Technology Assisted Collaborative Care Intervention to Improve Patient-centered Outcomes in Dialysis Patients

University of Pittsburgh424 enrolled

Overview

The goal of this study is to learn if a collaborative care intervention of pharmaco-therapy and/or cognitive behavioral therapy (CBT), delivered in a real-world setting, improves symptoms of pain, fatigue and/or depression.

The goal of this study is to conduct a hybrid Type II effectiveness-implementation, cluster randomized trial of TĀCcare 2.0 facilitated by dialysis staff in a real-world setting. This is a multi-center, dialysis-clinic level cluster randomized trial of 424 patients from 36 dialysis clinics comparing TACcare 2.0 facilitated by dialysis staff versus usual care. Patients' dialysis clinic will be placed randomly into one of two study groups: the Technology Assisted Stepped Collaborative Care Intervention Group or the Usual Care Group. The intervention will target three of the most debilitating End State Kidney Disease (ESKD) related symptoms- fatigue, pain and depression. A stepped collaborative care approach for pharmaco and/or CBT allows for shared decision-making and individualization of treatment according to a patient's clinical status, preferences and treatment response. The TĀCcare 2.0 intervention will build on successful design elements of the original intervention, enhance depression management strategies and increase durability of effect by incorporating monthly longitudinal telemedicine-delivered booster sessions to complete a total 12-month intervention. Additionally, using a collaborative care approach, the patients' symptom management will be integrated with their dialysis treatment, thus increasing patient acceptability and adherence.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

424

Conditions

Chronic Kidney Disease Requiring Hemodialysis

Interventions

Technology Assisted Stepped Collaborative CareBEHAVIORAL

The TĀCcare 2.0 intervention will provide pharmacotherapy recommendations and/or CBT for pain, fatigue and depression. A stepped-treatment approach will be used to intensify treatment. CBT will be provided through 12 weekly telehealth sessions (done during dialysis treatment or from home) with the behavioral specialist. Booster sessions will be used to enhance the maintenance of effect following the initial intervention to complete a total 12 month intervention. A collaborative care approach will be used so that patients' symptom management will be integrated with their dialysis treatment. Throughout the study, participants will be asked to complete phone surveys about their symptoms and health.

Usual Care ArmOTHER

Participants in the Usual Care Arm will continue with their usual care.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Eligibility Criteria: 1. age 18 years or older; 2. undergoing thrice-weekly maintenance hemodialysis (HD) for \> 3 months; 3. English or Spanish speaking; 4. able to provide informed consent Ineligibility Criteria: 1. active thought disorder, delusions or active suicidal ideation 2. active substance abuse 3. enrolled in hospice or life expectancy \< 6 months (based on clinician's judgement) 4. too ill or cognitively impaired to participate based on renal provider's judgement 5. living kidney transplant scheduled in \<3 months 6. undergoing active cancer treatment. 7. enrolled in another research study 8. plan to transition to home dialysis within 3 months 9. plan to move to another dialysis facility within 3 months

Locations (2)

UNM

Albuquerque, New Mexico, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

TĀCcare 2.0 Effectiveness evaluation/Change in fatigue (co-primary outcome)

Change in fatigue is a primary outcome. The Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) will be used to measure fatigue. Scores range from 0-52 with lower scores indicating greater fatigue.

Time frame: 6 months

TĀCcare 2.0 Effectiveness evaluation/Change in Pain Intensity (co-primary outcome)

Change in pain intensity score is also a primary outcome measure. The Brief Pain Inventory (BPI) will be used to measure pain intensity. The BPI uses a scale of 0 to 10. Higher scores on the pain intensity scale indicate greater pain severity.

Time frame: 6 months

TĀCcare 2.0 Effectiveness evaluation/Change in Depression (co-primary outcome)

Change in depression severity score is also a primary outcome measure. The Beck Depression Inventory-II will be used to measure the depression severity score. Each item is scored on a 4 point scale ranging from 0 to 3, allowing for a total score ranging from 0 to 63. Higher scores indicate more severe symptoms.

Time frame: 6 months

Secondary Outcomes

Fatigue

Change in fatigue measured by The Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F). Scores range from 0-52 with lower scores indicating greater fatigue.

Time frame: 3 and 12 months

Pain Intensity

Change in pain intensity measured by Brief Pain Inventory (BPI), which uses a scale of 0 to 10. Higher scores on the pain intensity scale indicate greater pain severity.

Time frame: 3 and 12 months

Depression

Change in depression severity score using The Beck Depression Inventory-II (BDI-II). Each item is scored on a 4 point scale ranging from 0 to 3, allowing for a total score ranging from 0 to 63. Higher scores indicate more severe symptoms.

Central Contacts

Manisha Jhamb, MD, MPH

CONTACT

412-647-7062 jhambm@upmc.edu

Mark Unruh, MD, MS

CONTACT

(505) 272-0407 MLUnruh@salud.unm.edu

Data from ClinicalTrials.gov

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