Developing a toolkit to implement the Statin Choice Conversation Aid at scale: application of a work reduction model

Background Guidelines recommend shared decision making (SDM) for determining whether to use statins to prevent cardiovascular events in at-risk patients. We sought to develop a toolkit to facilitate the cross-organizational spread and scale of a SDM intervention called the Statin Choice Conversation Aid (SCCA) by (i) assessing the work stakeholders must do to implement the tool; and (ii) orienting the resulting toolkit’s components to communicate and mitigate this work. Methods We conducted multi-level and mixed methods (survey, interview, observation, focus group) characterizations of the contexts of 3 health systems (n = 86, 84, and 26 primary care clinicians) as they pertained to the impending implementation of the SCCA. We merged the data within implementation outcome domains of feasibility, appropriateness, and acceptability. Using Normalization Process Theory, we then characterized and categorized the work stakeholders did to implement the tool. We used clinician surveys and IP address-based tracking to calculate SCCA usage over time and judged how stakeholder effort was allocated to influence outcomes at 6 and 18 months. After assessing the types and impact of the work, we developed a multi-component toolkit. Results At baseline, the three contexts differed regarding feasibility, acceptability, and appropriateness of implementation. The work of adopting the tool was allocated across many strategies in complex and interdependent ways to optimize these domains. The two systems that allocated the work strategically had higher uptake (5.2 and 2.9 vs. 1.1 uses per clinician per month at 6 months; 3.8 and 2.1 vs. 0.4 at 18 months, respectively) than the system that did not. The resulting toolkit included context self-assessments intended to guide stakeholders in considering the early work of SCCA implementation; and webinars, EMR integration guides, video demonstrations, and an implementation team manual aimed at supporting this work. Conclusions We developed a multi-component toolkit for facilitating the scale-up and spread of a tool to promote SDM across clinical settings. The theory-based approach we employed aimed to distinguish systems primed for adoption and support the work they must do to achieve implementation. Our approach may have value in orienting the development of multi-component toolkits and other strategies aimed at facilitating the efficient scale up of interventions. Trial registration ClinicalTrials.gov NCT02375815. Electronic supplementary material The online version of this article (10.1186/s12913-019-4055-8) contains supplementary material, which is available to authorized users.

Thank you for taking the time to talk with me today. Our research team is working with your health system to implement the Statin Choice Decision Aid into primary care practice and to study the factors that impact this process. The Statin Choice Decision Aid is a tool that patients and clinicians use together to have a shared decision making conversation about whether to start a statin for primary prevention of cardiovascular events. As a primary care clinician, you have special insight into factors that can affect the up-take and use of the Statin Choice Decision Aid and we are very interested in understanding your perspective.
In this interview, I will be asking you questions about your thoughts and experiences. I want to assure you that your participation is voluntary and that you can choose to stop at any time. If a question makes you uncomfortable or you do not want to answer, that is fine; you do not have to.
To respect your privacy, all of your responses will be held in confidence and no one will be able to connect you to any of the things you say.
You should feel open to express your thoughts and experiences honestly and to ask for clarification if any questions seem confusing.
Okay, do you have any questions before we get started?

WARM-UP CHAT (unstructured):
Okay, great. So, first I'd just like to learn a little bit about you. Please tell me about your scope of practice in this health system. How long have you been here? Have you participated in any research studies before? Etc… Transition: Okay. Thank you. This is all very helpful to me.

SDM CULTURE:
Every organization has a unique culture and way of doing things. I would like to hear your perspective on the culture of this health system. How would you describe the culture of this health system? Probes: • What are its major priorities?
• How does this health system work to make care more patient-centered?
• Have you ever heard of the concept of shared decision making?
• How does this health system work to encourage shared decision making?
Transition: I understand. This is very helpful.

CAPACITY FOR CHANGE:
As a primary care clinician, I know you're aware of the challenges involved in changing behaviors and routines. These challenges can be even greater when trying to promote change at an organizational level. I am interested in hearing your perspective on this health system's potential for change. How would you describe the capacity of this health system to make systemwide changes in practice? Probes: • Please describe an example of a time when this health system tried to make a change and succeeded • Please describe an example of a time when this health system tried to make a change and failed • Please describe your perception of the factors that are important in making change happen in this health system in general Transition: I understand. This is excellent information and very helpful to us.

MAJOR FACILITATORS TO SCDA:
For the rest of the interview, I'd like to focus specifically on the Statin Choice Decision Aid. The Statin Choice Decision Aid is a web-based tool that patients and clinicians can use together to facilitate a shared decision making conversation about starting a statin for primary cardiovascular risk prevention. If you have seen or used this tool, I would like you to reflect on your experiences when answering these questions. Probes: • Please describe a feature of the tool that makes it valuable to you • Please describe a feature of your context or health system that helps to promote usage of the tool Transition: Okay. This is good for us to know.

MAJOR BARRIERS TO SCDA:
Now I'd like to ask the same questions but focus on the things that impede usage of the Statin Choice Decision Aid. In your opinion, what are the factors that cause clinicians not to use this tool? • Please describe a feature of the tool that makes it difficult to use or reduces its value to you • Please describe a feature of your context or health system that inhibits usage of the tool I understand. This has all been very helpful. I think that's all I need unless you have any other comments or questions.
Okay, thank you again for taking the time to chat with me about this. System ID: Clinician ID:

Implementation Team Survey
The Statin Choice Implementation Project Your health system is participating in a research study of the Mayo Clinic Care Network. The purpose of this questionnaire is to obtain information from you about your experiences in trying to implement the Statin Choice Decision Aid into routine primary care practice.
This is a research study and your participation is completely voluntary. To respect your confidentiality, this survey will be de-identified as soon as you return it. No one will be able to connect you to your responses in any way. By completing this survey you agree to participate in this research study.
Your answers to these questions will help direct efforts to improve the quality of care for patients in your health system and generate research knowledge that can improve care for many others.
If you have any questions or comments about this survey or study, please call: 1-507-XXX-XXXX Thank you for answering these questions! Thank you for taking the time to talk with me today. As a member of the Statin Choice Implementation Team, you have special insight into the factors that impact the up-take and use of the Statin Choice Decision Aid in your health system. We are very interested in understanding your perspective.

Implementation Team Survey
In this interview, I will be asking you questions about your thoughts and experiences related to implementing the Statin Choice Decision Aid. I want to assure you that your participation is voluntary and that you can choose to stop at any time. If a question makes you uncomfortable or you do not want to answer, that is fine; you do not have to. To respect your privacy, all of your responses will be held in confidence and no one will be able to connect you to any of the things you say.
You should feel open to express your thoughts and experiences honestly and to ask for clarification if any questions seem confusing.
Okay, do you have any questions before we get started?

WARM-UP CHAT (unstructured):
Okay, great. So, first I'd just like to learn a little bit about you. Please tell me about what you do in this health system. Why were you chosen to be on the implementation team? How long have you been here? Have you participated in any research studies before? Etc… Transition: Okay. Thank you. This is all very helpful to me.

SDM CULTURE:
Every organization has a unique culture and way of doing things. I would like to hear your perspective on the culture of this health system. How would you describe the culture of this health system? Probes: • How is it different from other health systems?
• What are its major priorities?
• How does this health system work to make care more patient-centered?
• Have you ever heard of the concept of shared decision making?
• How does this health system work to encourage shared decision making?
Transition: I understand. This is very helpful.

CAPACITY FOR CHANGE:
As a member of the Statin Choice Implementation Team, I know you're aware of the challenges involved in changing behaviors and routines. I am interested in hearing your perspective on this health system's potential for change. How would you describe the capacity of this health system to make system-wide changes in practice a reality? Probes: • Please describe an example of a time when this health system tried to make a change and succeeded • Please describe an example of a time when this health system tried to make a change and failed • Please describe your perception of the factors that are important in making change happen in this health system in general Transition: I understand. This is excellent information and very helpful to us.

IMPLEMENTATION STRATEGY FOR SCDA:
For the rest of the interview, I'd like to focus specifically on your thoughts and experiences related to implementing the Statin Choice Decision Aid. Implementation strategies are any and all of the things we do to encourage a change in practice. Implementation strategies include things like training clinicians, changing processes or policies, or introducing reminders or incentives to change practice, etc. Implementation strategies can focus on the intervention, the clinician/practitioner, and/or the system/context. In your opinion, what strategy or strategies will be (or have been essential) to effectively implement the Statin Choice Decision Aid in this health system? In other words, if you could design the perfect implementation strategy for Statin Choice in this health system, what would it look like? Probes: • Thank you for taking the time to participate in this discussion today. As members of the Statin Choice Implementation Team, you have special insight into the factors that impact the up-take and use of the Statin Choice Decision Aid in your health system. We are very interested in understanding your perspectives.
I will be facilitating the discussion. It is important to hear everyone's perspective and I encourage you all to share your thoughts, but to do so in an orderly fashion. To encourage and direct discussion, I will be asking you questions about your thoughts and experiences related to implementing the Statin Choice Decision Aid. My colleague will be observing the discussion and taking notes. The focus group will also be audio-recorded for analysis. This is a research study. Your participation is voluntary and you can choose to stop or leave the room at any time. If a question makes you uncomfortable or you do not want to answer, that is fine; you do not have to. To respect your privacy, all of your responses will be held in confidence and your names will be deleted from the audio transcripts. No one will be able to connect you to any of the things you say.
You should feel open to express your thoughts and experiences honestly and to ask for clarification if any questions seem confusing.
Okay, do you have any questions before we get started?

WARM-UP CHAT (unstructured):
Okay, great. So, first let's just go around the room and do some quick introductions. Tell me your name, what you do in this health system, and what your role has been on the Implementation Team so far. If you are not sure or have not been actively involved to date, just say so; your perspective is still very important to us.
Transition: Okay. Thank you. This is all very helpful to me.

NPT REMINDER:
During our last visit, we did an assessment at the end of the workshop that was intended to help us understand important factors related to succeeding in this project. Some of you were probably there and might remember it. We had you answer a series of questions by raising and lowering your hand as we moved an indicator along a bar on the screen. Do any of you remember this?
Okay, well, today we are going to have a more in-depth discussion about some of these things.
We hope it will help give all of us more insight about how to learn from and guide success here and in other organizations.

COHERENCE:
One of the things we know is that for new practices to be taken up, they need to make sense to those involved. The implication of this is that everyone involved must be informed about what the new practice is and what it means. This can be particularly confusing in a project like SCIP. How would you describe the overall goal of this project? How do you think others in this health system would describe the overall goal of this project?
One of the things we talked about in the last visit was making the distinction between shared decision making and the Statin Choice tool itself. How would you describe the challenge of making this distinction? Is there confusion or mixed messages? Within this group? Within the leadership? Among the clinicians?
This is a major implementation project that crosses the entire health system. Do you feel like you had a good sense of what you were getting into? Was the scope of the activities required a surprise? How so?
Every health system and organization has numerous competing priorities. Where does this organization find value in implementing the Statin Choice tool or shared decision making? Explain.

COGNITIVE PARTICIPATION:
In order for interventions to be taken up in practice, it inevitably requires people to get involved and to actively participate. What has the level of engagement been within this team? Are there individuals or groups that have been less or more engaged? Have people been added to or removed from the team? Why? What has the effect of this been? What about the level of engagement outside of this team?
Transition: Okay. This is good for us to know.

COLLECTIVE ACTION:
SCIP is a complex intervention, particularly because it requires participation from so many different individuals and departments.