March 1, 2023: This Week’s PCT Grand Rounds Highlights Implementation Lessons From GGC4H

Headshots of Margaret Kuklinski and Stacy Sterling with the GGC4H logoIn this Friday’s PCT Grand Rounds, Dr. Margaret Kuklinski and Dr. Stacy Sterling will present “Adoption, Implementation and Sustainment of Family-Focused Prevention in Health Care Systems: How Do We Get There?” Kuklinski and Sterling are the principal investigators of GGC4H, an NIH Pragmatic Trials Collaboratory Trial.

The Grand Rounds session will be held on Friday, March 3, 2023, at 1:00 pm eastern.

Kuklinski is an associate professor of social work and the director of the Social Development Research Group in the University of Washington School of Social Work. Sterling is a senior research scientist in the Kaiser Permanente Division of Research.

Join the online meeting.

July 14, 2022: Solving Unexpected Challenges in Pragmatic Trial Data Collection

Headshot of Dr. Keith MarsoloDuring the NIH Pragmatic Trials Collaboratory Steering Committee meeting and 10th anniversary celebration, Dr. Keith Marsolo, Co-chair of the Electronic Health Records Core, moderated a panel on “Barriers and Challenges: Data Collection and Merging Datasets.” Four panelists shared their experiences collecting and aggregating data from diverse data sets and how they solved unexpected challenges.

The panelists included Drs. Ted Melnick (EMBED), Holt Oliver (ICD-Pieces), Margaret Kuklinski (GGC4H), and Andrea Cheville (NOHARM).

During the discussion, panelists shared lessons learned from collecting electronic health record (EHR) data during large pragmatic clinical trials across multiple health systems. Common challenges included:

  • Privacy concerns and not having the ability to collect deidentified patient or clinician demographic information
  • Working across health systems that use different EHR platforms and collecting data consistently across sites
  • Turnover of IT staff at participating sites and changes in site data agencies during the study period
  • Updates to the EHR that affect study algorithms and other issues with algorithms not identifying data as expected
  • Overcoming technical barriers with practice workflows and integrating with IT systems

The panelists shared solutions and possible best practices for future studies, including the need for planning, coordinating, and testing before study launch, the importance of being able to pivot and change directions as problems arise, being open to alternative data collection methods such as surveys to augment findings, and having the right team at the right time to be responsive to problems, which for one study meant having informaticists and expert EHR builders embedded in the trial team.

Panelists identified two key policy and infrastructure changes that would help trials be successful in the future. These changes include development of a national unique patient identifier across health systems and incentivizing EHR vendors to find common ground to better support research.

The Electronic Health Records Core continues to learn from experiences of the program’s NIH Collaboratory Trials and shares emerging information, resources, and EHR-related recommendations to improve future pragmatic research.

View slides from the discussion panel.

Learn more

View video collection that highlights advances in Electronic Health Records for pragmatic research.

Watch the August 2021 Interview with Electronic Health Record Core leaders Drs. Rachel Richesson and Keith Marsolo

May 31, 2022: GGC4H Guides Parents and Teens Toward Better Health Amid Challenging Times

GGC4H, an NIH Pragmatic Trials Collaboratory Trial, uses the RE-AIM framework to test the feasibility and effectiveness of implementing a guidance curriculum for parents to address problems common to early adolescents. Dr. Margaret Kuklinski, Co-PI of the GGC4H project, discussed the study in an interview for the NIH Collaboratory’s annual Steering Committee meeting.

 

 

“GGC4H is a 5- or 6-session intervention that helps promote health and prevent prevalent problem behaviors in the teen years,” Kuklinski explained. “It’s been shown in a randomized trial to reduce substance use, depression, and anti-social behavior by strengthening bonds between parents and their kids.” The project is finishing its fourth year by wrapping up the intervention with a second cohort of parents and teens.

One of the main challenges faced by the GGC4H project was the COVID-19 pandemic. COVID-19 delayed the start of the study by 7 months. Baseline surveys had to be redone, and the study intervention redesigned to be delivered virtually. By conducting the study during the pandemic, “we’ve been able to see from parents, just how stressed they are in COVID, and that’s been the silver lining at the end of this process—being able to help families in these challenging times,” Kuklinski said.

“The Collaboratory has been a huge asset to our study,” Kuklinski said. “All of the work groups that we’re able to routinely be a part of means that we don’t have to solve problems on our own as if these problems are unique to our study. We really gain from our partners.”

“What we really hope to do is motivate the routine provision of anticipatory guidance to parents and pediatric primary care,” Kuklinski said. “Programs like Guiding Good Choices allow us to do that in such a deep way, because we have time that pediatricians don’t have.”

View the full video.

GGC4H is supported within the NIH Collaboratory by a cooperative agreement from the National Center for Complementary and Integrative Health and receives logistical and technical support from the NIH Collaboratory Coordinating Center.

Guiando Buenas Decisiones: Implementing GGC4H for Spanish-Speaking Families of Young Adolescents

Dr. Stacy Sterling of Kaiser Permanente Northern California discusses a pilot study to explore the feasibility of implementing a universal prevention curriculum for Spanish- speaking families of young adolescents, a supplement to GGC4H, an NIH Collaboratory Trial.

🔙 Return to the complete collection of Diversity Workshop video modules.

February 8, 2022: Patient-Centered Outcomes Core Highlights Lessons From the NIH Collaboratory Trials

PRO figure

In new additions to the Living Textbook, the Patient-Centered Outcomes Core of the NIH Pragmatic Trials Collaboratory explores lessons learned from the NIH Collaboratory Trials and provides information about including patient-reported outcomes (PROs) in pragmatic clinical trials.

The new content includes:

  • A Case Study from Guiding Good Choices for Health in which the principal investigators provide their most critical advice and tips for study teams
  • A new section about the Food and Drug Administration’s Patient-Focused Drug Development series. This 4-part series provides guidance about how to collect and submit patient experience data in clinical research.
  • New content on Cultural Adaptation and Linguistic Translation from the NIH HEAL Initiative’s PRISM program—Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing. The PRISM NIH Collaboratory Trials are designed to assess the effectiveness of non-opioid interventions for pain management. Cultural and linguistic adaptation of PRO measures enables inclusion of a broader study population and enhanced generalizability of results.
  • New content on acceptability and burden in the chapter on Incorporating PRO Data into the Electronic Health Record (EHR).

Read the Patient-Reported Outcomes chapter.

The PRISM program is a part of the Helping to End Addiction Long-Term Initiative℠, or NIH HEAL Initiative℠. The NIH Pragmatic Trials Collaboratory Coordinating Center serves as the PRISM Resource Coordinating Center.

 

 

 

October 11, 2019: Guiding Good Choices for Health (GGC4H) Pragmatic Trial Enrolls First Participant

The GGC4H NIH Collaboratory Trial, now in its implementation phase, has begun enrollment of study participants. Congratulations to Drs. Kuklinski, Sterling, and Catalano and the entire GGC4H study team!

GGC4H is a cluster-randomized trial that is testing the feasibility and effectiveness of implementing Guiding Good Choices—a universal evidence-based anticipatory guidance curriculum for parents of early adolescents—in three large, integrated healthcare systems serving socioeconomically diverse families. In prior community trials, the Guiding Good Choices curriculum has been shown to prevent adolescent substance use, depressive symptoms, and delinquent behavior. This study offers an opportunity to test the intervention’s effectiveness with respect to improving adolescent behavioral health outcomes when implemented at scale in pediatric primary care within a pragmatic trial.

Read more about GGC4H:

GGC4H NIH Collaboratory Trial

PI Interview

PCT Grand Rounds webinar

June 25, 2019: GGC4H Awarded Continuation From Planning to Implementation Phase

The investigators of Guiding Good Choices for Health (GGC4H), an NIH Collaboratory Trial, have received approval to move from the planning phase to the implementation phase of their study. Congratulations to the GGC4H study team for their excellent work!

At the May 2019 NIH Collaboratory Steering Committee meeting, we talked with Drs. Stacy Sterling, Margaret Kuklinski, and Richard Catalano to hear about progress and challenges during the UG3 planning phase. The goal of GGC4H is to test the feasibility and effectiveness of implementing Guiding Good Choices—a universal evidence-based anticipatory guidance curriculum for parents of early adolescents—in 3 large, integrated healthcare systems serving socioeconomically diverse families.

“Guiding Good Choices is a tested and proven intervention in community and school-based settings. We think primary care is an ideal implementation setting because pediatricians have parents’ trust, and the AAP recommends that they offer anticipatory guidance to parents. Community and school settings do not often have the same advantages.” — Rico Catalano, Co-PI of GGC4H

In the UG3 phase, the study team partnered with 5 pediatric primary care clinics in Kaiser Permanente Northern California, Kaiser Permanente Colorado, and Henry Ford Health System, finalized the trial protocol, obtained IRB approval, and presented UG3 and pilot study findings at 2 recent national meetings: the Society for Prevention Research and the National Academy of Medicine Collaborative for Healthy Parenting in Primary Care.

Were there any surprises during the study’s planning phase?

“I’ve been pleased and surprised to see the near universal excitement for Guiding Good Choices across the 3 healthcare systems and in multiple clinics. My previous work has been with adolescents who have already started to develop problems and are clearly at risk. Often when you are engaging those teens and their parents, they are coming from a place of crisis and have a lot of anxiety and worry. With Guiding Good Choices, we’re offering it to all families of young adolescents in the pediatric clinics, and we’re heartened to see pediatricians and parents welcoming this.

“The parents and kids were so enthusiastic and excited in our pilot. It’s been extremely heartening, and I think it bodes well for the reception we’re going to get.” — Stacy Sterling, Co-PI of GGC4H

What is an example of a challenge that you were able to overcome with the help of a Core Working Group?

Our study has two core questions: Will Guiding Good Choices improve adolescent behavioral health when offered in a health care setting? Will parents in a health care setting actually enroll in Guiding Good Choices and to what degree? Our initial study design attended more to the second question, and in doing that, raised problems for the valid assessment of effectiveness. These issues could have prevented us from transitioning to the implementation phase, so we needed a good design for assessing both effectiveness and implementation. Our original plan would have included all adolescents who had well visits, but at some clinics, 25% of teens don’t have them. Our new design, developed with the IRB chair and the Biostatistics and Study Design Core, includes everyone who receives care at the pediatric clinic. Although we may enroll some people who don’t engage with the intervention, this will make the study results more generalizable and valid for both effectiveness and implementation.

What words of advice do you have for investigators conducting their first embedded PCT?

“It’s a really fasted-paced year. I think we have complementary strengths across the leaders at our sites, and that is important. Pay attention to the qualities of your team and how they can help you hit the ground running and eventually help you get across the finish line to the UH3 phase.”  — Margaret Kuklinski, Co-PI of GGC4H

GGC4H is supported within the NIH Collaboratory by a cooperative agreement from the National Center for Complementary and Integrative Health and receives logistical and technical support from the NIH Collaboratory Coordinating Center. Read more about GGC4H in the Living Textbook, and learn more about the NIH Collaboratory Trials.