Clinical Trial (v2021A)

Specifications Manual for Joint Commission National Quality Measures (v2021A)

Posted: 7/29/2020

Home » Clinical Trial

Release Notes:
Data Element
Version 2021A

Name:

Clinical Trial

Collected For:

ACHF-01, ACHF-02, ACHF-03, ACHF-06, ACHFOP-01, ACHFOP-02, ACHFOP-03, ACHFOP-04, ACHFOP-05, CCCIP-01, CCCIP-02, CCCIP-03, CCCIP-04, CCCOP-01, CCCOP-02, CSTK-04, CSTK-06, STK, VTE-6

Definition:

Documentation that during this hospital stay the patient was enrolled in a clinical trial in which patients with the same condition as the measure set were being studied (i.e. STK, VTE).

Question:

During this hospital stay, was the patient enrolled in a clinical trial in which patients with the same condition as the measure set were being studied (i.e. STK, VTE)?

Format:

Length:	1
Type:	Alphanumeric
Occurs:	1

Allowable Values:

Y (Yes) There is documentation that during this hospital stay the patient was enrolled in a clinical trial in which patients with the same condition as the measure set were being studied (i.e. STK, VTE).

N (No) There is no documentation that during this hospital stay the patient was enrolled in a clinical trial in which patients with the same condition as the measure set were being studied (i.e. STK, VTE), or unable to determine from medical record documentation.

Notes for Abstraction:

To select “Yes” to this data element, BOTH of the following must be true:
1. There must be a signed consent form for clinical trial. For the purposes of abstraction, a clinical trial is defined as an experimental study in which research subjects are recruited and assigned a treatment/intervention and their outcomes are measured based on the intervention received. Treatments/interventions most often include use of drugs, surgical procedures, and devices. Often a control group is used to compare with the treatment/intervention. Allocation of different interventions to participants is usually randomized.
2. There must be documentation on the signed consent form that during this hospital stay the patient was enrolled in a clinical trial in which patients with the same condition as the measure set were being studied (i.e. STK, VTE). Patients may either be newly enrolled in a clinical trial during the hospital stay or enrolled in a clinical trial prior to arrival and continued active participation in that clinical trial during this hospital stay.
In the following situations, select "No:”
1. There is a signed patient consent form for an observational study only. Observational studies are non-experimental and involve no intervention (e.g., registries). Individuals are observed (perhaps with lab draws, interviews, etc.), data is collected, and outcomes are tracked by investigators. Although observational studies may include the assessment of the effects of an intervention, the study participants are not allocated into intervention or control groups.
2. It is not clear whether the study described in the signed patient consent form is experimental or observational.
3. It is not clear which study population the clinical trial is enrolling. Assumptions should not be made if it is not specified.

STK: Only capture patients enrolled in clinical trials studying patients with stroke.

VTE: Only capture patients enrolled in clinical trials studying patients with VTE (prevention or treatment interventions).

ACHF and ACHFOP: Only capture patients enrolled in clinical trials studying patients with heart failure.

Suggested Data Sources:

ONLY ACCEPTABLE SOURCES:
Signed consent form for clinical trial

Additional Notes:

Guidelines for Abstraction:

Inclusion	Exclusion
None	None

Specifications Manual for Joint Commission National Quality Measures (v2021A)
Discharges 01-01-21 (1Q21) through 06-30-21 (2Q21)

LICENSE FOR USE OF CURRENT PROCEDURAL TERMINOLOGY, FOURTH EDITION (“CPT®”)

You, your employees and agents are authorized to use CPT® only as contained in The Joint Commission performance measures solely for your own personal use in directly participating in healthcare programs administered by The Joint Commission. You acknowledge that the American Medical Association (“AMA”) holds all copyright, trademark and other rights in CPT®.

Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CPT® for resale and/or license, transferring copies of CPT® to any party not bound by this Agreement, creating any modified or derivative work of CPT®, or making any commercial use of CPT®. License to use CPT® for any use not authorized herein must be obtained through the American Medical Association, Intellectual Property Services, AMA Plaza, 330 North Wabash Avenue, Suite 39300, Chicago, Illinois 60611-5885. Applications are available at the American Medical Association Web site, www.ama- assn.org/go/cpt.

U.S. Government Rights This product includes CPT® which is commercial technical data, which was developed exclusively at private expense by the American Medical Association, 330 North Wabash Avenue, Chicago, Illinois 60611. The American Medical Association does not agree to license CPT® to the Federal Government based on the license in FAR 52.227-14 (Data Rights - General) and DFARS 252.227-7015 (Technical Data - Commercial Items) or any other license provision. The American Medical Association reserves all rights to approve any license with any Federal agency.

Disclaimer of Warranties and Liabilities. CPT® is provided “as is” without warranty of any kind, either expressed or implied, including but not limited to the implied warranties of merchantability and fitness for a particular purpose. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT®, and the (AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The responsibility for the content of this product is with The Joint Commission, and no endorsement by the AMA is intended or implied. The AMA disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this product.

This Agreement will terminate upon notice if you violate its terms. The AMA is a third party beneficiary to this Agreement.

Should the foregoing terms and conditions be acceptable to you, please indicate your agreement and acceptance by clicking below on the button labeled “accept”.