Chronic Kidney Diseases, End Stage Renal Disease
Conditions
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.
Interventions
BEHAVIORALDIAL-SDM
Communication intervention for nephrologists and coaching intervention for patients.
OTHERusual care
regular nephrology care
Sponsors
University of Rochester
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Feasibility of Intervention Measure | Approximately 12-14 weeks | Feasibility was assessed using a structured questionnaire that asked participants whether the coaching, question prompt list, booklet, and videos seemed possible, doable, easy to use, and able to be carried out in practice. Each item was rated on a scale from 1 ("completely disagree") to 5 ("completely agree"). Item scores were summed for each participant to create a total feasibility score, ranging from a minimum of 4 to a maximum of 20, with higher scores indicating greater feasibility. Assessments occurred at 12 and 14 weeks post-baseline; all data collected within this window were averaged to yield a single value per participant, and group means were reported. |
| Mean Acceptability of Intervention Measure | Approximately 12-14 weeks | Acceptability was assessed using the Acceptability of Intervention Measure. Patients and caregivers rated comfort with coaching, helpfulness for dialysis decision making, and likelihood to recommend it, as well as the question prompt list, booklet, and videos. Items were scored 0 to 4 and summed to total scores ranging from 6 to 15, with higher scores indicating greater acceptability and a more favorable outcome. Nephrologists rated approval, appeal, and acceptance of the coaching intervention on a 1 to 5 scale, summed to total scores ranging from 4 to 20, with higher scores indicating greater acceptability and a more favorable outcome. Assessments were collected 12 to 14 weeks post baseline and averaged per participant. |
| Mean Total Fidelity of Intervention Measure | Assessed across all coaching sessions (First Visit, Second Visit, and Follow-Up Call) over approximately 12-14 weeks post-baseline | Fidelity of coaching sessions was assessed using standardized Patient Coach Fidelity Check Forms for each session type: First Visit (maximum score = 51), Second Visit (maximum score = 42), and Follow-Up Phone Call (maximum score = 33). Each item was rated from 0 ("not at all") to 3 ("completely"). For each participant, scores from the First Visit, Second Visit, and Follow-up Call were converted to percentages (0-100%), then averaged to create a single fidelity score per participant, reflecting coaching quality across all sessions. Higher scores indicate greater fidelity. Assessments occurred between 12 and 14 weeks post-baseline; all data collected within this window were averaged to yield a single value per participant, and group means were reported. |
Countries
United States
Participant flow
Pre-assignment details
This was a cluster randomized trial, with randomization performed at the nephrologist level. Each nephrologist's participating patients (and their caregivers, when applicable) were assigned to the same study arm as the nephrologist. A total of 17 nephrologists were randomized: 9 to the Intervention group and 8 to the Control group.). Enrollment included nephrologists, patients, and caregivers.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical Caregivers <=18 years | 0 Participants |
| Age, Categorical Caregivers >=65 years | 10 Participants |
| Age, Categorical Caregivers Between 18 and 65 years | 9 Participants |
| Age, Categorical Nephrologists <=18 years | 0 Participants |
| Age, Categorical Nephrologists >=65 years | 0 Participants |
| Age, Categorical Nephrologists Between 18 and 65 years | 9 Participants |
| Age, Categorical Patients <=18 years | 0 Participants |
| Age, Categorical Patients >=65 years | 30 Participants |
| Age, Categorical Patients Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Caregivers Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Caregivers Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Nephrologists Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Nephrologists Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Nephrologists Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Patients Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Patients Not Hispanic or Latino | 60 Participants |
| Ethnicity (NIH/OMB) Patients Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Caregivers American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Caregivers Asian | 0 Participants |
| Race (NIH/OMB) Caregivers Black or African American | 2 Participants |
| Race (NIH/OMB) Caregivers More than one race | 0 Participants |
| Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Caregivers White | 12 Participants |
| Race (NIH/OMB) Nephrologists American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Nephrologists Asian | 10 Participants |
| Race (NIH/OMB) Nephrologists Black or African American | 0 Participants |
| Race (NIH/OMB) Nephrologists More than one race | 0 Participants |
| Race (NIH/OMB) Nephrologists Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Nephrologists Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Nephrologists White | 7 Participants |
| Race (NIH/OMB) Patients American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Patients Asian | 1 Participants |
| Race (NIH/OMB) Patients Black or African American | 5 Participants |
| Race (NIH/OMB) Patients More than one race | 1 Participants |
| Race (NIH/OMB) Patients Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Patients Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Patients White | 23 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Caregivers Female | 21 Participants |
| Sex: Female, Male Caregivers Male | 3 Participants |
| Sex: Female, Male Nephrologists Female | 6 Participants |
| Sex: Female, Male Nephrologists Male | 6 Participants |
| Sex: Female, Male Patients Female | 16 Participants |
| Sex: Female, Male Patients Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 30 | 2 / 30 | 1 / 11 | 2 / 14 | 0 / 9 | 0 / 8 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 11 | 0 / 14 | 0 / 9 | 0 / 8 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 11 | 0 / 14 | 0 / 9 | 0 / 8 |
Outcome results
None listed