The NIH Collaboratory recently welcomed 2 new embedded pragmatic clinical trials on pain management and reducing opioid prescribing. The projects are funded through the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program as part of the NIH’s Helping to End Addiction Long-term Initiative℠, or NIH HEAL Initiative℠. The new projects join 4 PRISM projects that are just finishing their first year and 15 other NIH Collaboratory Trials that are in various phases of completion.

We heard from some of the “more seasoned” principal investigators of these trials to glean lessons learned and tips for the new trials.

What are your top 2 lessons learned to share with the investigators conducting their first embedded pragmatic clinical trial?

Dr. Jeffrey Jarvik, Lumbar Imaging with Reporting of Epidemiology (LIRE):

1. Keep the intervention as simple as possible; it is easy for it to spiral into something complex given that the setting is a healthcare system. Things change all the time and get more and more complex.

2. Understand the unique complexities of your partner healthcare systems. This requires a dedicated partnership with healthcare systems leaders. Have those partnerships in place from the start,

and understand that there will be a back-and-forth across time.

Dr. Doug Zatzick, Trauma Survivors Outcomes and Support (TSOS)

1. Our intervention was multifaceted and complex, involved numerous centers, and we took on a huge regulatory task that included many independent IRB reviews. My recommendation is to track your project in parallel across the Core Working Groups so they can help you.

2. Given how new embedded pragmatic clinical trials are, you might encounter unexpected barriers and challenges. Rely on the Living Textbook and the Cores. Bring all your issues to the Cores—whatever comes up. Be transparent. You can get through the issues with their help.

Dr. Karen Sherman, Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults (BackInAction)

1. It is challenging to get pilot work done and have your study protocol drafted in the first year. You should start working on that now, on your outcome measures, and incorporating HEAL domains.

2. When you have a problem someone has encountered before, the Cores can easily help. When you encounter unique problems, then your problem can be used as a test case. Try to keep ahead in areas where you can. It is a huge amount of work.

Dr. Natalia Morone, Group-Based Mindfulness for Patients With Chronic Low Back Pain in the Primary Care Setting (OPTIMUM)

1. Adaptability is crucial. There may be changes that are requested from HEAL, or there might be changes in your design because the Biostatistics Core may see ways to improve, or you may have to adapt your trial due to outside forces. For example, we had to adapt our intervention to virtual because of COVID-19. Our 3 healthcare systems are different from each other and many adaptations needed to be made.

2. Expect and accept change. If you expect change, then it will be less stressful.

Dr. Miguel Vazquez, Improving Chronic Disease Management with Pieces (ICD-Pieces™)

1. I echo the themes of simplicity, flexibility, adaptability. Also be well organized. This is a Collaboratory, so it requires collaboration among multiple teams, individuals, and organizations. Be willing to bring others onto your team to make things possible. Go beyond a small group, and be deliberate.

2. Besides being organized and deliberate, you also need to be persistent. Healthcare systems are competing for priorities on all sides, and there can be methods changes, personnel changes, and guidelines changes. Because we can’t control workflows, we need be persistent to ask for help from healthcare system partners and frontline leaders.

Dr. Michael Ho, Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge)

1. In your planning year, keep track of the milestones. The first year is short; you have about 9 months to get your pilot work done, write it up, and start submitting for your UH3.

2. Keep the Collaboratory Coordinating Center and Cores up to date and get advice from them, especially in the first year.

Other advice and encouragement from the PRISM projects:

Dr. Morone: I was grateful that the other folks are seeing this process as very time intensive and they were also feeling the deer in the headlights feeling. The new PIs should feel free to contact us. There are some simple questions that can easily be answered by me and the other PIs. You will come out the other end. And you will come out fine.

Dr. Sherman: We just finished our first year, and we are here, and we are smiling. Feel free to reach out. You want to make sure that your team is happy, because they will have to work hard. There are lots of resources, and you will get through this. Keep going and you’ll survive.

What tips do you have for managing year 1?

How did your team engage the Cores?

• Delegate specialists on your team who can attend Core meetings and summarize the information for you.
• Really participate and share openly. Don’t be afraid to air your problems to the Core—you can benefit and learn from the wisdom of a highly experienced crowd.
• Remember that one of the other PIs may have encountered a problem before, and the Cores can help. If you encounter something new, the Cores may ask you do document it so you can write a paper on it in order for your experience to be helpful to others in the future.

How do you balance delegating activities and staying in the loop?

• We split our team across the Cores, which helped keep the coinvestigators invested in the project.
• Divide and conquer. And proactively reach out and ask questions.

How did you manage deliverables & milestones?

• Have good people on your team and an organized project manager.
• Stay in regular communication with the site PIs.
• Have established, untouchable times and dates where the PIs review everything that happens in a project.

How did you manage administrative requirements?

• DSMB expertise is variable—and this can have a big impact on your trial.
• Have bidirectional communication with the DSMB. With very close oversight, there is effort to provide detailed reports, and can make your study stronger.

The NIH Collaboratory serves as the resource coordinating center for the NIH Collaboratory Trials. The 2 newest projects are GRACE and BeatPain Utah.

• Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (GRACE)
• Nonpharmacologic Pain Management in Federally Qualified Health Centers Primary Care Clinics (BeatPain Utah)

Congratulations to all the investigators for their groundbreaking work on their NIH Collaboratory Trials and for your efforts to help each other!