Progressive Patient Care study on dbGaP (2,385 participants)

phs001641 — Implementation, Adoption, and Utility of Family History in Diverse Care    Settings

The purpose of this study is to address the key question of whether and how family health history (FHH) is adopted as a tool to more efficiently manage patients at risk for breast, colon, ovarian, and hereditary cancer syndromes as well as thrombophilia and coronary heart disease (CHD) and to provide evidence supporting clinical utility -- improved health behaviors in patients and physician screening recommendations. Five health care delivery organizations will participate in this demonstration project: Duke University, the Medical College of Wisconsin, the Air Force, Essentia Health, University of North Texas. Duke will serve as a coordinating center for this project (Pro00043372) as well as a site. Healthcare Effectiveness Data and Information Set (HEDIS) measures as intermediate clinical effectiveness measures for Coronary Heart Disease (CHD) and selected cancers as well as survey/formative data and electronic medical record (EMR) data will be used as outcomes measures. The research model is purposely designed to mimic clinical delivery as an important step toward widespread implementation and sustainability. In addition, a cost-effectiveness analysis comparing usual care to the FHH guided preventive health model will be used. The completion of this project will result in an optimal strategy for integration of FHH data collection and clinical decision support (CDS) tools into an EMR and demonstrate the utility of the FHH intervention among diverse primary care patients, their settings, their providers, and the health systems that deliver their care. Specific Aim 1: To optimize the collection of patient entered FHH in diverse clinical environments for coronary heart disease, thrombosis, and selected cancers Specific Aim 2: To export FHH data to an open clinical decision support (open CDS) platform and return CDS results to providers and patients (and to EMRs where relevant). To explore the integration of genetic risk and FHH data at selected sites. Specific Aim 3: To assess the clinical and personal utility of FHH using a pragmatic observational study design to assess reach, adoption, integrity, exposure, and sustainability, and to capture, analyze, and report effectiveness outcomes at each stakeholder level: patient, provider, and clinic/system. Specific Aim 4: To take a leadership role in the dissemination of guidelines for a FHH intervention across in diverse practice settings. AAA Hypertension Lupus Multiple sclerosis Obesity Osteoporosis Thyroid disease Rheumatoid arthritis Blood clotting (6): <ul> <li>Blood Clot (high risk features)</li> <li>Factor V</li> <li>PT mutation</li> <li>AT III deficiency</li> <li>Protein S deficiency</li> <li>Protein C deficiency</li> </ul> Brain Disorders (5): <ul> <li>Dementia</li> <li>Hemorrhagic stroke</li> <li>Ischemic stroke</li> <li>Macrocephaly</li> <li>Seizure</li> </ul> Cancer/Adenomas (32): <ul> <li>Bone cancer</li> <li>Brain cancer</li> <li>Breast cancer</li> <li>Colon cancer</li> <li>Adrenal cortex tumor</li> <li>Neuroendocrine tumor</li> <li>Paraganglioma</li> <li>Pheochromoctyoma</li> <li>Pituitary adenoma</li> <li>Medullary thyroid cancer</li> <li>Non-medullary (follicular or papillary) thyroid cancer</li> <li>Don't know type of thyroid cancer</li> <li>Thyroid nodule</li> <li>Other type of endocrine cancer</li> <li>Esophageal cancer</li> <li>Kidney cancer</li> <li>Leukemia</li> <li>Lipoma</li> <li>Liver cancer</li> <li>Muscle cancer</li> <li>Ovarian cancer</li> <li>Pancreatic cancer</li> <li>Prostate cancer</li> <li>Rectal cancer</li> <li>Retinoblastoma</li> <li>Melanoma</li> <li>Non-melanoma skin cancer</li> <li>Do not know type of skin cancer</li> <li>Small bowel cancer</li> <li>Stomach cancer</li> <li>Uterine cancer</li> <li>Other type of cancer</li> </ul> Cardiovascular/heart/artery disease (5): <ul> <li>Atrial fibrillation</li> <li>Carotid stenosis</li> <li>Heart attack/coronary artery disease</li> <li>Peripheral arterial disease</li> <li>Other heart disease</li> </ul> Diabetes (3): <ul> <li>Gestational diabetes</li> <li>Diabetes type I</li> <li>Diabetes type 2</li> </ul> Digestive Disorders (5): <ul> <li>Colon polyp</li> <li>Crohn's disease</li> <li>Irritable bowel syndrome</li> <li>Ulcerative colitis</li> <li>Other digestive disorder</li> </ul> Eye Disorder (3): <ul> <li>Blindness</li> <li>Glaucoma</li> <li>Macular degeneration</li> </ul> Hereditary Cancer Syndromes (22): <ul> <li>Birt-Hogg-Dube syndrome</li> <li>Cowden syndrome</li> <li>Familial adenomatous polyposis</li> <li>Hereditary breast and ovarian cancer syndrome</li> <li>Hereditary diffuse gastric cancer</li> <li>Hereditary leiomyomatosis and renal cell carcinoma syndrome</li> <li>Hereditary melenoma</li> <li>Hereditary papillary renal cancer syndrome</li> <li>Hereditary paraganglioma-pheochromocytoma syndrome</li> <li>Hereditary retinoblastoma</li> <li>Juvenile polyposis</li> <li>Li-Fraumeni syndrome</li> <li>Lynch syndrome</li> <li>Mutyh-associated polyposis</li> <li>Malignant hyperthermia susceptibility</li> <li>Multiple endocrine neoplasia type 1</li> <li>Multiple endocrine neoplasia type 2</li> <li>Nevoid basal cell carcinoma syndrome</li> <li>Peutz-Jeghers syndrome</li> <li>Tuberous Sclerosis complex</li> <li>Von-Hippel Lindau syndrome</li> <li>Other hereditary cancer</li> </ul> Hereditary Cardiovascular syndromes (10): <ul> <li>Long qt</li> <li>Brugada</li> <li>Catecholaminergic polymorphic ventricular tachycardia</li> <li>Hypertrophic cardiomyopathy</li> <li>Dilated cardiomyopathy</li> <li>Left ventricular non-compaction syndrome</li> <li>Arrhythmogenic right ventricular dysplasia</li> <li>Ehlers-Danlos syndrome</li> <li>Marfan syndrome</li> <li>Other hereditary cardiovascular syndrome</li> </ul> High cholesterol (2): <ul> <li>Hyperlipidemia</li> <li>Familial hypercholesterolemia</li> </ul> Kidney Disease (6): <ul> <li>Cystic kidney disease</li> <li>Diabetic kidney disease</li> <li>Kidney nephrosis</li> <li>Nephritis</li> <li>Nephrotic syndrome</li> <li>Other kidney disease</li> </ul> Liver Disease (6): <ul> <li>Alpha 1 antitrypsinase deficiency</li> <li>Auto-immune hepatitis</li> <li>Hereditary hemochromatosis</li> <li>Primary biliary cirrhosis</li> <li>Sclerosing cholangitis</li> <li>Wilson's disease</li> </ul> Lung Disease (3): <ul> <li>Asthma</li> <li>COPD/chronic bronchitis/emphysema</li> <li>Other lung disease</li> </ul> Psychological disorder (14): <ul> <li>Addiction</li> <li>ADHD</li> <li>Autism</li> <li>Bipolar</li> <li>Depression</li> <li>Eating disorder</li> <li>Intellectual disability</li> <li>Obsessive compulsive disorder</li> <li>Panic disorder</li> <li>Personality disorder</li> <li>PTSD</li> <li>Schizophrenia</li> <li>Social phobia</li> </ul> Sickle cell/thalassemia (3): <ul> <li>Sickle cell disease</li> <li>Sickle cell trait</li> </ul> Thalassemia