Ethnicity & Race: Messaging to Improve Patient-Provider Communication and Engagement on Risks of Alcohol Use During Pregnancy

CDC/ATSDR Formative Research and Tool Development

Attachment F_Provider IDI Guide_all_instruments_combined

Ethnicity & Race: Messaging to Improve Patient-Provider Communication and Engagement on Risks of Alcohol Use During Pregnancy

OMB: 0920-1154

Document [docx]
Download: docx | pdf

Form Approved

OMB No. 0920-1154

Exp. Date: 1/31/2020












Communication Risks of Alcohol Use

Provider In-Depth Interview

OMB number 0920-1154

AIR IRB number

Current SBI User





Interviewer name: ____________

Participant ID: ___________

Date and Time: ___________









Interviewer Questions

The answers for questions 1 through 7 need to be pre-filled before the interview. Questions 1-3 will be completed by the interviewer and questions 4-7 provided from respondent’s answers to the web survey.



Ref #

Question/Prompt

Response


Preliminary Information


1

Name of interviewer




2

Date




3

Participant ID



4

Age




5

Participant’s Gender

(note: Do not ask participant)

 Male Female

6

Participant’s Profession

 Physician Nurse Practitioner

7

SBI behavior

Currently delivers alcohol SBI

Used to deliver alcohol SBI but no longer does

 Has never delivered alcohol SBI


Road Map of Discussion



Issues / Information to be Discussed

Approx. Number of Minutes Allotted to Discussion

Introduction, consent, segment confirmation

5 (not part of the interview)

Conceptual frameworks for understanding alcohol use

3

Method efficacy of alcohol SBI

5

Alcohol SBI practice

3-4

Screen for alcohol use

2-3

Discuss substance use with patients

6

HCPs' KABs about the nature of alcohol use and pregnancy

5-6

HCPs' confidence in managing patient reactions

3-4

Conclusion

1

Total Time (in minutes):

27-31













Introduction and Consent

(5 minutes)



INTERVIEWER INSTRUCTIONS: The interviewer should not read the script word for word, but should be familiar enough with its contents to conduct the interview in a natural and conversational manner, paraphrasing or giving further explanation as appropriate.


Introduction:

Hello, my name is ________ and I am a researcher with a company called EurekaFacts conducting a project in collaboration with the American Institutes for Research (AIR) on behalf of the Centers for Disease Control and Prevention. Thank you for agreeing to speak with me today and answer my questions.


I wanted to talk to you today because you recently answered a survey about practices related to alcohol screening and brief intervention (or alcohol SBI) with your female patients. The purpose of this in-depth interview is to further understand your clinical practices with your female patients regarding risky alcohol use. Your responses to this interview will help us improve communication materials to help providers like you talk about risky alcohol use and reduce the prevalence of fetal alcohol spectrum disorders.


Now, before we continue, it is important that you know that, as part of the research team, I am neutral on this topic. I am interested in getting your point of view to understand what clinicians’ perspectives are on current alcohol SBI procedures. As a neutral researcher, I am simply trying to learn more about different views people may have. Please keep in mind that there are no ‘right’ or ‘wrong’ answers. There are no known risks to participating in this study. No more than minimal risk is expected during any phase of this study. Some individuals might experience discomfort when talking about sensitive topics like alcohol use, contraception (birth control), and pregnancy. You may choose to refuse to answer any question and stop the interview at any time during the interview.

You may not directly benefit from this research; however, we hope that your participation in the study may help the CDC to assess its outreach efforts to healthcare providers and improve patient communication materials about this important topic as well as to understand any other informational needs healthcare providers may have.

I anticipate that our conversation should last around 30 minutes today. You will receive an incentive as a token of appreciation for your participation from the panel provider, ResearchNow. I will be taking notes and also recording our conversation with your permission, but everything that you tell me will be kept confidential and treated in a secure manner. Your answers in this study will remain private. By agreeing to participate in this interview survey, you are allowing the CDC to use the information from this study. The information collected is for research only, and your name will not be shared with anyone outside of this study, except as otherwise required by law. The only instance when we would release information about you to anyone outside the project would be if we were required to do so by law, such as a subpoena or if we learned someone were in danger of harm. Any results that come from this study will be presented as an aggregate and your name will not be linked to your answers.

Your participation in this study is completely voluntary and you can stop at any time. You are free to skip any question that you choose. There will not be any penalties if you refuse to participate in this study or refuse to answer any questions.

This survey has been approved by AIR’s IRB. If you have any questions, please contact Dr. Hanno Petras (Project Director) at [email protected] or at 202-403-5639 or Erin Morrison Wallace (IRB Chair) at [email protected] or at 202-403-5542.

Do you agree that you are at least 18 years old, have read and understood this consent form, and agree to participate in this research study?

☐ Yes If Yes, continue

☐ No If No, Excuse and use Script A (at end of document)

Do you consent to having this conversation recorded?

☐ Yes If Yes, continue

☐ No If No, Excuse and use Script A (at end of document)



Segment Confirmation (for Quality Control Purposes)

For participants who CURRENTLY deliver alcohol SBI:

Alcohol screening and brief intervention, or SBI, has two components: 1) a validated set of screening questions to identify patients' drinking patterns (e.g., AUDIT, etc.) and 2) a short conversation with patients who are drinking too much and, for patients at severe risk, a referral to specialized treatment.

Do you currently deliver alcohol SBI?

☐ Yes If Yes, continue to interview

☐ No If No, Excuse and use Script B (at end of document)



Ok, let’s get started.



Conceptual frameworks for understanding alcohol use and alcohol-exposed pregnancies

(3 minutes)

1.) Thinking broadly about reproductive health and alcohol, in your opinion, what circumstances lead to alcohol-exposed pregnancies? What attitudes or behaviors may contribute to a woman consuming alcohol while pregnant? What socio-demographic or social factors are associated with alcohol-exposed pregnancies? How can they be prevented?



2.) What do you do at your practice to prevent alcohol-exposed pregnancies? How effective are those efforts? Why are they effective or not effective?



Method efficacy of Alcohol SBI

(5 minutes)

For the next part of our conversation, I need to provide you some definitions. Alcohol screening and brief intervention, or alcohol SBI, as we mentioned at the start of this interview, has two components: 1) a validated set of screening questions to identify patients' drinking patterns and 2) a short conversation with patients who are heavy or risky drinkers and, for patients with possible alcohol dependence, a referral to specialized treatment.

Risky alcohol use includes binge drinking, heavy drinking, and any use by pregnant women or those under age 21. Binge drinking is drinking five or more drinks on a single occasion for men or four or more drinks on a single occasion for women. Heavy drinking (also considered high weekly or daily consumption) is drinking 15 or more drinks per week for men or eight or more drinks per week for women.

3.) Consider for a moment, alcohol SBI overall. As a comprehensive method, is alcohol SBI an effective practice for preventing alcohol-exposed pregnancies? What are the reasons for its effectiveness or lack of it?



4.) In your opinion, is screening for alcohol use an effective method for identifying risky or heavy drinking patterns (i.e., not alcohol dependence) for women of reproductive age? What are the reasons for its effectiveness or lack of it?

4a.) [For those who say that it is not effective:] What would make it more effective? Is there a different approach that you would recommend? If so, please explain.



5.) In your experience, is performing a brief intervention an effective method of helping your female patients of reproductive age change their behaviors around risky alcohol use to healthier habits? What are the reasons for its effectiveness or lack of it?

5a.) Is a brief intervention more or less effective for certain groups of women (e.g., trying vs. not trying to get pregnant; different age groups; differences by race/ethnicity)?

5b.) [For those who say that it is not effective:] What would make it more effective?



SBI Practice

(3-4 minutes)

6.) What were some of the challenges you encountered in delivering alcohol SBI? How did you work through them?

6a.) Were these challenges related to the alcohol screening, brief intervention, or both? If needed, clarify that we are just asking about the brief intervention for heavy or risky drinkers (and not about dependence with referral to treatment).



7.) What would make that process of integrating alcohol SBI into your clinical practice easier? Are there certain resources or materials that would help?



8.) What advice would you give to other healthcare providers who are considering delivering alcohol SBI for addressing these challenges?



Screen for alcohol use

(2-3 minutes)

I would like to ask you about your clinical practices with regard to alcohol use.



9.) What are the differences, if any, in criteria for deciding when to screen for alcohol for the general patient population vs. female patients of reproductive age?

9a.) Which particular screening tool(s) are used? What are the reasons for using that method?

9b.) Thinking specifically about screening female patients of reproductive age, what is working well about this approach to screening? What is not working well?

9c.) Are there resources or materials that might improve screening with female patients of reproductive age?









Discuss substance use with women of reproductive age

(6 minutes)

Now let’s talk about your discussions about contraception (birth control), alcohol and substance use, and pregnancy with women of reproductive age



10.) What are the circumstances in which you discuss contraception with women of reproductive age?

10a.) Do alcohol or other substances enter into that conversation? What are the reasons for that?





11.) In your setting, if a female patient of reproductive age screens positive for risky alcohol use, do you conduct a brief intervention or have a discussion with her around her alcohol intake? In what situations do you provide a brief intervention for a patient?

9a.) What is working well about this approach? What is not working well?



12.) Now let’s talk about women who are pregnant. In what situations do you discuss alcohol or other substances with them? What are the reasons for that?



13.) Since the start of the opioid overdose crisis, do you find that you have changed the way you practice at all? If so, how would you say that it has changed?



14.) How would you describe the risks to the developing baby of opioid use in pregnancy compared to alcohol use in pregnancy? What are the different long or short-term risks?



HCPs' KABs about the nature of alcohol use and pregnancy

(5-6 minutes)

15.) Let’s talk for a few moments about the advice that you give your female patients. What do you tell your patients who are consuming alcohol, are not trying to get pregnant, but are at risk of pregnancy (i.e., not using effective contraception)? Why do you give that advice? If needed, clarify: females aged 21 or older.

15a.) Do you provide different advice about alcohol consumption for (1) those who are trying to get pregnant and (2) those who are pregnant? Does your advice about alcohol use change over the course of a woman’s pregnancy, i.e., first, second, or third trimester?

15b.) In your view, what are the reasons for the differences in the amount of alcohol female patients can consume in each situation, if any?

15c.) In your experience, have you observed any socio-demographic factors (race/ethnicity, income level, education, age, geographic region, etc.) that may be related to alcohol use while pregnant?

15d.) Do you provide different advice for your patients on alcohol consumption based on these socio-demographic differences?



16.) What would you recommend be done to help healthcare providers communicate the risks of alcohol use and pregnancy with their patients who are pregnant or might be pregnant?





HCPs' confidence in managing patient reactions

(3-4 minutes)

17.) Talking about alcohol use, pregnancy, and contraception can be a challenge. In your experience, how do your female patients typically react to questions and conversations about these topics?

17a.) Are certain populations you see easier or harder to have these interactions with?



18.) Sometimes patients can respond negatively to these conversations. How do you manage those patient reactions so that you can have a productive conversation? What would make those interactions easier?

18a.) How confident do you feel in your ability to strengthen your patients’ motivation to change their behavior (for alcohol use or contraception)? Why? What would make building their motivation an easier process for you?

Conclusion

We are just about to wrap it up here. Do you have anything else you would like to share with me before we conclude?



Thank you so much for your time and insight, your input is very important and useful to us. Again, your responses will be kept confidential. You have been very helpful, and I appreciate it. Have a great day.









Termination Scripts



Script A – Termination for lack of consent to participate or record

Thank you so much for agreeing to talk with me today. I need your consent to participate or record the interview, and so we will stop this interview, I appreciate your willingness to answer my questions, and those are all the questions I have at the moment. Have a great day.



Script B – Termination for never having delivered SBI (when we want people who currently or used to deliver it)

Thank you so much for agreeing to talk with me today. Since all of my questions have to do with alcohol screening and brief intervention, I need to speak with people who currently deliver it. I appreciate your willingness to answer my questions, and those are all the questions I have at the moment. Have a great day.













Communication Risks of Alcohol Use

In-Depth Interview



OMB number 0920-1154

AIR IRB number



Former SBI User





Interviewer name: ____________

Participant ID: ___________

Date and Time: ___________



Interviewer Questions

The answers for questions 1 through 7 need to be pre-filled before the interview. Questions 1-3 will be completed by the interviewer and questions 4-7 provided from respondent’s answers to the web survey.



Ref #

Question/Prompt

Response


Preliminary Information


1

Name of interviewer




2

Date




3

Participant ID



4

Age




5

Participant’s Gender

(note: Do not ask participant)

 Male Female

6

Participant’s Profession

 Physician Nurse Practitioner

7

SBI behavior

Currently delivers alcohol SBI

Used to deliver alcohol SBI but no longer does

 Has never delivered alcohol SBI




Road Map of Discussion



Issues / Information to be Discussed

Approx. Number of Minutes Allotted to Discussion

Introduction, consent, segment confirmation

5 (not part of the interview)

Conceptual frameworks for understanding alcohol use

3

Method efficacy of alcohol SBI

5

Alcohol SBI practice

3-4

Screen for alcohol use

2-3

Discuss substance use with patients

6

HCPs' KABs about the nature of alcohol use and pregnancy

5-6

HCPs' confidence in managing patient reactions

3-4

Conclusion

1

Total Time (in minutes):

27-31





Introduction and Consent

(5 minutes)



INTERVIEWER INSTRUCTIONS: The interviewer should not read the script word for word, but should be familiar enough with its contents to conduct the interview in a natural and conversational manner, paraphrasing or giving further explanation as appropriate.


Introduction:

Hello, my name is ________ and I am a researcher with a company called EurekaFacts conducting a project in collaboration with the American Institutes for Research (AIR) on behalf of the Centers for Disease Control and Prevention. Thank you for agreeing to speak with me today and answer my questions.


I wanted to talk to you today because you recently answered a survey about practices related to alcohol screening and brief intervention (or alcohol SBI) with your female patients. The purpose of this in-depth interview is to further understand your clinical practices with your female patients regarding risky alcohol use. Your responses to this interview will help us improve communication materials to help providers like you talk about risky alcohol use and reduce the prevalence of fetal alcohol spectrum disorders.


Now, before we continue, it is important that you know that, as part of the research team, I am neutral on this topic. I am interested in getting your point of view to understand what clinicians’ perspectives are on current alcohol SBI procedures. As a neutral researcher, I am simply trying to learn more about different views people may have. Please keep in mind that there are no ‘right’ or ‘wrong’ answers. There are no known risks to participating in this study. No more than minimal risk is expected during any phase of this study. Some individuals might experience discomfort when talking about sensitive topics like alcohol use, contraception (birth control), and pregnancy. You may choose to refuse to answer any question and stop the interview at any time during the interview.

You may not directly benefit from this research; however, we hope that your participation in the study may help the CDC to assess its outreach efforts to healthcare providers and improve patient communication materials about this important topic as well as to understand any other informational needs healthcare providers may have.

I anticipate that our conversation should last around 30 minutes today. You will receive an incentive as a token of appreciation for your participation from the panel provider, ResearchNow. I will be taking notes and also recording our conversation with your permission, but everything that you tell me will be kept confidential and treated in a secure manner. Your answers in this study will remain private. By agreeing to participate in this interview survey, you are allowing the CDC to use the information from this study. The information collected is for research only, and your name will not be shared with anyone outside of this study, except as otherwise required by law. The only instance when we would release information about you to anyone outside the project would be if we were required to do so by law, such as a subpoena or if we learned someone were in danger of harm. Any results that come from this study will be presented as an aggregate and your name will not be linked to your answers.

Your participation in this study is completely voluntary and you can stop at any time. You are free to skip any question that you choose. There will not be any penalties if you refuse to participate in this study or refuse to answer any questions.

This survey has been approved by AIR’s IRB. If you have any questions, please contact Dr. Hanno Petras (Project Director) at [email protected] or at 202-403-5639 or Erin Morrison Wallace (IRB Chair) at [email protected] or at 202-403-5542.

Do you agree that you are at least 18 years old, have read and understood this consent form, and agree to participate in this research study?

☐ Yes If Yes, continue

☐ No If No, Excuse and use Script A (at end of document)

Do you consent to having this conversation recorded?

☐ Yes If Yes, continue

☐ No If No, Excuse and use Script A (at end of document)





Segment Confirmation (for Quality Control Purposes)

For participants who USED TO deliver SBI:

Screening and brief intervention, or SBI, has two components: 1) a validated set of screening questions to identify patients' drinking patterns (e.g., AUDIT) and 2) a short conversation with patients who are drinking too much and, for patients at severe risk, a referral to specialized treatment.

Do you currently deliver SBI?

☐ Yes If Yes, Excuse and use Script B (at end of document)

☐ No If No, continue

Have you ever delivered SBI in the past?

☐ Yes If Yes, continue to interview

☐ No If No, Excuse and use Script B (at end of document)



Ok, let’s get started.



Conceptual frameworks for understanding alcohol use and alcohol-exposed pregnancies

(3 minutes)

1) Thinking broadly about reproductive health and alcohol, in your opinion, what circumstances lead to alcohol-exposed pregnancies? What attitudes or behaviors may contribute to a woman consuming alcohol while pregnant? What socio-demographic or social factors are associated with alcohol-exposed pregnancies? How can they be prevented?



2.) What do you do at your practice to prevent alcohol-exposed pregnancies? How effective are those efforts? Why are they effective or not effective?



Method efficacy of Alcohol SBI

(5 minutes)

For the next part of our conversation, I need to provide you some definitions. Alcohol screening and brief intervention, or alcohol SBI, as we mentioned at the start of this interview, has two components: 1) a validated set of screening questions to identify patients' drinking patterns and 2) a short conversation with patients who are heavy or risky drinkers and, for patients with possible alcohol dependence, a referral to specialized treatment.

Risky alcohol use includes binge drinking, heavy drinking, and any use by pregnant women or those under age 21. Binge drinking is drinking five or more drinks on a single occasion for men or four or more drinks on a single occasion for women. Heavy drinking (also considered high weekly or daily consumption) is drinking 15 or more drinks per week for men or eight or more drinks per week for women.

3.) Consider for a moment, alcohol SBI overall. As a comprehensive method, is alcohol SBI an effective practice for preventing alcohol-exposed pregnancies? What are the reasons for its effectiveness or lack of it?



4.) In your opinion, is screening for alcohol use an effective method for identifying risky or heavy drinking patterns (i.e., not alcohol dependence) for women of reproductive age? What are the reasons for its effectiveness or lack of it?

4a.) [For those who say that it is not effective:] What would make it more effective? Is there a different approach that you would recommend? If so, please explain.



5.) In your experience, is performing a brief intervention an effective method of helping your female patients of reproductive age change their behaviors around risky alcohol use to healthier habits? What are the reasons for its effectiveness or lack of it?

5a.) Is a brief intervention more or less effective for certain groups of women (e.g., trying vs. not trying to get pregnant; different age groups; differences by race/ethnicity)?

5b.) [For those who say that it is not effective:] What would make it more effective?



SBI Practice

(4 minutes)



6.) What were the circumstances that lead to your clinic no longer delivering alcohol SBI?

6a.) Of the various factors that made it difficult to deliver alcohol SBI, which one was the most crucial?

6b.) What would have made the process of delivering alcohol SBI easier?

7.) What advice would you give to other healthcare providers who are considering delivering alcohol SBI?

8.) Picture yourself one year from now. Your setting now delivers alcohol SBI for all patients. What would need to change for this to happen in one year’s time?



Screen for alcohol use

(2-3 minutes)

I would like to ask you about your clinical practices with regard to alcohol use.



9.) What are the differences, if any, in criteria for deciding when to screen for alcohol for the general patient population vs. female patients of reproductive age?

9a.) Which particular screening tool(s) are used? What are the reasons for using that method?

9b.) Thinking specifically about screening female patients of reproductive age, what is working well about this approach to screening? What is not working well?

9c.) Are there resources or materials that might improve screening with female patients of reproductive age?













Discuss substance use with women of reproductive age

(6 minutes)

Now let’s talk about your discussions about contraception (birth control), alcohol and substance use, and pregnancy with women of reproductive age



10.) What are the circumstances in which you discuss contraception with women of reproductive age?

10a.) Do alcohol or other substances enter into that conversation? What are the reasons for that?





11.) In your setting, if a female patient of reproductive age screens positive for risky alcohol use, do you conduct a brief intervention or have a discussion with her around her alcohol intake? In what situations do you provide a brief intervention for a patient?

10a.) What is working well about this approach? What is not working well?



12.) Now let’s talk about women who are pregnant. In what situations do you discuss alcohol or other substances with them? What are the reasons for that?



13.) Since the start of the opioid overdose crisis, do you find that you have changed the way you practice at all? If so, how would you say that it has changed?





14.) How would you describe the risks to the developing baby of opioid use in pregnancy compared to alcohol use in pregnancy? What are the different long or short-term risks?



HCPs' KABs about the nature of alcohol use and pregnancy

(5-6 minutes)

15.) Let’s talk for a few moments about the advice that you give your female patients. What do you tell your patients who are consuming alcohol, are not trying to get pregnant, but are at risk of pregnancy (i.e., not using effective contraception)? Why do you give that advice? If needed, clarify: females aged 21 or older.

15a.) Do you provide different advice about alcohol consumption for (1) those who are trying to get pregnant and (2) those who are pregnant? Does your advice about alcohol use change over the course of a woman’s pregnancy, i.e., first, second, or third trimester?

15b.) In your view, what are the reasons for the differences in the amount of alcohol female patients can consume in each situation, if any?

15c.) In your experience, have you observed any socio-demographic factors (race/ethnicity, income level, education, age, geographic region, etc.) that may be related to alcohol use while pregnant?

15d.) Do you provide different advice for your patients on alcohol consumption based on these socio-demographic differences?



16.) What would you recommend be done to help healthcare providers communicate the risks of alcohol use and pregnancy with their patients who are pregnant or might be pregnant?



HCPs' confidence in managing patient reactions

(3-4 minutes)

17.) Talking about alcohol use, pregnancy, and contraception can be a challenge. In your experience, how do your female patients typically react to questions and conversations about these topics?

17a.) Are certain populations you see easier or harder to have these interactions with?



18.) Sometimes patients can respond negatively to these conversations. How do you manage those patient reactions so that you can have a productive conversation? What would make those interactions easier?

18a.) How confident do you feel in your ability to strengthen your patients’ motivation to change their behavior (for alcohol use or contraception)? Why? What would make building their motivation an easier process for you?

Conclusion

We are just about to wrap it up here. Do you have anything else you would like to share with me before we conclude?



Thank you so much for your time and insight, your input is very important and useful to us. Again, your responses will be kept confidential. You have been very helpful, and I appreciate it. Have a great day.











Termination Scripts



Script A – Termination for lack of consent to participate or record

Thank you so much for agreeing to talk with me today. I need your consent to participate or record the interview, and so we will stop this interview, I appreciate your willingness to answer my questions, and those are all the questions I have at the moment. Have a great day.



Script B – Termination for either currently delivering never having delivered SBI (when we want people who used to deliver it)

Thank you so much for agreeing to talk with me today. Since all of my questions have to do with alcohol screening and brief intervention, I need to speak with people who have delivered it in the past but do not currently do so. I appreciate your willingness to answer my questions, and those are all the questions I have at the moment. Have a great day.















Communication Risks of Alcohol Use

Provider Follow Up In-Depth Interview



OMB number 0920-1154

AIR IRB number



Never SBI User





Interviewer name: ____________

Participant ID: ___________

Date and Time: ___________









Interviewer Questions

The answers for questions 1 through 7 need to be pre-filled before the interview. Questions 1-3 will be completed by the interviewer and questions 4-7 provided from respondent’s answers to the web survey.



Ref #

Question/Prompt

Response


Preliminary Information


1

Name of interviewer




2

Date




3

Participant ID



4

Age




5

Participant’s Gender

(note: Do not ask participant)

 Male Female

6

Participant’s Profession

 Physician Nurse Practitioner

7

SBI behavior

Currently delivers alcohol SBI

Used to deliver alcohol SBI but no longer does

 Has never delivered alcohol SBI


Road Map of Discussion



Issues / Information to be Discussed

Approx. Number of Minutes Allotted to Discussion

Introduction, consent, segment confirmation

5 (not part of the interview)

Conceptual frameworks for understanding alcohol use

3

Method efficacy of alcohol SBI

5

Alcohol SBI practice

3-4

Screen for alcohol use

2-3

Discuss substance use with patients

6

HCPs' KABs about the nature of alcohol use and pregnancy

5-6

HCPs' confidence in managing patient reactions

3-4

Conclusion

1

Total Time (in minutes):

27-31





INTERVIEWER INSTRUCTIONS: The interviewer should not read the script word for word, but should be familiar enough with its contents to conduct the interview in a natural and conversational manner, paraphrasing or giving further explanation as appropriate.


Introduction:

Hello, my name is ________ and I am a researcher with a company called EurekaFacts conducting a project in collaboration with the American Institutes for Research (AIR) on behalf of the Centers for Disease Control and Prevention. Thank you for agreeing to speak with me today and answer my questions.


I wanted to talk to you today because you recently answered a survey about practices related to alcohol screening and brief intervention (or alcohol SBI) with your female patients. The purpose of this in-depth interview is to further understand your clinical practices with your female patients regarding risky alcohol use. Your responses to this interview will help us improve communication materials to help providers like you talk about risky alcohol use and reduce the prevalence of fetal alcohol spectrum disorders.


Now, before we continue, it is important that you know that, as part of the research team, I am neutral on this topic. I am interested in getting your point of view to understand what clinicians’ perspectives are on current alcohol SBI procedures. As a neutral researcher, I am simply trying to learn more about different views people may have. Please keep in mind that there are no ‘right’ or ‘wrong’ answers. There are no known risks to participating in this study. No more than minimal risk is expected during any phase of this study. Some individuals might experience discomfort when talking about sensitive topics like alcohol use, contraception (birth control), and pregnancy. You may choose to refuse to answer any question and stop the interview at any time during the interview.

You may not directly benefit from this research; however, we hope that your participation in the study may help the CDC to assess its outreach efforts to healthcare providers and improve patient communication materials about this important topic as well as to understand any other informational needs healthcare providers may have.

I anticipate that our conversation should last around 30 minutes today. You will receive an incentive as a token of appreciation for your participation from the panel provider, ResearchNow. I will be taking notes and also recording our conversation with your permission, but everything that you tell me will be kept confidential and treated in a secure manner. Your answers in this study will remain private. By agreeing to participate in this interview survey, you are allowing the CDC to use the information from this study. The information collected is for research only, and your name will not be shared with anyone outside of this study, except as otherwise required by law. The only instance when we would release information about you to anyone outside the project would be if we were required to do so by law, such as a subpoena or if we learned someone were in danger of harm. Any results that come from this study will be presented as an aggregate and your name will not be linked to your answers.

Your participation in this study is completely voluntary and you can stop at any time. You are free to skip any question that you choose. There will not be any penalties if you refuse to participate in this study or refuse to answer any questions.

This survey has been approved by AIR’s IRB. If you have any questions, please contact Dr. Hanno Petras (Project Director) at [email protected] or at 202-403-5639 or Erin Morrison Wallace (IRB Chair) at [email protected] or at 202-403-5542.

Do you agree that you are at least 18 years old, have read and understood this consent form, and agree to participate in this research study?

☐ Yes If Yes, continue

☐ No If No, Excuse and use Script A (at end of document)

Do you consent to having this conversation recorded?

☐ Yes If Yes, continue

☐ No If No, Excuse and use Script A (at end of document)



Segment Confirmation (for Quality Control Purposes)



For participants who have NEVER delivered SBI:

Screening and brief intervention, or SBI, has two components: 1) a validated set of screening questions to identify patients' drinking patterns (e.g., AUDIT) and 2) a short conversation with patients who are drinking too much and, for patients at severe risk, a referral to specialized treatment.

Have you ever delivered SBI, now or in the past?

☐ Yes If Yes, Excuse and use Script B (at end of document)

☐ No If No, begin interview



Ok, let’s get started.





Conceptual frameworks for understanding alcohol use and alcohol-exposed pregnancies

(3 minutes)

1.) Thinking broadly about reproductive health and alcohol, in your opinion, what circumstances lead to alcohol-exposed pregnancies? What attitudes or behaviors may contribute to a woman consuming alcohol while pregnant? What socio-demographic or social factors are associated with alcohol-exposed pregnancies? How can they be prevented?



2.) What do you do at your practice to prevent alcohol-exposed pregnancies? How effective are those efforts? Why are they effective or not effective?





Method efficacy of Alcohol SBI

(5 minutes)

For the next part of our conversation, I need to provide you some definitions. Alcohol screening and brief intervention, or alcohol SBI, as we mentioned at the start of this interview, has two components: 1) a validated set of screening questions to identify patients' drinking patterns and 2) a short conversation with patients who are heavy or risky drinkers and, for patients with possible alcohol dependence, a referral to specialized treatment.

Risky alcohol use includes binge drinking, heavy drinking, and any use by pregnant women or those under age 21. Binge drinking is drinking five or more drinks on a single occasion for men or four or more drinks on a single occasion for women. Heavy drinking (also considered high weekly or daily consumption) is drinking 15 or more drinks per week for men or eight or more drinks per week for women.

3.) Consider for a moment, alcohol SBI overall. As a comprehensive method, is alcohol SBI an effective practice for preventing alcohol-exposed pregnancies? What are the reasons for its effectiveness or lack of it?



4.) In your opinion, is screening for alcohol use an effective method for identifying risky or heavy drinking patterns (i.e., not alcohol dependence) for women of reproductive age? What are the reasons for its effectiveness or lack of it?

4a.) [For those who say that it is not effective:] What would make it more effective? Is there a different approach that you would recommend? If so, please explain.



5.) In your experience, is performing a brief intervention an effective method of helping your female patients of reproductive age change their behaviors around risky alcohol use to healthier habits? What are the reasons for its effectiveness or lack of it?

5a.) Is a brief intervention more or less effective for certain groups of women (e.g., trying vs. not trying to get pregnant; different age groups; differences by race/ethnicity)?

5b.) [For those who say that it is not effective:] What would make it more effective?



SBI Practice

(2 minutes)

6.) Have you or your administrators ever considered delivering SBI in your setting? What helped you make a decision to not deliver it?



7.) Picture yourself one year from now. Your setting now delivers alcohol SBI for all patients. What would need to change for this to happen in one year’s time?



Screen for alcohol use

(2-3 minutes)

I would like to ask you about your clinical practices with regard to alcohol use.



8.) What are the differences, if any, in criteria for deciding when to screen for alcohol for the general patient population vs. female patients of reproductive age?

8a.) Which particular screening tool(s) are used? What are the reasons for using that method?

8b.) Thinking specifically about screening female patients of reproductive age, what is working well about this approach to screening? What is not working well?

8c.) Are there resources or materials that might improve screening with female patients of reproductive age?























Discuss substance use with women of reproductive age

(6 minutes)

Now let’s talk about your discussions about contraception (birth control), alcohol and substance use, and pregnancy with women of reproductive age



9.) What are the circumstances in which you discuss contraception with women of reproductive age?

9a.) Do alcohol or other substances enter into that conversation? What are the reasons for that?





10.) In your setting, if a female patient of reproductive age screens positive for risky alcohol use, do you conduct a brief intervention or have a discussion with her around her alcohol intake? In what situations do you provide a brief intervention for a patient?

10a.) What is working well about this approach? What is not working well?



11.) Now let’s talk about women who are pregnant. In what situations do you discuss alcohol or other substances with them? What are the reasons for that?



12.) Since the start of the opioid overdose crisis, do you find that you have changed the way you practice at all? If so, how would you say that it has changed?





13.) How would you describe the risks to the developing baby of opioid use in pregnancy compared to alcohol use in pregnancy? What are the different long or short-term risks?



HCPs' KABs about the nature of alcohol use and pregnancy

(5-6 minutes)

14.) Let’s talk for a few moments about the advice that you give your female patients. What do you tell your patients who are consuming alcohol, are not trying to get pregnant, but are at risk of pregnancy (i.e., not using effective contraception)? Why do you give that advice? If needed, clarify: females aged 21 or older.

14a.) Do you provide different advice about alcohol consumption for (1) those who are trying to get pregnant and (2) those who are pregnant? Does your advice about alcohol use change over the course of a woman’s pregnancy, i.e., first, second, or third trimester?

14b.) In your view, what are the reasons for the differences in the amount of alcohol female patients can consume in each situation, if any?

14c.) In your experience, have you observed any socio-demographic factors (race/ethnicity, income level, education, age, geographic region, etc.) that may be related to alcohol use while pregnant?

14d.) Do you provide different advice for your patients on alcohol consumption based on these socio-demographic differences?



15.) What would you recommend be done to help healthcare providers communicate the risks of alcohol use and pregnancy with their patients who are pregnant or might be pregnant?





HCPs' confidence in managing patient reactions

(3-4 minutes)

16.) Talking about alcohol use, pregnancy, and contraception can be a challenge. In your experience, how do your female patients typically react to questions and conversations about these topics?

16a.) Are certain populations you see easier or harder to have these interactions with?



17.) Sometimes patients can respond negatively to these conversations. How do you manage those patient reactions so that you can have a productive conversation? What would make those interactions easier?

17a.) How confident do you feel in your ability to strengthen your patients’ motivation to change their behavior (for alcohol use or contraception)? Why? What would make building their motivation an easier process for you?

Conclusion

We are just about to wrap it up here. Do you have anything else you would like to share with me before we conclude?



Thank you so much for your time and insight, your input is very important and useful to us. Again, your responses will be kept confidential. You have been very helpful, and I appreciate it. Have a great day.









Termination Scripts



Script A – Termination for lack of consent to participate or record

Thank you so much for agreeing to talk with me today. I need your consent to participate or record the interview, and so we will stop this interview, I appreciate your willingness to answer my questions, and those are all the questions I have at the moment. Have a great day.



Script B – Termination for having delivered SBI (when we want people who have never delivered it)

Thank you so much for agreeing to talk with me today. Since all of my questions have to do with alcohol screening and brief intervention, I need to speak with people who have never delivered it. I appreciate your willingness to answer my questions, and those are all the questions I have at the moment. Have a great day.



Public reporting burden of this collection of information is estimated to average 30 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. 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 CDC/ATSDR Information Collection Review Office, 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-1154).




File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File Modified0000-00-00
File Created0000-00-00

© 2024 OMB.report | Privacy Policy