Clinical trial NCT03395366: Improving Outcomes for Hemodialysis Patients
Official title: Improving Outcomes for Hemodialysis Patients by Addressing Poor Health Related Quality of Life With Cognitive Behavioral Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
End Stage Renal Disease
Keywords: Hemodialysis
End Stage Renal Disease
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Satellite Healthcare
First posted: 2018-01-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be designed as a 16-week randomized controlled trial in which 40 subjects on hemodialysis with below average HrQOL will be assigned to one of two educational interventions.
Primary purpose: OTHER

Brief summary: End stage renal disease (ESRD) affects approximately 700,000 Americans of which approximately 400,000 are on life-saving hemodialysis therapy. Hemodialysis can take a physical and emotional toll on patients, and most patients on hemodialysis describe poor quality of life. Patients on hemodialysis have worse health related quality of life (HrQOL) than patients with any other chronic illness including cancer and congestive heart failure. This poor quality of life can affect how well these patients manage their own health or their self-care, and can ultimately lead to poor health outcomes. Despite this, there are no commonly used programs to improve quality of life or self-care for patients on hemodialysis. The investigators have developed a simple 3-step program to improve quality of life and self-care for patients on hemodialysis. The first step involves presenting quality of life scores to the dialysis health care team so that a program can be designed. The second step involves 8-12 education sessions combined with behavioral training designed to improve quality of life and self-care. The final step is monthly re-evaluation of progress. In this study, the investigators will test this 3-step program, compared to dialysis education alone, to see if it improves quality of life and self-care. By improving quality of life and self-care the investigators believe patient outcomes including hospitalizations will improve.

Detailed description: Hemodialysis (HD) patients have worse health related quality of life (HrQOL) than patients with any other chronic illness. In this population, poor quality of life and depressive symptoms (a major component of HrQOL) are associated with medication non-compliance, dietary indiscretion, interdialytic weight gain, and missed dialysis. These associations likely explain the link between low HrQOL scores and adverse medical outcomes. Even small decrements in HrQOL score are associated with an increased risk of hospitalizations and mortality. Moreover, depressive symptoms occur in one-third of HD patients and are themselves associated with increased hospitalizations and with a 1.5 times higher mortality risk.

To address poor HrQOL in HD patients, the Centers for Medicare Services (CMS) mandated its screening on a regular basis in all HD patients. However, CMS has not mandated how to present HrQOL results to key HD providers, or how to treat those with poor HrQOL. Nor are there widely applied methods of doing so. Although prior interventions in HD patients have improved quality of life and self-management, these interventions were limited by poor patient and physician adoption, a lack of reproducible methods, selective inclusion and exclusion criteria and a lack of translatability. To date there are no widely adopted interventions to improve quality of life in this population. Thus, it is not surprising that, HrQOL scores remain unchanged in 8 years since the CMS mandate. In sum, HrQOL survey results have not been applied in a manner that makes a difference for patients.

Cognitive behavioral therapy (CBT) is a structured psychotherapy intervention designed to address and treat dysfunctional cognitions, negative emotions and maladaptive behaviors. In patients with chronic illness, CBT has been adapted to successfully improve adherence to self-management behaviors. In patients with ESRD, several studies have used cognitive behavioral strategies to improve self-management, quality of life, and depressive symptoms. These studies however were limited by high drop-out rates and a lack of translatability. To date, cognitive behavioral (CB) strategies are not routinely used in the care of ESRD patients.

The investigators have developed a simple, translatable 3-step intervention to improve poor HrQOL in hemodialysis patients. The first step is a one-page dashboard that presents actionable HrQOL data to key stakeholders (social workers, nutritionists, primary nurses, nurse-practioners, physicians, patients and family members) during monthly case conference. The second step is a treatment approach that combines self-management education with CB strategies through 8-12 simple sessions delivered chair-side over 12 weeks. These sessions are designed to be delivered by unit social workers and are highly translatable to other US hemodialysis units. The final step is monthly re-evaluation at clinical case conference where patient progress will be assessed and the dashboard and behavioral-education sessions refined. Each step of the intervention was designed to be highly translatable to current hemodialysis care. The dashboard utilizes data that is currently checked, the treatment sessions are delivered by social workers that are already employed at hemodialysis centers and re-evaluation occurs during monthly case conference sessions that are already being held.

The investigators hypothesize that implementing their multi-faceted intervention will improve HrQOL, depressive symptoms and self-management, and will be immediately translatable to other US hemodialysis units. Therefore, the investigators propose to conduct a 16-week randomized controlled trial in 40 subjects on hemodialysis with poor HrQOL to test the impact of the intervention on these outcomes. The primary outcome, Kidney Disease Quality of Life Short Form 36 (KDQOL-36™) survey scores, will be measured at 0, 8, and 16 weeks. Through end-of-study focus groups, the investigators will refine the intervention and help translate our intervention into practice. Additionally, the investigators will develop a translatable toolbox that will give step-by-step instructions on how to implement our intervention at other US hemodialysis units. Finally, the investigators will explore the effect of our intervention on hospitalizations.

Eligibility criteria: Inclusion Criteria:

* Adult patients on hemodialysis for at least 3 months
* Most recent 36-question Kidney Disease Quality of Life (KDQOL-36), Physical Component Summary (PCS), or Mental Component Summary (MCS) score below 50
* KDQOL-36 burden of disease score 80
* Expected survival 6 months
* English-speaking

Exclusion Criteria:

* Bipolar or Psychotic disorder
* Moderate or severe cognitive impairment as determined by the hemodialysis staff or documented in the electronic medical record (EMR)
* Severe vision or hearing impairment
* Drug or alcohol dependence
* Active suicidal ideation or a history of suicide attempt (determined based on screening patient health questionnaire-9 and EMR)
* Current participation in a behavioral or education treatment program

Primary outcomes:
measure: Change in score on Kidney Disease Quality of Life Short Form 36 (KDQOL-36™)
timeFrame: 0 weeks, 8 weeks, 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: DaVita Columbia University Dialysis
state: New York
Study officials:
affiliation: Columbia University
name: Shayan Shirazian, MD
role: PRINCIPAL_INVESTIGATOR
References: