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RCT of a Stepped Peer Navigator-licensed Clinical Social Worker Intervention for Racial/Ethnic Minority Dialysis Patients

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ClinicalTrials.gov Identifier: NCT03978806
Recruitment Status : Not yet recruiting
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Lilia Cervantes, Denver Health and Hospital Authority

Brief Summary:
Latinos with End-Stage Renal Disease (ESRD) represent 17% of the US adult ESRD community and compared to non-Latino whites, they are 1.6 times more likely to develop depressive affect. Depressive affect among ESRD patients is associated with a reduced Health-Related Quality of Life (HRQOL), reduced renal therapy adherence, greater morbidity, and increased mortality. In addition, depressive affect is adversely affected by Limited English Proficiency (LEP) and many other social factors. With support from the Amos award from the Robert Wood Johnson Foundation (RWJF), the investigators assessed the feasibility of a 5-visit lay Peer Navigator intervention to support Latino ESRD patients with social challenges and to activate them to seek mental healthcare. The investigator's peer navigator intervention is feasible; however, the investigator's research showed that two-thirds of Latino ESRD patients with limited English proficiency report depressive affect yet do not seek care due to cultural preferences and language barriers. The proposed study will build on the investigator's Amos RWJF work by expanding the peer navigator intervention to include a bilingual Licensed Clinical Social Worker (LCSW) that will provide individual dialysis Chairside Cognitive Behavioral Therapy (CCBT) sessions while the peer navigator provides support with social factors. This patient-centered approach is culturally tailored and will bridge the gap to mental health services. The overall aims of this proposal are to: 1) engage key operational and clinical stakeholders early-on to develop a Peer Navigator-Licensed Clinical Social Worker (PN-LCSW) intervention; 2) conduct a pilot RCT of the PN-LCSW intervention versus standard care to test feasibility and acceptability; and 3) assess the efficacy of the intervention on depressive affect (primary outcome) as well as health-related quality of life and hemodialysis adherence (secondary outcomes).

Condition or disease Intervention/treatment Phase
Racial/Ethnic Minorities on Dialysis Behavioral: Active Comparator: peer navigator - licensed clinical social worker Other: Placebo Comparator: Control Arm (standard of care) Not Applicable

Detailed Description:

Specific Aim: Conduct a pilot RCT of the PN-LCSW intervention to test feasibility and acceptability.

Overview: The goal of this project is to develop a culturally tailored intervention to improve outcomes for Latino ESRD patients with LEP and depressive affect. The investigators will conduct a pilot RCT study comparing a culturally tailored intervention that includes both a PN and a LCSW to control (standard care). In the culturally tailored intervention, the bilingual PN will provide support with social factors during 5 visits and a bilingual LCSW will provide mental health therapy during eight 60-minute dialysis Chairside Cognitive Behavioral Therapy (CCBT) sessions. The investigators will assess the feasibility of (1) referral, (2) recruitment, (3) retention, (4) intervention implementation, and (5) data collection. Acceptability will be assessed with qualitative interviews of patients, the PN and LCSW, and dialysis center staff to explore barriers and facilitators in preparation for the R01.

Hypothesis: A culturally tailored intervention using a bilingual PN who provides support with social factors and a bilingual LCSW who provides CCBT for depressed LEP Latino ESRD patients is feasible and acceptable.

Study design and setting: This will be a pilot RCT of a 20-week intervention of Latino ESRD patients with depressive affect (Beck Depression Inventory II score >10,5)and Limited English Proficiency (Census-LEP) that will be randomized to one of two arms: 1) PN and LCSW Arm, in which a bilingual PN provides support with social factors during 5 visits and a bilingual LCSW provides mental health support over eight 60-minute dialysis CCBT sessions or 2) Control (standard care) Arm. The investigators will ask participants if they have any concerns about the privacy setting and have a designated room where patients can opt to have their CCBT session before or after dialysis. If a participant reveals intent to harm self or others, the investigators will notify dialysis staff and a Denver psychologist who agrees to be contacted in an emergency situation and will oversee the risk assessment .

Study population: Participants will include 100 Latino adults with depressive affect, ESRD, and LEP.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a pilot RCT of a 20-week intervention of Latino ESRD patients with depressive affect (Beck Depression Inventory II score >10)22,52 and Limited English Proficiency (Census-LEP)53 that will be randomized to one of two arms: 1) PN and LCSW Arm, in which a bilingual PN provides support with social factors during 5 visits and a bilingual LCSW provides mental health support over eight 60-minute dialysis CCBT sessions or 2) Control (standard care) Arm.
Masking: Single (Investigator)
Masking Description: The PI will not know arm assignment.
Primary Purpose: Health Services Research
Official Title: Pilot RCT of a Stepped Peer Navigator-licensed Clinical Social Worker Intervention for Racial/Ethnic Minority Dialysis Patients to Improve Patient-centered and Clinical Outcomes
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Active Comparator: peer navigator-licensed clinical social worker
The bilingual PN will provide support with social factors during 5 visits and the bilingual LCSW will provide mental health therapy during eight 60-minute dialysis CCBT sessions.
Behavioral: Active Comparator: peer navigator - licensed clinical social worker
The intervention is aimed to provide support with social challenges and mental health well-being. The peer navigator will meet with patients to provide support with social challenges while the licensed clinical social worker may provide cognitive behavioral therapy.

Placebo Comparator: Control Arm (standard of care)
Control patients will have met the same inclusion and exclusion criteria as intervention patients. For all study subjects, we will communicate the outcome of the BDI-II depression screen with dialysis center staff. When a patient is diagnosed with depression, CMS Quality Incentive Program (QIP) requires a 'follow-up plan' which must include at least one of the following: 1) additional evaluation for depression; 2) suicide risk assessment; 3) referral to a practitioner who is qualified to diagnose and treat depression; or 4) pharmacologic interventions. If a patient reveals intent to harm self or others, we will notify dialysis staff and a psychologist who agrees to be contacted in an emergency situation and will oversee the risk assessment.
Other: Placebo Comparator: Control Arm (standard of care)
Control patients will have met the same inclusion and exclusion criteria as intervention patients. For all study subjects, we will communicate the outcome of the BDI-II depression screen with dialysis center staff. When a patient is diagnosed with depression, CMS Quality Incentive Program (QIP) requires a 'follow-up plan' which must include at least one of the following: 1) additional evaluation for depression; 2) suicide risk assessment; 3) referral to a practitioner who is qualified to diagnose and treat depression; or 4) pharmacologic interventions.




Primary Outcome Measures :
  1. Depressive Affect [ Time Frame: Change from baseline depression up to 24 months ]
    Beck Depression Inventory-II: 21-item self-report instrument (BDI>10 for depressive affect) - available in Spanish and both valid and reliable among various ethnic groups.


Secondary Outcome Measures :
  1. Health-related quality of life [ Time Frame: Change from baseline health-related quality of life up to 24 months ]
    Kidney Disease Quality Of Life - Short Form 3641,42

  2. Social well-being [ Time Frame: Change from baseline social well-being up to 24 months ]
    Multi-dimensional scale of perceived social support

  3. Patient navigation [ Time Frame: From date of randomization until study completion up to 24 months ]
    Patient Navigation Process and Outcomes (PNPOM) Questionnaire: The questionnaire includes questions that will assess self-efficacy, patient activation, and support with resources

  4. Dialysis adherence [ Time Frame: Assessed 3 months prior to enrollment, monitored monthly during intervention, and followed for 3 months after intervention ]
    Hemodialysis adherence (skipping or shortening) Skipped treatments will be defined as the proportion of monthly scheduled sessions missed (other than for vacation or hospitalization) and shortened sessions as the proportion of monthly sessions that were shortened by patient request by ≥ 10 minutes.

  5. Fluid adherence [ Time Frame: Assessed 3 months prior to enrollment, monitored monthly during intervention, and followed for 3 months after intervention ]
    Inter-dialytic weight gain will be calculated as the monthly average of the difference between the pre-dialysis weight and the weight at the end of the previous dialysis session, divided by determined dry weight, expressed as a percentage of change in weight per day (%Δkg per day).



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ESRD diagnosis
  • Received dialysis for more than 3 months
  • Self-identifies as Latino
  • Depressive symptoms (Beck Depression Inventory II score > 10)22,34,52 5)
  • Limited English proficiency and assessed using the U.S. Census English proficiency question (Census-LEP)53
  • Ability to provide informed consent
  • Age ≥ 18.

Exclusion Criteria:

  • Active suicidal intent
  • Present or past psychosis or bipolar disorder
  • Active use of substances (e.g.,alcohol or drugs)
  • Patient to receive kidney transplant in the next 3 months.

Publications:

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Responsible Party: Lilia Cervantes, Associate Professor, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT03978806     History of Changes
Other Study ID Numbers: DH
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: There is no plan to share individual participant data at this time. If this changes, this section will be modified.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No