Shared Decision Making in Dialysis

Chronic Kidney Diseases Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04392440
• Other study ID #: STUDY00004907
• Secondary ID: K23DK121939
• Status: Completed
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: May 14, 2024

Study information

• Verified date: June 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: May 14, 2024
• Est. primary completion date: May 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• DIAL-SDM
Communication intervention for nephrologists and coaching intervention for patients.

Other:
• usual care
regular nephrology care

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of DIAL-SDM intervention	This outcome will be measured in 30 patients in the Intervention Group	Approximately 12 months
Primary	acceptability of DIAL-SDM intervention	This outcome will be measure in 30 patients in the Intervention Group	Approximately 12 months
Primary	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.	Approximately 12 months