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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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This study will implement and evaluate a patient-centered medical home for kidney disease (PCMH-KD) compared to the usual model of dialysis care. Patients will be observed for an initial baseline period under the usual care model and then the usual dialysis care team will be expanded to include a pharmacist, community health worker, nurse coordinator and a primary care doctor. Outcomes of interest will be assessed at baseline and then every 6 months after the PCMH-KD intervention commences.
Patients with end-stage renal disease (ESRD), have unique and complex care needs associated with renal disease and common comorbidities (e.g., diabetes, hypertension), and under the current care model, receive fragmented care from multiple providers at multiple locations. ESRD patients typically spend three to five hours undergoing dialysis three days a week. Scheduling and traveling to other appointments are difficult to manage, increase patient and caregiver burden, and reduce patients' quality of life. These challenges keep many ESRD patients from receiving care for other conditions outside of the dialysis setting, resulting in higher rates of complications, and emergent healthcare use.
The patient-centered medical home (PCMH) model has been proposed as a solution to patients with complex needs such as those with ESRD. The purpose of this project is to compare a PCMH model of care with the usual care of ESRD patients and their caregivers. We propose to enhance the usual care team for ESRD patients by providing a primary care doctor in the context of regularly scheduled dialysis sessions and by adding community health workers to help support patients and their caregivers. Patient and family stakeholders and care team members will assist in the design and refinement of the PCMH model.
We plan to implement this model at the University of Illinois Hospital and Health Sciences System (UIHS) dialysis center and a local Fresenius Medical Care dialysis center. Patients receiving dialysis at participating centers will receive an initial comprehensive care visit followed by ongoing care from a multispecialty provider team during the patients' regularly scheduled dialysis visits. Each patient's care team will include a kidney doctor, a primary care doctor, a nurse coordinator, a dialysis nurse, a dietician, a pharmacist, a social worker, and a community health worker. The primary care doctor will be available in the dialysis clinic to provide general and preventive care to the patient before or after dialysis sessions. This doctor would also coordinate care with other specialists/clinicians on the patient's care team. The trained, bilingual (English/Spanish) community health worker will assist with making and rescheduling appointments, obtaining transportation, and reinforcing education components.
We expect that this approach will increase patient access to care for other conditions and will increase care coordination and communication among members of the patient's care team. These improvements could potentially increase the likelihood of preventing complications or identifying problems earlier and allow for a more successful treatment. We expect that this enhanced care team will reduce emergency room visits and hospitalizations for dialysis patients. In addition, we anticipate that the addition of community health workers to the clinical team will help support and educate patients and their caregivers and as a result, patient quality of life will improve and caregiver burden may be reduced.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCMH-KD dialysis care | Experimental | Dialysis care team is expanded to include a primary care doctor, nurse coordinator, community health worker, and pharmacist. Enrolled patients are observed for an initial baseline period receiving care under the usual dialysis care model called the 'usual dialysis care phase'. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-Centered Medical Home for Kidney Disease (PCMH-KD) | Other | A PCMH-KD enhances the usual dialysis care team by adding a primary care doctor, pharmacist, nurse coordinator and community health worker to the care team. |
| Measure | Description | Time Frame |
|---|---|---|
| Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. | Baseline (0) to 18 months |
| Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. Adjusted means are from random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Baseline (0) to 18 months |
| Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. | Baseline (0) to 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denise Hynes, PhD, MPH, RN | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fresenius Medical Care Chicago Westside dialysis center | Chicago | Illinois | 60608 | United States | ||
| University of Illinois Hospital and Health Sciences System dialysis center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25735489 | Background | Porter AC, Fitzgibbon ML, Fischer MJ, Gallardo R, Berbaum ML, Lash JP, Castillo S, Schiffer L, Sharp LK, Tulley J, Arruda JA, Hynes DM. Rationale and design of a patient-centered medical home intervention for patients with end-stage renal disease on hemodialysis. Contemp Clin Trials. 2015 May;42:1-8. doi: 10.1016/j.cct.2015.02.006. Epub 2015 Feb 28. | |
| 27197911 |
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Clinical data (six months prior to enrollment date) was collected from the electronic medical record for all participants to compare the "usual care" for enrolled patients with the care received during the PCMH-KD intervention.
The PCMH-KD model was implemented at two dialysis centers, an academic dialysis center and a private dialysis center. Patients were recruited, screened and enrolled at both sites. After consenting, study participants completed a baseline survey and on a rolling basis three follow-up interviews at six, twelve, and eighteen months.
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| ID | Title | Description |
|---|---|---|
| FG000 | PCMH-KD Dialysis Care | Dialysis care team is expanded to include a primary care doctor, nurse coordinator, community health worker, and a pharmacist. Patient-Centered Medical Home for Kidney Disease (PCMH-KD): A PCMH-KD enhances the usual dialysis care team by adding a primary care doctor, pharmacist, nurse coordinator and community health worker to the care team. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Period 1: 0-6 Months |
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| Intervention Period 2: 6-12 Months |
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| Intervention Period 3: 12-18 Months |
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| ID | Title | Description |
|---|---|---|
| BG000 | PCMH-KD Dialysis Care | Enrolled patients had access to an expanded care team inlcuding a primary care doctor, nurse coordinator, community health worker, and pharmacist. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. | Overall number of participants analyzed are the number who completed the KDQOL at each visit. They differ slightly from the number of participants in the flow chart due to missing KDQOL data. Ns are slightly lower for some scale scores due to missing items (see below). | Posted | Mean | Standard Deviation | units on a scale | Baseline (0) to 18 months |
|
Baseline to 18 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 | PCMH-KD Dialysis Care | Dialysis care team is expanded to include a primary care doctor, nurse coordinator, community health worker, and pharmacist. Patient-Centered Medical Home for Kidney Disease (PCMH-KD): A PCMH-KD enhances the usual dialysis care team by adding a primary care doctor, pharmacist, nurse coordinator and community health worker to the care team. |
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Subjects were not randomized to the intervention, although their experience prior to the intervention (baseline measures) served as the historical control. Only two sites were included in the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Denise M. Hynes, Professor, College of Medicine | University of Illinois, Chicago | 312-355-0083 | dhynes@uic.edu |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Chicago |
| Illinois |
| 60612 |
| United States |
| Cukor D, Cohen LM, Cope EL, Ghahramani N, Hedayati SS, Hynes DM, Shah VO, Tentori F, Unruh M, Bobelu J, Cohen S, Dember LM, Faber T, Fischer MJ, Gallardo R, Germain MJ, Ghahate D, Grote N, Hartwell L, Heagerty P, Kimmel PL, Kutner N, Lawson S, Marr L, Nelson RG, Porter AC, Sandy P, Struminger BB, Subramanian L, Weisbord S, Young B, Mehrotra R. Patient and Other Stakeholder Engagement in Patient-Centered Outcomes Research Institute Funded Studies of Patients with Kidney Diseases. Clin J Am Soc Nephrol. 2016 Sep 7;11(9):1703-1712. doi: 10.2215/CJN.09780915. Epub 2016 May 19. |
| 26622920 | Background | Hynes DM, Buscemi J, Quintiliani LM; Society of Behavioral Medicine Health Policy Committee. Society of Behavioral Medicine (SBM) position statement: SBM supports increased efforts to integrate community health workers into the patient-centered medical home. Transl Behav Med. 2015 Dec;5(4):483-5. doi: 10.1007/s13142-015-0340-1. Epub 2015 Aug 28. |
| 27769897 | Result | Hynes DM, Fischer MJ, Schiffer LA, Gallardo R, Chukwudozie IB, Porter A, Berbaum M, Earheart J, Fitzgibbon ML. Evaluating a novel health system intervention for chronic kidney disease care using the RE-AIM framework: Insights after two years. Contemp Clin Trials. 2017 Jan;52:20-26. doi: 10.1016/j.cct.2016.10.003. Epub 2016 Oct 18. |
| Death |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Hispanic/other category consist of Hispanic and participants of unidentified race | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Interview language | Count of Participants | Participants |
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| Race/ethnicity*language | Count of Participants | Participants |
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| Primary language | Count of Participants | Participants |
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| Marital status | Count of Participants | Participants |
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| Children under 18 yr in household | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Employment | No Response: 1 participant | Count of Participants | Participants |
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| Income | Count of Participants | Participants |
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| Dialysis History | Missing dialysis information for one (1) study participant. | Mean | Standard Deviation | years |
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| Primary transportation to clinic | Count of Participants | Participants |
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| Insurance (any type) | Count of Participants | Participants |
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| Comorbidities | Count of Participants | Participants |
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| Stressful life events (e.g. hospitalization, loss of employment or family member) in past 6 months | Count of Participants | Participants |
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| Regular doctor (Primary Care Physician) | Count of Participants | Participants |
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| Primary Care Assessment Survey (PCAS) | Primary Care Assessment Survey (PCAS) assesses patient satisfaction for five (5) primary care characteristics Longitudinal Continuity, Comprehensive Knowledge, Communication, Interpersonal Treatment, and Integration of Care. PCAS scale scores ranges from 0 to 100. Higher scores are more positive (better outcome). |
| Mean | Standard Deviation | units on a scale |
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| Self-Efficacy for Managing Chronic Disease (SEMCD) | This 6-item scale measures confidence in common activities needed to managechronic conditions. Scores range from 1 to 10. Higher scores indicate higher self-efficacy. | Missing data for (1) study participant. | Mean | Standard Deviation | units on scale |
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| Chronic Hemodialysis Knowledge Survey (CHeKS) | Chronic Hemodialysis Knowledge Survey (CHeKS) measures patient's hemodialysis knowledge. Score ranges from 0 to 100. Mean score closer to 100 means better outcome/score. | Missing data for one (1) study participant. | Mean | Standard Deviation | units on scale |
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| Health Literacy | Health literacy score ranges from 3 to 15 with lower score meaning higher health literacy. | Count of Participants | Participants |
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| OG001 | 6 Months | KDQOL collected at 6 months |
| OG002 | 12 Months | KDQOL collected at 12 months |
| OG003 | 18 Months | KDQOL collected at 18 months |
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| Primary | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. Adjusted means are from random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Ns shown in the table are the number of records at each visit with data for the KDQOL scale score and all covariates. All available records were used to estimate the adjusted means. For all scales, N=173 participants; 2 were excluded due to missing data for covariates: dialysis vintage and PCP at baseline. | Posted | Mean | Standard Error | units on a scale | Baseline (0) to 18 months |
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| Primary | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. | All records with data for the KDQOL scale score (dependent variable) and covariates were included in the analysis. Two participants were excluded due to missing data for covariates: dialysis vintage and PCP at baseline. The previous table (adjusted means) shows the number of records with complete data for each visit. | Posted | Mean | Standard Error | units on a scale | Baseline (0) to 18 months |
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| 0 |
| 175 |
| 0 |
| 175 |
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| D052776 |
| Female Urogenital Diseases |
| 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 |
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| Mental Component Summary (MCS) |
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| Burden of Kidney Disease |
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| Symptoms/Problems of Kidney Disease |
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| Effects of Kidney Disease |
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| Mental Component Summary (MCS) |
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| Burden of Kidney Disease |
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| Symptoms/Problems of Kidney Disease |
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| Effects of Kidney Disease |
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| MCS: From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Mixed Models Analysis | 0.23 | This is the MCS KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3. | Superiority or Other |
| Burden: From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Mixed Models Analysis | 0.18 | This is the Burden KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3. | Superiority or Other |
| Symptoms: From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Mixed Models Analysis | 0.02 | This is the Symptoms KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3. | Superiority or Other |
| Effects: From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Mixed Models Analysis | 0.004 | This is the Effects KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3. | Superiority or Other |
| PCS: From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Mixed Models Analysis | 0.01 | This is the PCS KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3. | Superiority or Other |
| MCS: From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Mixed Models Analysis | 0.21 | This is the MCS KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3. | Superiority or Other |
| Burden: From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Mixed Models Analysis | 0.77 | This is the Burden KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3. | Superiority or Other |
| Symptoms: From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Mixed Models Analysis | 0.77 | This is the Symptoms KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3. | Superiority or Other |
| Effects: From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Mixed Models Analysis | 0.14 | This is the Effects KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3. | Superiority or Other |
| PCS: From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Mixed Models Analysis | 0.45 | This is the PCS KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3. | Superiority or Other |
| MCS: From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Mixed Models Analysis | 0.79 | This is the MCS KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3. | Superiority or Other |
| Burden: From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Mixed Models Analysis | 0.77 | This is the Burden KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3. | Superiority or Other |
| Symptoms: From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Mixed Models Analysis | 0.03 | This is the Symptoms KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3. | Superiority or Other |
| Effects: From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Mixed Models Analysis | 0.12 | This is the Effects KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3. | Superiority or Other |
| PCS: From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Mixed Models Analysis | 0.29 | This is the PCS KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3. | Superiority or Other |
| MCS: From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Mixed Models Analysis | 0.01 | This is the MCS KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3. | Superiority or Other |
| Burden: From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Mixed Models Analysis | 0.08 | This is the Burden KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3. | Superiority or Other |
| Symptoms: From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Mixed Models Analysis | 0.61 | This is the Symptoms KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3. | Superiority or Other |
| Effects: From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. | Mixed Models Analysis | 0.02 | This is the Effects KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3. | Superiority or Other |