Speaker

Tumaini Rucker Coker, MD, MBA
Professor of Pediatrics
Division Head for General Pediatrics
University of Washington Department of Pediatrics
Seattle Children’s Hospital

Slides

Keywords

Pediatrics, Preventive Medicine, Community Health, Well Child Care

Key Points

• There are 10 preventive care visits from ages 0-3, usually scheduled as 15-20 minute visits with a pediatrician. This may be the only interaction the family has with a healthcare professional, so if there are needs around behavior, health, social needs they will be addressed during these visits. This time is not used appropriately now because there is so much that needs to fit into that visit.

• The American Academy of Pediatrics (AAP) Bright Futures guidelines for preventive visits include history, measurements, physical exam, developmental and behavioral screening, anticipatory guidance, and psychosocial and social needs screening and guidance.

• How might we better structure preventive visits? Donabedian’s Quality Framework includes a structure that supports care, a process for the provision and receipt of care, and health outcomes, providing a process without a structure to support it. Adapted for early childhood preventive care, the structure should be team- and community-based.

• The Parent-Focused Redesign for Encounters, Newborns to Toddlers (PARENT) study was a randomized controlled trial of PARENT verses usual care for parents with infants 12 months and younger over a 12-month study period. The PARENT group added interventions such as a community health worker “parent coach,” a pre-visit tool to help identify parent priorities, a text message service to keep in touch between visits, and a brief, focused clinician visit.

• In the initial PARENT trial, intervention families had better performance on receipt of well child care, and patients reported better patient experience and fewer emergency department visits. Parents loved the text messaging service.

• Based on these findings, the research team initiated a larger PARENT trial that had 3 parent coaches at federally qualified health centers. The trial was cluster randomized by clinic for usual care or intervention arms; participants were parents with infants 12 months and younger. The first year was spent allowing the clinics to make the project their own, with input from parents and clinicians.

• Ten clinics were randomized, and 937 parents participated with 785 completing 12-month follow up. The average child age was 4 months. 93% of participants were Medicaid insured, 95% were mothers, 8% had a college degree, and 63% had a household annual income of less than $30,000. The intervention families had better performance on receipt of well child care services, better parent experiences of care, no change in Emergency Department visits, and were more likely to be up-to-date on well child care visits.

• Integrating a community health care workers into the well child care team improves well child care for Medicaid-insured children. Evidence for PARENT, and other clinic-based interventions that utilize community health care workers in a team-based approach to early childhood well child care. Clinics and practices will need Medicaid state plan amendments that provide adequate funding for community health care workers in well child care and support for implementation.

• The research team is in the next phase of local adaptation, having received funding from PCORI for PARENT Adaptation for Black Families: NCH-PCN Partnership. The intervention was quite strong with Latino families but did not have the power to understand what it looks like with Black families. It will be a stepped-wedge randomized trial at 12 Nationwide Primary Care Clinics with adaptations and implementation and parent, staff, and provider engagement.

 

Learn more

Read more about PARENT in JAMA.

Discussion Themes

-What did stakeholder engagement change in the process? From the beginning we did not know what the intervention was going to be. As we went to each new clinical space there were things we could not have anticipated that they wanted to change for their clinic. For example, one local clinic did not have the room space, so the coaches called the family the day before then they could pop in quickly for a brief discussion. Doing the formative work builds ownership of the intervention.

-In areas of quality improvement people often do not consider cluster randomized design or people may be disappointed if they are randomized to usual care. In the PCORI funded trial we are doing stepped wedge so everyone gets the intervention at some point, which was important to our partners. For the first small trial, we randomized at an individual level, which takes a lot of manpower to maintain. Our partners wanted to know at the end of the trial, will this make care better, and when the answer is yes, they are willing to participate. Our partners want to know the data and what it takes to collect it in a rigorous way.

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#pctGR, @Collaboratory1

Speaker

Pasquale Rummo, PhD, MPH
Associate Professor
NYU Grossman School of Medicine

Slides

Keywords

Randomized clinical trial; Food insecurity; Nutrition; Online retailer; Equity

Key Points

• Supplemental Nutrition Assistance Program (SNAP) provides nutrition assistance benefits to supplement food budgets with the goal of mitigating food insecurity. SNAP does not focus on mitigating nutrition insecurity, which is where nutrition incentive programs come into play. Nutrition incentive programs match SNAP dollars for people to use on fresh produce at supermarkets, which increases sales and consumption of produce in brick-and-mortar settings. However, the results of nutrition incentive programs had not been evaluated previously in an online setting.

• Behavioral nudges may increase healthy food purchasing by “nudging” consumers to purchase healthier options by providing discounts or lower-cost options. Default options have been shown to increase healthy food orders in restaurants, but no studies had not been previously conducted to represent the effects of online shopping carts pre-filled with tailored fruit and vegetable items.

• SNAP Online Purchasing Pilot rapidly expanded during the pandemic with the goal of creating equitable access to online grocery shopping, leading to the growth of online grocery shopping sales among those with low incomes.

• The goals of this project were to characterize online food shopping behaviors in an online survey and conduct a randomized clinical trial of behavioral economic strategies on fruit and vegetable purchases in an online grocery store.

• The sample included 2,744 adults at least 18 years of age who currently or had previously received SNAP benefits. Participants were randomized into four different groups: 1) Control – participants received no discount, and shopping cart was not prefilled; 2) Discount – participants who received a 50% discount on eligible fruits and vegetables; 3) Default – participants who had shopping carts were prefilled with tailored fruit and vegetables; 4) Combination (Discount and Default) – participants who received a prefilled shopping cart plus a 50% discount on eligible fruits and vegetables.

• Participants were asked to shop for a typical week’s worth of groceries for their household on a budget adjusted for household size. The team created an online grocery store that simulates a real online retailer to conduct this experiment.

• The team analyzed non-discounted dollars spent on eligible fruits and vegetables per food basket and out-of-pocket dollars spent on fruits and vegetables, as well as non-discounted dollars spent on fresh, frozen, and canned fruits and vegetables as well as the macronutrients from these fruits and vegetables.

• The results showed that about 20% of the cart total was spent on fruits and vegetables across all cases. Over 90% of people in the default and combination groups purchased at least one of the default fruits and/or vegetables in their cart. About half of those in the control and discount groups purchased at least one of the fruits and vegetables offered to the default group on their own accord. About two thirds of the participants stated that they would support the default strategy with or without the discounts offered to them. Compared with the control group, participants in the discount, default, and combination groups spent greater percentages of non-discounted dollars on fruits and vegetables.

• These findings suggest that the expansion of nutrition incentives to online settings is a potentially promising strategy to promote equitable access to food. Providing default options is also an effective strategy in motivating individuals to purchase fruits and vegetables. Additionally, combining discounts and default options creates a synergistic effect of increasing the amount of fresh produce people purchase. This may also be a more equitable strategy than defaults alone, as it may increase purchasing power for individuals with food insecurity.

 

Discussion Themes

– Compared to some of the other work that you and your colleague shave done, would you describe this as easier to do since you’re taking advantage of online approaches, or was it harder? In terms of balance, it was easier. I think there’s probably a lot of people here who know how difficult it is to recruit people in person. It was also easier because we used a survey research firm, although I will say we are progressively considering and have started recruiting people through alternate methods. The part that’s more difficult is operationalizing all of this, as none of our team has expertise in computer science, for example, which has been really challenging. One thing we want to do in the future is pair with people who can help us do things that are more sophisticated, rather than just asking a question in a survey that says, “Here’s five options. Which do you purchase the most?”

– Did you have any intention to evaluate if the behavior would continue without the incentives? I want to acknowledge that there’s definitely questions about the sustainability of types of behavior changes like the default options or even the economic incentives. My thoughts differ for each strategy. I would love for the financial incentive for fruits and vegetables for participants to remain a permanent strategy. I’m a little less interested in the sustainability of those effects. I’d be more interested in this with respect to the default strategy. But, to answer your question more directly, we didn’t look at the sustainability of these behaviors, as this trial was cross-sectional. I’m proposing and writing a grant now to run a longitudinal study focused on at different strategies to address this issue over time.

– Could you comment on the magnitude of the changes in purchasing and whether you think those are of sufficient size to have an impact on clinical outcomes? I’m also wondering if we know people who receive these discounts and save the money on the healthy food are substituting it and using that money to purchase unhealthy food? To me, the goal of these incentives is to make healthy eating more affordable, so I think it accomplishes that goal. With respect to whether this would change clinical outcomes, I’m skeptical, especially given the size of the effect that we saw. I think we would need several different strategies all in combination to effect clinical outcomes. As far as the savings go, I looked at substitution spending in a prior study, and at least for other grocery orders, people didn’t substitute to some of the unhealthy categories. I’m proposing to evaluate another incentive program with that in mind in order to more closely track those purchase. For this study, people are ultimately buying more fruits and vegetables regardless of what they choose to spend their savings on.

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#pctGR, @Collaboratory1

Speaker

Gabriela Schmajuk, MD, MS
Professor of Medicine
UCSF and the San Francisco VA

Slides

Keywords

Patient-Reported Outcomes, Rheumatoid Arthritis, EHR

Key Points

• Clinicians rely on patient-related outcomes (PROs) to track disease and function over time in patients with rheumatoid arthritis (RA). These outcomes include disease activity, function status, and pain score.

• These PROs have been integrated into RA guidelines and they are recommended by professional societies. The treatment philosophy for RA is to treat-to-target based on PRO disease activity scores. There are 4 components to the treat-to-target approach: record disease activity using a composite measure every 3 months; specify disease activity target; adjust medications to target; and document shared decision making. However, there is a gap between collecting the PROs and communicating about the PROs with patients.

• To try to bridge the gap between PRO collection and meaningful use during clinical encounters, the RA PRO dashboard was developed. The team collected focus group feedback from patients and clinicians and worked with IT professionals to pull data directly from the electronic health record and design an interface that could be used by all patients.

• The RA PRO dashboard was tested as part of a stepped wedge, cluster randomized trial at the clinician level. The hypothesis was that the RA PRO dashboard used during clinical encounters will increase patient engagement, foster shared decision making, and improve health outcomes for patients with RA.

• There were 4 clusters with 4-6 physicians each (a mix of attendings and fellows). There were 1:1 training sessions, regular reminders on how to use the dashboard, clinical research coordinators who collected patient information, conferences for sharing successes and challenges, training for medical assistants on collecting PROs, and information sheet for patients. 552 unique patient participated in the trial.

• In the 18 months of the trial, there were not see changes in the quantitative outcomes that were measured. Patients completed a dashboard survey, which gave the study a lot of qualitative measures. Despite the negative quantitative outcomes, 80% of patients said they would like to continue to use the dashboard, the dashboard helped them talk to their clinician about their symptoms and medicines, and it helped them understand more about their arthritis.

• The trial team also did a qualitative analysis with the clinicians and analyzed according to the technology acceptance model. In general, the clinicians perceived a lot of usefulness of the dashboard though they were anxious about discussing the PROs when the disease score came up high and it might not have to do with RA. They found the dashboard easy to use and discussed the lack of patient data that made it less useful.

• There were technical and non-technical challenges of maintaining the intervention. There was a big gap between when the dashboard was built and launched. There are new medications now that were not showing up that required regular updates to the dashboard. There were also challenges with many software and security updates that impacted to the dashboard. There were also major changes to the clinic workflows during the COVID-19 pandemic and issues with data completeness with clinic turnover.

 

Discussion Themes

-Do you think you would have gotten increased adoption, less technical difficulties if you had built the dashboard within EPIC instead of as a Sidecar app. Building in EPIC as we did several years ago, we would not have been able to get the customization that we wanted for the dashboard.

-Was patient recall about past visits accurate several months later? Could this be a reason for a no effects trial? We struggled with when to collect the surveys. We tried collecting the surveys through a phone call after the visit and found we were not able to reach many of the patients. We tried collecting some of the information at the end of the visit and found people were in a hurry. We had to balance the proportion of people who were going to respond to the survey against the timing of when the survey was delivered.

–For an intervention that did not have demonstrable effect but did have qualitative patient value, how do you think about continuing the dashboard verses de-implementing it or do you think over time it will become more useful in more ways? I am still optimistic that we will see some improvements in the outcomes we specified. I am interested in doing a future survey on some of the outcomes.

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Speakers

Prof Sir Martin Landray, FMedSci
Professor of Medicine & Epidemiology
University of Oxford
Chief Executive, Protas

Khair ElZarrad, PhD, MPH
Director, Office of Medical Policy
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)

Slides

Keywords

Pragmatic trials; Research; Guidance, Regulatory, Data Governance

Key Points

• The clinical trial enterprise needs modernization. Time, cost and failure to recruit trial participants are significant barriers that must be addressed. The rapidly evolving ecosystem now relies on real-world data, which is becoming increasingly more advanced, and clinical trial design is becoming more complex and innovative.
• The International Council for Harmonisation of Technical Requirements for Human Use (ICH) is a unique harmonization organization involving regulators and the pharmaceutical industry. Its objective is to improve efficiency of new drug development and registration processes, in addition to promoting public health, preventing duplication of clinical trial in humans and minimizing the use of animal testing without compromising safety and effectiveness.
• The E6 Good Clinical Practice clinical trial conduct principles was intended to be an improvement of the G8 clinical trial design principles. The working group is engaging with academic stakeholders to determine new approaches to enhance transparency. An extensive training program with use-cases focused on trial designs still needs to be developed in the application of GCP guidelines.
• The new structure aims to provide clarity and better readability. The scope is focused, and the language aims to facilitate innovation in trial design. It also aims to set a foundation for practical and feasible expectations around the responsibilities from the sponsor and investigator, encourage a fit-for-purpose approach and incorporate learning from innovative trial design. Annex-2 of E6(R3) will include additional considerations of GCP principles focused on decentralized elements, pragmatic elements and real-world data sources.
• The principles aim to promote good science and ethics, be clear and concise, be inclusively developed and be progressive and durable.
• While E6(R3) provides a foundation for GCP expectations, guidelines alone are not adequate. The field will also need to collaborate on implementation and capacity building, develop responsive and accessible training and avoid all-or-nothing approaches on design and technologies.
• Better guidelines are needed to promote better trials, which will promote better health. Clinical trials should incorporate quality in their scientific and operational design, conduct and analysis.
• The principles focus on the concepts that “Good Trials” produce a scientifically sound answer to a relevant question through the principles: Principle 01) Informative and relevant; Principle 02) Respectful of participants; Principle 03) Collaborative and transparent; Principle 04) Feasible for their context; and Principle 05) Efficient and well managed.
• The current 11 ICH principles are generally sound, and the structure of Introduction > Principles > Annexes support critical application. However, improvements can be made, and further modifications are needed to ensure that the annexes are treated as implementation guides and not rules.
• Current proposed modifications include grouping principles into overarching themes, restructuring each principle and explicitly cross-referencing principles in Annex-1. There are also concerns that the ICH document fails to include scientific issues encountered quite often, such as allocation concealment, randomization, loss-to-follow-up, blinded evaluation of endpoints and others.
• There are also some excessive details on data, records and computer systems, which are unlikely to stand the test of time. This could stifle innovation and quality when new and different technologies are more relevant. Unnecessary, irrelevant, or ultra-specific guidance can cause more harm than good.
• GCTC will publish its comments at goodtrials.org and the public is encouraged to submit feedback as the work continues to improve the guidance.

Discussion Themes

–How much work was needed to get to this stage where the revisions are up for public comment? The work started before COVID-19, and the idea was to meet every six months. We had an opportunity to meet once, and then everything became virtual. The amount of work that went into the gap analysis alone was several months because we needed to have a thorough understanding of where the community is coming from, especially in areas that we knew were seeing advancements in design. We wanted to make sure we were encouraging flexibility of design and use of technology, while still highlighting what people need to be careful with. We also included multiple meetings with our academic stakeholders. We need to be clearer and more concise, while making sure that the statement fits with the needs of researchers. Training is also going to be essential to move this forward.   

–How did the pandemic impact the updates to the guidance? COVID-19 made us think about things differently, because one couldn’t apply rules, one had to apply principles. You must apply what really matters regarding the critical quality factors – for example, you can’t disrupt critical health care. The principles were the only thing we could fall back on, so I think that’s why it’s so important to get the principles right and lean on the trainings in all of our department.

–How do you balance precision and fit-for-purpose quality checks with more situations in which investigators are conducting trials using data from entire systems of health care? We need to create a space where this is an open dialogue and these kinds of conversations can happen. I think collectively, we want to promote the utilization of health care in research. We see that as an important part of the future. It would be such a waste of valuable data, valuable approaches, and valuable infrastructure to not embed clinical trials effectively into health care systems.

–What are the next steps? We encourage people to review the guidance and provide feedback. One important note is that we specifically moved away from a checklist approach. The guidance should not remove the need to think. Even when we have a guideline, we want to lead investigators to think based on the principles of this guidance.

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Speaker

Eric Perakslis, PhD
Chief Science & Digital Officer
Duke Clinical Research Institute
Professor, Department of Population Health Sciences
Chief Research Technology Strategist
Duke University School of Medicine

Slides

Keywords

Artificial intelligence; Machine learning; Gamification; Healthcare

Key Points

• Once people start learning about what technology can do right and wrong, the immediate response is often to start minimizing the risks of technology. However, Dr. Perakslis advocates that “instead of spending time and energy solving small problems, we should be solving big problems with bold solutions.”

• The key to quality AI and utilizing AI in a beneficial way relates to the quality of the data. It’s important for organizations to recognize this and upgrade their data in order to use these technologies more effectively and efficiently.

• “Serious games” are games designed for a purpose beyond pure entertainment. They use motivation, game design, competition, curiosity, collaboration, challenges, media, and learning to accomplish something. An example of when serious games have been useful is the creation of video games to treat depression and insomnia. However, gamification could have serious negative effects, and the benefits of these games in health care would relate to how well or how poorly they’re gamified, based on data, execution, and use cases. It’s important that people apply good judgement when utilizing these new technologies, especially in fields of science and medicine.

• Serious games pique the interest of people and can increase their likelihood of continuing a behavior. This can be useful in the context of clinical trials. For example, if the method of patient reported outcomes is gamified, patients will be more likely to continue reporting their outcomes on a regular basis rather than giving up or forgetting after the first time, which may increase the quality and quantity of data for the trial overall.

• In an interactive video game, people interact with NPCs (non-player characters). Those NPCs learn from interacting with human intelligence. This concept could be an interesting way to think about consent. In some ways, the idealized informed consent process would be one where the patients could ask the questions on their mind and get the answers, rather than only checking boxes on a plethora of situations that feel foreign to them. There are still risks associated with this process, but gamifying the game could ultimately create a more individualized approach to health care that prioritize the needs of each patient.

• Today’s toughest health care problems could be easily gamified so that people can access technologies that allow them to ask and answer questions. Implementing this is critical and doable according to Dr. Perakslis. The key is to have a deep understanding and control over the data being used. The smallest change in data can completely change the results when AI is involved.

Discussion Themes

-It seems like the speed of AI use is accelerating and our awareness isn’t keeping up. What is going to keep AI in the boundaries for health hand research right now? People need to be really focused. Tech companies that are promoting AI and rolling out these new tools quickly are going to be in the cross hairs of the aftermath when those tools are inevitably misused. It’s important to be thoughtful in picking partners to work with and making sure you ask the right questions before proceeding. The bleeding edge of these technologies is human talent, so if you’re struggling to keep up in this space, hire smart people. It’s also important to focus on the basics (cleaning up your data, etc.) before jumping into these new technologies to ensure the technologies work in your favor.

-Do you think AI within the context of health and research will be replacing people? If there’s one thing that’s absolutely true it’s that these new technologies can produce an unprecedented amount content, which is good and bad. For people, there are some jobs that will inevitably be replaced by these new technologies. However, these new technologies are more likely to replace people who can’t use the new technologies. The important thing is to learn and adapt to the changes.

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Speaker

Carl T. Bergstrom, PhD
Professor, Department of Biology
University of Washington

Slides

Keywords

Research, Misinformation, Media, Social Media

Key Points

• Misinformation abounds in medicine and about medicine. As researchers, we are producers and consumers of the medical literature.

• It is important to know and understand the information landscape into which your research is going out. What are the debates and controversies in the press and social media? If you’re working on a paper about vaccine safety, you have to understand the conversation about vaccine safety. How will it be framed in the public discourse? This will help you release information responsibly.

• It is important to avoid hype. Be very explicit about what findings do and do not provide.

• Issue responsible press releases. Researchers should consider themselves personally responsible for press releases. Researchers need to understand how preprints are received. It is important to understand that there are different standards depending on the topic. If you’re not prepared to see your manuscript appear in a leading medical journal, you should think carefully before posting it as a preprint.

• As a research community, we need to think about auditing citations because they are used as evidence for claims we make but many are falling short of that aim. One step journals can take is checking to see if cited papers have been retracted. More broadly, citations in medical journals often do not reflect the material cited. 10-20% of the time the claim is not a fair representation of what is being cited. We need to find a way to tackle this.

• Design stand-alone data visualizations because one thing that happens in a social media world is that the graphs and visualizations very quickly escape their containers. A paper is posted, it has a data figure, model or schematic, and it gets excerpted in the media or on individual’s social media feeds and the context is left behind. All of the necessary context should be included in the figure itself so people cannot accidentally snip it away from the relevant context.

• When we are communicating about our science, it is important to engage with traditional media and take the time to get to know reporters who are interested in the science. Engaging with social media  is important, particularly as false information starts to spread, it can make its way into traditional media. One of the best ways to stop false information on social media is having the author step in and clarify or correct misinformation. This is a very powerful and effective thing to do.

• We all have to prepare for generative AI. The landscape is changing so fast compared to other technologies. We already have the devices and platforms where generative AI is displayed. AI generated work has been submitted to journals and other publications. Publishers will need to rethink how to identify who is saying things and what are their credentials to make sure the ideas in the scientific literature are coming from humans who are trustworthy.

Learn more

Read Misinformation in and about science.

Discussion Themes

-Are you an optimist for the future? I am an optimist about science. We can innovate and change our norms and institutions to tackle problems. I am very pessimistic about big tech and social media, who are motivated by clicks and ads with no oversight. The data of what is happening with social media is not available unless you are collaborating with social media.

-How can we prioritize where to focus the resources to address misinformation? One thing that is essential is working within marginalized communities to understand the effects of misinformation on and in these communities and to partner with the communities most effected by misinformation to better understand where are the biggest harms being caused.

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Speaker

Christopher B. Granger, MD
Donald F. Fortin, M.D. Distinguished Professor of Medicine
Professor of Nursing
Duke University

Neha J. Pagidipati, MD MPH
Associate Professor of Medicine,
Duke University School of Medicine

Slides

Keywords

COORDINATE-Diabetes; Cardiovascular disease; Intervention; Cluster-randomized trial; Implementation; Prescription

Key Points

• High-intensity statins, ACEi/ARBs, and SGLT2i and GLP-1RA have been shown to improve recovery and maintenance outcomes for patients with diabetes and atherosclerotic cardiovascular disease (ASCVD). However, these therapies are highly underused in routine clinical practice.

• The objective of COORDINATE-Diabetes trial was to improve the implementation and adoption of these therapies by testing the impact of a clinic-level, multifaceted intervention on the prescription of 3 key groups of evidence-based therapies. This was a cluster-randomized trial of 42 cardiology clinics across the U.S., in which participants had type 2 diabetes mellitus and ASCVD. The cardiology clinics were randomized to one of two groups. The first group consisted of a usual care arm, where they received basic guidelines for treating diabetes or ASCVD. The second group of clinics implemented a multifaceted intervention at the provider level. The intervention included assessment of local practices and barriers, development of strategies to overcome those barriers, and audit and feedback of quality metrics, with the goal of improving the way clinics approach treatment of these diseases.

• About 6-12 months after enrollment, patients were assessed for the primary outcome, which was the prescription of all 3 recommended therapies. These therapies included an anti-hyperglycemic agent with evidence for cardiovascular benefit, ACEi/ARB/ARNI, and high-intensity statin.

• In the usual care arm sites, 14.5% of the patients ended up being prescribed all 3 therapies, and 37.9% of patients were prescribed all 3 therapies across the intervention sites. The 23.4% absolute difference highlights the important benefits of utilizing the provider education and interdisciplinary care pathway tools included in the intervention being tested in this trial.

• An important aspect of the intervention was regular phone calls and check-ins to patients prescribed the therapies to ensure they were taking the prescriptions. Results of the study showed a positive correlation between prescription of the therapies and the patients actually using the medications.

• Key study limitations were the need for remote delivery due to the COVID-19 pandemic and the lack of total representation of the broader U.S. or international population across the selected sites and patients.

• Ultimately, this trial concluded that a coordinated, multifaceted intervention increased prescription of 3 groups of evidence-based therapies in adults with T2D and ASCVD. The results of this trial highlight the under-use of evidence-based therapies in clinical practice and the lack of high-quality data on how to improve this gap. It is essential to scale this intervention across cardiology practices in order to improve the quality of care being delivered more broadly to ensure the implementation of these trial results.

Learn more

Read about the COORDINATE-Diabetes trial. 

Discussion Themes

-What are the challenges of implementing the implementation intervention of this trial? What is the trade-off between simple approaches versus multi-faceted approaches? Simple approaches are scalable and less expensive, but the benefits are less impressive. In this program, we were trying to change a more complex behavior with a higher activation energy, which is not only to prescribe one therapy, but to take a very complex patient population and prescribe multiple therapies, which inherently requires more than just a prompt here or there. One of the barriers we faced was a lack of education and familiarity with the therapies, which takes more than just a prompt to overcome. In this trial, we tried to land somewhere in the middle of the trade-off between simple and multi-faceted.

-Is there a reason for the disproportionate number of participants between the usual care and intervention groups? Ideally all participants would be identified and enrolled prior to starting the trial. This was not the case for COORDINATE-Diabetes primarily due to time constraints. They randomized the clinics, then enrolled the patients. This can be a limitation of cluster-randomized trials, as the knowledge of which group they are randomized to could impact patient enrollment.

-How can you sustain this intervention across all components of the process? That might be an important jumping point for the second leg of COORDINATE-Diabetes to answer questions such as: How do you get payers and Medicare to sustain these interventions? How do you elevate the pharmacists to get embedded in the clinics and remain engaged? How do you incentivize patients to see this through?

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