Clinical trial NCT06178302: DEscripitive Patient Analysis to Enable Risk-based Quality Improvement Measures in a lArge iNternal mediCIne grouP Practice
Official title: DEscripitive Patient Analysis to Enable Risk-based Quality Improvement Measures in a lArge iNternal mediCIne grouP Practice - The EMANCIPATE Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Liver Dysfunction
Thyroid
Atherosclerosis
Heart Failure
Intestinal Disease
Heart Diseases
Lead sponsor: Imed19
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient population of a large group practice for internal medicine

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.

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.


Eligibility 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.

Primary outcomes:
measure: Baseline characteristics
timeFrame: Baseline/time of study inclusion
measure: Risk evaluation
timeFrame: At baseline and as available during routine clinical follow-up, up to 10 years (no formal follow-up visits/time frames))
measure: Quality of care evaluation
timeFrame: At baseline and as available during routine clinical follow-up, up to 10 years (no formal follow-up visits/time frames)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: