Shared Decision Making in Dialysis (DIAL-SDM)
Primary Purpose
End Stage Renal Disease, Chronic Kidney Diseases
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DIAL-SDM
usual care
Sponsored by
About this trial
This is an interventional supportive care trial for End Stage Renal Disease
Eligibility Criteria
Inclusion Criteria:
For nephrologist:
- Member of Strong nephrology group working at Strong Memorial Hospital
- Treat patients with CKD
For patients:
- Age ≥65 years old
- Presence of advanced CKD stage 4 or 5 (i.e. e GFR ≤ 20 ml/min)
- Patient's nephrologist is enrolled in the study, and has seen that nephrologist at least once
- Speaks English
- Have not attended a dialysis education class or met with the dialysis education coordinator.
- Have not made a dialysis decision
For Caregivers:
- Self-identified caregiver (per definition:"family member, partner, friend or someone else who is involved with your health care issues, for example, someone who you talk to about personal issues including medical decisions or who comes to doctor appointments with you. This person may also help with routine day-to-day activities, like transportation or paperwork.")
- 21 years of age or older.
Exclusion Criteria:
For Nephrologists:
- Expecting to leave in six months.
For Patients:
- Patient has already been seen by a palliative care clinician or is enrolled in hospice
- Is already on dialysis
- Hospitalized at the time of recruitment
- Cognitive impairment
- Does not speak English
For Caregivers:
- If Support is offered primarily in a professional role (e.g., clergy).
- Cognitive impairment
Sites / Locations
- University of RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
intervention
control
Arm Description
Usual care
Outcomes
Primary Outcome Measures
feasibility of DIAL-SDM intervention
This outcome will be measured in 30 patients in the Intervention Group
acceptability of DIAL-SDM intervention
This outcome will be measure in 30 patients in the Intervention Group
fidelity of DIAL-SDM intervention
This outcome will be measured by looking at the fidelity in which the interventionists complete the intervention checklist after each visit for 30 patients in the Intervention Group.
Secondary Outcome Measures
Full Information
NCT ID
NCT04392440
First Posted
May 1, 2020
Last Updated
April 19, 2023
Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT04392440
Brief Title
Shared Decision Making in Dialysis
Acronym
DIAL-SDM
Official Title
Pilot Testing of a Communication Intervention to Promote Shared Dialysis Decision Making in Older Patients With Chronic Kidney Disease (DIAL-SDM Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Older patients ≥65 years with chronic kidney disease (CKD) face challenges in decision making about dialysis. These patients report little effort by physicians to elicit treatment preferences, discuss prognoses, or explain the burdens/benefits of dialysis options including conservative management. Older patients with CKD often prefer maintaining the quality of life over prolonging life, and many regret their decision to start dialysis: nearly one quarter withdraw from dialysis each year. Shared dialysis decision-making requires active engagement between nephrologists and patients to align patient, caregiver, and physician communication around common goals. The proposed study is a pilot randomized cluster trial of a dialysis shared decision-making (DIAL-SDM) intervention for nephrologists (n=20) and their patients ≥65 years old (n=60) with an estimated glomerular filtration rate (eGFR) of ≤ 20 ml/min/ /1.73 m2. Nephrologists in the Intervention Group will receive 3 communication training sessions, delivered by a standardized patient instructor (SPI) who enact clinical scenarios and offer feedback. In parallel, patients (and caregivers, if available) will receive 2 coaching sessions provided by health coaches, who will explore each patient's relevant contextual information (values, preferences, and goals), and help them identify and practice important questions for their nephrologist. Nephrologists in the Control Group will provide their patients with usual care. The study outcomes will be assessed during two nephrology office visits and at 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Chronic Kidney Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Title
control
Arm Type
Other
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
DIAL-SDM
Intervention Description
Communication intervention for nephrologists and coaching intervention for patients.
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
regular nephrology care
Primary Outcome Measure Information:
Title
feasibility of DIAL-SDM intervention
Description
This outcome will be measured in 30 patients in the Intervention Group
Time Frame
Approximately 12 months
Title
acceptability of DIAL-SDM intervention
Description
This outcome will be measure in 30 patients in the Intervention Group
Time Frame
Approximately 12 months
Title
fidelity of DIAL-SDM intervention
Description
This outcome will be measured by looking at the fidelity in which the interventionists complete the intervention checklist after each visit for 30 patients in the Intervention Group.
Time Frame
Approximately 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
For nephrologist:
Member of Strong nephrology group working at Strong Memorial Hospital
Treat patients with CKD
For patients:
Age ≥65 years old
Presence of advanced CKD stage 4 or 5 (i.e. e GFR ≤ 20 ml/min)
Patient's nephrologist is enrolled in the study, and has seen that nephrologist at least once
Speaks English
Have not attended a dialysis education class or met with the dialysis education coordinator.
Have not made a dialysis decision
For Caregivers:
Self-identified caregiver (per definition:"family member, partner, friend or someone else who is involved with your health care issues, for example, someone who you talk to about personal issues including medical decisions or who comes to doctor appointments with you. This person may also help with routine day-to-day activities, like transportation or paperwork.")
21 years of age or older.
Exclusion Criteria:
For Nephrologists:
- Expecting to leave in six months.
For Patients:
Patient has already been seen by a palliative care clinician or is enrolled in hospice
Is already on dialysis
Hospitalized at the time of recruitment
Cognitive impairment
Does not speak English
For Caregivers:
If Support is offered primarily in a professional role (e.g., clergy).
Cognitive impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon M Hanley, BS
Phone
585-275-7033
Email
shannon_hanley@urmc.rochester.edu
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Hanley, BS
Phone
585-275-7033
Email
shannon_hanley@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Fahad Saeed, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Shared Decision Making in Dialysis
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