PCORI funds implementation projects to promote the use of findings from PCORI-funded studies. This project focuses on implementing findings from the completed PCORI-funded research project: Monitoring Oxygen Levels of Premature Babies at Home and in the Clinic--The RHO Trial.
1. What were the results from the original PCORI-funded research study?
The Recorded Home Oxygen (RHO) study compared two home oxygen weaning management strategies. The first group was randomly assigned to standard of care, which included standard monthly pulmonary follow-up clinic visits to determine readiness to wean. In comparison, the interventional arm (RHO group) had the same standard monthly clinic visits but with the addition of recorded home oximetry to guide clinical decision-making between monthly clinic visits using a structured algorithm. The RHO trial found that utilization of RHO is a safe and effective strategy for managing home oxygen therapy in premature infants. In the RHO group, mean time to discontinue oxygen therapy was shorter, 78 days versus 100 days in the standard of care group. RHO also was found to decrease respiratory-related emergency room visits and hospitalizations, saw improved growth outcomes and was not more stressful for families.
2. Why is this research finding important?
Prolonged home oxygen therapy is a source of tremendous stress for families. Lack of available evidence-based home oxygen management guidelines results in longer newborn intensive care unit stays, and stress for both families and providers. Improvements in neonatal care have led to increased survival of premature infants, including thousands currently requiring supplemental oxygen after neonatal intensive care unit discharge, and the potential for even greater numbers if safe protocols were available. Currently there are no standard clinical-based guidelines to safely and effectively manage home oxygen therapy in formerly premature infants. This study provided the first evidence regarding safety and efficacy of any specific home oxygen therapy management protocol. Evidence that safe home oxygen protocols not only exist but that use of specific data-driven protocols are associated with decreased adverse effects with shorter duration of home oxygen may enable more infants to be discharged home on oxygen with shorter neonatal intensive care unit stays.
3. What is the goal of this project?
The project team is working to help 12 medical systems implement recorded home oximetry into the standard management practice for formerly premature infants on supplemental home oxygen.
For the current proposal, our Specific Aims are:
- Test the implementation of the RHO program in 12 diverse medical systems.
- Test the hypothesis that implementation of RHO will be associated with: (a) REACH: increased number of sites offering recoded home oximetry; (b) EFFECTIVENESS: reductions in duration of HOT in infants utilizing recorded home oximetry and decreased NICU length of stay; (c) ADOPTION: increased number of neonatologists utilizing home oxygen and number of patients offered home oxygen; (d) IMPLEMENTATION: Specific determinants affecting implementation; and (e) MAINTENANCE: sustained compliance, including increased providers and home care companies using the program as standard of care.
- Identify the recipient factors: Organizational characteristics, (i.e. cohorted NICU follow-up program versus general pediatric pulmonary clinic), and patient/family characteristics, (i.e. sociodemographic characteristics, disease burden of prematurity, and parental knowledge and beliefs) that predict variation in the adoption of recorded home oximetry across sites, to inform iterative improvements and future widespread dissemination.
4. What is the project team doing?
At 12 academic medical systems across the United States, the RHO study team is working with neonatologists and pediatric pulmonologists to implement the RHO management strategy as part of their standard practice. The study team will create educational toolkits to educate physicians on the safety and effectiveness of home oxygen therapy, as well as the benefits of a data-driven weaning management protocol. At each site, infants being discharged on home oxygen therapy will receive an oximeter capable of electronic data transmission and will have standard monthly clinic visits with their pediatric pulmonologist. Twice weekly, the central data coordinating center will download and analyze patients recorded home oximetry and communicate these results to the local provider, who will incorporate this data into their clinical decision-making to guide oxygen weaning.
5. How is the team evaluating this project?
The study team is incorporating the Practical, Robust, Implementation, and Sustainability (PRISM) model and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to guide our evaluation methods. We will measure the duration of home oxygen therapy for patients at each site, measured from time of neonatal intensive care unit discharge until successful discontinuation of oxygen. Respiratory rehospitalizations and growth outcomes will also be measured. The team will also survey families about their experience with the protocol. Outcomes and processes associated with successful adoption of RHO will also be tracked as indicators of successful program implementation and maintenance in the program. These include rates of adherence with key intervention processes. In addition, we will examine barriers and facilitators to intervention implementation using a qualitative and mixed-methods approach, including individual interviews and content analysis of open-ended participant surveys.
6. How is the team involving patients and others in making sure the findings reach people who can use them?
Our study team includes an active Parent Advisory Board, who have been instrumental in every aspect of project planning and implementation. Neonatologists, pediatric pulmonologists, clinic staff, and parents will work together throughout each aspect of the proposed project to adapt the program into each participating clinic. In addition, the study team will create a family-centered website to offer a tool for families to receive education, support, and project results. In addition, oximeter manufacturers and several home care equipment companies have been included as stakeholders to help guide the implementation of the RHO program. All participating stakeholders will participate in bi-annual meetings to review the program and defined barriers and facilitators.
7. How will this project help ensure future uptake and use of findings from patient-centered outcomes research?
We aim to demonstrate the safety and effectiveness of a data-driven weaning strategy to help guide physicians on their patient’s readiness to wean from supplemental home oxygen. We have included a diverse set of hospitals from around the country to enhance generalizability of our findings. The sites chosen to represent influential leaders in the management of premature infants requiring supplemental home oxygen, so their success and demonstration of superior health outcomes will enhance future uptake from additional centers. Our study team will also examine site-specific and overall barriers and facilitators to successful implementation, enabling more streamlined dissemination for future sites. The inclusion of parent advocates will enhance dissemination of evidence-based findings from our patient-centered research to both families and physicians. The simplicity of our process, the clear communication of our findings, our provision of available resources online, and the demonstration of clear improvement in health outcomes will be the key drivers of successful uptake.
Original PCORI-funded Research Project
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.