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Comprehensive Care Approach for High Cholesterol (CARE-FH Trial)

N/A
Waitlist Available
Led By Laney K Jones, PharmD, MPH
Research Sponsored by Geisinger Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 9, 12, 18, 24, 30, 36, 42
Awards & highlights
No Placebo-Only Group

Summary

This trialwill use implementation science to improve diagnosis and treatment of high cholesterol, to prevent heart attacks in people with familial hypercholesterolemia. It could help other health care systems improve diagnosis rates.

Who is the study for?
This trial is for primary care clinicians within the Geisinger Healthcare System. It aims to involve doctors who practice in pediatrics, community medicine, or internal medicine. There are no specific exclusion criteria mentioned, so it appears open to all clinicians in these fields.
What is being tested?
The CARE-FH trial is testing a series of strategies designed to improve diagnosis rates of familial hypercholesterolemia (FH) in primary care settings. These include educational materials and outreach, quality monitoring tools, interventions with clinicians and patients, identifying clinical champions for lipids management, and providing feedback on performance.
What are the potential side effects?
Since this trial focuses on implementation strategies rather than medical treatments or drugs, there are no traditional side effects associated with participation. However, participants may experience changes in clinic workflow or increased workload due to the new diagnostic programs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 9, 12, 18, 24, 30, 36, 42
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 9, 12, 18, 24, 30, 36, 42 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability (Aim 3)
FH diagnosis rate (Aim 2)
Timeliness (Aim 4)
Secondary study objectives
Best Practice Alert (Aim 2)
Cost (Aim 3)
FH Clinic Note (Aim 2)
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: Phase 5Experimental Treatment8 Interventions
Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
Group II: Phase 4Experimental Treatment8 Interventions
Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
Group III: Phase 3Experimental Treatment8 Interventions
Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
Group IV: Phase 2Experimental Treatment8 Interventions
Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
Group V: Phase 1Experimental Treatment8 Interventions
Phased rollout to clinic sites across the the Geisinger system using stepped wedge design

Find a Location

Who is running the clinical trial?

Geisinger ClinicLead Sponsor
155 Previous Clinical Trials
1,978,097 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,361 Total Patients Enrolled
Laney K Jones, PharmD, MPHPrincipal InvestigatorGeisinger Clinic
Samuel S Gidding, MDPrincipal InvestigatorGeisinger Clinic

Media Library

FH diagnosis program Clinical Trial Eligibility Overview. Trial Name: NCT05284513 — N/A
High Cholesterol Research Study Groups: Phase 4, Phase 5, Phase 1, Phase 2, Phase 3
High Cholesterol Clinical Trial 2023: FH diagnosis program Highlights & Side Effects. Trial Name: NCT05284513 — N/A
FH diagnosis program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05284513 — N/A
~250 spots leftby Jan 2027
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