Collaborative Approach to Reach Everyone With Familial Hypercholesterolemia (CARE-FH) (CARE-FH)
Primary Purpose
Familial Hypercholesterolemia
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FH diagnosis program
Implementation strategy package: Develop and implement tools for quality monitoring
Implementation strategy package: Develop educational materials
Implementation strategy package: Conduct educational outreach visits
Implementation strategy package: Intervene with clinicians and patients to enhance
Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions
Implementation strategy package: Audit and provide feedback
Implementation strategy package: Stage implementation scale up
Sponsored by
About this trial
This is an interventional other trial for Familial Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- Primary care clinicians (pediatrician, community medicine, internal medicine) in the Geisinger Healthcare System
Exclusion Criteria:
- None
Sites / Locations
- Geisinger Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Other
Other
Other
Other
Other
Arm Label
Phase 1
Phase 2
Phase 3
Phase 4
Phase 5
Arm Description
Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
Outcomes
Primary Outcome Measures
FH diagnosis rate (Aim 2)
FH diagnosis rate, is achieving both the scheduling of a clinic visit and evidence the clinician, at that visit, has completed evidence-based FH diagnostic evaluation, defined as completing one of: using the FH clinic note to document care, adding FH diagnosis on the problem list, using the FH smart-set (or ordered a genetic test for FH), making a referral to the lipid clinic, or starting a statin for an evidence-based indication
Acceptability (Aim 3)
Clinician and patient satisfaction and self-efficacy with the FH diagnosis program
Timeliness (Aim 4)
Time to FH screen, time to diagnostic evaluation, time to statin initiation
Secondary Outcome Measures
Initiation medication use (Aim 2)
Initiation of lipid lowering medication by healthcare clinician
Lipid measurement (Aim 2)
Order of a lipid panel
Genetic testing (Aim 2)
Order of a genetic test for FH
Problem list diagnosis of FH (Aim 2)
Clinician adds diagnosis of FH to the patients problem list in the electronic health record
FH smartset (Aim 2)
Clinician uses and completes all field of the FH smartset
Best Practice Alert (Aim 2)
Clinician adheres to and acts on recommendation in the Best Practice Alert
FH Clinic Note (Aim 2)
Clinician completes the FH clinic note
Fidelity (Aim 3)
Documentation of adaptations to the FH diagnosis program
Cost (Aim 3)
Cost to implement the implementation strategy package
Function (Aim 4)
Return of genetic result to patient (if ordered and patient undergoes testing)
Function (Aim 4)
Reduction in lipid level from baseline to end of the study period
Function (Aim 4)
Patient side effects to medications
Full Information
NCT ID
NCT05284513
First Posted
November 18, 2021
Last Updated
February 6, 2023
Sponsor
Geisinger Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT05284513
Brief Title
Collaborative Approach to Reach Everyone With Familial Hypercholesterolemia (CARE-FH)
Acronym
CARE-FH
Official Title
Collaborative Approach to Reach Everyone With Familial Hypercholesterolemia (CARE-FH)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 9, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Geisinger Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Diagnosis rates of familial hypercholesterolemia (FH) are low in the United States, despite multiple guidelines and recommendations for screening and treatment of high cholesterol, to prevent heart attacks in those affected. Using a stepped-wedge design, the investigators plan to utilize tools from implementation science to improve uptake, acceptability, and sustainability of FH diagnostic programs in primary care settings. If successful, this study will provide tools generalizable to other health care systems to improve FH diagnosis rates.
Detailed Description
Familial hypercholesterolemia (FH) is a common genetic disorder (prevalence 1 in 250) that requires lifelong sustained medical care. Evidence-based guidelines for screening and treatment for FH exist. These include universal screening of children ages 9-11, of adolescents ages 18-20, and of adults ages 40 and above; approved diagnostic tools including lipid panels and genetic testing; and recommendations for initiation of lipid lowering medication. FH diagnosis is currently made too late in life, often after a premature heart attack has occurred creating a care gap that results in excess cardiovascular morbidity and mortality. Diagnosing FH in the primary care setting would optimize treatment for individuals with FH and close this care gap. Utilizing tools from implementation science and human centered design, and by considering uptake, acceptability, and sustainability of programs related to FH care should improve earlier diagnosis. Implementation strategies that include insights from patients, clinicians, and healthcare systems are necessary. The long-term goal is to create an effective FH diagnosis program that is practical and sustainable in the real-world setting. The main objective of this project is to determine the uptake of an FH diagnosis program integrated into primary care practices to promote early identification of adult and pediatric patients that is generalizable to other healthcare settings. The research question is, does using a multi-level implementation strategy package, designed to address the specific needs of patients, clinicians, and healthcare systems, improve the diagnosis and activation of care management for individuals with FH. The specific aims are to: 1) to design a clinical trial to assess multi-level implementation strategies for improving FH diagnosis in an integrated health system, 2) compare FH diagnosis rates among primary care clinicians who receive the implementation strategy package versus those who do not, 3) to measure implementation success of an organized FH diagnosis program, and 4) to explore patient-related service and health outcomes related to an FH diagnosis program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Hypercholesterolemia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Stepped-wedge design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
532 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phase 1
Arm Type
Other
Arm Description
Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
Arm Title
Phase 2
Arm Type
Other
Arm Description
Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
Arm Title
Phase 3
Arm Type
Other
Arm Description
Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
Arm Title
Phase 4
Arm Type
Other
Arm Description
Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
Arm Title
Phase 5
Arm Type
Other
Arm Description
Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
Intervention Type
Behavioral
Intervention Name(s)
FH diagnosis program
Intervention Description
Uptake of screening, diagnosis, and initiation of care management for FH
Intervention Type
Behavioral
Intervention Name(s)
Implementation strategy package: Develop and implement tools for quality monitoring
Intervention Description
EHR tools to order labs, record results, and document FH care
Intervention Type
Behavioral
Intervention Name(s)
Implementation strategy package: Develop educational materials
Intervention Description
Education regarding guidelines for identification and treatment of FH
Intervention Type
Behavioral
Intervention Name(s)
Implementation strategy package: Conduct educational outreach visits
Intervention Description
Continuing medical education (CME) material for FH that is presented to
Intervention Type
Behavioral
Intervention Name(s)
Implementation strategy package: Intervene with clinicians and patients to enhance
Intervention Description
Notify patients simultaneously with clinicians about the need for screening
Intervention Type
Behavioral
Intervention Name(s)
Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions
Intervention Description
Clinical lipid champions
Intervention Type
Behavioral
Intervention Name(s)
Implementation strategy package: Audit and provide feedback
Intervention Description
Provide aggregate level feedback to clinics on diagnosing FH
Intervention Type
Behavioral
Intervention Name(s)
Implementation strategy package: Stage implementation scale up
Intervention Description
Develop the timeline for the stepped-wedge rollout to primary care
Primary Outcome Measure Information:
Title
FH diagnosis rate (Aim 2)
Description
FH diagnosis rate, is achieving both the scheduling of a clinic visit and evidence the clinician, at that visit, has completed evidence-based FH diagnostic evaluation, defined as completing one of: using the FH clinic note to document care, adding FH diagnosis on the problem list, using the FH smart-set (or ordered a genetic test for FH), making a referral to the lipid clinic, or starting a statin for an evidence-based indication
Time Frame
Up to 45 months
Title
Acceptability (Aim 3)
Description
Clinician and patient satisfaction and self-efficacy with the FH diagnosis program
Time Frame
Month 9, 12, 18, 24, 30, 36, 42
Title
Timeliness (Aim 4)
Description
Time to FH screen, time to diagnostic evaluation, time to statin initiation
Time Frame
Up to 45 months
Secondary Outcome Measure Information:
Title
Initiation medication use (Aim 2)
Description
Initiation of lipid lowering medication by healthcare clinician
Time Frame
Up to 45 months
Title
Lipid measurement (Aim 2)
Description
Order of a lipid panel
Time Frame
Up to 45 months
Title
Genetic testing (Aim 2)
Description
Order of a genetic test for FH
Time Frame
Month 9, 12, 18, 24, 30, 36, 42
Title
Problem list diagnosis of FH (Aim 2)
Description
Clinician adds diagnosis of FH to the patients problem list in the electronic health record
Time Frame
Up to 45 months
Title
FH smartset (Aim 2)
Description
Clinician uses and completes all field of the FH smartset
Time Frame
Month 9, 12, 18, 24, 30, 36, 42
Title
Best Practice Alert (Aim 2)
Description
Clinician adheres to and acts on recommendation in the Best Practice Alert
Time Frame
Up to 45 months
Title
FH Clinic Note (Aim 2)
Description
Clinician completes the FH clinic note
Time Frame
Up to 45 months
Title
Fidelity (Aim 3)
Description
Documentation of adaptations to the FH diagnosis program
Time Frame
Up to 45 months
Title
Cost (Aim 3)
Description
Cost to implement the implementation strategy package
Time Frame
Up to 45 months
Title
Function (Aim 4)
Description
Return of genetic result to patient (if ordered and patient undergoes testing)
Time Frame
Up to 45 months
Title
Function (Aim 4)
Description
Reduction in lipid level from baseline to end of the study period
Time Frame
Up to 45 months
Title
Function (Aim 4)
Description
Patient side effects to medications
Time Frame
Up to 45 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary care clinicians (pediatrician, community medicine, internal medicine) in the Geisinger Healthcare System
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laney K Jones, PharmD, MPH
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samuel S Gidding, MD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Clinic
City
Multiple Locations
State/Province
Pennsylvania
ZIP/Postal Code
00000
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Available upon request from PIs
Learn more about this trial
Collaborative Approach to Reach Everyone With Familial Hypercholesterolemia (CARE-FH)
We'll reach out to this number within 24 hrs