Centralized Prescribing for Statins

Status Active, not recruiting

Clinical Trial Summary

Clinical Trial Description

This pilot study consists of a pair of pragmatic clinical trials that will evaluate two separate methods for optimizing referral of eligible patients to a centralized pharmacy service for statin management: 1) A stepped wedge clinical trial, with randomization at the level of the provider, evaluating a visit-based nudge for referral to pharmacy services versus usual care; 2) A cluster randomized trial, with randomization at the level of the practice, evaluating a non-visit based nudge for referral to pharmacy services versus usual care. For trial #1, the investigators will identify PCPs at a single practice with at least 10 patients on their panel who are eligible for but not yet prescribed high- or moderate-intensity statin medication. These physicians will be randomized in stepped-wedge fashion to usual care or to a nudge, delivered at the time of a scheduled office visit, to refer appropriate patients to centralized pharmacy services for initiation and/or titration of a statin medication. In trial #2, the investigators will identify PCPs at 12 practices with at least 10 patients on their panel who are eligible for but not yet prescribed high- or moderate-intensity statin medication. Practices will be randomized to usual care or to a non-visit-based nudge to refer appropriate patients to centralized pharmacy services for initiation and/or titration of a statin medication. It is estimated that 13 practices and 83 providers will be eligible to participate in the two trials. The invesitgators will run the intervention over a 9-month time frame. The primary outcome is the prescription of a statin for eligible patients during the 9-month timeframe. Secondary outcomes will include the prescription of guideline-directed intensity of statin medications as well as statin pharmacy dispense rate. The investigators will also assess LDL control over the study period. ;

Study Design

Related Conditions & MeSH terms

Hyperlipidemias

Clinical Trial Details

NCT number	NCT05537064
Study type	Interventional
Source	University of Pennsylvania
Contact
Status	Active, not recruiting
Phase	N/A
Start date	November 2, 2022
Completion date	December 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03793985` - Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337	Phase 1
Recruiting	`NCT03947866` - Ezetimibe-Rosuvastatin Evaluation Study
Withdrawn	`NCT04922424` - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men	Phase 1
Completed	`NCT04516291` - A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70)	Phase 2
Completed	`NCT03632668` - Evaluating the Pharmacokinetic Interaction Between AD-2071 and AD-2072	Phase 1
Completed	`NCT04701775` - Effect of Different Probiotic Strains in Hypercholesterolemic Patients	N/A
Completed	`NCT03534661` - L-NMMA on GLP-2 Mediated Intestinal Lipoprotein Release	Phase 2/Phase 3
Completed	`NCT03422666` - Plasma Lipoprotein Response to Glucagon-like Peptide-2	Phase 2/Phase 3
Completed	`NCT00536796` - Percentage of Secondary Prevention Patients Treated to Their LDL-C Targets	N/A
Completed	`NCT03643705` - A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention	N/A
Recruiting	`NCT04560296` - Community-based E-Health Program for Older Adults Living With Chronic Diseases	N/A
Terminated	`NCT04073134` - The CHORAL Flow Study	Phase 4
Recruiting	`NCT05103254` - Bempedoic Acid Pregnancy Surveillance Program
Not yet recruiting	`NCT05015348` - Effects of Omega-3 PUFA on Lipids, Inflammatory Factors and Body Composition in Patients With Hyperlipidemia	N/A
Active, not recruiting	`NCT05082350` - Nutritional Intervention With Black Garlic	N/A
Not yet recruiting	`NCT04398771` - To Evaluate Safety and Effectiveness of RovatitanTab.
Not yet recruiting	`NCT04064281` - The Healthy Cantonese Diet on Cardiometabolic Syndrome	N/A
Recruiting	`NCT06257641` - Impact of the Mediterranean Diet on Patients With Psoriasis	N/A
Completed	`NCT03690778` - The PK Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male Volunteers.	Phase 1
Completed	`NCT04354987` - Compare the Pharmacokinetics and Safety of CKD-391	Phase 1

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.