Trial Outcomes & Findings for Bringing Care to Patients: Patient-Centered Medical Home for Kidney Disease (NCT NCT02270515)
NCT ID: NCT02270515
Last Updated: 2017-04-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
175 participants
Primary outcome timeframe
Baseline (0) to 18 months
Results posted on
2017-04-07
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Intervention Period 1: 0-6 Months
STARTED
|
175
|
|
Intervention Period 1: 0-6 Months
COMPLETED
|
159
|
|
Intervention Period 1: 0-6 Months
NOT COMPLETED
|
16
|
|
Intervention Period 2: 6-12 Months
STARTED
|
159
|
|
Intervention Period 2: 6-12 Months
COMPLETED
|
127
|
|
Intervention Period 2: 6-12 Months
NOT COMPLETED
|
32
|
|
Intervention Period 3: 12-18 Months
STARTED
|
127
|
|
Intervention Period 3: 12-18 Months
COMPLETED
|
103
|
|
Intervention Period 3: 12-18 Months
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Intervention Period 1: 0-6 Months
Withdrawal by Subject
|
1
|
|
Intervention Period 1: 0-6 Months
No longer patient at study site
|
5
|
|
Intervention Period 1: 0-6 Months
Received transplant
|
3
|
|
Intervention Period 1: 0-6 Months
Death
|
7
|
|
Intervention Period 2: 6-12 Months
Withdrawal by Subject
|
2
|
|
Intervention Period 2: 6-12 Months
No longer patient at study site
|
7
|
|
Intervention Period 2: 6-12 Months
Received transplant
|
1
|
|
Intervention Period 2: 6-12 Months
Death
|
5
|
|
Intervention Period 2: 6-12 Months
Intervention ended before follow-up
|
17
|
|
Intervention Period 3: 12-18 Months
Withdrawal by Subject
|
1
|
|
Intervention Period 3: 12-18 Months
No longer patient at study site
|
2
|
|
Intervention Period 3: 12-18 Months
Received transplant
|
2
|
|
Intervention Period 3: 12-18 Months
Death
|
3
|
|
Intervention Period 3: 12-18 Months
Intervention ended before follow-up
|
16
|
Baseline Characteristics
No Response: 1 participant
Baseline characteristics by cohort
| Measure |
PCMH-KD Dialysis Care
n=175 Participants
Enrolled patients had access to an expanded care team inlcuding a primary care doctor, nurse coordinator, community health worker, and pharmacist.
|
|---|---|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 15 • n=175 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=175 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=175 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African-American
|
86 Participants
n=175 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic/other
|
89 Participants
n=175 Participants
|
|
Region of Enrollment
United States
|
175 participants
n=175 Participants
|
|
Interview language
English
|
117 Participants
n=175 Participants
|
|
Interview language
Spanish
|
58 Participants
n=175 Participants
|
|
Race/ethnicity*language
African-American
|
86 Participants
n=175 Participants
|
|
Race/ethnicity*language
Hispanic/other, English interview
|
31 Participants
n=175 Participants
|
|
Race/ethnicity*language
Hispanic, Spanish interview
|
58 Participants
n=175 Participants
|
|
Primary language
English
|
107 Participants
n=175 Participants
|
|
Primary language
Spanish/other
|
54 Participants
n=175 Participants
|
|
Primary language
Both equally
|
14 Participants
n=175 Participants
|
|
Marital status
Single, never married
|
70 Participants
n=175 Participants
|
|
Marital status
Married/Living with a partner
|
62 Participants
n=175 Participants
|
|
Marital status
Widowed
|
22 Participants
n=175 Participants
|
|
Marital status
Separated, divorced
|
21 Participants
n=175 Participants
|
|
Children under 18 yr in household
No children under 18 yr in household
|
132 Participants
n=175 Participants
|
|
Children under 18 yr in household
1 child under 18 yr in household
|
22 Participants
n=175 Participants
|
|
Children under 18 yr in household
≥ 2 children under 18 yr in household
|
21 Participants
n=175 Participants
|
|
Education
Not HS graduate
|
62 Participants
n=175 Participants
|
|
Education
HS graduate/GED
|
100 Participants
n=175 Participants
|
|
Education
Bachelor's degree
|
13 Participants
n=175 Participants
|
|
Employment
Full-time/Self-employed
|
16 Participants
n=174 Participants • No Response: 1 participant
|
|
Employment
Part-time
|
15 Participants
n=174 Participants • No Response: 1 participant
|
|
Employment
Not employed
|
143 Participants
n=174 Participants • No Response: 1 participant
|
|
Income
Less than $20,000
|
108 Participants
n=175 Participants
|
|
Income
$20,000-$39,999
|
30 Participants
n=175 Participants
|
|
Income
≥ $40,000
|
22 Participants
n=175 Participants
|
|
Income
Refused
|
15 Participants
n=175 Participants
|
|
Dialysis History
Years on dialysis
|
4.4 years
STANDARD_DEVIATION 5.2 • n=174 Participants • Missing dialysis information for one (1) study participant.
|
|
Dialysis History
Years at current center
|
3.3 years
STANDARD_DEVIATION 4.4 • n=174 Participants • Missing dialysis information for one (1) study participant.
|
|
Primary transportation to clinic
Car (drive or ride)
|
87 Participants
n=175 Participants
|
|
Primary transportation to clinic
Transit (L train or bus)
|
14 Participants
n=175 Participants
|
|
Primary transportation to clinic
Medicar (Medicaid)
|
42 Participants
n=175 Participants
|
|
Primary transportation to clinic
PACE paratransit/door to door
|
17 Participants
n=175 Participants
|
|
Primary transportation to clinic
Other
|
15 Participants
n=175 Participants
|
|
Insurance (any type)
Yes
|
158 Participants
n=175 Participants
|
|
Insurance (any type)
No
|
17 Participants
n=175 Participants
|
|
Comorbidities
None
|
15 Participants
n=175 Participants
|
|
Comorbidities
1
|
55 Participants
n=175 Participants
|
|
Comorbidities
2 to 3
|
91 Participants
n=175 Participants
|
|
Comorbidities
4 to 7
|
14 Participants
n=175 Participants
|
|
Stressful life events (e.g. hospitalization, loss of employment or family member) in past 6 months
Yes
|
79 Participants
n=175 Participants
|
|
Stressful life events (e.g. hospitalization, loss of employment or family member) in past 6 months
No
|
96 Participants
n=175 Participants
|
|
Regular doctor (Primary Care Physician)
Has regular personal doctor
|
104 Participants
n=175 Participants
|
|
Regular doctor (Primary Care Physician)
No regular personal doctor
|
71 Participants
n=175 Participants
|
|
Primary Care Assessment Survey (PCAS)
Longitudinal Continuity
|
52.9 units on a scale
STANDARD_DEVIATION 37.2 • n=104 Participants • 1. Longitudinal Continuity, Comprehensive Knowledge, Communication and Interpersonal Treatment scores are calculated for patients who reported having a regular personal doctor. 2. Integration of Care is calculated for patients who reported having a regular personal doctor and reported receiving referrals. 3. Numbers differ due to missing data.
|
|
Primary Care Assessment Survey (PCAS)
Comprehensive Knowledge
|
65.4 units on a scale
STANDARD_DEVIATION 21.3 • n=104 Participants • 1. Longitudinal Continuity, Comprehensive Knowledge, Communication and Interpersonal Treatment scores are calculated for patients who reported having a regular personal doctor. 2. Integration of Care is calculated for patients who reported having a regular personal doctor and reported receiving referrals. 3. Numbers differ due to missing data.
|
|
Primary Care Assessment Survey (PCAS)
Communication
|
74.3 units on a scale
STANDARD_DEVIATION 18.8 • n=104 Participants • 1. Longitudinal Continuity, Comprehensive Knowledge, Communication and Interpersonal Treatment scores are calculated for patients who reported having a regular personal doctor. 2. Integration of Care is calculated for patients who reported having a regular personal doctor and reported receiving referrals. 3. Numbers differ due to missing data.
|
|
Primary Care Assessment Survey (PCAS)
Interpersonal Treatment
|
75.2 units on a scale
STANDARD_DEVIATION 17.3 • n=104 Participants • 1. Longitudinal Continuity, Comprehensive Knowledge, Communication and Interpersonal Treatment scores are calculated for patients who reported having a regular personal doctor. 2. Integration of Care is calculated for patients who reported having a regular personal doctor and reported receiving referrals. 3. Numbers differ due to missing data.
|
|
Primary Care Assessment Survey (PCAS)
Integration of Care
|
67.8 units on a scale
STANDARD_DEVIATION 22.2 • n=64 Participants • 1. Longitudinal Continuity, Comprehensive Knowledge, Communication and Interpersonal Treatment scores are calculated for patients who reported having a regular personal doctor. 2. Integration of Care is calculated for patients who reported having a regular personal doctor and reported receiving referrals. 3. Numbers differ due to missing data.
|
|
Self-Efficacy for Managing Chronic Disease (SEMCD)
|
7.2 units on scale
STANDARD_DEVIATION 2.0 • n=174 Participants • Missing data for (1) study participant.
|
|
Chronic Hemodialysis Knowledge Survey (CHeKS)
|
51.8 units on scale
STANDARD_DEVIATION 15.7 • n=174 Participants • Missing data for one (1) study participant.
|
|
Health Literacy
Adequate (3-8)
|
106 Participants
n=175 Participants
|
|
Health Literacy
Inadequate/marginal (9-15)
|
69 Participants
n=175 Participants
|
PRIMARY outcome
Timeframe: Baseline (0) to 18 monthsPopulation: 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).
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.
Outcome measures
| Measure |
Baseline
n=174 Participants
KDQOL collected at Baseline
|
6 Months
n=153 Participants
KDQOL collected at 6 months
|
12 Months
n=125 Participants
KDQOL collected at 12 months
|
18 Months
n=103 Participants
KDQOL collected at 18 months
|
|---|---|---|---|---|
|
Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted
Physical Component Summary (PCS)
|
35.5 units on a scale
Standard Deviation 10.2
|
38.4 units on a scale
Standard Deviation 11.4
|
36.3 units on a scale
Standard Deviation 11.2
|
36.8 units on a scale
Standard Deviation 11.2
|
|
Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted
Mental Component Summary (MCS)
|
49.2 units on a scale
Standard Deviation 10.6
|
50.4 units on a scale
Standard Deviation 11.3
|
51.8 units on a scale
Standard Deviation 10.2
|
52.4 units on a scale
Standard Deviation 9.7
|
|
Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted
Burden of Kidney Disease
|
46.5 units on a scale
Standard Deviation 27.1
|
48.8 units on a scale
Standard Deviation 26.7
|
49.6 units on a scale
Standard Deviation 23.3
|
51.2 units on a scale
Standard Deviation 30.3
|
|
Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted
Symptoms/Problems of Kidney Disease
|
76.5 units on a scale
Standard Deviation 15.9
|
79.9 units on a scale
Standard Deviation 14.2
|
79.7 units on a scale
Standard Deviation 13.6
|
76.8 units on a scale
Standard Deviation 16.7
|
|
Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted
Effects of Kidney Disease
|
72.3 units on a scale
Standard Deviation 20.6
|
76.3 units on a scale
Standard Deviation 20.6
|
78.3 units on a scale
Standard Deviation 18.9
|
76.1 units on a scale
Standard Deviation 20.1
|
PRIMARY outcome
Timeframe: Baseline (0) to 18 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Baseline
n=172 Participants
KDQOL collected at Baseline
|
6 Months
n=147 Participants
KDQOL collected at 6 months
|
12 Months
n=125 Participants
KDQOL collected at 12 months
|
18 Months
n=102 Participants
KDQOL collected at 18 months
|
|---|---|---|---|---|
|
Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted
Physical Component Summary (PCS)
|
35.7 units on a scale
Standard Error 0.9
|
38.3 units on a scale
Standard Error 1.0
|
36.0 units on a scale
Standard Error 1.0
|
36.7 units on a scale
Standard Error 1.1
|
|
Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted
Mental Component Summary (MCS)
|
48.9 units on a scale
Standard Error 0.9
|
50.1 units on a scale
Standard Error 1.0
|
51.4 units on a scale
Standard Error 1.0
|
51.7 units on a scale
Standard Error 1.1
|
|
Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted
Burden of Kidney Disease
|
45.8 units on a scale
Standard Error 2.4
|
48.4 units on a scale
Standard Error 2.5
|
49.0 units on a scale
Standard Error 2.5
|
49.7 units on a scale
Standard Error 2.7
|
|
Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted
Symptoms/Problems of Kidney Disease
|
77.1 units on a scale
Standard Error 1.3
|
79.6 units on a scale
Standard Error 1.4
|
79.3 units on a scale
Standard Error 1.5
|
76.4 units on a scale
Standard Error 1.5
|
|
Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted
Effects of Kidney Disease
|
73.0 units on a scale
Standard Error 1.8
|
77.2 units on a scale
Standard Error 1.9
|
79.6 units on a scale
Standard Error 2.0
|
76.9 units on a scale
Standard Error 2.1
|
PRIMARY outcome
Timeframe: Baseline (0) to 18 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Baseline
n=173 Participants
KDQOL collected at Baseline
|
6 Months
n=173 Participants
KDQOL collected at 6 months
|
12 Months
n=173 Participants
KDQOL collected at 12 months
|
18 Months
n=173 Participants
KDQOL collected at 18 months
|
|---|---|---|---|---|
|
Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models
Physical Component Summary (PCS)
|
2.6 units on a scale
Standard Error 0.8
|
-2.3 units on a scale
Standard Error 0.9
|
0.7 units on a scale
Standard Error 1.0
|
1.0 units on a scale
Standard Error 1.0
|
|
Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models
Mental Component Summary (MCS)
|
1.2 units on a scale
Standard Error 1.0
|
1.3 units on a scale
Standard Error 1.0
|
0.3 units on a scale
Standard Error 1.1
|
2.8 units on a scale
Standard Error 1.1
|
|
Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models
Burden of Kidney Disease
|
2.6 units on a scale
Standard Error 2.0
|
0.6 units on a scale
Standard Error 2.0
|
0.6 units on a scale
Standard Error 2.2
|
3.8 units on a scale
Standard Error 2.1
|
|
Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models
Symptoms/Problems of Kidney Disease
|
2.6 units on a scale
Standard Error 1.1
|
-0.4 units on a scale
Standard Error 1.2
|
-2.9 units on a scale
Standard Error 1.3
|
-0.7 units on a scale
Standard Error 1.3
|
|
Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models
Effects of Kidney Disease
|
4.3 units on a scale
Standard Error 1.5
|
2.4 units on a scale
Standard Error 1.6
|
-2.8 units on a scale
Standard Error 1.8
|
3.9 units on a scale
Standard Error 1.7
|
Adverse Events
PCMH-KD Dialysis Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Denise M. Hynes, Professor, College of Medicine
University of Illinois, Chicago
Phone: 312-355-0083
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place