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  2. CQM-1809

Clinical Trials data element

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      Clinical trial exclusions have been removed from all hospital eCQMs as of the 2015 publication of the measures because of lack of terminology to ascertain if a clinical trial is related to a particular condition, which is the intent of the exclusion for these measures.

      For EP measures CMS140 (breast cancer) and 141 (colon cancer), the 'Clinical Trial' data element should be specific to breast or colon cancer respectively. For instance, in CMS140 ‘Breast Cancer: Hormonal Therapy for Stage IC-IIIC Estrogen Receptor/Progesterone Receptor (ER/PR) Positive’, the patient should be participating in a clinical trial related to breast cancer treatment in order to meet the clinical trial data element in the denominator exceptions. In the given example, the reason the patient did not receive an order for or is not taking tamoxifen or aromatase inhibitor is because she is in the clinical trial and may be getting different treatments.
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      Clinical trial exclusions have been removed from all hospital eCQMs as of the 2015 publication of the measures because of lack of terminology to ascertain if a clinical trial is related to a particular condition, which is the intent of the exclusion for these measures. For EP measures CMS140 (breast cancer) and 141 (colon cancer), the 'Clinical Trial' data element should be specific to breast or colon cancer respectively. For instance, in CMS140 ‘Breast Cancer: Hormonal Therapy for Stage IC-IIIC Estrogen Receptor/Progesterone Receptor (ER/PR) Positive’, the patient should be participating in a clinical trial related to breast cancer treatment in order to meet the clinical trial data element in the denominator exceptions. In the given example, the reason the patient did not receive an order for or is not taking tamoxifen or aromatase inhibitor is because she is in the clinical trial and may be getting different treatments.
    • CMS30v5/NQF0639, CMS53v4/NQF0163, CMS60v4/NQF0164, CMS100v4/NQF0142, CMS171v5/NQF0527, CMS172v5/NQF0528, CMS178v5/NQF0453, CMS188v5/NQF0147
    • CMS140v3/NQF0387, CMS141v4/NQF0385

      Our hospitals will be reporting on selected eMeasures. Among these there is a common data element: "Clinical Trial."

      We are considering the use of flowsheets within our EPIC EMR based on their recommendations to faciliate accurate capture of the Clinical Trial data element. For the data element "Clinical Trial" does the clinical trial have to be specific to the measure set as it is with manually chart-abstracted measures?

      For example, if a provider places a "YES" for the Clinical trial question in the flowsheet row and there is no specifics as to what type of clinical trial it is, would that suffice for the "Clinical Trial" data element for eCQM?

      How about patients on a research study, research protocols? Are they considered the same and does the research study or protocol have to be measure-specific?

      Thank you

            edave Mathematica EC eCQM Team
            cphilip Christopher Philip (Inactive)
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