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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
CARE-FH Trial 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.Check my eligibility
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.See study design
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.
CARE-FH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 9, 12, 18, 24, 30, 36, 42
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 9, 12, 18, 24, 30, 36, 42
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability (Aim 3)
FH diagnosis rate (Aim 2)
Timeliness (Aim 4)
Secondary outcome measures
Best Practice Alert (Aim 2)
Cost (Aim 3)
FH Clinic Note (Aim 2)
+7 moreCARE-FH 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
148 Previous Clinical Trials
1,885,561 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,305,964 Total Patients Enrolled
Laney K Jones, PharmD, MPHPrincipal InvestigatorGeisinger Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- This criterion specifies that only primary care clinicians within the Geisinger Healthcare System, such as pediatricians, community medicine doctors, and internal medicine doctors, are eligible to participate in the study.Not applicable.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 4
- Group 2: Phase 5
- Group 3: Phase 1
- Group 4: Phase 2
- Group 5: Phase 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment in this trial currently open to eligible participants?
"As indicated on clinicaltrials.gov, this medical trial has ceased its recruitment efforts; the original posting was dated September 9th 2022 with an edit from February 6th 2023. While there are no further openings for this study, 69 other research projects are currently recruiting participants."
Answered by AI
What is the primary objective of this research experiment?
"This 45 month medical trial is designed to analyse the FH diagnosis rate (Aim 2), as well as evaluate how adaptations made in this program affect fidelity (Aim 3). Additionally, genetic testing will be ordered for individuals with FH and healthcare clinicians are expected to initiate lipid lowering medications."
Answered by AI
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