DIAL-SDM: Shared Decision Making in Dialysis
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: intervention
|
Behavioral: DIAL-SDM
Communication intervention for nephrologists and coaching intervention for patients.
|
| Other: control Usual care |
Other: usual care
regular nephrology care
|
Outcome Measures
Primary Outcome Measures
- Mean feasibility of DIAL-SDM intervention [Approximately 12 months]
This outcome will be measure in 30 patients in the Intervention Group by the following measure. Feasibility of the Intervention Measure is a 4-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Higher scores indicate greater feasibility. The score ranges from 0-20.
- mean acceptability of DIAL-SDM intervention [Approximately 12 months]
This outcome will be measure in 30 patients in the Intervention Group by the following measures respectively. Acceptability of the Intervention Measure is a 4-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Higher scores indicate greater acceptability. The score ranges from 0-20.
- fidelity of DIAL-SDM intervention [Approximately 12 months]
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. It will be reported as the number of checklists that are at least 90% complete.
Eligibility Criteria
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)
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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.
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Rochester | Rochester | New York | United States | 14642 |
Sponsors and Collaborators
- University of Rochester
- National Institutes of Health (NIH)
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00004907
- K23DK121939