Study Pivots to Serve At-Risk Youth Amidst Pandemic
CHR team goes above and beyond for participants
By Jill Pope, Senior Technical Writer/Editor
Greg Clarke, PhD
COVID-19 has completely changed the way we live, forcing us to conduct many daily activities at a distance. The virus has also prompted major changes in health care, including the way the Kaiser Permanente Center for Health Research (CHR) conducts its studies. Social distancing has meant that for some studies, researchers can no longer meet with participants in person. The STEP2Health study, which seeks to prevent self-injury and suicide among teens and young adults, has pivoted admirably to continue serving its participants.
The study, led by Principal Investigator Greg Clarke, PhD, and funded by the National Institute for Mental Health, is comparing two ways to support young people and reduce suicides. One group is receiving normal care from their Kaiser Permanente doctor and health care team—a suicide-specific program called the Zero Suicide Initiative. The other group is receiving normal care and care from the STEP2Health intervention team. A study therapist develops a tailored care plan for each participant, which might include individual counseling sessions, group counseling, access to online resources, and monthly check-ins. Participants enroll for one year—six months of acute treatment followed by six months of monthly phone check-ins.
COVID Throws a Wrench in Study Plans
When COVID-19 struck in March, the study had been set to finish enrollment a few months later. According to Research Associate Alison Firemark, who supervises the study’s therapists, “We were on the final lap when COVID-19 threw a wrench in our plans.” The study had to put recruitment on hold for 10 weeks to determine how to proceed.
The pandemic threw a wrench into ongoing study operations as well. The team had been delivering two in-person group sessions each week—one for teens and their parents, and one for young adults on their own. Many participants also attended individual sessions. “We had to contact our participants and tell them we need to push pause, because we are no longer allowed to bring you into our building,” Firemark explained. With nearly forty participants in active treatment, the study team had to figure out how to deliver sessions virtually. Groups went on hold while the team found its way to Vidyo, a telehealth videoconference platform. But that solution didn’t meet all of the study’s needs, which included recording every session, and required a workaround. After hearing about the study’s struggles, CHR IT Director Harry Mayfield reached out to folks at the Zoom meeting platform. “We were thrilled that he took it upon himself to explore this with Zoom,” said Firemark. “Somehow, in the midst of the transition to remote work, he found time to facilitate getting us a better product.” With Mayfield’s help, the study gratefully switched to Zoom.
Going Above and Beyond
As it turns out, the study’s transition to virtual delivery created plenty of opportunities for study team members and other CHR staff to expand their roles.
Kristen Semelsberger, one of three study therapists, took on the role of tech support. She did her own research into the features and functionality of the study’s initial video platform and brought her lessons back to the rest of the team to integrate into their group process. Firemark said two therapists run each group session—one leader and one co-leader. Now, she said, “Kristen, our co-leader for both groups, was fielding phone calls from participants and requests for technical assistance. Talk about beyond the scope of your practice!”
Meanwhile, study therapist Blake Locher had to re-imagine group session materials as a set of powerpoint slide decks. Without being able to write on a board or use hand-outs, slides now had to convey everything to participants. “After Blake outlines what is needed on each slide, Lisa Fox, our Senior Graphic Designer, works her magic to create a visually appealing and engaging tool for the group leaders to use,” Firemark explained. A slide deck has now been created for all 18 group sessions. “Blake’s work with Lisa on developing the group materials has been a huge project that he willingly took the lead on. He saw the need and the opportunity to stretch his skills and dove right in. And Lisa has been wonderful to work with,” says Firemark.
Building the Right Tools
Anna Edelmann, the study’s lead recruitment interviewer, became an expert at REDCap, a survey and database software program. She created an environment in REDCap for recruitment activities that the study’s other two recruiters, Delanie Brown and Stacey Bunnell, helped her fine-tune. Using tutorials, Edelmann learned how to create an informed consent process that can capture digital signatures, which Project Manager Christina Sheppler calls “groundbreaking.” Edelmann also built an electronic version of a hard copy case file for the therapists. “She tapped into a special place,” Firemark said. “This was definitely outside the scope of what she needed to do.”
Meagan Shaw, the third study therapist, worked closely with Edelmann to help her build tools for the therapists in REDCap. As an interviewer, Edelmann was not familiar with how the study therapists use some documents interactively with patients in the moment. “Meagan stepped in to help, drawing on her previous experience with REDCap and her knowledge of what exactly the therapists would need, in a way that nobody else was able to do,” said Firemark.
An Assist from Compliance
Sheppler, the study’s Project Manager, was quick to highlight Firemark’s contributions, saying, “In times like this, you just see people shine.” She described Firemark as an invaluable “link in the chain” —someone who understood the study therapists’ needs and could communicate what changes were needed. Sheppler, in turn, would run the ideas by CHR’s Compliance Department and submit study modifications to the Institutional Review Board (IRB). The study’s new mode of delivery required not only an updated protocol, but repeatedly getting new or amended materials approved. Sheppler said Mark McNamara, CHR’s IRB Coordinator, was particularly helpful in approving modifications on tight turnarounds: “Every day something new was coming up that required a study modification. Mark understood the situation and ensured the reviews happened in a timely manner.”
Changes May Be Lasting
Some of the changes the study has made, born of necessity, may be long-lasting. For example, Sheppler says, “We will likely use REDCap for consenting participants in future studies—even if we move back to in-person visits—because it captures all of the documentation needed for our regulatory records, provides the participant with a copy, and eliminates the need for printing.” In a recent planned audit of the study’s documentation compliance, the review staff, led by Melinda Bodayla, remarked on how comprehensive and organized the study procedures were—especially the REDCap system.
Clarke, the study PI, expressed profound thanks to every person who has helped the study transition to virtual delivery. “The speed with which staff made these changes, while at the same time maintaining contact with enrolled participants, was amazing—and all at the same time as they were having to reorganize their own work and personal lives to accommodate the stay-at-home order. STEP2Health’s successful transition through the start of the pandemic was due to their hard efforts, and mastery of tasks and skills they were never hired for.”
More than a dozen CHR employees have been instrumental in keeping the STEP2Health study going. They seem to share an understanding: In carrying out the study’s mission to serve young people at risk for self-harm and suicide, failure is not an option.
S2H study team
- Kristina Booker, Project Assistant
- Delanie Brown, Behavioral Health Interviewer
- Stacy Bunnell, Behavioral Health Interviewer
- Greg Clarke, Principal Investigator
- Anna Edelmann, Lead Behavioral Health Interviewer
- Donna Eubanks, Senior IT Engineer
- Alison Firemark, Interventionist Team Lead
- Weiming Hu, Statistical Research Analyst
- Blake Locher, Study Interventionist
- Kristen Semelsberger, Study Interventionist
- Meagan Shaw, Study Interventionist
- Katie Vaughn, Intervention Team Support
- Christina Sheppler, Project Manager
Additional help from:
- Melinda Bodayla, Research Compliance Program Manager
- Lisa Fox, Senior Graphic Designer
- Kaija Maggard, IRB Manager
- Mark McNamara, IRB Coordinator
- Harry Mayfield, Information Technology Director
- Jennifer Rivelli, Behavior Assessment and Change Department Manager
- Andrea Seykora, Research Compliance Manager