Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178302
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-27
First Post:
2023-12-03
Brief Title:
DEscripitive Patient Analysis to Enable Risk-based Quality Improvement Measures in a lArge iNternal mediCIne grouP Practice
Sponsor:
Imed19
Organization:
Imed19
Study Overview
Official Title:
DEscripitive Patient Analysis to Enable Risk-based Quality Improvement Measures in a lArge iNternal mediCIne grouP Practice - The EMANCIPATE Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMANCIPATE
Brief 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
AimsObjectives
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
MethodsFacility 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
AimsObjectives
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
MethodsFacility 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None