Collaborative Approach to Reach Everyone with Familial Hypercholesterolemia: CARE-FH Protocol
Abstract
:1. Introduction
2. Materials and Methods
2.1. Overview
2.2. FH Diagnostic Evaluation Program
- -
- Used FH clinic note to document care
- -
- Added FH diagnosis on the problem list or used the Dutch Lipid Clinic Network score (DLCN) tool to exclude FH diagnosis
- -
- Used the FH smart-set (i.e., ordered a genetic test for FH)
- -
- Made a referral to the lipid clinic [12]
- -
- Initiate evidence-based lipid lowering medications
2.3. Potenital Implementation Strategies
3. Specific Aim 1 (R61): Design a Clinical Trial to Assess Multi-Level Implementation Strategies for Improving FH Diagnosis in an Integrated Health System
3.1. Objectives and Work Plan by Team
3.1.1. Implementation Science Team (ImpT)
- Identification of healthcare system level barriers.
- Tailor selected implementation strategies to meet the needs of the clinical implementation sites.
- Alpha testing of implementation strategy package into two preselected clinical implementation sites.
- Define a measurement of implementation outcomes.
Survey
Contextual Inquiries
Deliberative Engagement Meetings
3.1.2. Medical Science Team (MedT)
- Partner with the InfT to revise content for EHR tools in the implementation strategy package and subsequent adaptations.
- Finalize FH care plan for adults and children.
- Finalize strategy for incorporation of genetics counselors and specialty referrals into a care plan.
- Finalize study timeline, including the schedule and sites for rolling out the implementation strategy package.
- Alpha test the implementation strategy package at one adult and one pediatric practice site.
3.1.3. Informatics and Data Science Team (InfT)
- Partner with the MedT to develop content for building EHR tools for the implementation strategy
- Provide EHR support for the alpha test.
- Finalize the data analysis plan.
- Collect baseline outcomes data, including estimates of patient flow, for the clinical trial design.
4. Specific Aim 2 (R33): Compare FH Diagnostic Evaluation Rates among Primary Care Clinicians Who Receive the Implementation Strategy Package versus Those Who Do Not
Data Collection and Analysis for Adoption and Penetration
5. Specific Aim 3 (R33): Measure Implementation Success of an Organized FH Diagnostic Evaluation Program
- What is the acceptability of an FH diagnostic evaluation program across different demographic regions of the health system?
- How does the implementation strategy package fit (from Aim 2) within and between different clinic settings and patient populations and what adaptations were made?
- What are the costs to the healthcare system to implement and maintain an FH diagnostic evaluation program?
5.1. Data Collection and Analysis for Each Implementation Outcome
5.1.1. Acceptability
5.1.2. Cost
5.1.3. Feasibility
5.1.4. Fidelity
5.1.5. Sustainability
6. Specific Aim 4 (R33): Measure Patient-Related Outcomes after Implementation of an FH Diagnostic Evaluation Program
6.1. Data Collection and Analysis for Service and Health Outcomes
6.1.1. Timeliness
6.1.2. Function
7. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Conflicts of Interest
References
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Name of Strategy * | Study Specific Definition | Actor | Action | Action Target |
---|---|---|---|---|
Develop and implement tools for quality monitoring | EHR tools to order labs, record results, and document FH care | ImpT, MedT, and InfT | Use EHR to record, order, and prescribe FH Care | Service and health outcomes |
Develop educational materials | Education regarding guidelines for identification and treatment of FH | MedT and InfT | Create a CME course for clinicians about FH. Explore clinician workflow and educational needs to design novel focused educational interventions integrated within clinical workflows to support evidence-based care | MedT ready to train clinicians on FH |
Conduct educational outreach visits | CME educational material for FH that is presented to each clinic | MedT and clinicians | Attend CME course on FH | Improve knowledge about FH |
Intervene with patients to enhance uptake and adherence | Reach out directly to patients to recommend screening for FH | Clinicians and ImpT | Letter sent to the patient. Clinician schedules patient for appointment. | Patients diagnosed with FH from those at-risk |
Identify and prepare champions | Clinical lipid champions | MedT | Identify and train lipid champions | Improved performance of study metrics, reduced costs |
Stage FH care delivery model scale up | Develop the timeline for the stepped-wedge rollout to primary care | Leadership team | Notify practices of roll out and schedule education | Begin the trial |
Audit and provide feedback | Provide aggregate level feedback to clinics on diagnosing FH | MedT, InfT, and clinical leadership | Report back to clinicians’ aggregate level data | Improve effectiveness of the FH Diagnosis Program |
Advisory board review | Clinical trial protocol | Advisory Board | Provide feedback on the clinical trial regarding protocol, generalizability and ethical issues | Protocol revision based on feedback |
Domain | Aim | Outcome | Construct Measured | Data Source |
---|---|---|---|---|
Implementation | 2 | Adoption | FH diagnostic evaluation defined as completed of one of the following:
| EHR, administrative data |
Penetration | Proportion of the primary care clinicians that completed the five components of the FH diagnostic evaluation compared to those that did not use it. | |||
3 | Acceptability | Clinician and patient satisfaction and self-efficacy with the implementation strategy package | Semi-structured interviews | |
Cost | Cost to implement the implementation strategy package | Micro-costing | ||
Feasibility | Clinician adoption and penetration for completion of the FH diagnostic evaluation and measured utility of implementation strategy package | Semi-structured interviews and EHR data | ||
Fidelity | Documentation of adaptations to the FH diagnostic evaluation program | Checklist, direct observation | ||
Sustainability | Potential for institutionalization | Surveys, Advisory board consultation | ||
Service | 4 | Timeliness | Time to: FH screen, completion of diagnostic evaluation, medication initiation | EHR, administrative data |
Health | Safety | Medication-related side effects | ||
Intermediate | LDL-C reduction | |||
Process | Return of genetic result | |||
Initiation of cascade screening |
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Jones, L.K.; Williams, M.S.; Ladd, I.G.; Cawley, D.; Ge, S.; Hao, J.; Hassen, D.; Hu, Y.; Kirchner, H.L.; Kobylinski, M.; et al. Collaborative Approach to Reach Everyone with Familial Hypercholesterolemia: CARE-FH Protocol. J. Pers. Med. 2022, 12, 606. https://doi.org/10.3390/jpm12040606
Jones LK, Williams MS, Ladd IG, Cawley D, Ge S, Hao J, Hassen D, Hu Y, Kirchner HL, Kobylinski M, et al. Collaborative Approach to Reach Everyone with Familial Hypercholesterolemia: CARE-FH Protocol. Journal of Personalized Medicine. 2022; 12(4):606. https://doi.org/10.3390/jpm12040606
Chicago/Turabian StyleJones, Laney K., Marc S. Williams, Ilene G. Ladd, Dylan Cawley, Shuping Ge, Jing Hao, Dina Hassen, Yirui Hu, H. Lester Kirchner, Maria Kobylinski, and et al. 2022. "Collaborative Approach to Reach Everyone with Familial Hypercholesterolemia: CARE-FH Protocol" Journal of Personalized Medicine 12, no. 4: 606. https://doi.org/10.3390/jpm12040606