All of the patient and family member Co-Investigators participated in the research planning discussions and engagement process (see Figure 1). After convening the Co-Investigators, we asked them open-ended questions about what research ideas were essential to them. We drafted research questions and a research design, and received more feedback from patients and family members that informed the final study design (see Table 2).54 Three patient-centered themes emerged from our data related to engagement that informed our research plan: decision-making, care transitions, and outcomes.
Identified Need to Address Decision-Making
After extensive open discussions, the patients and family members came to a consensus that the most essential aspect of CKD care that needed improvement was decision-making. Patients and families felt there was not enough information and help for people diagnosed with kidney disease, and they were not prepared for kidney disease or choosing a treatment. Patients and family members thought that people with kidney disease needed education and information about kidney disease progression and related treatments as early as possible when diagnosed with CKD and that this information should be tailored to help people make kidney treatment decisions at different stages in the disease.
Every one of the patient and family member Co-Investigators had personal experience with this systemic problem. One of the family members summed this up, stating:
"I always think about cancer patients, no matter what stage they are at, they [doctors] sit down with them and the family, they talk about what stage they are at, what the options are, what may or may not happen, so that they can be fully prepared. But that doesn't happen with kidney patients and it should because it is a chronic illness and the person could end up on artificial life support or dead if they don't have the right options in place ahead of time. The same thing should be done for kidney patients."
A patient also stated,
"I still to this day cannot believe how ignorant and misinformed I was. This is why I volunteered for this study. I do not want another patient to go through what I went through."
Identified Need to Support Kidney Disease Care Transitions
The patient and family member Co-Investigators believed that education and information were not enough to help people diagnosed with CKD, and they believed support was also needed at many stages of kidney disease care transitions. One patient stated, "as good as my doctor is, I still felt abandoned in the sea of information." Together we decided that patients needed assistance and support to navigate treatment information because people who receive a CKD diagnosis feel overwhelmed with the amount of information to digest about kidney disease, kidney failure, and kidney disease treatments. The full team decided that patients need care transitions assistance as CKD progresses, and believed this assistance needed to be multifaceted. i.e., delivered by professionals, self-directed, class learning, and peer support. One of the family members stated in one of our meetings, "I wish such a strategy had been implemented when my husband was first diagnosed with kidney failure. Too many patients lack supportive services needed to carry the burden of their disease."
Identified Patient-centered Outcomes
Patient and family member research Co-Investigators identified patient-centered outcomes for the project that were most important to them: grief, anxiety, depression, acceptance, control, empowerment, and kidney disease knowledge. As people with kidney disease or family members of people with kidney disease, these Co-Investigators knew well the emotional impact of a CKD diagnosis. As one of the patients stated, he was "blind-sided" by his diagnosis of kidney failure. In team meetings, there were many conversations about how CKD can have a significantly negative impact on a patient and result in grief, anxiety, and depression. It was important to the team that the intervention addresses these common responses to a CKD diagnosis and that our project would help improve patient control, empowerment, and acceptance of CKD. It was also critically important to the team that the intervention helps improve knowledge about kidney disease and its treatment options.
Intervention Design
During research team meetings, we collaboratively designed an intervention to improve a health system (Geisinger Health) to respond to the critical themes of kidney disease decision-making and care transitions to improve patient-centered outcomes. The specific aims of the project directly reflect patients' and family members' suggestions and were refined by the entire team:
- Establish a Patient-Centered Kidney Transitions Care infrastructure that (a) prioritizes kidney patients' informed self-care and treatment decisions, and (b) supports patients through their transitions across kidney disease stages by providing education, psychosocial support, and biomedical preparation.
- Study the effectiveness of the new Patient-Centered Kidney Transitions Care infrastructure to improve patients' values-aligned kidney care, empowerment, and well-being.
This intervention would help patients with kidney disease make the best treatment decisions, have the best transitions across stages of kidney disease, and be designed to improve the outcomes most important to patients and family members.
Engagement Plan
Throughout the research application process, researchers were fully transparent and collaborative about all aspects of the process required to complete our submission. While compiling the PCORI application, it was essential to discuss the composition of the research team and the roles that the patients and family members would play on this team. As researchers, we believed that to fully embrace the PCOR principles, the patients and family members would be considered the true team experts and full partners on the research project. This would mean patients and family members would attend regular research team meetings and not serve only in an "advisory" role, but provide input on the study design and conduct, and be involved in study analyses and dissemination. Each patient and family partner accepted personal invitations via phone calls from the principal investigator to be a Co-Investigator in the study.
Finalizing our project engagement plan, we wrote into the application to PCORI that patient and family Co-Investigators would participate in weekly task committee and monthly full team project meetings using teleconference and internet conferencing technology. Also, they would participate in two in-person meetings at the end of Year 2 and Year 5 of the project. They would actively participate in all project workgroups, and patient and family Co-Investigator input would be solicited on all aspects of the study, including monitoring the conduct of the project, reviewing data collection procedures, data analysis, and interpretation of findings. Before submitting the proposal, patient and family Co-Investigators collectively decided that a rate of $35/hour for their work on this project would be fair if the study were funded. We agreed that patient and family Co-Investigators would work approximately 102 hours per year on the study (based on meeting frequency) and that their travel to in-person meetings would be funded by the study. If necessary, we also agreed to help patients schedule dialysis treatments for any study-related travel. The patient and family Co-Investigators helped write and edit several drafts of the PCORI application. The team was notified in 2015 that our project was funded for five years (https://www.pcori.org/research-results/2015/can-patient-centered-approach-preparing-patients-kidney-failure-improve).
Ongoing Engagement
As we moved forward in the project (see Figure 2),54 patients and family members are compensated Co-Investigators, have been trained in the conduct of human subjects research, participate in team meetings and provide input on the study and intervention implementation. They also help disseminate information about the study. Co-Investigators write blogs for our website about their experiences having kidney disease as well as their experience in the research project (https://www.kidneypreparenow.org/blog). At the Co-Investigators' request, we created and provided them project business cards and brochures to share at the kidney disease conferences and events they attend.
To encourage their engagement in the study, patient and family Co-Investigators all actively participated in weekly project workgroups during the initial year of the project during the intervention development phase (e.g., kidney transition workflows, patient materials for kidney education classes) and the development of processes to measure patient reported outcomes (e.g., telephone surveys). During the roll-out of the intervention, patients and family members continued to be engaged in the monitoring of the intervention by participating in monthly full team research meetings. The patient and family Co-Investigators also have monthly meetings to have regular "check-ins" to make sure they are meaningfully involved in and contributing fully to the study. One researcher Co-I is the main point person for this group and (along with project staff) routinely communicates with these Co-Investigators individually and as a group. Since project implementation, the patient and family Co-Investigators have been significantly engaged in every aspect of our research (see Table 3). This allows for our engagement process to continue to reflect the PCOR engagement principles.
Challenges
Some of the challenges in PCOR engagement have emerged as we have executed our study and project activities. First, some of the patient Co-Investigators receive in-center hemodialysis, and some work full-time, which limits their meeting availability on some days and times. We addressed this by having larger team meetings on different days to increase participation. We schedule Co-Investigator monthly meetings on a day and time that works for all, and adjust this schedule as needed throughout the year. Second, having a research team with members living all across the country also requires frequent and meaningful communication. To address this limitation, we have frequent email and phone conversations with the Co-Investigators and utilize video conferencing to share documents and materials that everyone can review at the same time. If materials are not available electronically, we mailed items to the Co-Investigators. We have many group conversations, but also, a researcher Co-Investigator has additional personal conversations with the patient and family Co-Investigators. At the start of the project, we also created a booklet of team member biographies that included everyone's photo and personal details like hobbies/interests and why this project was important to everyone. This booklet was shared with all of the research team as a way to promote engagement across a team that had not met in person yet (these biographies are located on our project website https://www.kidneypreparenow.org/our-team.html).
A third challenge is that some patients and family members were initially reluctant to actively participate in meetings and deferred comments and opinions to the research professionals during team discussions. We addressed this challenge very early in meetings by telling the patients and family member Co-Investigators that they were the most important experts on this project, and we valued their expertise. We honored this commitment by following up on these sentiments and using their ideas in all aspects of the project and asking them to share their ideas in team meetings. We conduct group meetings using many open-ended questions and allowing the patients and family members to tell us what they wanted to research. As with any large group, some members may not participate as much as others, and we addressed this by explicitly asking for feedback from Co-Investigators who may not have shared an answer to a question or contributed to the meetings. Research teams that conduct patient-centered research have reported similar challenges,55 and our approaches for addressing these limitations may be helpful for other PCOR studies.
Current Activities
As our project ends its final year, the patient and family Co-Investigators continue to be fully engaged in all activities and review all study processes such as project implementation and study recruitment. They are also involved in all of the data analyses, interpretation and dissemination. Partnering with these patient and family Co-Investigators, we have submitted two additional PCORI applications to continue collaborative patient outcomes research. This project has created new opportunities for the Co-Investigators to be involved in research beyond this project. Several of the Co-Investigators are PCORI Ambassadors and have attended three PCORI national meetings. Two patient Co-Investigators now review grants for PCORI, and one patient Co-Investigator was invited to participate in the National Symposium on Renal Anemia Research sponsored by PCORI.