Impact of the Global Pandemic on Accrual for a Non-Covid-19 ICU Clinical Trial
American Journal of Respiratory and Critical Care Medicine
; 205(1), 2022.
Article
in English
| EMBASE | ID: covidwho-1927873
ABSTRACT
RATIONALE Enrollment and retention of participants for any research study is challenging. The unpredictable nature of the ICU environment coupled with tenuous physiological status of patients can significantly thwart clinical trial accrual goals. The COVID-19 pandemic has pushed ICU census numbers to unprecedented levels with severely ill patients experiencing lengthy hospitalizations, delaying turn-over of beds. Anecdotal reports suggest challenges in achieving trial recruitment goals. The aims of this study were to describe the impact of the pandemic on a non-COVID-19 ICU clinical trial's screening and accrual of patients receiving mechanical ventilatory support. METHODS:
A descriptive, retrospective design was used to address the study aims. Screening and accrual data were obtained from a Midwestern academic medical center in North America's parent clinical trial (R01HL130881). The primary aims of the efficacy trial are to test if patient selfadministration of dexmedetomidine (n = 190) reduces anxiety, delirium, ventilator days and ICU stay. A 3-step screening process prior to informed consent consists of (1) electronic health record (EHR) automated ICU census reports of mechanically ventilated patients, (2) in-depth review of the EHR for inclusion criteria, then (3) bedside assessment of grip strength to use a push-button medication delivery device and ability to follow commands. Descriptive statistics and Chi-square were used to compare screening and accrual data from a pre-pandemic timeframe (8/27/2018- 3/15/2020) to a pandemic timeframe (3/16/2020-12/31/2021).RESULTS:
Of 91 eligible patients, 49 were accrued (53.8%) during the pre-pandemic timeframe. Patients were not accrued due to patient/LAR declination (78%) or primary medical team declination (22%). The three most frequent reasons for ineligibility were unarousable (25%), hypotension (11%) and not following commands (9%). While the pandemic timeframe had 30 fewer eligible patients, 40 of 61 (67%) were accrued. Patients were not accrued due to patient/LAR declination (87%) or medical team declination (13%), similar to pre-pandemic timeframe (p = 0.7). Pandemic timeframe had significantly more unarousable patients (32%, p < 0.0001) with fewer patients hypotensive (7%, p < 0.0001) or not following commands (7%, p = 0.01). Once COVID-19 infection was resolved, lengthy ventilator days, higher sedation levels, and prolonged immobility contributed to extremely weak grip strength, precluding trial eligibility.CONCLUSIONS:
These retrospective data confirm this trial's enrollment was hampered by the COVID-19 pandemic due to fewer eligible, unarousable patients. Declinations from patients/LARs were similar during both timeframes. Inability to meet accrual milestones risks continued.
antihypertensive agent; dexmedetomidine; adult; anxiety; artificial ventilation; clinical trial; conference abstract; controlled study; coronavirus disease 2019; delirium; drug self administration; drug therapy; electronic health record; eligibility; female; grip strength; human; hypotension; immobility; informed consent; major clinical study; male; North America; pandemic; retrospective study; sedation; university hospital; ventilated patient; ventilator
Full text:
Available
Collection:
Databases of international organizations
Database:
EMBASE
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Language:
English
Journal:
American Journal of Respiratory and Critical Care Medicine
Year:
2022
Document Type:
Article
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