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. Author manuscript; available in PMC: 2019 May 10.
Published in final edited form as: Am J Transplant. 2018 Mar 26;18(8):1954–1965. doi: 10.1111/ajt.14693

Effect of the iChoose Kidney decision aid in improving knowledge about treatment options among transplant candidates: A randomized controlled trial

Rachel E Patzer 1, Laura McPherson 1, Mohua Basu 1, Sumit Mohan 2, Michael Wolf 3, Mariana Chiles 2, Allison Russell 3, Jennifer C Gander 1, John J Friedewald 3, Daniela Ladner 3, Christian P Larsen 1, Thomas Pearson 1, Stephen Pastan 4
PMCID: PMC6510396  NIHMSID: NIHMS989862  PMID: 29446209

Abstract

We previously developed a mobile- and web-based decision aid (iChoose Kidney) that displays individualized risk estimates of survival and mortality for the treatment modalities of dialysis versus kidney transplantation. We examined the effect of iChoose Kidney on change in transplant knowledge and access to transplant in a randomized controlled trial among patients presenting for evaluation in three transplant centers. A total of 470 patients were randomized to standard transplantation education (control) or standard education plus iChoose Kidney (intervention). Change in transplant knowledge (primary outcome) among intervention versus control patients was assessed using nine items in pre- and postevaluation surveys. Access to transplant (secondary outcome) was defined as a composite of waitlisting, living donor inquiries, or transplantation. Among 443 patients (n = 226 intervention; n = 216 control), the mean knowledge scores were 5.1 ± 2.1 pre- and 5.8 ± 1.9 post-evaluation. Change in knowledge was greater among intervention (1.1 ± 2.0) versus control (0.4 ± 1.8) patients (P < .0001). Access to transplantation was similar among intervention (n = 168; 74.3%) versus control patients (n = 153; 70.5%; P = .37). The iChoose Kidney decision aid improved patient knowledge at evaluation, but did not impact transplant access. Future studies should examine whether combining iChoose Kidney with other interventions can increase transplantation. (https://Clinicaltrials.gov NCT02235571)

Keywords: clinical research/practice, dialysis, education, health services and outcomes research, kidney disease, kidney transplantation/nephrology, patient education, patient survival

1 |. INTRODUCTION

Despite the survival and quality of life benefit of kidney transplantation versus dialysis,1–4 only one-third of the approximately 703 000 United States patients living with end stage renal disease (ESRD) have received a kidney transplant, of which ~30% are living donor transplants.1 While transplant recipients have higher survival rates compared to dialysis patients, the relative survival advantage associated with kidney transplantation varies depending on individual characteristics, such as age, sex, race, and comorbidities.1,4 While ESRD patients actively seek involvement in providers’ decisions about their treatment options,5 they are often uninformed about kidney transplantation and have limited knowledge about the absolute and relative mortality of kidney transplantation versus dialysis.6–11

Education about kidney transplantation should ideally occur in stage 4 chronic kidney disease (CKD) and continue throughout each step of the transplant process to give patients more opportunities to process treatment information and actively discuss treatment options with providers. However, in-depth conversations between providers and patients may be inadequate due to provider time constraints, limited educational resources with individualized risk information, and difficulties clearly informing patients about treatment options.12–15 Decision aids such as pamphlets, videos, or mobile applications can improve decision-making among patients faced with multiple options to treat their disease.16,17 When used with clinicians, shared decision aids can initiate more in-depth and individually tailored discussions about treatment options.17

Given the barriers to transplant education among ESRD patients and the potential benefits of decision aids, we previously developed a shared patient-provider clinical decision aid called iChoose Kidney (iPad, iPhone, and website: www.ichoosekidney.emory.edu).18 This decision aid displays individualized risk estimates of survival or mortality for transplantation versus dialysis and is designed for clinical providers to use with patients to better inform them about the clinical implications of their treatment options. While the tool was previously developed,18 the effectiveness of the tool in improving patient knowledge of treatment options had not been tested in a rigorous manner.

We conducted a randomized controlled trial of the iChoose Kidney decision aid among patients undergoing evaluation for kidney transplantation at three major US transplant centers to analyze the effect of iChoose Kidney on improving patient knowledge about the benefits of kidney transplant compared to dialysis19; we also measured the association with transplant access (waitlisting, living donor inquiries, and living or deceased donor kidney transplant). It was hypothesized that ESRD patients using iChoose Kidney during their transplant evaluation would have improved knowledge about the benefits of transplant and be more likely to pursue the steps to receive a kidney transplant compared to control participants.

2 |. METHODS

2.1 |. Study overview and protocol

As previously described, the iChoose Kidney decision aid is a shared patient/provider mobile and web-based application that uses national surveillance data to provide individualized risk estimates of mortality and survival by treatment modality (dialysis vs. transplant; living vs. deceased donor transplant) based on patient characteristics.18 Using a series of visual displays, providers are prompted to input demographic and clinical characteristics specific to a patient. Once patient data are entered into the tool, iChoose Kidney communicates both absolute and relative risk estimates in written and graphic displays to increase patient and provider understanding of treatment benefit (Figure 1).

FIGURE 1.

FIGURE 1

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Screenshots of the iChoose Kidney Decision Aid (iPad version) outlining the varying message frames used to enter patient’s clinical information (gender, age, race, ethnicity, time on dialysis, various comorbidities) into the risk prediction calculator for individualized 1- and 3-year mortality (not shown) and survival estimates of dialysis versus kidney transplant and deceased versus living donor transplant

ESRD patients were recruited into the randomized controlled trial (clinicaltrials.gov NCT02235571) between December 2014 and October 2015 at the time of evaluation for kidney transplant in three United States transplant centers: Emory Transplant Center in Atlanta, the Renal and Pancreatic Transplant Program at Columbia University Medical Center in New York, and the Kovler Organ Transplantation Center of Northwestern University in Chicago. The Institutional Review Boards at Emory University (IRB1485996), Columbia University (IRB-AAAO1859), and Northwestern University (STU00102749) approved this study. Eligibility criteria included: (1) 18–70 years of age; (2) no previous solid or multiorgan transplant; English-speaking; and (4) no severe cognitive or visual impairment.

After assessing eligibility, research assistants obtained informed consent and randomized patients 1:1 with a random number generator application via iPad to receive center-specific standard of care education about kidney transplant with (intervention) or with- out (control) supplemental use of iChoose Kidney. The delivery of center-specific transplant education was not identical, with one center requiring patients to attend a group transplant education session led by a transplant surgeon. However, patients at all sites received printed transplant education materials with similar content, including risks and benefits of transplant and financial and social support. One month prior to study start, providers were administered a provider baseline survey to assess provider demographics, previous use of mobile tools, and how often they discussed the survival benefit of transplant versus dialysis with patients. On the day of evaluation, trained research assistants administered a baseline survey for patients via iPad before the patients met with the transplant nephrologist or surgeon. Providers were blinded to questions asked in patient surveys. If randomized to the intervention, iChoose Kidney was used with patients during the transplant evaluation by either the transplant nephrologist or surgeon; physicians were instructed at study start to use the aid with the intervention patients, but were not specifically given a script about how to present the individualized risk estimates to patients. Given the nature of the intervention, neither patients nor providers were blinded to the study group assignment. After the intervention, follow-up data was collected from patients and providers at multiple time points (Figure 2). Further details about the iChoose Kidney clinical trial study design are reported elsewhere.19

FIGURE 2.

FIGURE 2

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Study schema of the iChoose Kidney randomized controlled trial depicting the study process and points of data collection for both control and intervention patients, and providers (transplant nephrologists or surgeons), 2014–2015

2.2 |. Outcome measures

2.2.1 |. Change in patient transplant knowledge (primary endpoint)

The primary outcome was change in patient knowledge about the survival benefits of kidney transplant. Transplant knowledge was measured using a nine-item scale developed by a multidisciplinary group of transplant nephrologists, surgeons, behavioral scientists, and patients that was included in the patient baseline and follow-up surveys19 (Table S1). Evidence of face validity was assessed and established by these experts and pilot tested in a sample of patients. Questions were developed following theory-based intervention guidelines20,21 and were intended to assess the underlying theoretical construct of knowledge about the relative and absolute risks of mortality with dialysis versus transplant and deceased versus living donor transplant. Patients were also asked to estimate their relative risk of mortality with dialysis versus transplant (on a scale from 1–9) and whether they were (more, less, or equally likely) to die with dialysis compared to with a kidney transplant (Table S1). The numerical portion of this two-part item was discarded from analyses as research assistants noted patient confusion about this question in the early weeks of the study. However, the last portion of the item (more, less, or equally likely) was still included in the knowledge score. Transplant knowledge difference from pre- to post-evaluation was calculated by subtracting the mean pre-survey from post-survey transplant knowledge scale scores and comparing the differences between intervention versus control participants. Additionally, we conducted pre-planned subgroup analyses by sex, race, health literacy, and numeracy.

Patients missing all nine items of the knowledge scale in either the pre- or post-survey were excluded from analyses (n = 27; 5.7%). Additional sensitivity analyses were conducted to compare patients missing one or more knowledge items (n = 57) to patients with complete knowledge data (n = 386). Because health literacy and numercy were different between those two populations, we categorized a missing item as incorrect (0 points) for these 57 patients when calculating transplant knowledge scores versus excluding them from analyses.

2.2.2 |. Access to transplant (secondary endpoint)

Transplant access was defined a priori as a composite endpoint as having one of the following within one year of the patient’s transplant evaluation: ≥1 living donor inquiry, placement on the kidney transplant waiting list, or receipt of a living or deceased donor transplant. Outcome data were abstracted from patients’ electronic medical records (EMR) at study end.

2.2.3 |. Decisional conflict (secondary endpoint)

Decisional conflict was measured via O’Connor’s validated 10-item scale assessing personal perceptions of uncertainty in choosing options, modifiable factors contributing to uncertainty, and effective decision-making.22 The O’Connor scale was selected for its emphasis on treatment option decisional conflict and use in previous studies among chronic disease patients.23–25 The decisional conflict scale was included in patient baseline and follow-up surveys and consisted of 10 questions with responses being “Yes,” “Unsure,” or “No,” valued at 0, 2, or 4 points, respectively. The 10 items were summed, divided by 10, and multiplied by 25 to calculate the decisional conflict score, ranging from 0 (no decisional conflict) to 100 (high decisional conflict).26,27

2.2.4 |. Patient treatment preferences (secondary endpoint)

To assess whether the tool affected treatment preferences, patients were asked in baseline and follow-up surveys what type of treatment they preferred: hemodialysis, peritoneal dialysis, transplant, or unsure.

2.2.5 |. Provider opinions (secondary endpoint)

In the immediate provider follow-up survey administered after each patient visit, we asked providers if they used estimates of patient survival or of mortality to communicate risk estimates to their patients and compared how often providers discussed the benefit of transplant versus dialysis and living donor versus deceased donor transplant by study group. In addition, we surveyed transplant nephrologist and surgeon preferences, opinions, and satisfaction in order to evaluate usability of iChoose Kidney among providers in a provider post-study follow-up survey ~3 months after the study ended (Table S2).

2.3 |. Other covariates

2.3.1 |. Patient factors

Demographic and socioeconomic characteristics were self-reported and collected from patient surveys administered at time of evaluation. Variables included age, sex, and race/ethnicity. Socioeconomic variables included: household income before taxes, marital status, educational level, primary health insurance, employment status, internet access, and social support during evaluation (defined as at least one support member in attendance with the patient at the medical evaluation).

Health literacy was measured using the Newest Vital Sign, six- item scale (range: 0–6; categorized into low: 0–1, medium: 2–3, or high: 4–6).28 Numeracy was evaluated using the Lipkus, 11-item scale (range: 0–11; categorized into low: 0–4, medium: 5–8, and high: 9–11).29 These measures were selected as they were previously validated and appropriate for use among patients with limited literacy.

EMR data were extracted for several clinical variables: body mass index (categorized as >35 vs. ≤35 kg/m2), history of comorbidities (diabetes, hypertension, and cardiovascular disease), low albumin level (<3.5 g/dL), dialysis modality at time of evaluation, and dialysis start date to calculate time on dialysis (in days). In the case of missing survey data, EMR data were also abstracted.

2.4 |. Statistical analyses

Descriptive analyses of patient characteristics were conducted to evaluate differences between study arms at baseline using Pearson’s chi-square tests and t-tests. A t-test was used to determine significance of the mean difference-in-differences in transplant knowledge from pre- to post-evaluation in intervention versus control patients and the pre-planned subgroups.

For secondary endpoints, chi-square tests were used to determine if the proportion of patients with access to transplant differed by study group, to examine whether the proportion of patients with decisional conflict scores that decreased, remained the same, and increased pre- to post-evaluation, and to assess differences in the proportion of patients who changed treatment preference pre- to post-evaluation by study group. Chi-square analyses were also used to assess if there was a difference in the number of times providers had the conversation about the survival benefit of transplant versus dialysis and of living versus deceased donor transplants by study group. Results were considered statistically significant at P < .05. SAS 9.4 (SAS Institute, Cary, NC) was used for all statistical analyses.

Based on a repeated measures design consisting of two groups of subjects, each measured at two time points, we estimated that a sample size of 420 (210 in the control and intervention arm) achieved 80% power to detect a difference between the intervention and control groups in the mean difference-in-differences in transplant knowledge of 0.71 points with a standard deviation of 2.0 at the two time points. This calculation assumed a correlation of 0.01 between baseline and follow-up measurements. The significance level (alpha) is 0.05 using a two-sided, two-sample t-test. Secondary outcomes were pre-planned, but the study was not specifically powered to detect statistical significance for these outcomes.

3 |. RESULTS

A total of 657 patients were screened for participation in the iChoose Kidney randomized controlled trial from December 2014 to October 2015 until the target sample size was reached; 187 patients were excluded, because they did not meet study inclusion criteria (n = 106) or declined to participate (n = 81). Of the 470 patients consented and randomized to use (intervention; n = 238) or not use (control; n = 232) iChoose Kidney during medical evaluation, 27 patients were excluded for missing data on all transplant knowledge items (primary outcome). The final study population included 443 patients (intervention; n = 226 and control; n = 217; Figure 3).

FIGURE 3.

FIGURE 3

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Flow diagram of recruitment into the iChoose Kidney randomized controlled trial among ESRD patients evaluated for a kidney transplant at three US transplant centers, 2014–2015

3.1 |. Patient characteristics

Of the 443 eligible patients, the mean age was 50.6 (10.1) years, with 62.5% male, 47.9% African American, and 10.6% white Hispanic (Table 1). The majority of the patients had hypertension (79.0%) and reported having Medicare (49.7%) or private (52.6%) insurance (Table 1). About one-third of our study population had not been on dialysis prior to evaluation (33.2%), with the remaining two-thirds of patients on dialysis for a median of 356 days (Q1-Q3: 162–1146). The overall mean health literacy and numeracy scores were 3.5 out of 6 (2.0) and 6.1 out of 11 (3.2), respectively (Table 1).

TABLE 1.

Baseline characteristics of end-stage renal disease patients evaluated at three United States transplant centers according to the assigned study group in the iChoose Kidney Randomized Control Trial, 2014– 2015 (n = 443)

Patient characteristica,b Study population
n = 443		 Intervention
n = 226 (51.0)		 Control
n = 217 (49.0)
Patient sociodemographic characteristics
  Age, y, mean ± SD 50.6 ± 10.1 51.1 ± 9.9 50.1 ± 10.3
  Male sex, n (%)  277 (62.5) 143 (63.3) 134 (61.8)
  Race/ethnicity, n (%)
   African American or Black  212 (47.9) 114 (50.4)   98 (45.2)
   White, non-hispanic  152 (34.3)  72 (31.9)   80 (36.9)
   White, hispanic   47 (10.6)   25 (11.1)   22 (10.1)
   Otherc   31 (7.0)   15 (6.6)   16 (7.4)
  Household income before taxes, n (%)
   Less than $20 000  110 (24.8)   62 (27.4)   48 (22.1)
   $20 000-$40 000   77 (17.4)   36 (15.9)   41 (18.9)
   $40 001-$60 000   46 (10.4)   21 (9.3)   25 (11.5)
   $60 001-$80 000   58 (13.1)   26 (11.5)   32 (14.8)
   Greater than $80 000  106 (23.9)   58 (25.7)   48 (22.1)
   Prefer not to answer   39 (8.8)   19 (8.4)   20 (9.2)
  Married, n (%)  261 (58.9)  132 (58.4)  129 (59.5)
  Education level, n (%)
   8th grade or less   10 (2.3)   5 (2.2)   5 (2.3)
   Some high school   24 (5.4)   14 (6.2)   10 (4.6)
   High school diploma or GED  109 (24.6)   52 (23.0)   57 (26.3)
   Some college or vocational school  124 (28.0)   61 (27.0)   63 (29.0)
   College or vocational school degree  101 (22.8)   58 (25.7)   43 (19.8)
   Professional or graduate degree   69 (15.6)   32 (14.2)   37 (17.1)
  Health insurance, n (%)
   Medicare  220 (49.7)  107 (47.4)  113 (52.1)
   Medicaid  132 (29.8)   78 (34.5)   54 (24.9)
   Private insurance  233 (52.6)  122 (54.0)  111 (51.2)
   Other governmental insurance   14 (3.2)   7 (3.1)   7 (3.2)
   Other insurance   37 (8.4)   16 (7.1)   21 (9.7)
   No insurance   0   0   0
   Don’t Know   2 (0.5)   1 (0.4)   1 (0.5)
  Employment status, n (%)
   Employed  164 (37.0)   81 (35.8)   83 (38.3)
   Unemployed   96 (21.7)   50 (22.1)   46 (21.2)
   Retired  175 (39.5)   91 (40.3)   84 (38.7)
  Internet access, n (%)
   Both home and work   97 (21.9)   49 (21.7)   48 (22.1)
   Home Only  275 (62.1)  141 (62.4)  134 (61.8)
   Work Only   7 (1.6)   5 (2.2)   2 (0.9)
   Other   32 (7.2)   16 (7.1)   16 (7.4)
   Nowhere   29 (6.6)   14 (6.2)   15 (7)
  Social supportd, n (%)  236 (53.3)  123 (54.4)  113 (52.1)
  Health literacye, mean ± SD   3.5 ± 2.0   3.5 ± 2.1   3.6 ± 2.0
   Low (0−1 points), n (%)   90 (20.3)   50 (22.1)   40 (18.4)
   Medium (2−3 points), n (%)  107 (24.2)   54 (23.9)   53 (24.4)
   High (4−6 points), n (%)  240 (54.2)  118 (52.2)  122 (56.2)
  Health numeracyf, mean ± SD  6.1 ± 3.2  6.0 ± 3.2  6.1 ± 3.2
   Low (0−4 points), n (%)  135 (30.5)   69 (30.5)   66 (30.4)
   Medium (5−8 points), n (%)  180 (40.6)   93 (41.2)   87 (40.1)
   High (9−11 points), n (%)  120 (27.1)   60 (26.60)   60 (27.7)
  Kidney disease treatment preference, n (%)
   Hemodialysis (in-center)   56 (12.6)   29 (12.8)   27 (12.4)
   Peritoneal Dialysis (at-home)   37 (8.4)   19 (8.4)   18 (8.3)
   Transplant  328 (74.0)  165 (73.0)  163 (75.1)
   Don’t know   17 (3.8)   10 (4.4)   7 (3.2)
  Study site, n (%)
   Columbia  136 (30.7)   67 (29.7)   69 (31.8)
   Emory  153 (34.5)   83 (36.7)   70 (32.3)
   Northwestern  154 (34.8)   76 (33.6)   78 (35.9)
Patient clinical characteristics
 Body mass index > 35 kg/m2, n (%)   80 (18.1)   38 (16.8)   42 (19.4)
 History of hypertension, n (%)  350 (79.0)  184 (81.4)  166 (76.5)
 History of diabetes, n (%)  168 (37.9)   85 (37.6)   83 (38.3)
 History of cardiovascular disease, n (%)   39 (8.8)   19 (8.4)   20 (9.2)
 Albumin level < 3.5 g/dL, n (%)   76 (17.2)   42 (18.6)   34 (15.7)
 Time on dialysis prior to transplant evaluation, d,
  median (Q1–Q3)		  356 (162−1146)  336 (170−1053)  361 (157−1220)
 Dialysis modality, n (%)
  Hemodialysis  227 (51.2)  114 (50.4)  113 (52.1)
   Peritoneal dialysis   69 (15.6)   36 (15.9)   33 (15.2)
   Not on dialysis  147 (33.2)   76 (33.6)   71 (32.7)
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a

Percentages may not all add up to 100% due to missing data. Covariates with missing data include: race (n = 1); household income before taxes (n = 46); marital status (n = 5); educational level (n = 6); employment status (n = 8); self-rated health (n = 4); internet access (n = 3); social support (n = 44); time point first educated about transplant (n = 6); albumin level <3.5 g/dL (n = 16); health literacy (n = 6); numeracy (n = 8); kidney disease treatment preference (n = 5).

b

Measured at the time of transplant evaluation.

c

Includes Asian, American Indian/Alaskan Native, Native Hawaiian/Pacific Islander, Middle Eastern, East Indian, and multiracial.

d

Defined as at least one family member or friend accompanying the patient at the transplant evaluation.

e

Literacy score calculated using Newest Vital Sign, NVS, on a scale from 0 to 6.

f

Numeracy score calculated using the Lipkus scale, on a scale from 0 11.

3.2 |. Measured outcomes

3.2.1 |. Transplant knowledge

The mean transplant knowledge score pre- and post-evaluation for all patients improved from 5.06 (± 2.14) at baseline to 5.80 (± 1.92) at follow-up (out of nine) with a mean difference of 0.74 (± 1.81). Difference in transplant knowledge from pre- to post-evaluation was significantly higher among iChoose Kidney intervention (1.09 ± 1.96) versus control (0.38 ± 1.57) patients (difference-in-difference: 0.71; P < .001) (Table 2). Mean knowledge scores significantly improved from pre- to post-intervention among intervention versus control groups among males (0.76; 95% CI: 0.32, 1.19) and females (0.63; 95% CI: 0.12–1.14). At baseline, African Americans and Hispanics had lower mean knowledge scores than white, non-Hispanics (4.64 ± 2.08 and 4.60 ± 2.20 vs. 5.82 ± 1.97, respectively). Following the intervention, mean knowledge scores improved among all racial/ethnic groups, but was most substantial among Hispanics (difference-in-differences: 1.61; 95% CI: 0.37, 2.85, P = .01). At baseline, patients with lower literacy and numeracy also had lower knowledge scores compared to those with higher literacy and numeracy. All literacy and numeracy subgroups increased knowledge scores with iChoose Kidney, al-though patients with medium (difference-in-differences: 0.62; 95% CI: 0.04, 1.19; P = .04) and high literacy (difference-in-differences: 0.80; 95% CI: 0.34, 1.23; P < .001) and medium (difference-in-differences: 0.96; 95% CI: 0.45, 1.47; P < .001) and high numeracy (difference-in-differences: 0.68; 95% CI: 0.12, 1.25; P = .02) were greater than those with lower health literacy and numeracy levels (Table 2).

TABLE 2.

Mean transplant knowledge scores (range: 0−9 points) pre-evaluation, post-evaluation, and differences (pre- to post-evaluation) stratified by selected patient characteristics according to the assigned study group in the iChoose Kidney Randomized Controlled Trial, 2014-2015 (n = 443)

Selected patient
characteristics		 Study population (n = 443) Intervention (n = 226) Control (n = 217) Difference-in-differencesa
Pre- Post- Difference
from pre- to
post		 Pre- Post- Difference
from pre- to
post		 Pre- Post- Difference
from pre- to
post		 Mean (95% CI) P value
All patients, mean
 (SD)		 5.06 (2.14) 5.80 (1.92) 0.74 (1.81) 5.02 (2.12) 6.11 (1.91) 1.09 (1.96) 5.10 (2.16) 5.48 (1.87) 0.38 (1.57) 0.71 (0.39, 1.05) <.001
Sex, mean (SD)
 Male 4.87 (2.18) 5.77 (1.99) 0.90 (1.87) 4.83 (2.21) 6.09 (2.01) 1.27 (1.98) 4.92 (2.15) 5.43 (1.91) 0.51 (1.66) 0.76 (0.32, 1.19) <.001
 Female 5.37 (2.04) 5.86 (1.80) 0.48 (1.69) 5.35 (1.93) 6.14 (1.75) 0.80 (1.89) 5.40 (2.16) 5.57 (1.82) 0.17 (1.41) 0.63 (0.12, 1.14)   .02
Race, mean (SD)
 African American 4.64 (2.08) 5.48 (1.91) 0.84 (1.71) 4.68 (2.03) 5.81 (2.02) 1.13 (1.81) 4.60 (2.16) 5.10 (1.70) 0.50 (1.52) 0.63 (0.17, 1.09)   .007
 White, Hispanic 4.60 (2.20) 5.36 (2.15) 0.77 (2.24) 4.64 (2.14) 6.16 (1.82) 1.52 (1.96) 4.55 (2.32) 4.45 (2.18) −0.09 (2.27) 1.61 (0.37, 2.85)   .01
 White,
  non-Hispanic		 5.82 (1.97) 6.38 (1.74) 0.56 (1.86) 5.69 (2.05) 6.57 (1.77) 0.88 (2.21) 5.94 (1.89) 6.21 (1.70) 0.28 (1.44) 0.60 (0.09, 1.19)   .046
Health literacy scoreb, mean (SD)
 Low (0−1) 4.07 (1.98) 4.96 (1.94) 0.89 (1.98) 3.96 (2.02) 5.06 (2.07) 1.10 (2.11) 4.20 (1.94) 4.83 (1.77) 0.63 (1.79) 0.47 (−0.36, 1.31)   .26
 Medium (2−3) 4.65 (2.08) 5.55 (2.05) 0.90 (1.52) 4.98 (2.04) 6.19 (1.86) 1.20 (1.73) 4.32 (2.09) 4.91 (2.04) 0.58 (1.22) 0.62 (0.04, 1.19)   .04
 High (4−6) 5.64 (2.04) 6.26 (1.70) 0.63 (1.87) 5.53 (2.04) 6.57 (1.66) 1.03 (2.02) 5.74 (2.05) 5.97 (1.70) 0.23 (1.63) 0.80 (0.34, 1.23) <.001
Numeracy scorec, mean (SD)
 Low (0−4) 4.07 (2.18) 4.97 (2.02) 0.90 (2.00) 3.96 (2.23) 5.09 (2.09) 1.13 (2.09) 4.18 (2.13) 4.85 (1.96) 0.67 (1.88) 0.46 (−0.21, 1.14)   .18
 Medium (5−8) 5.26 (1.93) 6.06 (1.70) 0.79 (1.78) 5.23 (1.77) 6.48 (1.59) 1.26 (1.87) 5.30 (2.09) 5.60 (1.71) 0.30 (1.54) 0.96 (0.45, 1.47) <.001
 High (9−11) 5.93 (1.95) 6.47 (1.69) 0.54 (1.60) 6.00 (1.96) 6.88 (1.51) 0.88 (1.82) 5.85 (1.95) 6.05 (1.78) 0.20 (1.26) 0.68 (0.12, 1.25)   .02
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a

Between mean difference in intervention versus control differences; by t-test.

b

Health literacy score calculated by Newest Vital Sign (NVS).28

c

Numeracy score calculated by Lipkus Scale.29

3.2.2 |. Access to transplant

Among intervention patients, there were trends towards better access to kidney transplantation within one year of transplant evaluation, but results were not statistically significant (Table 3). Intervention patients were more often placed on the national waiting list (58.0% vs. 55.3%), had at least 1 living donor inquiry (53.5% vs. 46.1%), received a living donor transplant (13.7% vs. 12.0%), and received a living or deceased donor transplant (17.7% vs. 16.6%) compared to control patients. The proportion of patients with at least one of the three access measures was not significantly higher among iChoose (n = 168; 74.3%) versus control (n = 155; 71.4%) patients (P = .37) (Table 3).

TABLE 3.

Impact of the iChoose Kidney intervention tool on access to transplantation 1 y following transplant evaluation according to the assigned study group in the iChoose Kidney Randomized Controlled Trial, 2014–2015 (n = 443)

Access to kidney transplant
item		 Study population
(n = 443)		 Intervention
(n = 226)		 Control
(n = 217)		 P-value
Within 1 y after transplant evaluation, n (%)
 Received at least 1 living
  donor inquiry		 221 (49.9) 121 (53.5) 100 (46.1)
 Placed on the national
  waiting list		 251 (56.7) 131 (58.0) 120 (55.3)
 Received a living donor
  transplant		   57 (12.9)   31 (13.7)   26 (12.0)
 Received a living or
  deceased donor kidney
  transplant		   76 (17.2)   40 (17.7)   36 (16.6)
 Composite access of
  transplant access metrica 		323 (72.9) 168 (74.3) 155 (71.4) .49
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a

if patient had at least one of the following outcomes: waitlisting, deceased or living donor transplant, a minimum of 1 living donor inquiry.

3.2.3 |. Decisional conflict

Regardless of study group, the majority of patients’ decisional conflict score remained the same pre- to post-evaluation (n = 238; 53.7%). Decisional conflict decreased after evaluation for 181 patients; there were no significant differences between intervention (n = 96; 42.5%) versus control (n = 85; 39.2%) patients (P = .48) (Table S3).

3.2.4 |. Treatment preference

At baseline, the majority of patients reported a preference for transplant (n = 328; 74.0%) compared to hemodialysis (n = 56; 12.6%) or peritoneal dialysis (n = 37; 8.4%) (Table 1). About two-thirds (64.6%) of patients with a preference for transplant before their evaluation continued to select transplant as their preferred kidney disease treatment method after evaluation. The proportion of patients changing treatment preference from dialysis to transplant was not significantly different among iChoose (n = 19; 8.4%) versus control (n = 12; 5.5%) patients (P = .24) (Table S4).

3.2.5 |. Provider opinions

Of providers who took the baseline surveys prior to study start (n = 34), 90% were nephrologists; 34% had been practicing for <5 years, 35% for 5–10 years, and 31% for >10 years. Prior to the study, only 38% of providers had ever utilized educational tools with pre-transplant patients on a mobile device or computer. Providers from all study sites reported discussing the benefit of transplant verus dialysis with 95% of intervention patients versus 90% of controls (P = .04) in the immediate follow-up provider survey, with providers most often communicating survival risk estimates (58%) to patients versus mortality (25%) or both (17%). The benefit of living versus deceased donor transplant was discussed with 91% of intervention versus 78% of control patients via results of the immediate follow-up provider survey (P < .0001).

Among providers surveyed 3 months after the study (n = 19) in the post-study follow-up provider survey, all providers believed that patients were receptive to using iChoose Kidney, with 95% and 68% reporting that patients’ understanding of the survival benefit of transplant versus dialysis and living donor versus de-ceased donor transplant improved, respectively, due to the use of the tool. In this survey, the majority of providers (89%) indicated they “always” discussed the survival benefit of transplant versus dialysis with patients during evaluation, compared to only 35% reporting this prior to study start in the provider baseline survey. At the three-month follow-up, almost all of the surveyed providers (95%) indicated that providers could benefit from implementing the tool as part of their regular practice. However, 21% of providers believed that “adding time to the appointment” was a barrier to using the tool. Nonetheless, 94% of providers indicated they had a moderate or strong intention of using iChoose Kidney after the study.

4 |. DISCUSSION

The results of this randomized controlled trial suggest that the iChoose Kidney decision aid was effective in improving transplant knowledge among ESRD patients undergoing an evaluation for transplant. The decision aid was most successful in improving transplant knowledge among male and Hispanic patients and patients with medium to high levels of health literacy and numeracy. However, iChoose Kidney did not significantly improve access to kidney transplant in the year following medical evaluation, suggesting that the decision aid alone may not be effective enough to improve transplant access, or may not be as effective among a population already fairly well educated about transplantation. However, iChoose Kidney did increase the likelihood that clinical providers would discuss the survival benefits of transplant versus dialysis and living versus deceased donor transplant and provider believed that it improved patients’ understanding of treatment options.

While the effect size of 0.71 was relatively small with regard to knowledge improvement, intervention versus control patients answered ~1 more question correctly following their evaluation, which may still be clinically meaningful given the small scale (range: 0–9) and the fairly high baseline knowledge of our patient population. Previous studies have shown an association between higher transplant knowledge and better access to transplant.12,30–33 If iChoose Kidney was used in a large population (eg, among all patients in a transplant center or for a longer period of time), an increase in knowledge has the potential to lead to an improvement in transplant access. In addition, administering iChoose Kidney among ESRD patients at dialysis facilities, where patients may be less likely aware of transplantation, would possibly have a greater impact.

These findings are noteworthy in several respects. First, the use of decision aids to improve knowledge of treatment options among patients making healthcare decisions is well established in previous literature among similar populations. In a study evaluating the ef-ficacy of a mobile web application for increasing knowledge about increased risk donor kidneys, intervention participants using the app had higher knowledge scores (mean difference: 6.61; 95% CI: 5.37–7.86) than control participants where the knowledge scale ranged from 0 to 31.34 In another, patients who received intensive education about living donor transplant had higher knowledge (scaled from 0 to than patients who received usual care (12.7 vs. 11.7; P = .0008) one week after evaluation.35 A systematic review concluded that decision aids were effective in improving treatment option knowledge and clearer expectations of treatment risks and benefits.17 In a recent pilot study among liver transplant candidates, both knowledge and attitudes about organ quality improved after exposure to a web-based decision aid on the topic.36 Prior studies also suggest that comprehensive education of ESRD treatment options may not be uniformly distributed.7,14,37,38 Only 18% of dialysis facility social workers and nurses reported in-depth conversations with patients about the survival benefits of transplant.14 In addition to significant improvement in transplant knowledge among intervention (vs. control) patients, our results indicate that iChoose Kidney facilitated conversations about survival benefits of transplant more often.

At baseline, knowledge scores were significantly lower among African Americans and Hispanics compared to non-Hispanic whites, and knowledge increased with increasing health literacy and numeracy levels. In pre-planned subgroup analyses, we found that while patients of all race/ethnicities benefitted significantly, knowledge improvement was greatest among Hispanic patients. These results suggest some of the racial/ethnic disparities in transplant that result from inadequate knowledge could be reduced if iChoose Kidney was targeted to specific minority groups.7 The iChoose Kidney decision aid led to greater increases in knowledge among patients with medium to higher literacy and numeracy compared to those with lower literacy and numeracy. While best practice guidelines for decision aids were used in the development of iChoose Kidney,39 including the presentation of absolute and relative risks and the use of visual aids and plain languages, there may be other interventions more appropriate for patients with low literacy and numeracy. In our study, 11.8% of patients had low health literacy and 21.1% had low numeracy, and while this is higher than the general US population, the transplant community needs interventions to improve care for this population. Administering more comprehensive transplant education and materials in varying formats,40 such as easy-to-understand written materials or culturally competent videos with patient stories could further improve ESRD patients’ ability to make an informed decision about their treatment options.12

There are several reasons that could explain the insignificant difference in transplant steps by study group. First, our study was not powered to detect secondary outcomes. For example, while living donor inquiries were higher among intervention versus control patients (53.5% vs. 46.1%), a much larger study with extended follow-up would be needed to observe statistical significance. Second, our population was highly educated and knowledgeable about transplantation. The iChoose Kidney decision aid may be more effective earlier in the transplant process, such as among late-stage CKD patients and new dialysis patients, where patients may be more likely to benefit from educational interventions. Using the decision aid throughout the transplant process could provide more opportunities for dialogue about treatment options and encourage true shared decision making between providers and patients. Education at the time of dialysis start has substantial influences on transplant access. Kucirka et al. found that patients uninformed about transplant at time of dialysis initiation were less likely to be waitlisted and receive a living donor transplant.7 Reinforcing the importance of patient knowledge, Salter et al. found lower waitlisting within one year of dialysis start among patients reporting no receipt of transplant information.38

It is unlikely that the use of a single educational intervention could improve access to transplantation. In Waterman et al.’s study of dialysis facility education practices, facilities using more than three transplant education strategies had higher rates of waitlisting.14 The iChoose Kidney aid was one of several patient-level interventions used in a previous randomized controlled trial, the RaDIANT Community Study, which led to increased referral for transplant evaluation and reduced racial disparities in referral among dialysis patients in Georgia.41 Future research should test whether a combined approach of iChoose Kidney and other interventions can affect transplant access.

4.1 |. Study limitations

Our primary outcome of transplant knowledge about the survival benefit of transplant and dialysis was not externally validated; however, a multidisciplinary group of experts developed the survey and it was pilot tested prior to the study. Because patients had already completed several steps in the transplant process by starting the transplant evaluation, results may not be generalizable to all ESRD patients. Testing the decision aid in a pre-ESRD or dialysis facility setting earlier in the course of disease is important to determine the effect among a less educated, more vulnerable population. In addition, the effectiveness of the decision aid likely varies by provider and transplant center. Providers’ increased familiarity with the decision aid as the study progressed could potentially confound the results if they became more likely to discuss the survival benefits of transplant among control patients. However, there were no differences in change in transplant knowledge among control patients recruited in the first half versus second half of the study. Further, we were unable to control for differences in standard of care transplant education practices at each of the transplant centers. Despite this, results were similar across our three large, geographically diverse transplant center populations. Additional limitations included the inability to blind patients to the intervention, which could have confounded study results, and the inability to examine long-term effects of iChoose Kidney use on patient transplant knowledge.

4.1.1 |. Study conclusions

The results of this multicenter, randomized controlled trial among ESRD patients attending a medical evaluation at three large US transplant centers provides support for the iChoose Kidney decision aid’s effect in improving ESRD patient transplant knowledge and initiating provider-patient conversations about the survival benefits of transplant (vs. dialysis) and living donor (vs. deceased donor) transplant. Our findings also suggest the iChoose Kidney tool may not be effective enough in isolation to significantly impact patient behavior enough to improve access to kidney transplant.

Supplementary Material

Supplemental

ACKNOWLEDGMENTS

We would like to thank Norman S. Coplon Satellite Healthcare Foundation for funding this project. We would also like to acknowledge the research assistants who recruited and consented patients at each of the three study sites: (1) Emory: Kayla Smith, BS; Imani Morris, MPH; Elaine Lai, MPH; Chao Song, MPH; Kelsey Rogowski, MPH; Sarah McKinstry, MPH; Shamika Jones, MPH, CHES; (2) Columbia University: Doug Arbetter, MPH; Prativa Baral, MPH; Karl Foley, BA; Eric Bland, MA; Whitney Skillen, MPH; (3) Northwestern University: Ellie Serrano, MA; Christy Nowicki, BA. The randomized clinical trial was registered on clinicaltrials.gov (NCT02235571) as “iChoose Decision Kidney Aid for End- Stage Renal Disease Patients.” The full trial protocol is available in the journal Kidney International Reports.19

Funding information

Norman S. Coplon Satellite Healthcare Foundation

Abbreviations

BMI

body mass index

EMR

electronic medical records

ESRD

end-stage renal disease

RaDIANT

Reducing Disparities in Access to kidNey Transplantation

Footnotes

DISCLOSURE

The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation.

SUPPORTING INFORMATION

Additional Supporting Information may be found online in the supporting information tab for this article.

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