Digital Applications Targeting Medication Safety in Ambulatory High-Risk CKD Patients: Randomized Controlled Clinical Trial

Stephanie W. Ong; Sarbjit V. Jassal; Eveline C. Porter; Kyoyoon K. Min; Akib Uddin; Joseph A. Cafazzo; Valeria E. Rac; George Tomlinson; Alexander G. Logan

doi:10.2215/CJN.15020920

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Figure 1.
System architecture. The components included a smartphone application and Bluetooth-enabled BP monitor for patients, web-based dashboard for clinicians, data servers to execute algorithms and store data, and live interfaces with clinical repositories for medications and laboratory results.
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Figure 2.
CONSORT diagram.
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Figure 3.
Mobile application usage data and sustainability. (A) Number of patients using eKidneyCare with ≥ one patient-initiated medication review during the study duration. (B) Percentage of patients by group with at least one home BP reading per month. *The sharp reduction in the number of medication reviews in study month 12 is related to the large number of participants completing the study exit assessment in the 11th month. The mean study duration was 10.8 months.

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Table 1.

Baseline patient characteristics

Variable^a	eKidneyCare	MyMedRec
N	89	93
Age, yr (SD)	56 (14)	58 (16)
Male, n (%)	54 (61)	64 (69)
CKD stage, n (%)
3b	11 (12)	13 (14)
4	24 (27)	33 (36)
5	25 (28)	16 (17)
Dialysis	29 (33)	31 (33)
Home nocturnal hemodialysis	18 (20)	19 (20)
In-center hemodialysis	0 (0)	1 (1)
Peritoneal dialysis	11 (12)	11 (12)
Education, n (%)
Graduate	10 (11)	24 (26)
College/University	53 (60)	51 (55)
High school	19 (21)	15 (16)
Primary school	5 (6)	2 (2)
Not stated	2 (2)	1 (1)
Health literacy REALM scores, n (%)
Grade 3 or below	0 (0)	2 (2)
Grade 4–6	4 (5)	1 (1)
Grade 7–8	21 (24)	16 (18)
High school	62 (71)	71 (79)
Ethnicity, n (%)
White	53 (60)	49 (53)
Black (Non-Hispanic)	10 (11)	17 (18)
Asian (Southeast Asian, Asian, South Asian)	22 (25)	26 (28)
First nations	1 (1)	0 (0)
Hispanic	2 (2)	1 (1)
Other or did not disclose	1 (1)	7 (8)
Comorbidity
Number of comorbidities, median (IQR)	4 (3–6)	5 (3–7)
Number of comorbidities, n (%)
0–1	5 (6)	10 (11)
2–3	29 (33)	17 (18)
4–5	27 (30)	29 (31)
≥6	28 (32)	37 (40)
Diabetes mellitus, n (%)	26 (29)	31 (33)
Hypertension, n (%)	65 (73)	60 (65)
Medications
Total number of medications per patient, median (IQR)	10 (8–14)	11 (8–15)
Number with ten or more medications, n (%)	44 (49)	48 (52)
Antihypertensive medications, median (IQR)	2 (1–4)	2 (1–4)
Number with HTN medications, n (%)
0	11 (12)	14 (15)
1	17 (19)	20 (21)
2	19 (21)	19 (20)
≥3	42 (47)	40 (43)
Total medication discrepancy rate, median (IQR)	0.38 (0.25–0.54)	0.38 (0.29–0.53)
Clinically relevant medication discrepancy rate, median (IQR)	0.33 (0.20–0.46)	0.30 (0.17–0.50)
BP, mm Hg, mean±SD, mm Hg
Clinic systolic BP	125±23	122±20
Clinic diastolic BP	77±13	76±13
Home systolic BP	129±20	126±18
Home diastolic BP	77±13	76±12
Laboratory tests, n (%) in range
Hemoglobin (10.0–12.0 g/dl)	47 (53)	53 (57)
Potassium (3.5–5.1 mEq/L)	77 (88)	80 (87)
Phosphate (<4.6 mg/dl)	29 (39)	27 (34)
Patient-reported outcome measures, mean±SD
Hospital Anxiety and depression scale	8.7±5.8	9.0±6.3
Veterans Rand-12 physical component score	39.6±10.4	40.2±9.6
Veterans Rand-12 mental component score	50.2±9.2	49.8±10.7
EQ-5D	0.8±0.2	0.8±0.2
Use of technology, n (%)
Personal computer	75 (84)	77 (83)
Smartphone	53 (60)	56 (60)
Cellphone	43 (48)	42 (45)
Tablet	49 (55)	53 (57)
Home BP monitor	66 (74)	63 (68)
Use of medication management tools, n (%)
Nothing	30 (34)	25 (27)
Blister package	9 (10)	9 (10)
Dosette box	31 (35)	35 (38)
Handwritten list	12 (14)	9 (10)
Self-generated computer list	8 (9)	7 (8)
Pharmacy-generated list	10 (11)	17 (18)

REALM, Rapid Estimate of Adult Literacy in Medicine; IQR, interquartile range; HTN, hypertension; EQ-5D, EuroQol-5 Dimension.
↵a There were no significant differences between the two groups for any variable.

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Table 2.

Medication discrepancy outcomes at exit by study group

Outcome	eKidneyCare (n=82)	MyMedRec (n=83)	P value
Primary outcome
All medications
Discrepancy rate, median (IQR)	0.45 (0.33–0.63)	0.67 (0.40–1.00)	0.001
Change in discrepancies from entry, mean±SD	0.13±0.27	0.30±0.41	0.007
Number of discrepancies per patient, median (IQR)	5 (3–7)	6 (4–10)	0.01
Total number of medications per patient, median (IQR)	11 (8–14)	11 (8–13)	0.95
Secondary outcomes
Proportion of patients with ≥1 clinically relevant medication discrepancies, n (%)	62 (70)	70 (75)	0.30
Clinically relevant medications
Discrepancy rate, median (IQR)	0.33 (0.20–0.46)	0.50 (0.32–0.72)	<0.001
Change in discrepancies from entry, mean±SD.	0.02±0.29	0.18±0.43	0.004
Number of clinically relevant discrepancies per patient, median (IQR)	3 (2–4)	4 (2–6)	0.001
Number of clinically relevant medications per patient, median (IQR)	8 (6–11)	8 (6–11)	0.97
Severity of clinically relevant medication discrepancies^b, mean±SD
All categories	2.66±2.19	4.16±3.70	0.004 0.61 (0.48–0.78)^a
Category D or higher	1.66±1.88	3.08±3.31	<0.001 0.52 (0.38–0.70)^a
Category E or higher	0.94±1.25	1.65±1.83	0.002 0.54 (0.39–0.76)^a
Category E1 or higher	0.27±0.54	0.63±0.91	0.002 0.40 (0.24–0.66)^a

IQR, interquartile range.
↵a Rate ratio (95% confidence interval).
↵b Severity on the basis of National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Index.

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Table 3.

Secondary outcomes at exit by study group

Variable	eKidneyCare	n	MyMedRec	N	P Value
BP, mm Hg^a
Clinic BP, mean±SD
6 mo systolic BP	−0.16±20.1	82	−1.21±18.9	77	0.78
Diastolic BP	−0.26±11.1	82	−1.78±9.9	77	0.24
12 mo systolic BP	−1.81±22.2	83	−2.61±19.4	82	0.78
Diastolic BP	−1.52±12.9	83	−1.49±10.3	82	0.91
Home BP, mean±SD
12 mo systolic BP	−2.22±16.9	80	0.96±14.1	62	0.33
Diastolic BP	−0.26±8.9	80	0.10±7.1	62	0.92
Laboratory, mean±SD^a
Hemoglobin, g/dl	0.01±1.29	74	0.25±1.11	66	0.31
Potassium, mEq/L	−0.1±0.6	73	−0.1±0.7	67	0.71
Phosphate, mg/dl	0.03±1.36	61	−0.19±1.49	53	0.42
Patient-reported outcome, mean±SD^a
HADS	−0.1±4.6	81	0.5±5.8	70	0.33
VR12-PCS	−0.1±9.8	83	0.2±7.6	79	0.88
VR12-MCS	−1.1±8.9	83	−0.7±10.3	79	0.46
EQ-5D	0.8±0.1	82	0.8±0.2	77	0.41
Patient satisfaction: Mobile app data usage
Per-person totals of BP measurements over study period, median (IQR)	194 (94–338)	89	102 (28–182)	93	<0.001
Number of patients with a gap >60 d between consecutive BP readings over follow-up, n (%)	13 (15)	89	63 (68)	93	<0.001

HADS, Hospital Anxiety and Depression Scale; VR12-PCS, Veterans Rand-12 Physical Component Score; VR12-MCS, Veterans Rand-12 Mental Component Score; EQ-5D, EuroQol-5 Dimension; IQR, interquartile range.
↵a Mean±SD change from baseline to exit, with positive numbers indicating an increase and negative a decrease.