Results Summary
What was the research about?
Kidney disease affects more than 30 million adults in the United States. Advanced kidney disease can turn into kidney failure with little warning.
Treatments for kidney failure, such as dialysis or kidney transplant, can lengthen life. But each treatment has benefits and harms. If patients know about treatment options, they can choose a treatment that is right for them before kidney failure happens.
In this study, the research team tested whether a kidney transitions care program helped prepare patients for kidney failure. The program had two parts. First, clinics added alerts in patients’ health records to tell doctors when patients were ready for a transition in kidney care. Second, patients received support and education. A nurse and community health assistant offered classes on how to manage kidney disease, plans for kidney failure, and choosing a treatment. They also helped coordinate patients’ care. The team compared patients in the program with patients who received usual care.
What were the results?
Compared with patients who received usual care, patients in the program were more likely to have their kidney treatment preferences included in their health records.
Patients in the program and patients who received usual care didn’t differ in:
- Reports of feeling able to make decisions about their care and to manage their care
- Choice of kidney failure treatment
- Number of hospital stays
- Referrals for kidney failure treatment that matched patients’ choices
- The number of patients who had to get unplanned dialysis
- The time it took for patients to develop kidney failure
- The number of patients who received surgical preparation for dialysis
Who was in the study?
The study included 1,473 patients with advanced kidney disease. Of these patients, 99 percent were White and 1 percent were non-White; less than 1 percent were Hispanic. The average age was 74, and 57 percent were women. All received care at one of eight clinics in rural Pennsylvania.
What did the research team do?
The research team assigned clinics by chance to the kidney transitions care program or usual care. Patients received the program assigned to the clinic. For usual care, clinics followed recommended guidelines for transitions in kidney care treatment.
The research team surveyed patients by phone about their preferences and care. The team also looked at information in patients’ health records.
Patients with kidney disease, their family members, representatives from health systems, and doctors helped create the program and provided input on the study.
What were the limits of the study?
Few patients took the education and self-management classes in the program. Results may have differed if more patients had taken the classes. The study took place in one health system; most patients were White. Results may differ in other places or for patients of other racial and ethnic backgrounds.
Future research could continue to look at ways to prepare patients with advanced kidney disease for kidney failure treatment.
How can people use the results?
Doctors and clinics can use the results when considering ways to improve support for patients with advanced kidney disease.
Professional Abstract
Objective
To compare the effectiveness of the Patient-Centered Kidney Transitions Care intervention versus usual care for kidney disease in improving preparation for possible treatment for kidney failure among patients with advanced kidney disease
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 1,473 adults ages 18 and older with advanced kidney disease |
| Interventions/ Comparators |
|
| Outcomes |
Primary: patient-reported confidence and ability to manage kidney disease and choice of a treatment if kidney failure happens in the future; number of hospitalizations for any reason; patient referrals for kidney disease treatment; and documentation of patients’ treatment preferences in EHRs Secondary: unplanned dialysis initiation, time to kidney failure, and vascular access |
| Timeframe | 4-year follow-up for primary outcomes |
This cluster randomized controlled trial compared the effectiveness of the Patient-Centered Kidney Transitions Care intervention versus usual care for kidney disease on helping patients better prepare for kidney failure treatment.
Researchers randomly assigned four clinics to receive the Patient-Centered Kidney Transitions Care intervention and four clinics to continue usual care for kidney disease. The Patient-Centered Kidney Transitions Care intervention had two components. First, clinics made changes to their electronic health record (EHR) system, which included the addition of a disease registry link and a risk prediction program. The program alerted healthcare providers about patients who might need to transition to a more intensive level of kidney care and reminded them to ask about patients’ values and treatment preferences. Second, a nurse care manager and community health assistant supported patients by offering psychosocial support, helping them navigate care, offering educational classes about disease self-management, assisting with shared decision making, and coordinating communication among the healthcare team.
For usual care, clinics provided care based on kidney disease guidelines for transitioning to more intensive care.
The study included 1,473 patients with advanced kidney disease who were receiving care at one of eight clinics in rural Pennsylvania. Of these patients, 99% were White and 1% were non-White; less than 1% were Hispanic. The average patient age was 74, and 57% were female.
Researchers conducted phone surveys to collect patient-reported outcomes for empowerment, self-management, and choice of a self-care treatment; number of hospitalizations; and patient referrals for self-care modalities. Researchers also reviewed EHRs for documentation of patients’ treatment preferences, in addition to biomedical and health system outcomes.
Patients with kidney disease, family members, nephrologists, health system administrators, and health insurers helped develop the intervention and provided input on the study.
Results
After four years, compared with patients receiving usual care, patients receiving the intervention were more likely to have their kidney treatment preferences documented in their EHRs (incidence rate ratio: 1.34; 95% confidence interval: 1.06, 1.69). The two groups did not differ significantly in other study outcomes.
Limitations
Few patients participated in the support classes on education and self-management. Results may have differed if more patients had taken the classes. The study took place in one health system, and most patients were White. Results may differ in other health systems and with patients of other racial and ethnic backgrounds.
Conclusions and Relevance
In this study, the Patient-Centered Kidney Transitions Care intervention improved the documentation of patients’ preferences for kidney treatment but not other outcomes compared with usual care.
Future Research Needs
Future research could test ways to improve engagement in preparing for kidney failure treatment among patients with advanced kidney disease.
Final Research Report
View this project's final research report.
Engagement Resources
Journal Citations
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers stated that the causal model underlying the research question was not well-specified, so the hypothesized pathway between the intervention and outcomes was not clear. The researchers clarified that they based their framework on the Chronic Care Model and added text to the report explaining this model and how it was used for this study.
- The reviewers asked the researchers to provide more detail on their methods, such as how they blinded providers and study participants to the interventions. The researchers explained that the clinics were randomized to an intervention so all providers and participants in a clinic experienced the same intervention. Therefore, providers and study participants were not blinded to condition, but the people assessing outcomes were.
- The reviewers disagreed with the researchers’ conclusions about the generalizability of their results. The reviewers noted that the researchers implemented a novel intervention in a single health system. Therefore, the reviewers did not consider this study to be pragmatic. The researchers edited the report by further emphasizing the limited generalizability of the study and by removing any reference to this study being pragmatic.
- The reviewers noted that the researchers did not conduct a pilot study to test the acceptability of the novel intervention, which might have informed the researchers about the potential for low uptake. The researchers acknowledged that they did not conduct a formal pilot study, but they did test the intervention in a different clinic shortly before the study began and found no problems with update. In the report, they commented that it would have been useful to complete a longitudinal pilot study in several clinics before implementing the full study.