Quality Improvement Methods Can Improve Clinical Trial Design
Research By: Hadley Sauers-Ford MPH, CCRP
Post Date: March 13, 2026 | Publish Date: March 9, 2026
Researchers at Cincinnati Children’s set an example for enrolling and keeping patients engaged in randomized controlled trials
Randomized trials are vital for understanding what works in healthcare. But enrolling families, delivering the intervention as planned, and keeping participants engaged over time are common challenges. When these elements fall short, even well-designed trials can struggle to produce reliable results.
A recent study published in March 2026 in the Journal of Hospital Medicine demonstrates how quality improvement (QI) methods can help an RCT stay organized, responsive, and effective throughout its full study period.
“These results are important because randomized trials with strong recruitment and retention rates help us determine whether an intervention truly causes an improvement,” says Hadley Sauers-Ford, MPH, CCRP, senior author of the study. “Our team used QI methods to increase enrollment, to strengthen how consistently the intervention was delivered and to maintain high follow-up rates. We believe other research teams can adopt similar approaches to improve their studies.”
Leading by Example
The team’s work centers on the GET2HOME Study, a trial that tested ways to support families of children with medical complexity as they transition from hospital to home.
The study has involved hundreds of families and caregivers participating in multiple telehealth huddles, a discharge task tracker, and follow‑up surveys stretching 90 days post-discharge. Their goal: to determine which interventions are most effective at improving home-based care outcomes. The study protocol was published in August 2023 and enrollment is complete but results have not been published.
The team used Cincinnati Children’s Model for Improvement to assess recruitment, fidelity, and retention data every two weeks. A multidisciplinary team identified areas that would benefit from QI and strategized how to implement tests of change.
Several changes produced meaningful improvements to the study even as the work continued:
- Recruitment: A more transparent consent script—one that emphasized the altruistic impact of participation—helped raise enrollment from 53% to 72%.
- Intervention fidelity: Standardized communication scripts, workplace reminders, and clearer team roles helped staff follow the protocol more consistently, increasing fidelity across all components to 85–100%.
- Retention: When a new messaging platform required two-factor authentication and created confusion, the team adapted by adding earlier phone calls, reorganizing reminder timing and developing visual guides. These efforts helped keep retention high at 88–92%.
“Small changes made a big difference,” notes Sauers-Ford. “Whether it was the frequent review of rates, including altruistic language in our consent script or creating an infographic for our surveys, our recruitment, fidelity, and retention were positively impacted, and they were all low or no cost.”
Extending the Reach
The GET2HOME team identified several strategies that may help other research teams strengthen their trials:
- Start with partnership: Caregiver co-investigators shaped how the team approached families, ensuring the process was respectful, practical, and transparent.
- Use QI to improve as you go: Biweekly feedback loops, control charts, and Plan‑Do‑Study‑Act testing allowed the team to refine processes in real time rather than waiting until the trial ended.
- Keep changes simple and targeted: Revising consent language, adjusting staff schedules, and modifying reminder systems required minimal resources but generated large improvements.
- Standardize communication: Consistent scripts and visual aids helped reduce variability across providers and increased the reliability of intervention delivery.
Looking Ahead
The improvements to the GET2HOME study demonstrate that QI methods can be embedded into randomized trials without disrupting scientific rigor. Instead, they strengthened it by improving recruitment, supporting consistent implementation, and keeping families engaged throughout follow-up.
As more funders and institutions emphasize continuous progress monitoring, the strategies tested in the study may serve as a model for future work. The team hopes to expand this work, share lessons learned, and help other research groups incorporate QI approaches to improve trial success.
About the Study
Calise Curry and Skyler Patterson, Division of Hospital Medicine, were co-first authors and Hadley Sauers-Ford, MPH, CCRP was the senior author of the study. Cincinnati Children’s co-authors also included Patrick Brady, MD, MSc and Katherine Auger, MD, MSc.
Research reported in this publication was funded through a Patient‐Centered Outcomes.
Research Institute (PCORI) Award (IHS‐2021C2‐23558). The statements in this publication are solely the responsibility of the authors and do not necessarily represent the views of the Patient‐Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee.
| Original title: | Applying the model for improvement to enhance recruitment and retention in a discharge intervention randomized controlled trial |
| Published in: | Journal of Hospital Medicine |
| Publish date: | March 9, 2026 |
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The Research Horizons blog features news and insights about the latest discoveries and innovations developed by the scientists of Cincinnati Children's. This blog does not provide medical advice, diagnosis, or treatment. Email researchnews@cchmc.org with questions or ideas.
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