Original Investigation

Telehealth by an Interprofessional Team in Patients With CKD:

A Randomized Controlled Trial
Areef Ishani, MD, MS,1,2 Juleen Christopher, PhD,1 Deirdre Palmer, MD,1
Sara Otterness, NP,1 Barbara Clothier, MS,3 Sean Nugent, BA,3 David Nelson, PhD,3
and Mark E. Rosenberg, MD,2 on behalf of the Center for Innovative Kidney Care*

Background: Telehealth and interprofessional case management are newer strategies of care within
chronic disease management. We investigated whether an interprofessional team using telehealth was a
feasible care delivery strategy and whether this strategy could affect health outcomes in patients with chronic
kidney disease (CKD).
Study Design: Randomized clinical trial.
Setting & Participants: Minneapolis Veterans Affairs Health Care System (VAHCS), St. Cloud VAHCS,
and affiliated clinics March 2012 to November 2013 in patients with CKD (estimated glomerular filtration rate ,
60 mL/min/1.73 m2).
Interventions: Patients were randomly assigned to receive an intervention (n 5 451) consisting of care by
an interprofessional team (nephrologist, nurse practitioner, nurses, clinical pharmacy specialist, psychologist,
social worker, and dietician) using a telehealth device (touch screen computer with peripherals) or to usual
care (n 5 150).
Outcomes: The primary end point was a composite of death, hospitalization, emergency department visits,
or admission to skilled nursing facilities, compared to usual care.
Results: Baseline characteristics of the overall study group: mean age, 75.1 6 8.1 (SD) years; men, 98.5%;
white, 97.3%; and mean estimated glomerular filtration rate, 37 6 9 mL/min/1.73 m2. Telehealth and inter-
professional care were successfully implemented with meaningful engagement with the care system. One year
after randomization, 208 (46.2%) patients in the intervention group versus 70 (46.7%) in the usual-care group
had the primary composite outcome (HR, 0.98; 95% CI, 0.75-1.29; P 5 0.9). There was no difference between
groups for any component of the primary outcome: all-cause mortality (HR, 1.46; 95% CI, 0.42-5.11),
hospitalization (HR, 1.15; 95% CI, 0.80-1.63), emergency department visits (HR, 0.92; 95% CI, 0.68-1.24),
or nursing home admission (HR, 3.07; 95% CI, 0.71-13.24).
Limitations: Older population, mostly men, potentially underpowered/wide CIs.
Conclusions: Telehealth by an interprofessional team is a feasible care delivery strategy in patients with
CKD. There was no statistically significant evidence of superiority of this intervention on health outcomes
compared to usual care.
Am J Kidney Dis. 68(1):41-49. Published by Elsevier Inc. on behalf of the National Kidney Foundation, Inc.
This is a US Government Work. There are no restrictions on its use.

INDEX WORDS: Telemedicine; case management; chronic kidney disease (CKD); interprofessional relations;
chronic disease management; video monitoring; virtual visit; remote monitoring; patient education;
hypertension; hospitalization; mortality; randomized controlled trial.

location, and be of high value with the potential to reduce

Editorial, p. 5
overall health system costs.1 Telehealth is an example of
such a strategy. It has been used, with or without case

S trategies are needed to improve the care of patients

with chronic disease. This care should reduce
adverse health outcomes, provide a timely and conve-
nient care experience for patients regardless of their
management, in various forms to manage patients with
chronic illnesses such as chronic obstructive pulmonary
disease, heart failure, and diabetes mellitus.2-6 Despite its
growing use, telehealth outcomes have been variable

From the 1Section of Renal Diseases and Hypertension, Minne-
apolis Veterans Affairs Health Care System; 2Division of Renal
Diseases and Hypertension, University of Minnesota Medical School;
and 3Center for Chronic Disease Outcomes Research, Minneapolis
Veterans Affairs Health Care System, Minneapolis, MN.
*
A list of Center for Innovative Kidney Care members appears
in the Acknowledgements.
Received September 29, 2015. Accepted in revised form
January 14, 2016. Originally published online March 1, 2016.
Trial registration: www.ClinicalTrials.gov; study number:
NCT01446029.
Address correspondence to Areef Ishani, MD, MS, Department
of Medicine, Nephrology Section, Minneapolis VA Medical Cen-
ter, One Veterans Dr (111J), Minneapolis, MN 55417. E-mail:
isha0012@umn.edu
Published by Elsevier Inc. on behalf of the National Kidney
Foundation, Inc. This is a US Government Work. There are no
restrictions on its use.
0272-6386
http://dx.doi.org/10.1053/j.ajkd.2016.01.018

Am J Kidney Dis. 2016;68(1):41-49 41


and its expense is often considerable, emphasizing the
need to carefully assess its effectiveness.7,8
Previous studies have suggested that interprofessional
case management or home monitoring could improve
intermediate outcomes such as blood pressure in patients
with chronic kidney disease (CKD).9-11 The feasibility
and effectiveness of such interventions on patient-
centered outcomes is unclear. We conducted a ran-
domized controlled trial to determine whether an inter-
vention consisting of telehealth with interprofessional
team case management could be effectively imple-
mented and whether it could improve the combined end
point of death, hospitalization, emergency department
visits, or admission to a nursing home in patients with
moderate to severe CKD compared to usual care.
METHODS
Patients
We randomly assigned 451 participants to receive the intervention
and 150 participants to receive usual care from the Minneapolis
Veterans Affairs Health Care System (VAHCS), the St. Cloud, MN,
VAHCS, and their affiliated community-based clinics. A registry of
patients with CKD (estimated glomerular filtration rate [eGFR] ,
60 mL/min/1.73 m2 based on the most recent creatinine value within
past year) was created. From March 2012 through October 2012,
patients older than 18 years whose most recent eGFR (calculated
using the IDMS-traceable 4-variable MDRD [Modification of Diet
in Renal Disease] Study equation) within the last year was ,60 mL/
min/1.73 m2 were identified from the registry and invited to partic-
ipate in the study. Patients from rural areas were oversampled.12
Patients who were unable to give consent, had life expectancy less
than 1 year, lived in a skilled nursing facility, or had a primary care
provider unwilling to allow participation were excluded.
Potential participants were invited to be in the study by mail and
then by telephone. Interested individuals were scheduled for an in-
home visit, during which the written informed consent process was
completed, baseline measurements were collected, and participants
were randomly assigned to receive the intervention or usual care.
Participants randomly assigned to the intervention received a
second in-home visit during which the video monitoring device
with peripherals and broadband (most commonly cellular
connection) were installed. Participants in the usual-care group
were invited to attend a CKD education class and asked to follow
up with their primary care providers regarding management of
their kidney disease. Participants assigned to usual care may or
may not have been seen by a nephrologist during the course of the
trial, at the discretion of their primary care provider. The exact care
received by the usual-care group was not investigated.
Randomization and Masking
Eligible patients were randomly assigned to receive the inter-
vention or usual care using a centralized computer-generated
randomization scheme using permuted block sizes of 2, 4, or 6.
Randomization was stratified by eGFR (,30 vs $30 mL/min/
1.73 m2), presence of diabetes, and occurrence of a hospitalization
in the past year. Randomization occurred over the telephone by an
individual blinded to patient identity. Although participants could
not be masked to their assignment, outcome assessors were blin-
ded to participant study assignments.
Procedures
Participants in the intervention group received in-home training
regarding how to use the device (LifeView; AmericanTeleCare)
42
Ishani et al
and all the peripherals (blood pressure cuff, scale, glucometer,
pulse oximeter, stethoscope, and web camera) and how to contact
the clinical team. An interprofessional team consisting of a
nephrologist, nurse practitioner, nurses, clinical pharmacy
specialist, psychologist, social worker, telehealth care technician,
and dietician reviewed the health status of each intervention
participant and developed a patient-specific treatment plan
addressing short- and long-term goals. The goal of the intervention
program was comprehensive care of CKD and comorbid condi-
tions using components of the chronic care model.13 Specific is-
sues addressed included the following: management of blood
pressure, volume status, proteinuria, diabetes mellitus, lipid levels,
and depression; health literacy; and patient activation.14 The pro-
gram also addressed lifestyle modification (physical activity, diet,
weight reduction, and smoking cessation). A customized education
program was developed based on each patient’s comorbid condi-
tions and was delivered over broadband to the device. Patients
could interact with the educational modules at their own learning
pace. Patients were also given a customized self-monitoring
strategy based on their clinical condition. Vital signs were auto-
matically measured by the device and transmitted to the study
team.
The clinical team met daily to discuss high-risk patients. The
full interprofessional team met weekly to review intervention pa-
tients and their progress toward goals, hospitalizations, and risks
for recurrent or adverse events. Nurses also reviewed all vital signs
and module responses transmitted to the study team twice a day.
Vital signs were categorized as within or beyond range based on
individualized patient parameters. Nurses addressed vital signs that
were beyond the prespecified range with the assistance of a pro-
vider when clinically indicated. This typically involved interactive
video conferencing (a virtual visit) with the patient to review the
clinical situation, and possibly a medication change.
Medication management was conducted by nurses, a clinical
pharmacy specialist, and providers for all intervention participants
based on guidelines15 and self-measured values of blood pressure,
blood glucose, and volume status. Routine and acute video visits
were scheduled to address both long-term issues and acute
changes. Patients were seen periodically in the clinic by study staff
to address acute issues or obtain laboratory or imaging data to
follow up on issues identified during video visits. The clinical
team reviewed each hospitalization and emergency department
visit for each patient. Patients were contacted immediately after an
identified hospitalization to re-engage them with the health care
system and perform medication reconciliation. The frequency of
monitoring was intensified following hospitalizations until patients
returned to their baseline states.
All intervention patients were reviewed every 30 days to ensure
interaction with their devices and progress toward their individual
goals. Study staff contacted patients who were not adequately
using the system to encourage participation.
Every 3 months, members of the study team, blinded to study
assignment, contacted all participants. During these quarterly as-
sessments, participants were queried for outcome events and
possible adverse events. For events reported to have occurred at
non-Veterans Affairs (VA) facilities, we requested release of in-
formation permission from the participant and discharge infor-
mation from the facility. At the end of the study, all patients
received a final visit during which outcomes were assessed. In
addition to the reported events, the VA electronic medical record
was queried to identify events that occurred within the VA system
or for which the VA paid a claim from a third party.
End Points
The primary end point was a composite of death, hospitaliza-
tion, emergency department visits, and admission to a skilled
nursing facility. Secondary end points included each component of
Am J Kidney Dis. 2016;68(1):41-49
Telehealth for Patients With CKD
the primary end point and incidence of end-stage kidney disease.
Only self-reported events identified by the blinded study assessor
at each 3-month telephone call and results from the VA electronic
medical record query were used to define outcomes in the inter-
vention and usual-care groups.
Statistical Analysis
Our study sample size, n 5 600, was selected to provide sta-
tistical power of 80% to detect a 27% relative reduction in the
occurrence of the primary end point in the intervention group
compared to the usual-care group, using the 3:1 ratio of assign-
ment to intervention, assuming a primary end point rate of 50% in
the usual-care group, 10% loss to follow-up during the course of
the study, and a 2-sided 0.05 significance level. One participant
withdrew consent prior to device installation, so an additional
participant was recruited to the study; hence, the final sample size
of 601.
Characteristics of patients by treatment group were compared
using Pearson c2 (or Fisher exact test) and Wilcoxon rank sum
tests for categorical and continuous variables, respectively. Cox
proportional hazards models and corresponding maximum partial
likelihood–based Wald tests were used to examine the association
between intervention and time to first occurrence of the primary
outcome. Cox proportional hazards models were also used to
examine an association between intervention and time to first
occurrence of each component of the primary outcome and time to
the second occurrence of hospitalizations or emergency depart-
ment visits. Cox proportional hazards models were repeated to
include as additional explanatory measures baseline characteristics
with significant differences between study arms and examine
variation in the effect of the intervention by urban/rural residence
6805 Patients charts screened for inclusion
4105 Eligible by chart review
2449 Contacted
• 373 No response
• 1416 Declined
• 59 Ineligible after patient contact
601 Patients underwent randomization
Allocation
451 Assigned to 150 Assigned to
intervention usual care
Follow-Up at 1 Year
1 Withdrew consent
Analysis
450 Included in 150 Included in
primary analysis primary analysis
Figure 1. Flow diagram shows screening, randomization, and follow-up of study participants. Abbreviations: eGFR, estimated
glomerular filtration rate; VA, Veterans Affairs.
Am J Kidney Dis. 2016;68(1):41-49
of participants. All analyses were repeated confining analyses to
outcomes ascertained from the electronic medical record. All an-
alyses used an intention-to-treat approach.
An independent data and safety monitoring board monitored
safety and efficacy of the intervention, progress of the study with
respect to recruitment and follow-up, adherence to the study pro-
tocol, and quality of the study data. The human subjects’ safety
committee at the Minneapolis VAHCS approved the study. Data
analysis for this report was generated using SAS/STAT software,
version 9.2 (SAS Institute Inc).
RESULTS
From March 2012 through October 2012, a total of
6,805 patients were selected from the CKD registry
based on their most recent eGFR measurements. Of
these, 2,700 were deemed ineligible after chart review
(Fig 1). A total of 601 patients were randomly
assigned; 451 were assigned to the intervention, and
150, to usual care. A total of 547 (91.0%) patients had
complete follow-up at 12 months, with no differences
between groups in rates of follow-up completion. An
additional 23 (3.8%) patients had partial follow-up at
12 months; primary and secondary outcomes were
ascertained for all patients.
Baseline characteristics were similar between study
arms except for race and systolic blood pressure
(Table 1). Mean eGFR was 37 mL/min/1.73 m2.
2700 Were ineligible by chart review
• 319 Age > 85 years
• 290 Deceased
• 285 On Dialysis
• 340 Significant Mental Health Issue
• 154 No Address
• 225 Nursing Home/Hospice
• 145 Single eGFR < 60 mL/min/1.73 m2
• 838 Primary VA not Minneapolis
• 104 Other reason
1656 Not contacted after recruitment
target met
43
 Ishani et al

Table 1. Baseline Characteristics of Study Population

Characteristic Total (N 5 601) Intervention (n 5 451) Usual Care (n 5 150)

Age, y 75.1 6 8.1 75.3 6 8.1 74.3 6 8.1

Male sex 592 (98.5) 445 (98.7) 147 (98.0)
White racea,b 585 (97.3) 445 (98.7) 140 (93.3)
SBP, mm Hgb 133.1 6 19.7 134.3 6 19.9b 129.6 6 18.8
DBP, mm Hg 70.9 6 11.9 71.0 6 12.0 70.3 6 11.4
SBP . 140 mm Hg 193 (32.1) 151 (33.5) 42 (28.0)
eGFR, mL/min/1.73 m2 37 6 9 37 6 9 38 6 8
eGFR category
,30 mL/min/1.73 m2 108 (18.0) 81 (18.0) 27 (18.0)
30-44 mL/min/1.73 m2 363 (60.4) 274 (60.8) 89 (59.3)
$45-60 mL/min/1.73 m2 130 (21.6) 96 (21.3) 34 (22.7)

Hospitalization in year prior 172 (28.6) 127 (28.2) 45 (30.0)

ACR, mg/g 296 6 748 321 6 815 221 6 484
LDL-C, mg/dL 73 6 30 74 6 31 70 6 29
ACEi/ARB use 335 (55.7) 256 (56.8) 79 (52.7)
Education
#HS or did not graduate 238 (39.6) 179 (39.7) 59 (39.3)
Some college 214 (35.6) 157 (34.8) 57 (38.0)
$4-y degree 149 (24.8) 115 (25.5) 34 (22.7)

Health status good to excellenta 395 (65.7) 288 (63.9) 107 (71.3)
Diabetes mellitus 256 (42.6) 191 (42.4) 65 (43.3)
Diabetes medication use 223 (37.1) 168 (37.3) 55 (36.7)
Coronary artery disease 207 (34.4) 158 (35.0) 49 (32.7)
Congestive heart failure 125 (20.8) 95 (21.1) 30 (20.0)
History of stroke 99 (16.5) 78 (17.3) 21 (14.0)
Daily aspirin use 456 (75.9) 343 (76.1) 113 (75.3)
Previously seen nephrologist 320 (53.2) 239 (53.0) 81 (54.0)
Informed of CKD 378 (62.9) 285 (63.2) 93 (62.0)
Rural residence 334 (55.6) 244 (54.1) 90 (60.0)
Note: Values for categorical variables are given as number (percentage); for continuous variables, as mean 6 standard deviation.
Conversion factor for LDL-C in mg/dL to mmol/L, 30.02586.
Abbreviations: ACEi, angiotensin-converting enzyme inhibitor; ACR, albumin-creatinine ratio; ARB, angiotensin receptor blocker;
CKD, chronic kidney disease; DBP, diastolic blood pressure; eGFR, estimated glomerular filtration rate; HS, high school; LDL-C, low-
density lipoprotein cholesterol; SBP, systolic blood pressure.
a
Self-reported by patients.
b
All comparisons between groups were not significant except for white race and SBP, for which P , 0.05.

Prevalences of diabetes, coronary artery disease, and
history of stroke were 42.6%, 34.4%, and 16.5%,
respectively; 55.6% of patients were considered rural.
Patients lived on average 98 miles from the Minne-
apolis VAHCS; 147 (24.5%) patients lived more than
200 miles away.
Participants in the intervention group were engaged
in the intervention; 96.2% completed at least 1 video
visit. Mean numbers of measurements per participant
per month were 14.9 6 10.9 (standard deviation) for
blood pressure and 11.2 6 9.6 for weight, and on
average, each intervention participant interacted with
an educational module 5.8 6 7.9 days per month
(Fig 2). A total of 850 vital signs triggered a patient-
specific flag requiring an ad hoc patient contact
(median, 1 per patient; maximum, 19 per patient).
Mean numbers of visits per participant during
the intervention period were 3.8 scheduled nurse, 1.9
ad hoc nurse, 4.7 provider, 1.2 clinical pharmacy
specialist, 1.4 dietician, 0.9 psychologist, and 0.3
social worker visits.
At 1 year, the primary outcome of death, hospi-
talization, emergency department visits, or admission
to a skilled nursing facility occurred for 70 (46.7%)
patients in the usual-care group and 208 (46.2%) in
the intervention group (P 5 0.9; Table 2). The un-
adjusted hazard ratio (HR) for the primary end point
in the intervention group compared to the usual-care
group was 0.98 (95% confidence interval [CI], 0.75-
1.29; Table 2; Fig 3). When analyses were restricted
to events only ascertained through the electronic
medical record, none of the results were materially
different.
No significant differences between the 2 groups
were seen for any of the secondary end points
(Table 2). Median hospitalization durations for the
first visit were also similar between the intervention
and usual-care groups (3 days for the intervention

44 Am J Kidney Dis. 2016;68(1):41-49

Telehealth for Patients With CKD
Figure 2. Distribution of average number of blood pressure
readings, weight measurements, and days on which participants
viewed an educational module per month. Values displayed in
the box-and-whisker plots are the 5 number summary (minimum,
first quartile, median, third quartile, and maximum) and mean 6
standard deviation.
group vs 2 for the usual-care group; P 5 0.8). Pro-
portions with hospital readmissions were similar be-
tween groups (intervention vs usual care, 34.3% vs
40.0%; difference, 5.7%; 95% CI, 213.1% to 24.5%).
There was no difference between groups in time to
dialysis therapy initiation (Table 2). There was also
no difference between the intervention and usual-care
groups in control of intermediate variables such as
blood pressure, diabetes, hyperlipidemia, or smoking
(Table 3).
At baseline, the intervention and usual-care
groups were slightly imbalanced regarding race and
systolic blood pressure. There was no difference in
time to first event after adjusting for these baseline
Am J Kidney Dis. 2016;68(1):41-49
factors (HR, 1.02; 95% CI, 0.77-1.34). Similarly,
adjustment for baseline imbalance did not alter our
results for any of the secondary measures. Outcomes
did not differ between the intervention and usual-
care groups when stratified by key prespecified
subgroups, including age, eGFR category, diabetes,
hospitalization in the prior year, or congestive heart
failure (P for interaction . 0.1 for each comparison;
Table S1, available as online supplementary mate-
rial). There was also no difference in the primary
outcome by intensity of engagement with the system
(above or below median for number of transmissions
of blood pressure, weight, glucose level, etc; P . 0.1
for each comparison).
In examining whether the effect of the interven-
tion varied by urban/rural residence of participants,
the interaction between rurality and treatment arm
was not significant. However, among rural patients,
the intervention group tended to have better pri-
mary outcomes (HR, 0.85; 95% CI, 0.58-1.22)
compared to usual care, which was different
directionally compared with results observed for
urban patients (HR, 1.13; 95% CI, 0.76-1.69;
Table S2). Results for secondary outcomes between
rural and urban patients were mixed (Table S2).
Rural participants in the intervention arm tended
to have more transmissions of blood pressure,
glucose, temperature, and weight measurements
with the intervention device and more education
module use with a statistically significantly greater
number of weight transmissions compared to the
usual-care group.
DISCUSSION
In our randomized controlled trial of patients with
moderate to severe CKD, we found that delivery of
health care by an interprofessional team using tele-
health could be effectively implemented for both rural
and urban patients, but did not reduce the risk for
death, hospitalization, emergency department visits,
or admission to skilled nursing facilities compared to
usual care. Similarly, there was no reduction in
number of hospitalizations or median duration of
hospitalizations. These results were seen despite sig-
nificant engagement by patients in using the device
and numerous virtual visits by the interprofessional
team.
Although our study was focused on the manage-
ment of patients with CKD, we viewed CKD as a
marker for significant chronic disease burden. A total
of 42.6% of patients had diabetes; 34.4%, coronary
artery disease; 20.8%, congestive heart failure; and
16.5%, prior stroke. Telehealth in its various forms
has been used for the management of chronic diseases
including congestive heart failure, chronic obstructive
pulmonary disease, coronary artery disease, diabetes,
45
 Ishani et al

Table 2. Clinical End Points by Treatment Arm With Summary of Cox Proportional Hazards Analysis of Time-to-Event Variables

End Point Intervention (n 5 450) Usual Care (n 5 150) HR (95% CI)

Primary 208 (46.2) 70 (46.7) 0.98 (0.75-1.29)

Secondary
Death 13 (2.9) 3 (2.0) 1.46 (0.42-5.11)
Hospitalization 134 (29.8) 40 (26.7) 1.15 (0.80-1.63)
Emergency department visits 164 (36.4) 58 (38.7) 0.92 (0.68-1.24)
Admission to skilled nursing facility 18 (4.0) 2 (1.3) 3.07 (0.71-13.24)
Initiation of dialysis 11 (2.4) 2 (1.3) 1.86 (0.41-8.39)

Othera
Second hospitalizationb 46 (34.3) 16 (40.0) 0.89 (0.50-1.57)
Second emergency department visitb 64 (39.0) 26 (44.8) 0.87 (0.55-1.37)
No. of days of first hospital visitc 3.4 6 3.5 [3] 3.6 6 3.9 [2]
No. of days of all hospitalizationsc 5.7 6 8.6 [3] 6.2 6 6.5 [3]
No. of hospitalizations within yeara
0 316 (70.2) 110 (73.3)
1 88 (19.6) 24 (16.0)
$2 46 (10.2) 16 (10.7)
Note: Values for categorical variables are given as number (percentage); for continuous variables, as mean 6 standard deviation
[median]. No significant differences were seen between groups in any of the measured outcomes.
Abbreviations: CI, confidence interval; HR, hazard ratio.
a
Pearson c2 test for the categorized number of hospital admissions within the first year after randomization.
b
Percentage of those with a first visit.
c
Wilcoxon rank sum tests for duration of hospitalization.

obesity, depression and other mental health problems, telehealth relates to different levels of intervention
and chronic pain, with mixed results.2-8 Part of the intensity16,17 and the clinical relevance of the studied
reason for the lack of consensus on the value of outcomes, including both surrogate outcomes and
hard clinical end points.18,19
Our results are similar to other studies that have
Probability of Freedom from First Occurrence of Primary Outcome

1.0
evaluated case management in patients with CKD,
although our study involved a greater component of
Usual Care
interprofessional care than both these studies and also
Intervention
included home video monitoring and education.20-23
0.8
However, despite the intensity and broad scope of
our intervention, we were unable to detect an
improvement in clinical outcomes between groups.
0.6 Patients within rural areas have a number of bar-
riers to optimal health care, including higher preva-
lences of obesity, hypertension, diabetes, and tobacco
0.4 use.24 Rural areas also have a scarcity of nephrolo-
gists25 and these patients are less likely to visit a
nephrologist.25 Previous studies have suggested that
0.2
patients with CKD stages 3 to 4 in rural areas have
poorer process-based markers of care compared with
Log−rank p=0.902
urban patients, such as measurement of either hemo-
globin A1c in patients with diabetes, assessment of
0.0
urinary albumin excretion, or use of angiotensin-
0 1 2 3 4 5 6 7 8 9 10 11 12
converting enzyme inhibitors or angiotensin receptor
Months Since Enrollment
No. at risk blockers among patients with diabetes or significant
Usual 150 143 133 125 121 112 106 102 97 89 85 81
Care proteinuria.26 Rural patients with CKD also have a
Inter-
vention 450 432 409 385 357 341 321 302 289 274 261 255
greater risk for hospitalization and all-cause mortality
compared with urban patients.26 This pattern of
Figure 3. Kaplan-Meier time-to-event occurrences for the poorer care appears to have been reversed in our
primary end point of a composite of death, hospitalization, emer- study, with rural intervention patients having a trend
gency department visits, and admission to a skilled nursing facil-
ity. The hazard ratio for first occurrence with intervention was toward a lower incidence of the primary outcome.
0.98 (95% confidence interval, 0.75-1.29; P 5 0.90). The lack of statistical significance in this group is

46 Am J Kidney Dis. 2016;68(1):41-49

Telehealth for Patients With CKD

Table 3. Intermediate Outcomes at Study End by Treatment Group

Outcome Total Intervention Usual Care Pa

No. of participants with complete intermediate outcome data 444 340 104
No. with SBP # 140 mm Hg, LDL-C # 100 mg/dL, and HbA1c # 8% at study end 185 (54.4) 53 (51.0) 0.5

No. of participants with baseline SBP . 140 mm Hg and complete data 174 135 39
No. with SBP # 140 mm Hg at study end 72 (53.3) 20 (51) 0.8

No. of participants with baseline LDL-C . 100 mg/dL and complete data 76 61 15
No. with LDL-C # 100 mg/dL at study end 31 (51) 8 (53) 0.9

No. of participants with baseline HbA1c . 8% and complete data 48 33 15

No. with HbA1c # 8% at study end 14 (42) 3 (33) 0.6

No. of participants who were smokers at baseline 52 40 12

No. no longer smoking at study end 9 (23) 5 (42) 0.3
Note: Values are given as number (percentage). Conversion factor for LDL-C in mg/dL to mmol/L, 30.02586.
Abbreviations: HbA1c, hemoglobin A1c; LDL-C, low-density lipoprotein cholesterol; SBP, systolic blood pressure.
a
Pearson c2 test, except for Fisher exact test for smoking status due to small expected cell counts.

likely because the study was not powered to evaluate
outcomes within subgroups. Although the overall
study was negative, rural patients may be a selected
subgroup in which the use of telehealth and inter-
professional care may offer benefits, particularly in
areas that are scarce in subspecialty care. This sub-
group needs to be specifically tested in future studies.
There are a number of possible reasons that our
study was unable to demonstrate an overall benefit in
outcomes. First, aggressive home monitoring and
interprofessional care may simply be ineffective in
altering patient outcomes. Alternatively, the team may
have identified a greater number of issues that may be
ignored by patients without constant monitoring.27
Another possible explanation of negative results is
that patients in the intervention group did not engage
in using the system. Although a small number of
patients (3.8%) did not engage in the system, most
were fully engaged after 1 year of follow-up. Adher-
ence rates in our study were likely significantly
better than can be achieved in usual clinical care given
the resources available during the trial. Another pos-
sibility is that the duration of follow-up was too short.
It may be that differences between groups would be
observed with longer follow-up. Finally, it could be
that individuals in the usual-care group received very
aggressive therapy compared with those receiving
traditional usual care. We did not track interventions
provided to the usual-care group. However, during
the course of our study, the VA was changing the
model of primary care to that of a patient-centered
medical home, called PACT (Patient Aligned Care
Team), along with implementation of a structured
telehealth program. Implementation of the PACT and
home telehealth have independently been associated
with reductions in emergency department visits,
hospitalizations,21-23,28-30 and improved control of
hypertension.24,31 As an example, 51.3% of patients in
the usual-care group had incident control of hyper-
tension, an incident control rate that is substantially
greater than community standards. Aggressive imple-
mentation of therapy in the usual-care group (PACT,
telehealth, and case management) may have been why
we were unable to demonstrate a difference in either
intermediate or clinical outcomes between groups.
Another consideration is that disease progression
does not always follow a pattern of progressive
decline, but instead, patients may suddenly deterio-
rate. Therefore, early intervention to prevent clinical
deterioration may not always be possible. Also, the
specific monitored physiologic parameters may not be
those that best predict disease progression. We pow-
ered the study assuming a 50% event rate in the usual-
care group, with an observed event rate of 46.3%. Our
loss to follow-up was significantly smaller than
anticipated. Our study had sufficient power for effects
of this magnitude, but not for smaller effects.
Although our study results were negative, the ranges
of the CIs for our effect estimates do not rule out a
clinically significant benefit for a similar intervention.
Our study had numerous strengths. We examined
relevant and clinically important primary end points
and enrolled a patient population at high risk for
adverse outcomes. We attempted to target numerous
facets of care through the use of a diverse interpro-
fessional team. We sought to engage and activate
patients in their care, provide in-home education,
facilitate visits using video, manage chronic diseases,
and identify and address acute issues. The interven-
tion included medication management and compre-
hensive yet simple-to-understand educational
modules. We included both urban and rural patients
and randomly assigned patients in their homes,
potentially enhancing the generalizability of our

Am J Kidney Dis. 2016;68(1):41-49 47


findings.10 Finally, all our outcome assessors were
blinded to study assignment.
A potential weakness of our study is that patients in
the intervention group were likely queried more often
than those in the usual-care group about hospitaliza-
tions and emergency department visits, likely
enhancing their recall of these events during the
outcome assessment calls and potentially biasing our
results toward more adverse outcomes reported in the
intervention group. However, no difference between
groups was seen when we confined our analysis to
only VA electronic medical record2ascertained
events. We performed a complex intervention with
many different aspects. It is unclear whether any in-
dividual component of our intervention could be
associated with benefit that is overwhelmed by the
overall study results. However, our goal was to
deliver a comprehensive intervention to determine
whether a fully integrated model of care could alter
patient outcomes. Given the overall negative study
findings, it is unlikely that individual components of
care would result in a different outcome. The gener-
alizability of our results to other settings and other
patient populations remains to be determined.
In summary, a strategy of telehealth by an inter-
professional team could be effectively implemented in
both rural and urban patients but did not alter out-
comes in patients with moderate to severe CKD
compared with usual care. Strategies for improving
the care of this population are needed.
ACKNOWLEDGEMENTS
The Center for Innovative Kidney Care, which is based at
Minneapolis VAHCS, comprises Melissa Atwood, Ann Bangerter,
Theresa Borah, Olga Brusilovsky, Andrea Cutting, Mia Dobbs,
Wendy Elofson, Kori Geinert, Kanika Gupta, Kendra Hackney,
Ron Howell, Miles Jarzyna, Quinn Kellerman, Elaine Kroska,
LauraJean Krueger, Narlina Lalani, Shannon McCutcheon, Alec
Otteman, Megan Plumstead, Bethany Roberts, Keri Rowe, Jackie
Rust, Rita Schmitt, Herb Stockley, Jaclyn Strutt, Melvis Tambi,
and Callen Weispfennig.
The members of Data Safety Monitoring Board for this trial
were Kristine E. Ensrud, MD, MPH, Minneapolis VAHCS; Jeffrey
Connaire, MD, Minneapolis VAHCS; and Brent Taylor, PhD,
VAHCS. Nan Booth, MSW, MPH, ELS, provided manuscript
editing.
Portions of this work were presented at the 2014 American
Society of Nephrology Kidney Week, November 11-16, Phila-
delphia, PA.
Support: The project was funded by grants from the VA Center
for Innovation to Dr Ishani and Dr Rosenberg. The funder of the
study had no role in study design, data collection, data analysis,
data interpretation, or writing of the report.
Financial Disclosure: Dr Rosenberg has received honoraria
from Wolter Kluwer Health for serving as an author for UpToDate
and from the American Society of Nephrology for service as ed-
ucation director. The other authors declare that they have no
relevant financial interests.
Contributions: Study concept and design: AI, MER; data
acquisition, analysis or interpretation: AI, JC, DP, SO, BC, SN,
48
Ishani et al
DN, MER; statistical analysis: BC, DN; obtainment of funding:
AI, MER; administrative, technical, or material support: AI, JC,
DP, SO, BC, SN, DN, MER; study supervision: AI, MER. Each
author contributed important intellectual content during manu-
script drafting or revision and accepts accountability for the overall
work by ensuring that questions pertaining to the accuracy or
integrity of any portion of the work are appropriately investigated
and resolved. AI takes responsibility that this study has been re-
ported honestly, accurately, and transparently; that no important
aspects of the study have been omitted; and that any discrepancies
from the study as planned and registered have been explained.
Peer Review: Evaluated by 2 external peer reviewers, a Statis-
tical Editor, a Co-Editor, and the Editor-in-Chief.
SUPPLEMENTARY MATERIAL
Table S1: Clinical end points by strata at randomization with
summary of proportional hazards analysis of time-to-event
variables.
Table S2: Clinical end points stratified by setting at randomi-
zation with summary of proportional hazards analysis of time-to-
event variables.
Note: The supplementary material accompanying this article
(http://dx.doi.org/10.1053/j.ajkd.2016.01.018) is available at
www.ajkd.org
REFERENCES
1. Berwick DM, Nolan TW, Whittington J. The triple aim:
care, health, and cost. Health Aff (Millwood). 2008;27(3):759-769.
2. Wennberg DE, Marr A, Lang L, O’Malley S, Bennett G.
A randomized trial of a telephone care-management strategy.
N Engl J Med. 2010;363(13):1245-1255.
3. Chaudhry SI, Mattera JA, Curtis JP, et al. Telemonitoring in
patients with heart failure. N Engl J Med. 2010;363(24):2301-2309.
4. Kroenke K, Krebs EE, Wu J, Yu Z, Chumbler NR, Bair MJ.
Telecare collaborative management of chronic pain in primary
care: a randomized clinical trial. JAMA. 2014;312(3):240-248.
5. Goldstein RS, O’Hoski S. Telemedicine in COPD: time to
pause. Chest. 2014;145(5):945-949.
6. Gellis ZD, Kenaley BL, Ten HT. Integrated telehealth care
for chronic illness and depression in geriatric home care patients:
the Integrated Telehealth Education and Activation of Mood
(I-TEAM) study. J Am Geriatr Soc. 2014;62(5):889-895.
7. Wade VA, Karnon J, Elshaug AG, Hiller JE. A systematic
review of economic analyses of telehealth services using real time
video communication. BMC Health Serv Res. 2010;10(10):233.
8. McLean S, Sheikh A, Cresswell K, et al. The impact of
telehealthcare on the quality and safety of care: a systematic
overview. PLoS One. 2013;19(8):e71238.
9. Margolis KL, Asche SE, Bergdall AR, et al. Effect of home
blood pressure telemonitoring and pharmacist management on
blood pressure control: a cluster randomized clinical trial. JAMA.
2013;310(1):46-56.
10. Rifkin DE, Abdelmalek JA, Miracle CM, et al. Linking
clinic and home: a randomized controlled clinical effectiveness
trial of real-time, wireless blood pressure monitoring for older
patients with kidney disease and hypertension. Blood Press Monit.
2013;18(1):8-15.
11. Gordon EJ, Fink JC, Fischer MJ. Telenephrology: a novel
approach to improve coordinated and collaborative care for chronic
kidney disease. Nephrol Dial Transplant. 2013;28(4):972-981.
12. US Census Bureau. 2010 Census Urban and Rural Classi-
fication and Urban Area Criteria. https://www.census.gov/geo/
reference/ua/urban-rural-2010.html. Accessed August 1, 2015.
Am J Kidney Dis. 2016;68(1):41-49
Telehealth for Patients With CKD
13. Wagner EH, Austin BT, Von KM. Organizing care for
patients with chronic illness. Milbank Q. 1996;74(4):511-544.
14. Hibbard JH, Stockard J, Mahoney ER, Tusler M. Devel-
opment of the Patient Activation Measure (PAM): Conceptual-
izing and Measuring Activation in Patients and Consumers. Health
Serv Res. 2004;39(4 Pt 1):1005-1026.
15. Kidney Disease: Improving Global Outcomes (KDIGO)
CKD Work Group. KDIGO 2012 clinical practice guideline for
the evaluation and management of chronic kidney disease. Kidney
Int Suppl. 2013;3:1-150.
16. Feltner C, Jones CD, Cene CW, et al. Transitional care
interventions to prevent readmissions for persons with heart fail-
ure: a systematic review and meta-analysis. Ann Intern Med.
2014;160(11):774-784.
17. Inglis SC, Clark RA, McAlister FA, Stewart S, Cleland JG.
Which components of heart failure programmes are effective? A
systematic review and meta-analysis of the outcomes of structured
telephone support or telemonitoring as the primary component of
chronic heart failure management in 8323 patients: abridged
Cochrane review. Eur J Heart Fail. 2011;13(9):1028-1040.
18. Omboni S, Gazzola T, Carabelli G, Parati G. Clinical
usefulness and cost effectiveness of home blood pressure tele-
monitoring: meta-analysis of randomized controlled studies.
J Hypertens. 2013;31(3):455-467.
19. Worswick J, Wayne SC, Bennett R, et al. Improving
quality of care for persons with diabetes: an overview of sys-
tematic reviews - what does the evidence tell us? Syst Rev.
2013;7(2):1-14.
20. Barrett BJ, Garg AX, Goeree R, et al. A nurse-coordinated
model of care versus usual care for stage 3/4 chronic kidney dis-
ease in the community: a randomized controlled trial. Clin J Am
Soc Nephrol. 2011;6(6):1241-1247.
21. Hopkins RB, Garg AX, Levin A, et al. Cost-effective-
ness analysis of a randomized trial comparing care models for
chronic kidney disease. Clin J Am Soc Nephrol. 2011;6(6):
1248-1257.
22. Van Zuilen AD, Bots ML, Dulger A, et al. Multifactorial
intervention with nurse practitioners does not change cardiovascular
Am J Kidney Dis. 2016;68(1):41-49
outcomes in patients with chronic kidney disease. Kidney Int.
2012;82(11):710-717.
23. Peeters MJ, van Zuilen AD, van den Brand JA, et al. Nurse
practitioner care improves renal outcome in patients with CKD.
J Am Soc Nephrol. 2014;25(2):390-398.
24. Agency for Healthcare Research and Quality. 2010 Na-
tional Healthcare Quality Report. January 2013. Rockville, MD.
http://www.ahrq.gov/research/findings/nhqrdr/nhqr10/index.html.
Accessed August 1, 2015.
25. Yan G, Cheung AK, Ma JZ, et al. The associations between
race and geographic area and quality-of-care indicators in patients
approaching ESRD. Clin J Am Soc Nephrol. 2013;8(4):610-618.
26. Rucker D, Hemmelgarn BR, Lin M, et al. Quality of care
and mortality are worse in chronic kidney disease patients living in
remote areas. Kidney Int. 2011;79(2):210-217.
27. Weinberger M, Oddone EZ, Henderson WG. Does
increased access to primary care reduce hospital readmissions?
Veterans Affairs Cooperative Study Group on Primary Care and
Hospital Readmission. N Engl J Med. 1996;334(22):1441-1447.
28. Hebert PL, Liu CF, Wong ES, et al. Patient-centered
medical home initiative produced modest economic results for
Veterans Health Administration, 2010-12. Health Aff (Millwood).
2014;33(6):980-987.
29. Nelson KM, Helfrich C, Sun H, et al. Implementation of the
patient-centered medical home in the Veterans Health Adminis-
tration: associations with patient satisfaction, quality of care, staff
burnout, and hospital and emergency department use. JAMA Intern
Med. 2014;174(8):1350-1358.
30. Darkins A, Kendall S, Edmonson E, Young M, Stressel P.
Reduced cost and mortality using home telehealth to promote self-
management of complex chronic conditions: a retrospective
matched cohort study of 4,999 veteran patients. Telemed J E
Health. 2015;21(1):70-76.
31. O’Neill JL, Cunningham TL, Wiitala WL, Bartley EP.
Collaborative hypertension case management by registered nurses
and clinical pharmacy specialists within the Patient Aligned Care
Teams (PACT) model. J Gen Intern Med. 2014;29(suppl 2):S675-
S681.
49