Establishing Clinical Utility Evidence for Chronic Disease Management

Status Completed

Clinical Trial Summary

This is a national-level research study of primary care physicians. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling, and others) of a subset of common patient care indications.

Clinical Trial Description

In the original study protocol (approved on October 19th, 2021), which the investigators are now referring to as Phase 1, the investigators measured changes in clinical practice using Clinical Performance and Value (CPVs) vignettes, described below. Phase 1 utilized simulated patients to determine clinical variation in the management of chronic cardiometabolic diseases and assessed the impact of the CDMT results on physicians' clinical decision-making. CPVs are QURE's scientifically-validated measurement tool, first described in JAMA, 2000, and now used in scores of scientific investigations. In this research and derivative peer-reviewed publications, QURE's CPV studies efficiently measure clinical practice patterns among active physicians to determine if there is value in new technologies to payers. This amendment allows us to ask the same physicians if they change their practice in an actual clinical setting. Phase 2 extends the findings from Phase 1 by measuring the change in clinical practice using CPVs and securing data on practice patterns from abstracted medical records. the investigators will look for the same changes the investigators found in Phase 1 to determine the impact of CDMT on real-world clinical decisions and patient outcomes. The advantage of Phase 2 is that it leverages the same sample frame and the randomization by returning to the physicians in Round 1 who indicated that CDMT would change their practice. These physicians will be given, free of charge, the option of using CDMT on their real patients who share similar medical diagnoses as the CPV simulated patients. Phase 2 will thus provide patient-level data on the impact of medication adherence assessment on quality outcomes including, but not limited to, blood pressure control, blood sugar control, and parameters of disease progression ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05910684
Study type	Interventional
Source	Qure Healthcare, LLC
Contact
Status	Completed
Phase	N/A
Start date	July 19, 2022
Completion date	January 30, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05880758` - Impact of Yo-Yo Sleep on Cardiometabolic Health	N/A
Active, not recruiting	`NCT05192590` - Establishing Clinical Utility Evidence for Chronic Disease Management Testing	N/A
Completed	`NCT06058845` - Efficacy of Tamarindus Indica Fruit Juice in Optimizing Cardiometabolic Health of Patients Living With HIV	N/A
Completed	`NCT05473026` - Grateful Strides Toward Physical Activity and Well-Being for Black Breast Cancer Survivors	N/A
Enrolling by invitation	`NCT06284772` - FINRISK 2002 Re-examination
Completed	`NCT05071833` - Effects of Peppermint Oil in Cardiometabolic Outcomes	N/A
Active, not recruiting	`NCT05309057` - Network Meta-analysis of Intermittent Fasting and Cardiometabolic Risk
Recruiting	`NCT05897073` - Time-Restricted Eating, Exercise and Cardiometabolic Health in Obesity	N/A
Not yet recruiting	`NCT06371937` - iPSC Biobank of Biomarkers Diversity in Cardiovascular Disease
Not yet recruiting	`NCT06277661` - The Mom and Infant Outcomes (MOMI) Study	N/A
Recruiting	`NCT06003686` - Spinal Cord Injury Model Systems (SCIMS) - Education Module	N/A
Recruiting	`NCT05775016` - Effects of Adding L-BAIBA to Exercising Adult Overweight and Obese Men and Women	N/A
Recruiting	`NCT05350111` - CArdioMetabolic Prevention in Adolescents	N/A
Completed	`NCT06158191` - Long-term Benefits of Abdominal Fat Loss in Abdominally Obese Dyslipidemic Patients (SYNERGIE Study)	N/A
Recruiting	`NCT04801745` - Vegan Diet, Amla Fruits and Uric Acid	N/A
Not yet recruiting	`NCT06230861` - Effects of Quercetin on Cardiometabolic Outcomes	N/A
Recruiting	`NCT05627570` - A Study Comparing the Health Effects of Two Diets Following UK Dietary Guidance in People Living With Overweight or Obesity	N/A
Active, not recruiting	`NCT04784624` - Virtual Lifestyle Program Evaluation During Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Enrolling by invitation	`NCT05079529` - Development The Potentiality of β-1,3/1,6-D-Glucan (Polysaccharide Peptide) From Mycelia Extract of Indonesia's Ganoderma Lucidum as Adjuvant Therapy in Patients With Cardiometabolic Syndrome	Phase 2
Completed	`NCT04776629` - A Proof-of-Activity Study With Orticumab in Subjects With Psoriasis and Cardiometabolic Risk Factors	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Establishing Clinical Utility Evidence for Chronic Disease Management Testing Patient Study

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms