10 Attachment J: Clinical Data Collection Instrument_Cancer

Form Approved
OMB No. 0935-XXXX
Exp. Date XX/XX/20XX

Attachment J: Clinical Data Collection Form—Cancer Diagnostic Process Cohort

Reporting month: Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

Reporting year: 2023 2024 Case #: 1 2 3

Instructions: This clinical data collection form is intended to document each step in the cancer diagnostic process and to understand whether practices follow closed-loop processes along the cancer diagnostic pathway. Each month starting in June 2023 until the end of the intervention, you will be asked to complete this form for up to 3 patients suspected of having breast, colorectal, or lung cancer with a final diagnosis confirmed, ruled out, or who have been lost to followup.* You will be asked to submit up to 9 forms quarterly using this secure online data submission portal. The data collected will provide a more detailed understanding of whether the Safety Program is associated with improved communication, timeliness, and closed-loop processes along the cancer diagnostic pathway within participating practices.

To complete this form, you will need to review the medical record reflecting the patient’s journey after they presented to your practice for suspicion of cancer to assess the relevant diagnostic processes of this patient’s journey. Please answer each question to the best of your ability and provide as much detail as possible when indicated on the form. If you don’t know the answer to a question or cannot remember the answer, please select ‘don’t know/don’t remember’.

For step-by-step instructions on how to complete this tool, please navigate to the Data Collection and Submission Guides page and review the Clinical Data Collection Form Data Submission Guide.

*Please see the Clinical Data Collection and Submission Guides page for more information about defining a patient considered lost to follow-up.

Part I: Initial Patient Presentation to Clinic

Please review patient notes to assess processes involving patient history, exam, and tests ordered.

1. Which of the following situations first raised suspicion of breast, colon, or lung cancer in this patient?

• Patient presented with symptoms suspicious for cancer

• Positive cancer screening test (screening mammography, lung CT, screening colonoscopy, or fecal immunochemical test (FIT))

• An incidental finding with recommendations for follow-up

• Other; please specify:

2. How was the patient seen initially?

 Telemedicine

 In-person

3. Was there something different that could have been done to expedite their diagnosis at the initial presentation?

q No

 Yes (Please explain: ______________)

Part II: Diagnostic Tests

4. Were diagnostic tests ordered?

q Yes

q No

4a. (Skip logic, if yes to Q4) Which diagnostic tests were ordered?

	Chest x-ray
	CT chest
	Mammogram
	Breast ultrasound
	MRI
	Colonoscopy
	Other (Please specify: ______)

4b. (Skip logic, if yes to Q4) Was completion of any diagnostic tests delayed?

 No

 Yes (Please explain: ______________)

Part III: Specialty Referrals

5. Were specialty referrals made?

q No

q Yes

5a. (Skip logic, if yes to Q5) To which specialty(ies) was the patient referred?

	GI
	Pulmonary
	Oncology
	Surgery
	Other (please specify: ________________________________)

5b. (Skip logic, if yes to Q5) Were any of these visits provided via telemedicine?

q No

q Yes (Please indicate which specialty visits were provided via telemedicine. ________________________________)

5c. (Skip logic, if yes to Q5) Was completion of any specialty referrals delayed?

 No

 Yes (Please explain: ____________)

Part IV: Verification of Diagnostic Procedures

6. During the patient’s evaluation, did the clinician consult a specialist regarding which test(s) or referral(s) to order for this patient?

q No

 Yes

qDon’t know/don’t remember

6a. (Skip logic, if yes to Q6) Please specify which specialist was consulted. (open-ended)

6b. (Skip logic, if yes to Q6) How did this consultation take place?

 E-consult

Telephone

In person

Other (please specify: _________________)

qDon’t know/don’t remember

7. During the patient evaluation, did the clinician consult with a specialist regarding interpretation of test results or findings?

q No

q Yes

qDon’t know/don’t remember

7a. (Skip logic, if yes to Q7) Which specialist was consulted? (open-ended)

7b. (Skip logic, if yes to Q7) How did this consultation take place?

 E-consult

Telephone

In person

Other (please specify: _________________)

qDon’t know/don’t remember

Part V: Follow-up and Tracking

8. During the patient’s care was follow-up action or response to test results completed in a timely manner?

q No (Please explain: ______________)

q Yes

Part VI: Patient Communication

9. Did you inform the patient of the final diagnosis (including findings that were benign or of unknown significance)?

q No

q Yes

9a. (Skip logic, if no to Q9) Please specify who informed the patient of the final diagnosis or if unknown, please explain.

9b. (Skip logic, if yes to Q9) How did you inform the patient of the final diagnosis (including findings that were benign or of unknown significance)?

• Face-to-face during in-person visit

• Face-to-face during telemedicine visit

• Telephone call (spoke to patient or family member)

• Patient portal message

• Letter via mail

• Don’t know/don’t remember

• Other (specify: __________________________)

10. Was there a delay in communication of diagnosis to the patient?

q No

 Yes (Please explain: ___________________)

q Don’t know/don’t remember

11. Were any of the following barriers to communication present?

q No barriers to communication were present

q Language barrier

q Unable to reach patient

q Limited health literacy/comprehension

q Other (Please explain: _________________________)

Part VII: Diagnosis

12. In which month was the final diagnosis confirmed, ruled out, or the patient was determined lost to follow-up? (drop down menu of months)

13. What was the final diagnosis?

 Benign findings or other non-cancerous condition

 Breast cancer

 Colorectal cancer

 Lung cancer

Other not listed above (Please specify: ____________________)

qUnknown (patient lost to follow up)

14. Was there an opportunity to expedite diagnosis of this patient?

q No, the diagnosis was made in a timely manner

q Unknown/unsure (Please explain: ___________________)

 Yes (Please explain: ______________)

Public reporting burden for this collection of information is estimated to average 20 minutes per response, the estimated time required to complete the survey. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: AHRQ Reports Clearance Officer Attention: PRA, Paperwork Reduction Project (0935-XXXX) AHRQ, 540 Gaither Road, Room # 5036, Rockville, MD 20850.