PCORI funds implementation projects to increase awareness and promote the use of PCORI-funded research findings to improve health care practices and health outcomes. This project is proposing to conduct implementation activities for the results of the completed PCORI-funded study titled "Comparing Two Treatments for Depression among Patients with Kidney Failure Receiving Hemodialysis -- The ASCEND Study" across an entire dialysis organization, Satellite Healthcare.
1. What were the results from the original PCORI-funded research study?
ASCEND was a comparative clinical effectiveness trial to test two hypotheses: In patients undergoing hemodialysis with depression (major depressive disorder or dysthymia):
An engagement interview increases the acceptance of treatment for depression.
There is no difference in the efficacy of 12-week treatment with cognitive behavioral therapy (CBT) or sertraline drug therapy.
In phase 1, 184 patients were randomized to an engagement interview or a control visit. At 28 days from the visit, there was no significant difference in the proportion of patients that started treatment for depression between the groups. In phase 2, 120 patients were randomized to CBT or sertraline. There was an improvement in depressive symptoms with both. The improvement with sertraline was statistically larger than with CBT, but the difference was not clinically meaningful. There were more nonserious adverse events with sertraline than with CBT. The study team now proposes to make two effective treatments for depression available to patients within dialysis units as in ASCEND to overcome the many barriers to treating depression, with one adaptation: ASCEND therapists drove to the dialysis units to conduct in-person therapy sessions, but herein, the study team will deliver CBT via telehealth, as this is more readily scalable for large-scale adoption.
2. Why is this research finding important?
Depression is four times more common in people undergoing long-term dialysis, and at any time 25-38% have clinically significant depressive symptoms. In addition to low mood, patients with depression have impaired concentration and motivation, making it much more challenging for them to handle the complex adjustments to their lifestyle, high pill burden and care transitions with long-term dialysis. As such, patients with depression have higher non-adherence, hospitalizations and mortality than those without. Several trials have tested the efficacy of CBT with usual care in this population, and meta-analyses indicate a moderate certainty evidence for clinically meaningful improvement in depressive symptoms with CBT. ASCEND provided further confirmatory evidence for the efficacy of CBT. There are fewer trials with antidepressant drugs, but in ASCEND, drug therapy provided clinically equivalent improvement as with CBT. As importantly, treatments were made available within dialysis units in ASCEND, an approach that overcomes many barriers to treatment such as rigid dialysis schedules and transportation challenges. Thus, the field is ripe for an implementation project as evidence-based treatments are available to be deployed and there is a demonstrably successful strategy to make these treatments available within a dialysis unit.
3. What is the goal of this project?
The overarching goal of this implementation project is to make evidence-based treatments for depression available to patients within the dialysis unit using the strategy used in the PCORI-funded ASCEND trial, with the following three specific aims:
To develop a “unit-level” implementation bundle for onboarding unit personnel to adopt the strategy for managing depression within dialysis units, as in ASCEND.
To institute a six-phase roll-out for implementation within the 87 units operated by Satellite Healthcare over 25 months.
To continuously evaluate the effectiveness and sustainability of implementation.
4. What is the project team doing?
The ASCEND team, Drs. Mehrotra, Cukor and Unruh, have partnered with an implementation scientist, Dr. Goff, and a dialysis organization, Satellite Healthcare, for this proposal. The dialysis unit social workers and medical directors will be the Unit-level Champions for managing depression within each dialysis unit, and therapy social workers and all nephrology providers will provide CBT and sertraline therapy, respectively. In the first four months, the study team will:
Develop training materials for the “unit-level” implementation bundle.
Adapt results from ASCEND into educational materials for shared decision making for patients to select a treatment option.
Deploy a depression module within the electronic health records to track management of depression in real-time on an ongoing basis.
Over the next 25 months, the management strategy will be rolled out to the 87 dialysis units in six phases, with each phase preceded by training of the unit social workers, medical directors and nephrology providers. The implementation initiative will reach 8,350 patients undergoing in-center hemodialysis or home dialysis across four states. Among the target population, 38% have Medicaid as primary or secondary insurance, and 21% self-identify as Hispanic. Thus, compared with ASCEND, this project will have a much larger reach by many measures including patient numbers; site of dialysis, including in-home and in-center; and socioeconomic and racial diversity. Further, by making treatments available within dialysis units, it will make generally inaccessible evidence-based treatments for depression available for the first time across an entire organization. While the primary goal of treatment is to improve depressive symptoms, the study team anticipates improvements in other patient-centered outcomes such as quality of life, adherence and hospitalizations.
5. How is the team evaluating this project?
The study team will use RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) and CFIR (Consolidated Framework for Implementation Science) frameworks for evaluation. They will measure reach as percentage of eligible patients screened for depression and percentage who screen positive who complete a diagnostic interview, begin treatment and receive their treatment of choice. The study team will assess adoption as percentage of dialysis units that screen over 90% of eligible patients and treat over 75% of patients with positive screens within the dialysis unit. Clinical effectiveness will be measured as the percentage of treated patients with over 50% improvement in depressive symptoms, increased adherence to dialysis treatments and quality-of-life scores. Training effectiveness will be measured with pre-post surveys for dialysis unit social workers and nephrology providers.
The study team will measure fidelity by assessing completion of implementation processes, such as percentage of dialysis unit social workers trained. They will measure acceptability in the pre-post surveys and as part of semi-structured interviews with social workers, clinicians responsible for managing depression treatment and patients. Semi-structured interviews will also seek to understand patients’, social workers’ and treating clinicians’ perspectives on the best approaches to identifying and treating depression in patients receiving dialysis. CFIR domains (Innovation (ASCEND), Inner Setting, Outer Setting, Individuals and Implementation Processes) will serve as a guiding framework to understand barriers and facilitators to implementation at multiple levels.
6. How is the team involving patients and others in making sure the findings reach people who can use them?
ASCEND was conceived and executed with extensive patient and stakeholder engagement. As such, the approach used in ASCEND was highly patient-centered. The number and range of stakeholders supporting this implementation proposal is much larger than for ASCEND, underscoring the importance of this work to the entire dialysis care community. This includes every relevant professional group (nephrologists, social workers and nurses); patient advocacy organizations; and eight dialysis provider organizations that care for 90% of patients nationwide.
Yet, support from Satellite Healthcare is central to the success of the project. The study team has worked closely with the leadership at Satellite for eight months to develop every detail of this project. Satellite Healthcare has demonstrated a very high level of organizational readiness and commitment to its success (see letters of support from the chief executive officer, chief operating officer, chief medical officers and senior director). This will ensure that the findings from ASCEND for treating depression will be made available to patients within Satellite Healthcare.
7. How will this project help ensure future uptake and use of findings from patient-centered outcomes research?
This project will provide the first-such template for implementation of a strategy for managing depression in dialysis units, for other dialysis organizations to replicate and make such care available. The proposal for organization-wide implementation is highly relevant for future uptake as dialysis care in the United States is delivered by just a few large and several small dialysis organizations. Eight of these organizations that collectively provide care to 90% of patients nationwide have demonstrated strong commitment for future uptake by supporting this proposal. The study team’s partnerships with professional organizations and patient advocacy organizations will further help with dissemination and facilitate the update of investments by PCORI in patient-centered outcomes research.
Initial PCORI-Funded Research Study
This implementation project focuses on putting findings into practice from this completed PCORI-funded research study: Comparing Two Treatments for Depression among Patients with Kidney Failure Receiving Hemodialysis -- The ASCEND Study
*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.