| Literature DB >> 35866010 |
Lipika Samal1,2, John D D'Amore3, Michael P Gannon1, John L Kilgallon1, Jean-Pierre Charles1, Devin M Mann4, Lydia C Siegel1,2,5, Kelly Burdge6, Shimon Shaykevich1, Stuart Lipsitz1,2, Sushrut S Waikar6,7, David W Bates1,2, Adam Wright8.
Abstract
Rationale & Objective: To design and implement clinical decision support incorporating a validated risk prediction estimate of kidney failure in primary care clinics and to evaluate the impact on stage-appropriate monitoring and referral. Study Design: Block-randomized, pragmatic clinical trial. Setting & Participants: Ten primary care clinics in the greater Boston area. Patients with stage 3-5 chronic kidney disease (CKD) were included. Patients were randomized within each primary care physician panel through a block randomization approach. The trial occurred between December 4, 2015, and December 3, 2016. Intervention: Point-of-care noninterruptive clinical decision support that delivered the 5-year kidney failure risk equation as well as recommendations for stage-appropriate monitoring and referral to nephrology. Outcomes: The primary outcome was as follows: Urine and serum laboratory monitoring test findings measured at one timepoint 6 months after the initial primary care visit and analyzed only in patients who had not undergone the recommended monitoring test in the preceding 12 months. The secondary outcome was nephrology referral in patients with a calculated kidney failure risk equation value of >10% measured at one timepoint 6 months after the initial primary care visit.Entities:
Keywords: CKD awareness; CKD diagnosis; CKD management; Chronic kidney disease (CKD); clinical decision support (CDS); electronic health record (EHR); nephrology referral; primary care; primary care physician (PCP); randomized clinical trial (RCT); risk stratification
Year: 2022 PMID: 35866010 PMCID: PMC9293940 DOI: 10.1016/j.xkme.2022.100493
Source DB: PubMed Journal: Kidney Med ISSN: 2590-0595
Figure 1Clinical decision support application flow for patient screening, enrollment, randomization, and delivery of intervention. Abbreviations: CCD, Continuity of Care Document; CDS, clinical decision support; CKD, chronic kidney disease; CO2, carbon dioxide; eGFR, estimated glomerular filtration rate; PCP, primary care physician.
Figure 2Consolidated Standards of Reporting Trials (CONSORT) flowchart: participant enrollment, allocation, exclusion, and analysis. Abbreviations: KFRE, kidney failure risk equation.
Figure 3Partners electronic health record patient summary page showing clinical decision support hyperlink and rollover text.
Demographic and Clinical Characteristics at Baseline
| Patient characteristics | Total (N = 5,590) | Intervention (N = 2,794) | Control (N = 2,796) | |
|---|---|---|---|---|
| Age (y), mean (SD) | 77.20 (10.90) | 77.25 (10.90) | 76.96 (10.90) | 0.29 |
| Male sex, n (%) | 2,173 (38.87%) | 1,088 (38.94%) | 1,085 (38.81%) | 0.90 |
| Race/ethnicity, n (%) | ||||
| White | 5,397 (96.56%) | 2,700 (96.67%) | 2,697 (96.46%) | 0.67 |
| Non-White | 192 (3.44%) | 93 (3.33%) | 99 (3.54%) | |
| Marital status, n (%) | ||||
| Married | 2,544 (45.51%) | 1,275 (45.63%) | 1,269 (45.39%) | 0.84 |
| Single or other | 3,046 (54.49%) | 1,519 (54.37%) | 1,527 (54.61%) | |
| Tobacco use, n (%) | ||||
| Current | 379 (6.78%) | 192 (6.87%) | 187 (6.69%) | 0.85 |
| Former | 2,434 (43.54%) | 1,225 (43.84%) | 1,209 (43.24%) | |
| Never | 2,777 (49.68%) | 1,377 (49.28%) | 1,400 (50.07%) | |
| Insurance status, n (%) | ||||
| Public | 4,229 (75.65%) | 2,133 (76.34%) | 2,096 (74.96%) | 0.38 |
| Private | 1,354 (24.22%) | 658 (23.55%) | 696 (24.89%) | |
| Self-pay | 7 (0.13%) | 3 (0.11%) | 4 (0.14%) | |
| Diabetes | 1,773 (32%%) | 879 (32%%) | 894 (32%) | |
| Charlson comorbidity index, median (IQR) | 2.00 (1.00-4.00) | 2.0 (1.0-4.0) | 2.0 (1.0-4.0) | 0.82 |
| KFRE characteristics | ||||
| KFRE risk, median (IQR) | 2.30 (1.10-5.60) | 2.20 (1.10-5.50) | 2.30 (1.20-5.70) | 0.35 |
| KFRE risk >10%, n (%) | 840 (15.03%) | 419 (15.00%) | 421 (15.06%) | 0.95 |
Abbreviations: IQR, Interquartile range; KFRE, kidney failure risk equation; SD, standard deviation.
Figure 4Comparison of the proportion of patients with completion of tests or referrals. (A) Primary outcome: completion of tests necessary for calculation of the kidney failure risk equation in the intervention arm versus in the control arm patients. (B) Secondary outcome: completion of urinary albumin-to-creatinine ratio test in the intervention arm versus in the control arm patients. (C) Secondary outcome: completion of nephrology consultation for patients with a risk estimate of >10% in the intervention arm versus in the control arm patients.