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

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.

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Key information

Conditions

Liver Dysfunction Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Digestive System Diseases Endocrine System Diseases Gastrointestinal Diseases Heart Diseases Heart Failure Intestinal Disease Intestinal Diseases Liver Diseases Thyroid Thyroid Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
Routine laboratory results available within the last 3 months.
Available imaging data within the last 3 months performed on site.

Treatment and study plan

Primary outcomes

Baseline characteristics

Time frame: Baseline/time of study inclusion

To describe the baseline characteristics (age, weight, height, routinely assesses laboratory parameters such as creatinin, thyroid hormones, liver enzymes, lipids) of patients with heart failure in a community based internal medicine practice.
Risk evaluation

Time frame: At baseline and as available during routine clinical follow-up, up to 10 years (no formal follow-up visits/time frames))

Describe risk according to risk scores (the CHADS-VASC Score, the EU- TIRADS score, the ASCVD risk score, FIB-4 Score )
Quality of care evaluation

Time frame: At baseline and as available during routine clinical follow-up, up to 10 years (no formal follow-up visits/time frames)

Describe achievement of individual treatment targets according to current guidelines (Lipid targets, bloodpressure targets)

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Adlbrecht, MD

CONTACT

[email protected]

+4313671373

Sponsors and collaborators

Lead sponsor

Imed19

Other

Registry information

Official study title

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

Acronym: EMANCIPATE

Important dates

Study start: 2025
Primary completion: 2034
Study completion: 2035
First posted: Dec 20, 2023
Registry last updated: May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed