECADES. THE INCORPORATION OF A NON-ENDOSCOPIC DETECTION METHOD IN PRIMARY CARE PRACTICE WILL INCREASE THE POSITIVE PREDICTIVE VALUE OF EGD AND INCREASE THE DETECTION OF BARRETT'S ESOPHAGUS (BE). THIS STUDY WILL AIM TO DETERMINE SENSITIVITY, SPECIFICITY, AND POSITIVE PREDICTIVE VALUE OF ESOCHECK SAMPLING DEVICE ESOGUARD (DNA MARKER PANEL LABORATORY DIAGNOSTIC TEST) PERFORMED IN ROUTINE PRACTICE FOR DETECTING BE IN AN AT- RISK POPULATION. THE SECOND AIM OF THE STUDY IS TO COMPARE THE YIELD OF DETECTED BE USING AN ESOCHECK/ESOGUARD STRATEGY VERSUS STANDARD EGD ALONE STRATEGY IN ROUTINE PRACTICE IN AT-RISK POPULATIONS AT THE CLEVELAND VA SHORT TERM IMPACT: THE EXPECTED OUTCOME OF THE PROPOSED WORK IS THE GATHERING OF DETAILED INFORMATION ABOUT THE TEST PERFORMANCE CHARACTERISTICS, I.E. SENSITIVITY, SPECIFICITY, POSITIVE AND NEGATIVE PREDICTIVE VALUE. SHOULD THE SCREENING TEST PERFORM WELL, ESOCHECK/ESOGUARD TEST WOULD BE PRODUCED ON A LARGER SCALE, ITS MOLECULAR DIAGNOSTICS PROCESS WOULD BE AUTOMATED, DRIVING COSTS OF THE SCREENING DEVICE DOWN. TEST INDICATION COULD BE EXPANDED TO ALL OBESE PATIENTS OLDER THAN 50 WITHOUT A HISTORY OF CHRONIC GERD, EXPLORING THE PREVALENCE OF BE/ECA IN ASYMPTOMATIC INDIVIDUALS. LONG TERM IMPACT: FOLLOWING SUCCESSFUL VALIDATION OF THE PROPOSED NON- INVASIVE SCREENING METHOD, THE TEST COULD BE USED AS TRIAGING TOOL FOR ENDOSCOPY IN ESOPHAGEAL CANCER SCREENING. IMPLEMENTATION OF AN OFFICE BASED UNSEDATED TEST WOULD ALSO ENABLE SCREENING OF A BROADER POPULATION. PATIENTS WITH POSITIVE MOLECULAR TESTING, SUGGESTIVE OF THE PRESENCE OF METHYLATED DNA WOULD UNDERGO DIAGNOSTIC UPPER ENDOSCOPY. THIS TEST WOULD LIKELY IDENTIFY BE, BE WITH DYSPLASIA, OR EARLY ESOPHAGEAL CANCER. PATIENTS WITH DYSPLASTIC TISSUE WOULD BE ELIGIBLE FOR ENDOSCOPIC TREATMENT METHODS, INCLUDING ENDOSCOPIC MUCOSAL RESECTION OR RADIOFREQUENCY ABLATION. PATIENTS WITH DEEPER TISSUE INVOLVEMENT COULD STILL PROCEED TO SURGERY, RECEIVE CHEMOTHERAPY OR RADIATION. TREATMENT OPTIONS OTHER THAN PALLIATIVE CARE WOULD BE AVAILABLE LEADING TO IMPROVED DISEASE-FREE SURVIVAL.
    Geographies
    Not indicated
    Dates
    Jan 1, 2022 – Dec 31, 2022
    Source
    990
    No causes provided
    No populations provided
    –
    $172.3K

  • Knee Osteoarthritis Pain Management Study

    DR. VEIZI, CHIEF OF PAIN MEDICINE, AT THE CLEVELAND VA, RECEIVED AN NIH SUBAWARD THROUGH JOHNS HOPKINS UNIVERSITY FOR A MULTICENTER STUDY TITLED "A SEQUENCED-STRATEGY FOR IMPROVING OUTCOMES IN PATIENTS WITH KNEE OSTEOARTHRITIS PAIN" SKOAP STUDY. SKOAP IS A NATIONAL STUDY FUNDED BY THE HELPING ADDICTION LONG-TERM INITIATIVE OR NIH HEAL INITIATIVE. BACKGROUND: THE PURPOSE OF THE SKOAP STUDY (CLINICALTRIALS.GOV-NCT04504812) IS TO COMPARE DIFFERENT TREATMENT OPTIONS FOR PEOPLE LIVING WITH KNEE OSTEOARTHRITIS PAIN. THE GOAL IS TO REDUCE PAIN AND IMPROVE FUNCTION USING CONSERVATIVE TREATMENT AND IF NEEDED, NON-SURGICAL PROCEDURAL TREATMENTS. PROCESS: THIS STUDY HAS TWO PHASES 2700 PATIENTS AND BOTH PHASES COMPARE DIFFERENT NON-SURGICAL TREATMENTS FOR KNEE OSTEOARTHRITIS PAIN. PHASE 1: PEOPLE WHO PARTICIPATE ARE RANDOMIZED TO ONE OF THREE GROUPS: 1. BEST PRACTICES 2. DULOXETINE (AN ORAL MEDICATION USED TO IMPROVE PAIN) OR 3. ONLINE COPING SKILLS TRAINING. PHASE 2: PEOPLE WHO PARTICIPATE ARE RANDOMIZED INTO ONE OF THREE GROUPS. 1. JOINT INJECTION 2. NERVE BLOCK OR 3. NERVE ABLATION. THE IMPORTANCE OF SKOAP: THERE IS AN URGENT PUBLIC HEALTH NEED TO FIND CLINICALLY PROVEN TREATMENTS TO IMPROVE QUALITY OF LIFE AND REDUCE RELIANCE ON OPIOIDS, FOR LONG-TERM PAIN MANAGEMENT FOR PATIENTS SUFFERING FROM KNEE OA. THIS EFFECTIVENESS TRIAL WILL COMPARE AVAILABLE TREATMENTS FOR PAIN REDUCTION AND FUNCTIONAL IMPROVEMENT IN PATIENTS WITH KNEE OSTEOARTHRITIS. THE RESULTS CAN LEAD TO IMPROVED PATIENT SELECTION AND INFORM EVIDENCE- BASED GUIDANCE BY OFFERING WELL-TESTED, EFFECTIVE, NON-OPIOID ALTERNATIVES. DR. VEIZI IS A MEMBER OF THE NATIONAL EXECUTIVE COMMITTEE FOR THE SKOAP STUDY. SINCE JOINING THE STUDY, DR. VEIZI AND HIS TEAM, INCLUDING MS. STOUT, CNP AND MS. MECKLEY, RN AS RESEARCH COORDINATORS, DAMIEN KETER, PT AND DR. GANDHI AS SITE CO-I, HAVE BEEN RECOGNIZED MULTIPLE TIMES FOR THEIR IMPRESSIVE WORK IN EXCEEDING ENROLLMENT GOALS.
    Geographies
    Not indicated
    Dates
    Jan 1, 2022 – Dec 31, 2022
    Source
    990
    No causes provided
    No populations provided
    –
    $24.8K