Statin Use for the Primary Prevention of CVD in Adults: Patient-Facing CDS Intervention

Description
This artifact provides patient-centered, evidence-based preventive health information to patients between 40-75 years old who have one or more CVD risk factor (i.e., dyslipidemia, diabetes, hypertension, or smoking) and a calculated 10-year CVD event risk score of 10% or greater. The intervention text prompts them to discuss the possibility of initiating statin therapy with their primary care clinician to prevent CVD.
Creation Date
Version
0.1
Status
Experimental
False

Artifact Creation and Usage

Contributors

This artifact was developed by MITRE software engineers and clinical informaticists, in collaboration with clinical subject matter experts and leaders from the USPSTF.

Additional information about MITRE's health expertise is available here.   

Additional information about the USPSTF's preventive health expertise is available here.

If you would like further information, would like to give us feedback, or have any questions about this artifact, please contact us at ClinicalDecisionSupport@ahrq.hhs.gov.

IP Attestation The author asserts that this artifact has been developed in compliance with the intellectual property rights attributed to the source material.
Copyrights
Recommendation is copyrighted by USPSTF and administered by AHRQ
Implementation Details
Engineering Details
This CDS logic is expressed using Clinical Quality Language (CQL) and the FHIR Draft Standard for Trial Use 2 (DSTU2) data model. All value sets referenced in the logic are published on the Value Set Authority Center (VSAC). In addition, a FHIR Clinical Reasoning representation has been provided to demonstrate how the CDS logic can be contextualized using FHIR PlanDefinition and Library resources. Additional details about these resources can be accessed via the following URLs:
     CQL: https://ecqi.healthit.gov/cql-clinical-quality-language
     FHIR DSTU2: https://www.hl7.org/fhir/DSTU2/index.html       
     VSAC: https://vsac.nlm.nih.gov/
     FHIR Clinical Reasoning: http://hl7.org/fhir/R4/clinicalreasoning-module.html
Repository Information
Approval Date
Publication Date
Last Review Date
Knowledge Level

Structured code that is interpretable by a computer (includes data elements, value sets, logic)

Purpose and Usage
Purpose

This artifact provides an opportunity to present information to at-risk patients through a patient-facing health IT system (e.g., a patient portal, health app) to:

1) raise awareness that they may have one or more risk factor for heart disease and stroke

2) provide educational resources about the risks for developing CVD and the role statin therapy has in reducing lipid levels and thus reducing their CVD risk

3) encourage them to talk to their primary care clinician about ways to reduce their risk including starting a statin medication as a preventive measure 

Intended Population

This artifact applies to adults 40 years and older without a history of CVD who do not have current signs and symptoms of CVD (i.e., symptomatic coronary artery disease or ischemic stroke). 

Usage

This CDS artifact is designed to be implemented in a patient-facing information technology (IT) system (e.g., a patient portal or health and wellness app) to deliver preventive health recommendations outside of a traditional encounter with a clinician. Organizations that might consider implementing this logic range from a large self-insured healthcare organization that seeks to provide health and wellness resources to their employees and patients, to a healthcare innovator that culls patient data from numerous sources (e.g., electronic health records, claims, pharmacy-based management systems, biometric devices, patient-reported data) to provide personalized wellness information via a mobile app.


It is intended for use by patients to provide patient-centered, evidence-based information on preventive treatment options to consider based on that patient’s individual health history and risk factors. The patient is provided with user-friendly notifications, educational materials, and tools in lay language to facilitate patient action and encourage collaborative decision-making between the patient and their clinician and caregiver(s) to determine the most appropriate treatment or care choice. 

Cautions
The CDS Connect Repository hosts another artifact derived from the same evidence base: This artifact shares the same inclusion and exclusion logic as the Statin Use for Primary Prevention of CVD in Adults: Clinician-Facing CDS Intervention artifact published on the Repository. The only difference between the two is that this artifact generates CDS intervention text appropriate for a patient, whereas the other artifact generates intervention text geared towards a prescribing clinician. Please use caution when downloading the logic to ensure that you selected the right version for your use.

Evidence-base is in the process of being updated: As of September 12, 2019, this recommendation is in "Step 2" of being updated by the USPSTF (i.e., USPSTF members are reviewing the evidence and developing a draft recommendation). The updated recommendation will also have to move through "Step 3" of the update process (i.e., finalizing the Recommendation Statement) before it is released to the public.
Interested parties can visit the "Recommendations in Progress" page of the USPSTF website to learn more about the stages of USPSTF recommendation development and monitor the progress of updates to the Statin Use for Primary Prevention of CVD in Adults recommendation.

Implementation consideration: The patient notifications included in the structured CQL expression of this artifact are fairly general, enabling implementing organizations to expand upon and personalize the interventions based on their unique needs and patient population. Information provided to the patient translates the preventive care recommendation into lay language and provides additional resources in a user-friendly format and method. This user-friendly information facilitates patient action through the provision of vetted resources, and in the case of the customized piloted CDS, an opportunity to provide personalized motivational messaging and logistical support for appointments and followup. 
Additional information and resources: CQL Services, an open source publicly-available tool that facilitates integration of CQL code with a health IT system, was used during the pilot implementation of this artifact. CQL Services is available on GitHub here.
Supporting Evidence
Source Description

This artifact is derived from the USPSTF Statin Use for the Primary Prevention of CVD in Adults recommendation.

References

United States Preventive Services Task Force. 2016. Statin Use for the Primary Prevention of CVD in Adults. Journal of the American Medical Association. November 16, 2016. Volume 316, Number 19. Accessed on April 10, 2016 at: http://jamanetwork.com/journals/jama/fullarticle/2584058.

Recommendation

The USPSTF recommends that adults without a history of cardiovascular disease (CVD) (ie, symptomatic coronary artery disease or ischemic stroke) use a low- to moderate-dose statin for the prevention of CVD events and mortality when all of the following criteria are met: 1) they are aged 40 to 75 years; 2) they have 1 or more CVD risk factors (ie, dyslipidemia, diabetes, hypertension, or smoking); and 3) they have a calculated 10-year risk of a cardiovascular event of 10% or greater. 

Strength of Recommendation

Grade B (Grade definition information is available here)

Quality of Evidence

See the full recommendation report, available here.

Artifact Decision Notes
Artifact decision notes are outlined in Appendix A of the implementation guide attached to this artifact.
Artifact Representation
Triggers
The pilot organization ran this logic every night as a batch report. Other implementers may opt for a different triggering event.
Inclusions

Patient is >=40 and <=75 years of age

AND one or more risk factor:

        LDL-C lab result > 130 mg/dL, MOST RECENT VALUE within the past 6 years (final, amended)

        OR HDL-C < 40 mg/dL, MOST RECENT VALUE within the past 6 years (final, amended)

        OR diabetes (Type 1 or Type 2) (active, relapse)

        OR hypertension (active, relapse)

        OR smoking, MOST RECENT STATUS within the past 6 years (final, amended)

AND 10-year CVD risk score >=10 percent, MOST RECENT VALUE within the past 6 years (final, amended)

Exclusions

CVD

OR LDL-C lab result >190 mg/dL, MOST RECENT VALUE within the past 6 years (final, amended)

OR known familial hypercholesterolemia (active)

OR pregnancy (active)

OR pregnancy observation within the past 42 weeks (final, amended)

OR breastfeeding (active)

OR breastfeeding observation, MOST RECENT within the past 1 year (final, amended)

OR ESRD (active)

OR ESRD encounter, within the past 1 month (in progress, finished)

OR dialysis procedure, within the past 7 days (in progress, completed)

OR dependence on dialysis (active, relapse)

OR cirrhosis (active, relapse)

OR rhabdomyolysis (active, relapse)

OR statin medication order, within the past 2 years (active, completed)

OR statin medication statement, within the past 2 years (active)

Interventions and Actions

Display notification to patient: You may have some things putting you at risk (in other words, making it more likely) for getting cardiovascular disease (heart disease and stroke).

Common risk factors for cardiovascular disease (CVD) include high blood pressure, high LDL cholesterol (the “bad” kind of cholesterol), low HDL cholesterol (the “good” kind), diabetes, or smoking.

Recommendation: Experts (i.e., The U.S. Preventive Services Task Force) find that if you are 40 years or older and have one or more risk factors for CVD, you should consider taking a medication called a statin. Statins are medications that help to lower your LDL cholesterol (the ‘bad’ kind of cholesterol).

If you smoke, you should consider quitting.

Contact your doctor to schedule an appointment to discuss steps you can take to prevent heart disease and stroke, including whether taking a statin medication is right for you.

In addition, here is some additional information you may want to review:

  • Keep your heart healthy (available here)
  • Treating cholesterol (available here)
  • Medicines to Prevent Heart Attack and Stroke: Questions for the doctor (available here
  • The U.S. Preventive Services Task Force Recommendation on “Statin Use for the Primary Prevention of Cardiovascular Disease in Adults” (available here
Testing Experience
Pilot Experience

This artifact was tested by b.well® Connected Health over an 8-week period from June 2019 - August 2019, along with the following 4 artifacts (also posted on the CDS Connect Repository):

  • Healthful Diet and Physical Activity for CVD Prevention in Adults with CV Risk Factors
  • Abnormal Blood Glucose and Type 2 Diabetes Mellitus: Part 1, Screening
  • Abnormal Blood Glucose and Type 2 Diabetes Mellitus: Part 2, Counseling
  • CMS's Million Hearts® Model Longitudinal ASCVD Risk Assessment Tool for Baseline 10-Year ASCVD Risk

b.well offers a platform with personalized health management resources targeted to consumers to help them self-manage the entire healthcare process. AHRQ and MITRE would like to thank b.well for their partnership on the pilot. The collaborative effort provided a valuable opportunity to test the CQL CDS expression and learn from the implementation process and end user experiences. High-level details are outlined below. Detailed information on the pilot implementation can be found in the CDS Connect Pilot Report: Preventive Health CDS Interventions document posted within this artifact.

1. What went well?
·         The CDS was successfully integrated into the pilot site’s platform.
·         The pilot partner was extremely collaborative and responsive, meeting all deadlines and exceeding expectations despite a very tight timeframe.
·         The use of several communication tools helped streamline the sharing of documentation and software and enhanced the collaboration between the CDS Connect and b.well technical teams (i.e., Accellion kiteworks and Slack).
·         Leveraging the pilot partner’s expertise in patient/consumer engagement and health management resources and tools enhanced the pilot intervention process and contributed greatly to a successful pilot.
2. What did not go well?
·         The pilot technical team did not have prior experience with the standards used (e.g., Fast Healthcare Interoperability Resources [FHIR], CDS Hooks, and Clinical Quality Language [CQL]), which extended the technical integration time and efforts.
·         Data mapping consumed almost 25 percent of the pilot partner’s technical resource hours (80 hours) and an additional 20 hours of clinical and data/analytics resource time.
·         Some required data was simply not available. Given more time, the pilot partner could have enhanced existing capabilities to obtain the required data directly from the end users.
3. What would you do differently?
·         Initiate the pilot partnership no later than March to allow more time for integration and testing efforts, as well as end user engagement.
·         If more time was available, consider implementing  the CDS using the FHIR Release 4 (R4) in addition to FHIR Draft Standard for Trial Use 2 (DSTU2).
   4. What enhancements were suggested by the pilot partner?
·         Allow the calculation of an “inferred” diagnosis or potential “at risk” status for end users without a confirmed diagnosis, based on other available data. This would enable reaching a larger population of end users and providing them with education that may be valuable. The CDS Connect team opted not to implement this enhancement since expansion of the target population would diverge from the USPSTF recommendation.
·         If time had allowed, it would have been helpful to obtain end user input on the educational materials prior to implementing them. Instead, the pilot partner used health literacy and health communication best practices when developing the educational content.
·         It would have been helpful to survey a larger number of end users, and to provide the survey to the user directly after the intervention. This would allow more conclusive analysis of the survey results; however, the project team was required to follow Paperwork Reduction Act requirements which limited the number of survey recipients to 9 or less
·         Provision of more detailed information from CDS Hooks, to provide information such as the specific user data that qualified that user for the CDS intervention. This information could be used for both testing purposes as well as personalization of the intervention text.
   5. What were the key takeaways/lessons learned from the pilot experience?
·         Aggregating data from multiple sources provides a rich source of clinical information, but also presents challenges when using the data to satisfy CDS logic requirements. This is primarily due to the lack of standards employed by each data source (e.g., claims, electronic health systems, pharmacy benefits management systems, reference laboratories, and patient-generated health data). Much of the data were not linked to a standard clinical terminology code, and many of the required FHIR attributes were missing (e.g., “status,” “verificationStatus,” “onsetDateTime,” “valueQuantity”).
·         Data mapping to account for the issues listed above is a resource-intensive process that also requires knowledgeable clinical informatics expertise. The mapping efforts can impact the integration timeline.
·         The experience of the pilot technical team with FHIR and other evolving standards should be considered during the technical evaluation and planning stages.
·         Patient-facing CDS pilots should consider a pilot partner with consumer/patient-facing experience and expertise and should ensure a pilot timeframe that allows end user personalization and engagement opportunities to be realized.