Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in Integrated Palliative Outcome Score-Renal (IPOS-Renal) Score |
The scoring will include 11 questions on the degree of impact kidney-specific symptoms have had on patients over the past week, plus additional items on concerns beyond symptoms, such as information needs, practical issues, and family anxiety. This includes one question that has 15 sub-questions asking about specific physical symptoms. All scores are on a scale of 0-90, with lower scores representing less problems. |
Baseline, Month 6 |
|
Primary |
Recruitment Rate |
This will be reported as the percentage of participants who provide informed consent. |
Month 3 |
|
Primary |
Recruitment Rate |
This will be reported as the percentage of participants who provide informed consent. |
Month 6 |
|
Primary |
Recruitment Rate |
This will be reported as the percentage of participants who provide informed consent. |
Month 9 |
|
Primary |
Recruitment Rate |
This will be reported as the percentage of participants who provide informed consent. |
Month 12 |
|
Primary |
Recruitment Rate |
This will be reported as the percentage of participants who provide informed consent. |
Month 15 |
|
Primary |
Recruitment Rate |
This will be reported as the percentage of participants who provide informed consent. |
Month 18 |
|
Primary |
Recruitment Rate |
This will be reported as the percentage of participants who provide informed consent. |
Month 21 |
|
Primary |
Recruitment Rate |
This will be reported as the percentage of participants who provide informed consent. |
Month 24 |
|
Primary |
Number of Participants who Maintain Participation in the Study (Retention) |
|
Month 3 |
|
Primary |
Number of Participants who Maintain Participation in the Study (Retention) |
|
Month 6 |
|
Primary |
Number of Participants who Maintain Participation in the Study (Retention) |
|
Month 9 |
|
Primary |
Number of Participants who Maintain Participation in the Study (Retention) |
|
Month 12 |
|
Primary |
Number of Participants who Maintain Participation in the Study (Retention) |
|
Month 15 |
|
Primary |
Number of Participants who Maintain Participation in the Study (Retention) |
|
Month 18 |
|
Primary |
Number of Participants who Maintain Participation in the Study (Retention) |
|
Month 21 |
|
Primary |
Number of Participants who Maintain Participation in the Study (Retention) |
|
Month 24 |
|
Primary |
Number of participant dropouts (Retention) |
|
Month 3 |
|
Primary |
Number of participant dropouts (Retention) |
|
Month 6 |
|
Primary |
Number of participant dropouts (Retention) |
|
Month 9 |
|
Primary |
Number of participant dropouts (Retention) |
|
Month 12 |
|
Primary |
Number of participant dropouts (Retention) |
|
Month 15 |
|
Primary |
Number of participant dropouts (Retention) |
|
Month 18 |
|
Primary |
Number of participant dropouts (Retention) |
|
Month 21 |
|
Primary |
Number of participant dropouts (Retention) |
|
Month 24 |
|
Primary |
Average number of clinical visits attended per participant (Retention) |
|
Month 3 |
|
Primary |
Average number of clinical visits attended per participant (Retention) |
|
Month 6 |
|
Primary |
Average number of clinical visits attended per participant (Retention) |
|
Month 9 |
|
Primary |
Average number of clinical visits attended per participant (Retention) |
|
Month 12 |
|
Primary |
Average number of clinical visits attended per participant (Retention) |
|
Month 15 |
|
Primary |
Average number of clinical visits attended per participant (Retention) |
|
Month 18 |
|
Primary |
Average number of clinical visits attended per participant (Retention) |
|
Month 21 |
|
Primary |
Average number of clinical visits attended per participant (Retention) |
|
Month 24 |
|
Primary |
Ability to Collect Planned Data |
This will be reported as the percent of completed data surveys |
Month 3 |
|
Primary |
Ability to Collect Planned Data |
This will be reported as the percent of completed data surveys |
Month 6 |
|
Primary |
Ability to Collect Planned Data |
This will be reported as the percent of completed data surveys |
Month 9 |
|
Primary |
Ability to Collect Planned Data |
This will be reported as the percent of completed data surveys |
Month 12 |
|
Primary |
Ability to Collect Planned Data |
This will be reported as the percent of completed data surveys |
Month 15 |
|
Primary |
Ability to Collect Planned Data |
This will be reported as the percent of completed data surveys |
Month 18 |
|
Primary |
Ability to Collect Planned Data |
This will be reported as the percent of completed data surveys |
Month 21 |
|
Primary |
Ability to Collect Planned Data |
This will be reported as the percent of completed data surveys |
Month 24 |
|
Secondary |
Change in Kidney Disease Quality of Life (KDQOL-36) Score |
The KDQOL is a 36-item quality of life survey that includes five domains: Physical Component Summary (PCS), a Mental Component Summary (MCS), Burden of Kidney Disease Score, Symptoms and Problems of Kidney Disease Score, and Effect of Kidney Disease Score. All scores are on a scale of 0-100, with higher scores representing better quality of life. |
Baseline, Month 6 |
|
Secondary |
Engagement in Advance Care Planning |
Advance care planning will be measured by total number of advance care planning conversations held + number of documents such as surrogate decision makers, health care proxies, or treatment limiting directives. |
Baseline, Month 6 |
|