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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06178302
Acronym
EMANCIPATE
Enrollment
1000
Registered
2023-12-20
Start date
2025-12-31
Completion date
2035-06-30
Last updated
2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

Imed19
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Baseline characteristicsBaseline/time of study inclusionTo 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 evaluationAt 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 evaluationAt 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)

Contacts

Primary ContactChristopher Adlbrecht, MD
ordination@imed19-privat.at+4313671373

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026