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

NCT06178302 | Not Yet Recruiting

• 1 other identifier: Imed19 EMANCIPATE2023
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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. 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. 2.Routine laboratory results available within the last 3 months.
3. 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

Outcome Measures

Primary Outcomes (3)

• Baseline characteristics

  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.

  Baseline/time of study inclusion

• Risk evaluation

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

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

• Quality of care evaluation

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient population of a large group practice for internal medicine

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Imed19: lead

MeSH Terms

Conditions

Liver Diseases; Thyroid Diseases; Atherosclerosis; Heart Failure; Intestinal Diseases; Heart Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Endocrine System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Gastrointestinal Diseases

Central Study Contacts

Christopher Adlbrecht, MD

CONTACT

+4313671373; ordination@imed19-privat.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 20, 2023
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): June 1, 2035
• Last Updated: May 7, 2025

Record last verified: 2025-05