Form #3 Intake reporting form follow up

A PROTOTYPE CONSUMER REPORTING SYSTEM FOR PATIENT SAFETY EVENTS

Attachment E -- Intake Reporting Form Follow Up

Safety event intake form and follow up

OMB: 0935-0214

Document [doc]
Download: doc | pdf

CONSUMER REPORTING SYSTEM FOR PATIENT SAFETY: FOLLOW UP QUESTIONS FOR REPORTER


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


Consumer Reporting System for Patient Safety

Phone Introduction and Screener Script for Follow up Questions for Reporter


INTERVIEWER INSTRUCTIONS:


PRIOR TO THE CALL:

INTERVIEWER WILL HAVE READ THE SUBMITTED INTAKE FORM (I.E. REPORT) AND HIGHLIGHT IN THIS DOCUMENT THE INTAKE FORM QUESTIONS THAT NEED CLARIFICATION.

ONLY THOSE HIGHLIGHTED QUESTIONS WILL BE ASKED OF R.

R WILL ONLY ANSWER THE QUESTIONS FROM THEIR SUBMITTED INTAKE FORM THAT THE TEAM HAS DETERMEIND NEED SOME CLARIFICATION.

NOTE: BELOW ALL QUESTIONS ARE INCLUDED THAT ARE IN THE CRSPS INTAKE FORM.

  • Question numbers (1.1, etc.) are identical to the original intake form.

  • Question numbers 11.1 are the clarification questions for this interview.

INTERVIEW SHOULD HAVE A PRINTED COPY OF THE SUBMITTED INTAKE FORM AND THE FAQS IN FRONT OF THEM FOR THE CALL.


INSTRUCTIONS IF R OPTS TO RETRACT OR DOES NOT REMEMBER THE SUBMITTED REPORT:


If during the introduction or any time during the call, the R opts to retract the report or does not recall the submitted report, record here:

___ R opts to retract report [EXIT AND THANK FOR TIME]

___ R does not recall submitting the report [EXIT AND THANK FOR TIME]


Public reporting burden for this collection of information is estimated to average 10 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.




>INTRO<

Hello, my name is [FIRST AND LAST NAME] and I am calling for [Subject Name, first and last]


IF SOMEONE OTHER THAN RESPONDENT (R) ASKS WHY YOU ARE CALLING, SAY: “I’m sorry, but I can’t provide that information.”


(Check one answer)

a. No one by that name is at this number – skip to Q2

b. R not available – skip to Q3 {next page, PAGE 3}

c. If you are speaking to the subject or the subject comes to the phone – skip to Q8 {PAGE 4}

d. Refusal – THANK AND EXIT


>DID NOT REACH INTENDED RESPONDENT<

Q2: CONFIRM YOU HAVE DIALED CORRECTLY. ASK IF THE RESPONDENT WAS EVER AT THIS NUMBER AND IF THEY HAVE A NEW NUMBER FOR THE PERSON YOU ARE TRYING TO REACH. IF YOUR INFORMANT CANNOT GIVE YOU A NEW NUMBER, – THANK AND EXIT – THEN TRY DIRECTORY ASSISTANCE FOR A NEW LISTING. IF NO NEW NUMBER IS LISTED, NOTE AS NOT LOCATED.









>RESPONDENT NOT AVAILABLE, RESCHEDULE A TIME <

Q3: Is there a more convenient time to reach R?

          1. YES – continue go to Q4

          2. NO – go to Q5


Q4: SET CALL BACK APPOINTMENT.

                1. Date:

                2. Time:


Q5: Is this the best number to reach R or do you have a better number for him/her?

    1. YES – go to Q7

    2. NO – go to Q6


Q6: RECORD NEW NUMBER. “What is best number to reach R?” (___)______________


Q7: Okay, thank you. We will try again another time. May I leave you my name and number in case R wants to call me back?

          1. YES – provide name and toll free number

          2. NO – thank the informant and end the call

>CONSENT TO FOLLOW UP QUESTIONS <

Q8: I am calling you today to see if you are interested in answering a few follow up questions about information you submitted on XX/XXXX (FILL IN: Month and Year) via {FILL IN: phone or web} in a report to the Consumer Reporting System for Patient Safety Concerns.


Do you remember submitting such a report?

YES – go to Q10

NO – go to Q9


>VERIFICATION OF SUBMITTED REPORT <

Q9: We have that you submitted a report via the {FILL IN: phone or web} on XX/XXXX (FILL IN: Month and Year) concerning a patient safety concern that consented to us calling you at this number if we had any follow up questions. Do you remember this?

YES – [go to Page 5 and start the Follow up Questions beginning with Q11.1]

NO – EXIT AND THANK FOR TIME.


If R opts to retract report or does not recall submitting the report, flag below and on cover page.

___ R opts to retract report [EXIT AND THANK FOR TIME]

___ R does not recall submitting the report [EXIT AND THANK FOR TIME]



>INTRO2 <

Q10: Thank you for agreeing to answer a few follow up questions.

The Consumer Reporting System for Patient (CRSPS) allows patients and their families to voluntarily report on the safety of their health care. As a participant, you agree to give information that is true and that has all the facts. CRSPS staff will use the information that you and others give us to understand patients’ concerns. CRSPS staff are researchers from the RAND Corporation and the ECRI Institute. We will only tell doctors, hospitals, and pharmacists a compilation of what we learn; no individual reports are shared. We hope they will make changes and that health care will be safer. In reviewing your report, we have a few questions.


This should take about 10 minutes. You may skip any question or let me know if you do not want to answer a question. There are no right or wrong answers the more information you provide, the more we can learn from your experience. Your participation is completely voluntary and you may discontinue your participation at any time, even once our conversation has started.


  • Ask:

    • Do you have any questions? [If so, refer to FAQs list]

    • Do you understand everything I said or is there anything I should go over again?

    • May I use a tape recorder as we talk so I remember what you tell me exactly right?

____ YES START RECORDING “Thanks. I’ll start recording now.”

____ NO “Thanks. I will take notes only but not record our conversation.”


I am ready to ask you questions about your health care safety concern. Are you ready to begin?

POTENTIAL FOLLOW UP QUESTIONS -- MODULE 1: INTRODUCTION

[NOTE: Question numbers are identical to the original intake form]

    1. We have that the patient with a safety concern is:

    1. Me

    2. A child

    3. A spouse, domestic partner or other family member (for example, a grandparent, aunt, etc.)

    4. A friend

    5. A patient or client

    6. Someone else [Who is the patient? FREE TEXT BOX]


Q11.1: Could you please clarify who the patient is?


    1. We have that the safety concern occurred in [city and state]. You provided this information in a text box and we need some clarification.


Q11.2: Could you please clarify in what city and state did the safety concern occur?





Public reporting burden for this collection of information is estimated to average XX 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.





POTENTIAL FOLLOW UP QUESTIONS - MODULE 2: NARRATIVE


    1. We have the following information about the safety concern. [READ WHAT WAS IN THE TEXT BOX]


12.1 Could you please clarify:

What happened?

Where did it happen?

When did it happen?

Why did it happen?


2.2 We have the name of the patient as:

ENTER FIRST NAME: ­­­­­­­­­­­­­­___________________________________

ENTER LAST NAME: ___________________________________

12.2 Is this correct?


Now we will ask some additional clarifying questions to make sure we understand what happened.


2.3 We have that, in your opinion, the doctor, nurse, or other health care provider [did OR did not] make a medical mistake or error in the patient’s care. [POP-UP: A medical mistake or error is something that was done (or not done) by a health care provider that would be considered incorrect at the time it happened. Sometimes medical mistakes can result in harm or injury to the patient, but not every time.]

    1. Yes GO TO 3.1

    2. No GO TO 2.3.1

    3. Don’t know GO TO 2.3.1


12.2 Please confirm yes or no.

If answered in report that they do not know, read the pop-up and then ask if R about their confusion. Record their complete answer.


** When people are harmed or injured as a result of medical care, we call this a negative effect. Negative effects can be physical or emotional and they may include infections, drug reactions, or other complications.


2.3.1 Did a negative effect take place as a result of the patient’s care?

  1. Yes GO TO 4.1

  2. No GO TO 2.3.1.1

  3. Don’t know GO TO 2.3.1.1


12.3.1 Please confirm yes or no.

If answered in report that they do not know, read the pop-up and then ask R about their confusion. Record their complete answer.


2.3.1.1 You told us that a mistake did not take place (or that you don’t know) and that a negative effect did not take place (or that you don’t know). Is this correct?

  1. Yes GO TO 6.1

  2. No GO TO 6.1

  3. Don’t know GO TO 6.1


12.3.1.1 Please confirm yes or no.

If answered in report that they do not know, read the pop-up and then ask R about their confusion. Record their complete answer.


POTENTIAL FOLLOW UP QUESTIONS -- MODULE 3: MISTAKE


3.1 We have that the medical mistake or error involved the following? (Please choose the one answer that fits best.)

    1. A mistake related to a medicine [POP UP: Medicines can include prescription or non-prescription medication, herbs, dietary supplements, vaccines, contrast dye or other injected medicines] GO TO 3.1.1.1

    2. A mistake related to a test, procedure, or surgery [POP UP: This includes tests that involve taking samples of skin or tissue, inserting tubes to examine internal parts of your body, or other tests involving blood, urine, or X-rays.] GO TO 3.1.2.1

    3. A mistake related to pregnancy or childbirth [POP UP: This includes errors in diagnostic testing during pregnancy and errors during labor and delivery] GO TO 3.2

    4. A mistake related to a diagnosis or advice from a doctor, nurse, or other health care provider GO TO 3.1.3.1

    5. A mistake related to poor cleanliness or poor hygiene GO TO 3.2

    6. Something else, or more than one mistake [What was the mistake? FREE TEXT BOX] GO TO 3.2

13.1. Could you please clarify your response. Did the choices not fit well to your experience?


        1. We have that you wrote the medicine was: [Read the text box information about the name or description of the medicine]

13.1.1.1 Could you clarify this for me?



        1. We have that [FILL IN – it was OR it wasn’t OR you were unsure if it is] a prescription medicine? [POP UP: Don’t include over-the-counter medicines that you can buy without a prescription from a doctor or nurse.]


13.1.1.2 Could you clarify this for me?


        1. We have the following about the medicine mistake. It was: (Please choose the one answer that fits best.)

    1. Wrong medicine

  1. Wrong dose

  2. Something else [What did the mistake involve? FREE TEXT BOX]

13.1.1.3 Could you clarify this for me?


GO TO 3.2





        1. We have that you wrote the test, procedure, or surgery was: [Read the text box information about the name or description of the medicine]

13.1.2.1 Could you clarify this for me?


3.1.2.2 We have that the mistake with a test, procedure, or surgery involved the following? (Please check all that apply.)

                1. Wrong patient [POP UP: The patient was not correctly identified.]

                2. Wrong test, procedure, or surgery [POP UP: The wrong type of test, procedure, or surgery was done.]

                3. Wrong part of the body [POP UP: The test, procedure, or surgery was on the wrong part of the body.]

                4. A mistake was made during the test, procedure, or surgery

                5. The test, procedure, or surgery was delayed

                6. The test results were lost and the patient did not receive them

                7. The patient developed an infection

                8. A problem with anesthesia

                9. Something else [What did the mistake involve? FREE TEXT BOX]

13.1.2.2 Could you clarify this for me?


GO TO 3.2


        1. We have that the mistake with the diagnosis or medical advice was [READ WHAT WAS IN TEXT BOX]involved the following? (Please check all that apply.)


13.1.3.1 Could you clarify this for me?


    1. We have that the mistake happened in? (Please choose the one answer that fits best.)

    1. In a doctor’s office or a clinic

    2. In a pharmacy

    3. In the emergency department

    4. In a hospital

    5. At home

    6. Somewhere else [Where? FREE TEXT BOX]

    7. Don’t know

13.2 Could you clarify this for me?


3.3 We have that you [would OR would not] like to tell us the name and address of the health care doctor, nurse or other health care provider (or the health care facility) involved in the mistake.

□A Yes

□B Yes, but I do not know the name and address of the provider GO TO 3.4

□C No, I do not know the name and address of the provider GO TO 3.4

□D No, I do not want to tell you GO TO 3.4 13.3 Could you clarify this for me?


3.3.1 We have the following name and address of the health care doctor, nurse, or other health care provider (or the health care facility) involved in the mistake.


13.3.1 Could you clarify this for me?


3.3.2 We have that a second health care provider (or facility) [was OR was not] involved.

□A Yes

□B No GO TO 3.3.5

13.3.2 Could you clarify this for me?


3.3.3 We have that you [would OR would not] like to tell us the name and address of the second health care provider (or facility) involved in the mistake.

□A Yes

□B Yes, but I do not know the name and address of the provider GO TO 3.3.5

□C No, I do not know the name and address of the provider GO TO 3.3.5

□D No, I do not want to tell you GO TO 3.3.5

13.3 Could you clarify this for me?


3.3.4 We have the following name and address of the health care provider (or facility) involved in the mistake.

13.3.4 Could you clarify this for me?


    1. We have that the mistake happened in the [FILL IN month and year]

13.4 Is this correct? Please clarify



    1. We have that a doctor, nurse, or other health care provider [FILL IN – did OR did not] tell you the mistake happened.

  1. Yes GO TO 3.7

  2. No

13.5 Is this correct? Please clarify


      1. We have that you found out that the mistake happened?

[FREE TEXT BOX]

13.5.1 Is this correct? Please clarify



Sometimes medical mistakes affect patients financially. For example, patients may have to miss work, pay for extra tests or procedures, or take additional trips to a health care facility.


    1. We have that a mistake affected the patient financially?

  1. Yes

  2. No

  3. Don’t know

13.6 Is this correct? Please clarify


When people are harmed or injured as a result of medical care, we call this a negative effect. Negative effects can be physical or emotional and they may include infections, drug reactions, or other complications.


    1. We have that the patient experienced a negative effect as a result of the mistake or error.

  1. Yes

  2. No GO TO 5.1

  3. Don’t know GO TO 5.1

13.7 Is this correct? Please clarify


POTENTIAL FOLLOW UP QUESTIONS -- MODULE 4: NEGATIVE EFFECT


** Indicates that the question should be suppressed as the reporter was already asked a similar question in Module 3.


    1. **We have that the negative effect involved the following? (Please choose the one answer that fits best.)

    1. A negative effect related to a medicine

    2. A negative effect related to a test, procedure, or surgery

    3. A negative effect related to pregnancy or childbirth

    4. A negative effect related to a diagnosis or medical advice

    5. Unclean or unsanitary care

    6. Something else or more than one negative effect [What did it involve? FREE TEXT BOX]

14.1 Is this correct? Please clarify


    1. We have that the patient experienced the following kind of negative effects:

  1. Physical

  2. Emotional GO TO 4.4

  3. Both

14.2 Is this correct? Please clarify


4.3 We have that the patient experienced the following kind of physical negative effects (Please check all that apply.)

  1. Dizziness

  2. Sick to the stomach (nausea)

  3. Infection

  4. Pain

  5. A fall that caused an injury

  6. Open sores on skin

  7. A sexual problem

  8. Blood clot

  9. Uncontrolled bleeding

  10. Breathing difficulty

  11. Numbness or weakness

  12. Injury to teeth

  13. Injury to an eye

  14. Burn

  15. Heart attack or stroke

  16. Other physical effect [Please describe. FREE TEXT BOX]

  17. The negative effect was not physical.

14.3 Is this correct? Please clarify


    1. **We have that the negative effect first happened: Please choose the one answer that fits best.

  1. In a doctor’s office or a clinic

  2. In a pharmacy

  3. In the emergency department

  4. In a hospital

  5. At home

  6. Somewhere else [Where? FREE TEXT BOX]

  7. Don’t know

14.4 Is this correct? Please clarify


4.5 **We have that you [would OR would not] like to tell us the name and address of the health care doctor, nurse or other health care provider (or the health care facility) involved in the mistake.

□A Yes

□B Yes, but I do not know the name and address of the provider GO TO 4.6

□C No, I do not know the name and address of the provider GO TO 4.6

□D No, I do not want to tell you GO TO 4.6

13.3 Could you clarify this for me?


4.5.1 **We have the name and address of the doctor, nurse, or other health care provider (or health care facility) involved in the negative effect.

14.5.1 Please confirm the name and address. [Read the text in the text boxes]

4.5.2 **We have that a second health care provider (or facility) [was OR was not] involved.

□A Yes

□B No GO TO 4.5.5

14.5.2 Could you clarify this for me?


4.5.3 **We have that you [would OR would not] like to tell us the name and address of the second health care provider (or facility) involved in the mistake.

□A Yes

□B Yes, but I do not know the name and address of the provider GO TO 4.6

□C No, I do not know the name and address of the provider GO TO 4.6

□D No, I do not want to tell you GO TO 4.6

14.5.3 Could you clarify this for me?


4.5.4 **We have the name and address of the doctor, nurse, or other health care provider (or health care facility) involved in the negative effect.

14.5.4 Please confirm the name(s) and address (es). [Read the text in the text boxes]


4.6 **We have that the negative effect happened in the [READ month and year] (Your best estimate is fine.)

  1. MM

  2. YYYY

14.6 Is this correct? Please clarify


4.7 We have that the patient got additional medical testing or treatment because of the negative effect?

    1. Yes

    2. No

    3. Don’t know

14.7 Is this correct? Please clarify


4.8 We have that the patient found out how the negative effect happened by: (Please choose the one answer that fits best.)

    1. The patient noticed it.

    2. A friend or family member noticed it and told the patient.

    3. A doctor, nurse, or other health care provider told the patient about it.

    4. An administrator or manager told the patient about it

    5. The patient found out in some other way. [How? FREE TEXT BOX]

    6. The patient never knew about it.

4.8 Is this correct? Please clarify


4.9 We have that a doctor, nurse, or other health care provider made a special effort to help the patient handle the negative effect?

    1. Yes

    2. No GO TO 4.10

    3. Don’t know GO TO 4.10

14.9 Is this correct? Please clarify


4.9.1 We have that the doctor, nurse, or other health care provider was?

    1. Extremely helpful

    2. Very helpful

    3. Somewhat helpful

    4. Slightly helpful

    5. Not at all helpful

14.9.1 Is this correct? Please clarify


4.10 We have that the negative effect caused the patient to miss work, school, or other regular activities?

    1. Yes

    2. No

    3. Don’t know

14.10 Is this correct? Please clarify


**Sometimes patients experience negative financial effects. For example, patients may have to miss work, pay for extra testing or treatment, or take additional trips to a health care facility.


4.11 **We have that the negative effect caused financial problems for the patient?

    1. Yes

    2. No

    3. Don’t know

14.11 Is this correct? Please clarify




POTENTIAL FOLLOW UP QUESTIONS -- MODULE 5:

CONTRIBUTING FACTORS, CHANGES IN CARE,

DISCOVERY, & REPORTING


Now you were asked some questions about why the mistake or negative effect happened, and what the patient did afterward.


    1. We have that [FILL IN – something OR nothing] could have been done differently to prevent this negative effect from happening?

    1. Yes [FREE TEXT BOX]

    2. No

    3. Don’t know

15.1 Is this correct? Please clarify


5.2 We have that you think the mistake or negative effect happened because [READ FROM WHAT WAS IN TEXT BOX]

    1. Please clarify.


5.3 We have that, in your opinion, the following led to the mistake or negative effect.

Communication with doctors, nurses or other health care providers

The doctors, nurses, or other health care providers…

                1. did not listen to the patient?

                2. did not explain things to the patient in the patient’s language?

                3. used terminology the patient could not understand?

                4. did not spend enough time with the patient?

                5. spoke with an accent that was hard to understand?

                6. ignored what the patient told them?

                7. did not explain medications or their side effects?

                8. did not explain follow up care instructions?

Responsiveness of staff

Not getting…

  1. help as soon as the patient needed it?

  2. a referral as soon as the patient needed it?

  3. an appointment as soon as the patient needed it?

  4. care as soon as the patient needed it?

Coordination of care

Because…

  1. the doctors, nurses, or other health care providers were not aware of care that took place someplace else?

  2. of the lack of follow up by the doctors, nurses, or other health care providers?

  3. doctors, nurses, or other health care providers did not seem to work well together as a team?

Access

The patient…

  1. was not able to get in to see a specialist for care?

  2. was not able to get the tests or treatments that the patient believed necessary?

  3. was not able to get the tests or treatments that a provider believed necessary?

  4. did not get help or advice they needed?

Verification

Someone did not…

  1. correctly identify the patient?

  2. have the most recent and up-to-date information about the patient?

Other

The patient…

  1. couldn’t afford the care the patient believed necessary?

  2. couldn’t afford the care a provider believed necessary?

  3. had no insurance to pay for the care the patient believed necessary?

had no insurance to pay for the care a provider believed necessary?15.1 Is this correct? Please clarify



    1. We also have that this mistake or negative effect caused the patient to:

    1. Yes – Switched to a different health care provider

    2. Yes – Transferred to a different hospital

    3. Yes – Transferred to a different pharmacy

    4. Yes – Other [What was the switch? FREE TEXT BOX]

    5. No – There was no change

15.3 Is this correct? Please clarify


    1. We have that the patient told someone about the mistake or negative effect.

    1. Yes

    2. No GO TO 6.1

    3. Don’t know GO TO 6.1

15.4 Is this correct? Please clarify


      1. We have that the patient told the following people about the mistake or negative effect? (Please check all that apply.)

    1. A family member or friend

    2. A doctor, nurse, or other health care provider

    3. A health care administrator or manager

    4. Someone at the pharmacy

    5. A minister or other religious leader

    6. A lawyer

    7. Someone else [Who did the patient tell? FREE TEXT BOX]


15.4.1 Is this correct? Please clarify




POTENTIAL FOLLOW UP QUESTIONS -- MODULE 6: PATIENT INFORMATION


Our last questions will help us to understand whether some people are more likely than others to experience medical mistakes and negative effects.


6.2 We have the patient’s sex as:

    1. Male

    2. Female

16.2 Is this correct?


6.3 We have that at the time of the mistake or negative effect, the patient was approximately:

______ number of years old

16.3 Is this correct?


6.4 We have that the patient is

a. Mexican, Mexican American, Chicano/a

b. Puerto Rican

c. Cuban

d. Another Hispanic, Latino, or Spanish Origin

16.4 Is this correct?


6.5 We have the patient’s race as: (Please select one or more.)

  1. White

  2. Black or African American

  3. American Indian or Alaska Native

  4. Asian Indian

  5. Chinese

  6. Filipino

  7. Japanese

  8. Korean

  9. Vietnamese

  10. Other Asian

  11. Native Hawaiian

  12. Guamanian or Chamorro

  13. Samoan

  14. Other Pacific Islander

  15. Vietnamese

16.5 Is this correct?


6.6 [TBD: Add an additional question about race/ethnicity tailored to the demographics of the specific community]

16.6 Is this correct?


6.7 We have that the patient had the following type of health insurance at the time of the mistake or negative effect:

  1. Private insurance through an employer

  2. Private insurance that the patient bought

  3. Medicare

  4. Medicaid (including Medicaid managed care plans)

  5. Other [Health insurance: FREE TEXT BOX]

  6. Not insured (Please select this only if you have not picked any other answer)

  7. Don’t know

  8. I do not wish to disclose this information.

16.7 Is this correct?



6.9 We have that you learned about the Consumer Reporting System for Patient Safety from:

  1. A doctor, nurse, or other health care provider’s website

  2. A flyer or poster in a doctor’s office, clinic, hospital, emergency department, pharmacy, or other health care facility

  3. A computer kiosk in a doctor’s office, clinic, hospital, emergency department, pharmacy, or other health care facility

  4. A conversation with a doctor, nurse, or other health care provider

  5. Mailed materials from a doctor, nurse, or other health care provider

  6. Other [How did you learn about the system? FREE TEXT BOX]

16.9 Is this correct?


Thank you for your time today. And thank you for clarifying the information in your report and for helping to improve patient safety.

>EXIT<


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