CDS Connect: Abnormal Blood Glucose and Type 2 Diabetes Mellitus: Part Two, Counseling

Abnormal Blood Glucose and Type 2 Diabetes Mellitus: Part Two, Counseling

Description

This artifact provides patient-centered, evidence-based preventive health information to patients between the age of 40-70 who are identified as overweight or obese with at least one cardiovascular disease (CVD) risk factor and presents them with: 1) educational resources for learning about the risks for developing diabetes, 2) resources on how reduce those risks, 3) information on the role diabetes plays in CVD, and 4) encouragement to talk to their primary care physician about additional interventions such as counseling to promote a healthy diet and physical activity level. CVD risk factors include hypertension, dyslipidemia, impaired fasting glucose, and metabolic syndrome.

The artifact represents the second part of the USPSTF Abnormal Blood Glucose and Type 2 Diabetes Mellitus: Screening recommendation.

Creation Date
Version
0.1.1
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). 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/
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

Identifies adults who are overweight or obese, have an elevated blood glucose level, and have one or more CVD risk factor, and presents them with:

1) educational resources for learning about the risks for developing diabetes 

2) resources on how reduce those risks

3) information on the role diabetes plays in CVD

4) encouragement to talk to their primary care physician about additional interventions such as counseling to promote a healthy diet and physical activity level

Intended Population
This artifact is intended for use in a broad population of adults (aged 40-70) who are overweight or obese and who have at least one CVD risk factor (i.e., hypertension, dyslipidemia, impaired fasting glucose, or metabolic syndrome).
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

This artifact represents the second half of the USPSTF recommendation: This artifact represents the second half of the USPSTF Abnormal Blood Glucose and Type 2 Diabetes Mellitus: Screening recommendation (which encourages consideration of counseling if glucose screening results are abnormal). The first half of the recommendation (which identifies individuals who meet criteria to be screened for abnormal glucose and Type 2 DM) is represented by a distinct artifact (i.e., USPSTF Abnormal Blood Glucose and Type 2 Diabetes Mellitus, Part 1: Screening).

The CDS Connect team opted to develop two distinct artifacts from the one recommendation to simplify the logic and enable organizations to select portions of the recommendation that align with their organization's need.

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 on the USPSTF website to learn more about the stages of USPSTF recommendation development and view progress on updates to the Abnormal Blood Glucose and Type 2 Diabetes Mellitus: Screening 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 here.
Supporting Evidence
Source Description
Derived from USPSTF Recommendation on Abnormal Blood Glucose and Type 2 Diabetes Mellitus: Screening, available here.
References
Siu, A.L. (2015).  Screening for Abnormal Glucose and Type 2 Diabetes Mellitus. U.S. Preventive Services Task Force Recommendation Statement  Retrieved February 1, 2019 from https://annals.org/aim/fullarticle/2466368/screening-abnormal-blood-glucose-type-2-diabetes-mellitus-u-s
Recommendation
The USPSTF recommends screening for abnormal blood glucose as part of cardiovascular risk assessment in adults aged 40 to 70 years who are overweight or obese. Clinicians should offer or refer patients with abnormal blood glucose to intensive behavioral counseling interventions to promote a healthful diet and physical activity.
Strength of Recommendation

Grade B (see Appendix Table 1 for what the USPSTF Grades mean and suggestions for practice, available here)

Quality of Evidence
See full recommendation report for details regarding the Level of Certainty, available here.
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 years old AND <=70 years old

        AND BMI >=25kg/m2, MOST RECENT VALUE

OR Patient is >=18 years old and <40 years old

        AND BMI >=25kg/m2, MOST RECENT VALUE

        AND one of more of the following:

                Family history of diabetes

                OR polycystic ovary syndrome

                OR race = African American; American Indian or Alaskan Native; or Native Hawaiian or Pacific Islander

                OR ethnicity = Hispanic or Latino

OR Patient is >=18 years old and <=70 years old

        AND BMI >=23kg/m2, MOST RECENT VALUE

        AND race = Asian American

OR Patient is >=18 years old and <=70 years old

        AND gestational diabetes

AND

Hemoglobin A1c level >=5.7%, MOST RECENT VALUE within the past 3 years (final, amended)

OR fasting plasma glucose test result >=100 mg/dl, MOST RECENT VALUE within the past 3 years (final, amended)

OR oral glucose tolerance test result >=140 mg/dl, MOST RECENT VALUE within the past 3 years (final, amended)

Exclusions

Pregnancy (active)

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

OR one or more of the following:

        Behavioral counseling for nutrition and activity referral within the past 12 months (requested, active, accepted, completed)

        OR behavioral counseling for nutrition and activity order within the past 12 months (requested, received, accepted, in-progress, completed)

        OR behavioral counseling for nutrition and activity procedure within the past 12 months (in-progress, completed)

        OR behavioral counseling for nutrition and activity encounter within the past 12 months (in-progress, finished)

Interventions and Actions

Display notification to patient: You may be at risk for (in other words, more likely to get) type 2 diabetes based upon your high blood sugar test results and additional risk factors you may have. High blood sugar and diabetes can lead to heart disease and stroke.

Additional risk factors include being 45 years or older; being overweight; having a parent, brother or sister with diabetes; or if you are a woman with a history of  diabetes while pregnant (gestational diabetes) or polycystic ovarian syndrome (a condition where the ovaries produce higher-than-normal amounts of certain hormones). If you are African-American, Hispanic, Alaskan Native, American Indian, Asian American, or Native Hawaiian/Pacific Islander, you may also be more likely to have high blood sugar.

Recommendation: Experts (i.e., The U.S. Preventive Services Task Force) find that people whose blood tests show high blood sugar should consider ways to help control your blood sugar, including counseling and coaching, and programs that help you eat healthy foods and increase physical activity (exercise and moving around). These programs typically involve a trained counselor who provides education, helps you set goals, shares ways to eat a healthy diet and get more physical activity, and regularly follows up with you. Contact your doctor to discuss whether counseling is right for you.

In addition, the Task Force recognizes that all adults, whether they are at increased risk for diabetes or not, can improve their health through healthy eating and being more physically active. Here are some links to resources to help you get started:

  • Tips for healthy eating from healthfinder.gov (available here
  • Online cookbook with recipes for heart-healthy, tasty meals (available here
  • Ways to get more active! (available here
  • The U.S. Preventive Services Task Force Recommendation on “Abnormal Blood Glucose and Type 2 Diabetes Mellitus: Screening” (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 (which are also available 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
  • Statin Use for the Primary Prevention of CVD in Adults: Patient-Facing CDS Intervention
  • 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 published 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.