Form 8 Clinical Measures

HRSA Patient Navigator Demonstration Program

Clinical Measures/
Lab Tests Form (DRAFT)

Introduction to the Clinical Measures/Lab Tests Form

These are draft instructions. Do not train staff with this document until drafts have been finalized.

Revisions may be made to improve form/data entry screen layout and the clarity of instructions.

A final version of this document will be released no later than May 2011.

Suggestions for improvements are welcome.

The Clinical Measures/Lab Tests Form is a tool that may be used to facilitate the collection of clinical data. Clinical data for patients navigated will need to be collected and reported to NOVA Research for inclusion in the data analysis.

You are welcome to customize and otherwise modify the formatting of the Clinical Measures/Lab Form. For example, you may choose to highlight options under required elements (categories) applicable to your site, or to delete those that are not applicable. However, you are responsible for the information on the form, so take care to avoid deleting required data elements. Since the data entry screen on the online database will mirror this data entry form, major changes are likely to cause increased data entry effort. If there is doubt about whether a specific modification may cause problems, please contact NOVA.

Please email any questions or concerns regarding these instructions or the form to Debra Stark dstark@novaresearch.com and Caroline McLeod cmcleod@novaresearch.com.

Clinical Measures/Lab Tests Form (DRAFT)

Tests being report on for study Fasting blood glucose HbA1c Dilated eye check Diabetic foot check Diabetes self-management plan Blood pressure Antihypertensive prescription date Peak flow ER/Hospitalization Albulterol prescription date Lipids Statin prescription date BMI Diuretic prescription date Smoker Optional Measure (Specify)

Site use only: Local Identifier	Study ID	Test	Date	Result	Entered

Instructions for Completing the Clinical Measures/Lab Tests Form

These are draft instructions. Do not train staff with this document until drafts have been finalized.

Revisions may be made to improve form/data entry screen layout and the clarity of instructions.

A final version of this document will be released no later than May 2011.

Suggestions for improvements are welcome.

The data included on the Clinical Measures/Lab Tests Form should be collected at the time of intake into navigation and upon completion of navigation (or at the end of the project navigation period).

• Data must be entered within one month of intake.

• Data must be entered at completion of navigation or within two months prior to the end of the grant.

• Specific lab data are required based on the patient’s navigated condition as follows:

Navigated Condition	Required Lab Data
Asthma, at risk/pre-asthma	Smoker
Asthma, diagnosed	Peak Flow, ER/Hospitalization, Albuterol Prescription Date, Smoker
CHF, diagnosed	ER/Hospitalization, Diuretic Prescription, Smoker
CVD, at risk/family history	Smoker
CVD, diagnosed	Blood Pressure, ER/Hospitalization, Lipids, Smoker
Depression, positive screen	Smoker
Depression, diagnosed	Smoker
Diabetes, at risk/family history	Smoker; Fasting Blood Glucose or HbA1c
Diabetes, pre-diabetes	Smoker; Fasting Blood Glucose or HbA1c
Gestational diabetes	Smoker; Fasting Blood Glucose or HbA1c
Diabetes, diagnosed	HbA1c, Dilated Eye Check, Diabetic Foot Check, Diabetes Self-management Plan, Blood Pressure, ER/Hospitalization, Lipids, BMI, Smoker
Diabetes, hypertension, dyslipidemia	HbA1c, Dilated Eye Check, Diabetic Foot Check, Diabetes Self-management Plan, Blood Pressure, Antihypertensive Prescription Date, ER/Hospitalization, Lipids, Statin Prescription Date, BMI, Smoker
Hypertension, diagnosed	Blood Pressure, Antihypertensive Prescription Date, ER/Hospitalization, Lipids, Smoker
Hypertension, positive screen	Smoker
Obesity (Adult)	BMI, Smoker
Obesity (Pediatric)	BMI, Smoker
Cancer, screening	Smoker
Cancer, abnormal finding	Smoker
Cancer, diagnosis	Smoker

Local Identifier This item should be used to record whatever local identifier will be helpful to local staff; these data will not be entered into the study database.

Study ID Use this space to record the Study Identifier; this is the unique numeric ID assigned to each navigated patient. This may be left blank until procedures for assigning study IDs are in place.

Test Record the test being recorded (use the list at the top of the form for reference).

Optional Measure (Optional) If there are site-specific measures that could be entered efficiently through the online database, record the name of the measure here.

Date Record the date when the test was conducted or, for non-lab measures (e.g., Smoker), the date when the status was ascertained.

Result Record the numeric test result where applicable. No result is required for the prescription date measures or for measures verifying the completion of a process (e.g., diabetic foot check).

Entered This column exists on the paper form only, and is intended to assist sites in the data entry process. It is meant to be used to indicate that the item entered on that row has been entered into the online system. This field is not a required component of the cro