Shared Decision Making in Dialysis

NCT ID: NCT04392440

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2024-05-14

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.

Conditions

End Stage Renal Disease; Chronic Kidney Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

intervention

Group Type: EXPERIMENTAL

DIAL-SDM

Intervention Type: BEHAVIORAL

Communication intervention for nephrologists and coaching intervention for patients.

control

Usual care

Group Type: OTHER

usual care

Intervention Type: OTHER

regular nephrology care

Interventions

DIAL-SDM

Communication intervention for nephrologists and coaching intervention for patients.

Intervention Type: BEHAVIORAL

usual care

regular nephrology care

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Fahad Saeed

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

K23DK121939

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00004907

Identifier Type: -

Identifier Source: org_study_id