Clinical trial NCT04392440: Shared Decision Making in Dialysis
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
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Chronic Kidney Diseases
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-05-18
Enrollment: 107
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: feasibility of DIAL-SDM intervention
timeFrame: Approximately 12 months
measure: acceptability of DIAL-SDM intervention
timeFrame: Approximately 12 months
measure: fidelity of DIAL-SDM intervention
timeFrame: Approximately 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References: