Form 0920- Health System Leaders Interview Guide

Form Approve

OMB No: 0920-xxxx

Exp. Date: xx-xx-xxxx

Public Reporting burden of this collection of information is estimated at 1 hour, 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 Reports Clearance Officer, 1600 Clifton Road NW, MS D-74, Atlanta, GA 30333; Attn:  PRA (0920-xxxx).

Attachment C. Health System Leaders Interview Guide

Introduction

Hello, I’m (NAME) from Abt Associates. Thank you for taking the time to speak with us. I have [insert name(s)] on the phone with me.

As a reminder, Abt Associates is working with the Centers for Disease Control and Prevention (CDC) to evaluate the effects of your health system’s policies and evidence-based guidelines related to chronic pain management and opioid prescribing, including access to medications for opioid use disorder (MOUD).

This 60-minute healthcare system group interview aims to get a better understanding of your organization’s experiences with implementation of such policies and guidelines, and their effects on patient outcomes. This study is funded by the CDC.

For the purposes of this discussion, “chronic pain management policies/guidelines” refers to policies/guidelines that may include prescribing of opioid medications, nonpharmacologic therapies, and/or non-opioid medications for chronic pain, as well as opioid use disorder (OUD) assessment and treatment.

Oral consent

Before we begin, I want to read a few points about this interview:

• Your participation is voluntary.

• Your names and affiliation will be shared with CDC and included in the acknowledgements in any report or publication; however, we will not attribute our findings to you or your organization explicitly.

• You can decline to answer any question, without affecting your continued participation in the interview or your relationship with the CDC. There is a small risk of loss of confidentiality. We have many procedures in place to reduce this risk.

• This study has a “Certificate of Confidentiality” from the CDC to protect your privacy. Unless you consent, researchers cannot share or release information that may identify you¹, with a few exceptions² (please see footnotes).

• This interview will last approximately 60 minutes.

We also would like to record the interview, so we do not miss anything. The recording will not be shared with anyone outside Abt Associates or CDC.

• Do any of you have any questions before we get started?

• May we record this interview? Yes _____ No _____

Role

1. I understand that you all work for <healthcare system>. Could you please each briefly describe your position, role, and tenure (length of employment) at <healthcare system>?

Probes:

• How involved were each of you in the implementation of the chronic pain management guidelines and policies at your health system from 2016 to through the end of 2019? As a reminder, “chronic pain management guidelines/policies” may include guidelines/policies about prescribing of opioid medications, nonpharmacologic therapies, and/or non-opioid medications for chronic pain, as well as opioid use disorder (OUD) assessment and treatment for patients with chronic pain.

• What was your specific role?

• Has your role changed since the implementation? If yes, how?

• Do you remain involved in implementation of policies and guidelines?

Impetus to Improve Care

2. Please think back to [insert date] when your healthcare system first developed and introduced policies or guidelines on chronic pain management. As a reminder, “chronic pain management guidelines/policies” may include guidelines/policies about prescribing of opioid medications, nonpharmacologic therapies, and/or non-opioid medications for chronic pain, as well as opioid use disorder (OUD) assessment and treatment for patients with chronic pain. Can you describe how and why decisions were made to implement these guidelines or policies?

Probes:

• For each guideline or policy: who made those decisions, and how were they disseminated or introduced throughout your system?

• What existing guidelines, if any, did your health system use to inform your own policies and guidelines?

• When were each of your policies/guidelines released, and what were they?

3. Can you describe in more detail the policies/guidelines that have been implemented?

Probes:

• What policies/guidelines were implemented?

• For each policy/guideline - when was each one implemented?

• At what level of care were they implemented?

• Did all practice locations across your system implement these policies? If not, which clinical settings implemented them and which did not?

• Did they implement them at the same time?  

• How long was the implementation process for each policy/guideline?

• Are they all fully implemented? Partially implemented?

4. Are there additional policies/guidelines that you are planning to implement in the future?

Probes:

• If yes, which polices/guidelines?

• When do you plan to implement them?

Implementation Strategies

5. For those policies and guidelines implemented that you described above, what implementation strategies did you use: training, education, incentives, electronic health record (EHR) and/or clinical decision support (CDS) tools, use of quality improvement (QI) measures, ‘audit and feedback’, etc.? Or was the policy/guideline released without any specific implementation strategies?

Probes:

• Please describe the process of implementation and the key strategies used for implementation.

  • Did you use the same process for all policies and guidelines implemented?

• Did you use multiple approaches to implement the policies/guidelines?

• At which practices/level/clinics was this policy/guideline implemented?

• How did you ensure those policies were actually being followed by clinicians?

• Were you able to monitor variations in implementation at the site level?

• Do you have ongoing monitoring systems in place?

6. From the perspective of your specific role, were there any barriers and challenges encountered in policy and guideline implementation?

Probes:

• If yes:

  • What were they?

  • How did you address these barriers and challenges?

  • What lessons were learned, if any?

• How would you have modified your approach to mitigate challenges?

7. From the perspective of your role, what implementation approaches were successful?

Probes:

• How do you define success?

• Can you describe some of the successes?

• What were the determinants of success?

Implementation Determinants

8. Now, I’d like to shift to from your specific role to ask you to think about the health system. From the perspective of your health system as a whole, what were the facilitators and barriers in implementing your policies or guidelines?

Probes:

• If there were barriers, how were they overcome?

• Did you encounter clinician support and/or resistance? Please describe.

  • If clinician resistance, how was such resistance overcome?

• Did any of your clinicians change their prescribing patterns following the policy/guideline implementation?

• To your knowledge, did any of your clinical staff leave as a result of the implementation of new policies or guidelines?

• Did you encounter patient support and/or resistance? Please describe.

  • If there was patient resistance, how was it overcome?

  • To your knowledge, did any of your patients leave the practice following the policy/guideline implementation?

Addressing Racial and Ethnic Disparities

9. Nationally, there are clear racial and ethnic disparities in pain management and treatment of OUD. Do any of the guidelines, policies, or quality improvement initiatives implemented by your system focus on or address racial and ethnic disparities in chronic pain management? 

Probe:

• If yes, can you describe the initiatives?

10. Do any of the guidelines, policies, or quality improvement initiatives implemented by your system focus on or address racial and ethnic disparities in opioid prescribing?

Probe:

• If yes, can you describe the initiatives?

11. Do any of the guidelines, policies, or quality improvement initiatives implemented by your system focus on or address racial and ethnic disparities in diagnosis of OUD and/or access to MOUD?

Probe:

• If yes, can you describe the initiatives?

Unintended Consequences or Benefits

12. To what extent have there been unintended or unexpected benefits and consequences for patients and clinicians related to policies or guidelines?

Probes:

• Describe any unexpected benefits.

• Describe any unintended consequences.

13. If you were to implement these guideline(s) or other forms of guidance again, what would you do differently?

14. Has your system implemented any other chronic pain related policies or guidelines since the start of 2020?

Probe:

• If yes, what are they?

15. Has your health system implemented any other policies or guidelines related to the management of OUD since the start of 2020?

Probe:

• If yes, what are they?

COVID-19

16. From your perspective, did the COVID-19 pandemic affect care for patients with chronic pain management in your organization? If so, how?

Probe:

• How did you adjust to the changes caused by the pandemic for chronic pain patients?

17. From your perspective, did the COVID-19 pandemic affect care for patients with OUD who take MOUD in your organization? If so, how?

Probe:

How did you adjust to the changes caused by the pandemic for OUD patients who take MOUD?

18. Is there anything that I haven’t asked you regarding chronic pain management, opioid prescribing, and MOUD that would be important for me to know to help me understand your health system?

Thank you for your time!

1 Unless you consent, researchers cannot release information that may identify you for a legal action, a lawsuit, or as evidence. This protection applies to requests from federal, state, or local civil, criminal, administrative, legislative, or other proceedings. As an example, the Certificate would protect your information from a court subpoena.

2 The Certificate does not protect your information if a federal, state, or local law says it must be reported. For example, some laws require reporting of abuse, communicable (contagious, infectious) diseases, and threats of harm to yourself or others.  The Certificate cannot be used stop a federal or state government agency from checking records or evaluating programs. The Certificate does not stop reporting required by the U.S. Food and Drug Administration (FDA). The Certificate also does not stop your information from being used for other research if allowed by federal regulations.

Researchers may release your information when you consent. For example, you may give them permission to release information to insurers, your doctors, or any other person not connected with the research.  The Certificate of Confidentiality does not stop you from releasing your own information. It also does not stop you from getting copies of your own information. 

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