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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK121939 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental |
| |
| control | Other | Usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DIAL-SDM | Behavioral | Communication intervention for nephrologists and coaching intervention for patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Feasibility of Intervention Measure | 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. | Approximately 12-14 weeks |
| Mean Acceptability of Intervention Measure | 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. | Approximately 12-14 weeks |
| Mean Total Fidelity of Intervention Measure | 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. |
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Inclusion Criteria:
For nephrologist:
For patients:
For Caregivers:
Exclusion Criteria:
For Nephrologists:
- Expecting to leave in six months.
For Patients:
For Caregivers:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | DIAL-SDM: Communication intervention for nephrologists and coaching intervention for patients. |
| FG001 | Control | Usual care usual care: regular nephrology care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline measures include data from all participants who provided information at enrollment (patients, nephrologists, and caregivers). Separate rows show data for each group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | DIAL-SDM: Communication intervention for nephrologists and coaching intervention for patients and their caregivers when applicable. |
| BG001 | Control | Usual care: Regular nephrology care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Baseline measures include data from all participants who provided information at enrollment (patients, caregivers, and nephrologists). Separate rows show data for each group. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Feasibility of Intervention Measure | 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. | This outcome was measured in the intervention group only. | Posted | Mean | Standard Deviation | score on a scale | Approximately 12-14 weeks |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Patients | DIAL-SDM: Communication intervention for patients. | 1 |
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This was a small, pilot, cluster-randomized trial with a limited sample size (N=60 patients).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fahad Saeed, MD, Principal Investigator | Strong Nephrology | 585-275-4517 | Fahad_Saeed@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 28, 2025 | Sep 23, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 9, 2023 | Sep 23, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| usual care | Other | regular nephrology care |
|
| Assessed across all coaching sessions (First Visit, Second Visit, and Follow-Up Call) over approximately 12-14 weeks post-baseline |
| Lost to Follow-up |
|
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Baseline measures include data from all participants who provided information at enrollment (patients, nephrologists, and caregivers). Separate rows show data for each group. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Baseline measures include data from all participants who provided information at enrollment (patients, nephrologists, and caregivers). Separate rows show data for each group. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Baseline measures include data from all participants who provided information at enrollment (patients, nephrologists, and caregivers). Separate rows show data for each group. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
DIAL-SDM: Communication intervention for patients
| OG001 | Control Patients | Usual care: regular nephrology care |
| OG002 | Intervention Caregivers | DIAL-SDM: Communication intervention for caregivers |
| OG003 | Control Caregivers | Usual care: regular nephrology care |
| OG004 | Intervention Nephrologists | DIAL-SDM: Communication intervention for nephrologists |
| OG005 | Control Nephrologists | Usual care: regular nephrology care |
|
|
| Primary | Mean Acceptability of Intervention Measure | 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. | This outcome was only measured in the Intervention Group | Posted | Mean | Standard Deviation | score on a scale | Approximately 12-14 weeks |
|
|
|
| Primary | Mean Total Fidelity of Intervention Measure | 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. | The audio capture of the patient visit with the interventionist failed for two patients. This measure was only collected for patients in the intervention group. | Posted | Mean | Standard Deviation | percentage of score on a scale | Assessed across all coaching sessions (First Visit, Second Visit, and Follow-Up Call) over approximately 12-14 weeks post-baseline |
|
|
|
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Control Patients | Usual care: regular nephrology care | 2 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Intervention Caregivers | DIAL-SDM: Communication intervention for caregivers. | 1 | 11 | 0 | 11 | 0 | 11 |
| EG003 | Control Caregivers | Usual care: regular nephrology care | 2 | 14 | 0 | 14 | 0 | 14 |
| EG004 | Intervention Nephrologists | DIAL-SDM: Communication intervention for nephrologists. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG005 | Control Nephrologists | Usual care: regular nephrology care | 0 | 8 | 0 | 8 | 0 | 8 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Between 18 and 65 years |
|
| >=65 years |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Male |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|