Pragmatic clinic randomized trial to improve chronic kidney disease care: Design and adaptation due to COVID disruptions.
Contemp Clin Trials
; 109: 106501, 2021 10.
Article
in English
| MEDLINE | ID: covidwho-1309183
ABSTRACT
BACKGROUND:
We describe a clinic-randomized trial to improve chronic kidney disease (CKD) care through a CKD-clinical decision support (CKD-CDS) intervention in primary care clinics and the challenges we encountered due to COVID-19 care disruption. METHODS/DESIGN:
Primary care clinics (N = 32) were randomized to usual care (UC) or to CKD-CDS. Between April 17, 2019 and March 14, 2020, more than 7000 patients had accrued for analysis by meeting study-eligibility criteria at an index office visit age 18-75, laboratory criteria for stage 3 or 4 CKD (eGFR 15-59 mL/min/1.73 m2), and one or more opportunities algorithmically identified to improve CKD care such as blood pressure (BP) or glucose control, angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) use, discontinuance of a nonsteroidal anti-inflammatory drug (NSAID), or nephrology referral. At CKD-CDS clinics, CDS provided individualized treatment suggestions that were printed for patients and clinicians at the start of office encounters and were viewable within the electronic health record. By initial design, the impact of the CKD-CDS intervention on care gaps was to be assessed 12 months after the index date, but COVID-19 caused major disruptions to care delivery during the intervention period. In response to disruptions, the intervention was temporarily suspended while we expanded CDS use for telehealth encounters and programmed new criteria for displaying the CKD-CDS to intervention patients due to clinic closures and scheduling changes.DISCUSSION:
We describe a NIH-funded pragmatic trial of web-based EHR-integrated CKD-CDS and modifications necessary mid-study to complete the study as intended in the face of COVID-19 pandemic challenges.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Renal Insufficiency, Chronic
/
COVID-19
Type of study:
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
Limits:
Adolescent
/
Adult
/
Aged
/
Humans
/
Middle aged
/
Young adult
Language:
English
Journal:
Contemp Clin Trials
Journal subject:
Medicine
/
Therapeutics
Year:
2021
Document Type:
Article
Similar
MEDLINE
...
LILACS
LIS