TY - JOUR
T1 - Embedded point of care randomisation for evaluating comparative effectiveness questions
T2 - PROSPECTOR-critical care feasibility study protocol
AU - Wilson, Matthew G.
AU - Asselbergs, Folkert W.
AU - Miguel, Ruben
AU - Brealey, David
AU - Harris, Steve K.
N1 - Funding Information: The authors would like to acknowledge the help of Professor Matthew Sydes in advising on the study design and supporting MGW's PhD work in this field. We also thank Ms Nausheen Saleem for her ongoing support in the development of the ePOCR prompts together with the support of the UCL Clinical Research Informatics Unit. MGW is supported through a doctoral training partnership funded by the Medical Research Council. FWA and SKH are supported by University College London Hospitals National Institute for Health Research Biomedical Research Centre. SKH is supported by a Health Foundation Improvement Science Fellowship Funding Information: The authors would like to acknowledge the help of Professor Matthew Sydes in advising on the study design and supporting MGW’s PhD work in this field. We also thank Ms Nausheen Saleem for her ongoing support in the development of the ePOCR prompts together with the support of the UCL Clinical Research Informatics Unit. MGW is supported through a doctoral training partnership funded by the Medical Research Council. FWA and SKH are supported by University College London Hospitals National Institute for Health Research Biomedical Research Centre. SKH is supported by a Health Foundation Improvement Science Fellowship. Publisher Copyright: ©
PY - 2022/9/19
Y1 - 2022/9/19
N2 - INTRODUCTION: Many routinely administered treatments lack evidence as to their effectiveness. When treatments lack evidence, patients receive varying care based on the preferences of clinicians. Standard randomised controlled trials are unsuited to comparisons of different routine treatment strategies, and there remains little economic incentive for change.Integrating clinical trial infrastructure into electronic health record systems offers the potential for routine treatment comparisons at scale, through reduced trial costs. To date, embedded trials have automated data collection, participant identification and eligibility screening, but randomisation and consent remain manual and therefore costly tasks.This study will investigate the feasibility of using computer prompts to allow flexible randomisation at the point of clinical decision making. It will compare the effectiveness of two prompt designs through the lens of a candidate research question-comparing liberal or restrictive magnesium supplementation practices for critical care patients. It will also explore the acceptability of two consent models for conducting comparative effectiveness research. METHODS AND ANALYSIS: We will conduct a single centre, mixed-methods feasibility study, aiming to recruit 50 patients undergoing elective surgery requiring postoperative critical care admission. Participants will be randomised to either 'Nudge' or 'Preference' designs of electronic point-of-care randomisation prompt, and liberal or restrictive magnesium supplementation.We will judge feasibility through a combination of study outcomes. The primary outcome will be the proportion of prompts displayed resulting in successful randomisation events (compliance with the allocated magnesium strategy). Secondary outcomes will evaluate the acceptability of both prompt designs to clinicians and ascertain the acceptability of pre-emptive and opt-out consent models to patients. ETHICS AND DISSEMINATION: This study was approved by Riverside Research Ethics Committee (Ref: 21/LO/0785) and will be published on completion. TRIAL REGISTRATION NUMBER: NCT05149820.
AB - INTRODUCTION: Many routinely administered treatments lack evidence as to their effectiveness. When treatments lack evidence, patients receive varying care based on the preferences of clinicians. Standard randomised controlled trials are unsuited to comparisons of different routine treatment strategies, and there remains little economic incentive for change.Integrating clinical trial infrastructure into electronic health record systems offers the potential for routine treatment comparisons at scale, through reduced trial costs. To date, embedded trials have automated data collection, participant identification and eligibility screening, but randomisation and consent remain manual and therefore costly tasks.This study will investigate the feasibility of using computer prompts to allow flexible randomisation at the point of clinical decision making. It will compare the effectiveness of two prompt designs through the lens of a candidate research question-comparing liberal or restrictive magnesium supplementation practices for critical care patients. It will also explore the acceptability of two consent models for conducting comparative effectiveness research. METHODS AND ANALYSIS: We will conduct a single centre, mixed-methods feasibility study, aiming to recruit 50 patients undergoing elective surgery requiring postoperative critical care admission. Participants will be randomised to either 'Nudge' or 'Preference' designs of electronic point-of-care randomisation prompt, and liberal or restrictive magnesium supplementation.We will judge feasibility through a combination of study outcomes. The primary outcome will be the proportion of prompts displayed resulting in successful randomisation events (compliance with the allocated magnesium strategy). Secondary outcomes will evaluate the acceptability of both prompt designs to clinicians and ascertain the acceptability of pre-emptive and opt-out consent models to patients. ETHICS AND DISSEMINATION: This study was approved by Riverside Research Ethics Committee (Ref: 21/LO/0785) and will be published on completion. TRIAL REGISTRATION NUMBER: NCT05149820.
KW - Adult intensive & critical care
KW - Health informatics
KW - STATISTICS & RESEARCH METHODS
UR - http://www.scopus.com/inward/record.url?scp=85138136618&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/bmjopen-2021-059995
DO - https://doi.org/10.1136/bmjopen-2021-059995
M3 - Article
C2 - 36123103
SN - 2044-6055
VL - 12
SP - e059995
JO - BMJ Open
JF - BMJ Open
IS - 9
M1 - e059995
ER -