NCT06178302

DEscripitive Patient Analysis to Enable Risk-based Quality Improvement Measures in a lArge iNternal mediCIne grouP Practice

DEscripitive Patient Analysis to Enable Risk-based Quality Improvement Measures in a lArge iNternal mediCIne grouP Practice - The EMANCIPATE Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Imed19 · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: Clinical trials often include patients from large hospitals or university clinics. Information on patients cared for at offices from statutory health insurance-accredited physicians represent evidence gaps. Aims/Objectives: The present study has three aims: First, to systematically describe the patient population of a large group practice for internal medicine. Second, to identify high-risk patients using established risk scores. And third, to include routine imaging data to optimize patient management. Methods/Facility Enrolling Participants: This is a prospective, observational study assessing patients' baseline characteristics, risk evaluation and integrating data from imaging test. The setting of the present study is a large group practice for internal medicine which consists of statutory health insurance-accredited physicians. Study participants will be included during daily routine, real-world clinical care and therefore represent all-comers fulfilling the inclusion criteria: 1. Female or male patients aged above 18 years diagnosed with chronic liver disease, undergo on-site endoscopy, suffer from atherosclerosis, heart failure, are diagnosed with abnormal serum thyroid-stimulating hormone (TSH) levels, either overt or latent hypo- or hyperthyroidism, or are diagnosed with solitary or multiple thyroid nodules. 2. Routine laboratory results available within the last 3 months. 3. Available imaging data within the last 3 months performed on site. Perspective: The study is designed to evaluate the current situation and quality of health care in defined patient populations in the routine clinical setting of a large-scale public office. These data will provide a profound rationale to identify quality issues and limitations in our performance of guideline-conform treatment in routine patient care.

Conditions

• Liver Dysfunction
• Thyroid
• Atherosclerosis
• Heart Failure
• Intestinal Disease
• Heart Diseases

Timeline

• Start date: 2025-12-01
• Primary completion: 2034-12-01
• Completion: 2035-06-01
• First posted: 2023-12-20
• Last updated: 2025-05-07