Design considerations of a randomized controlled trial of sedation level during hip fracture repair surgery: A strategy to reduce the incidence of postoperative delirium in elderly patients

Research output: Contribution to journalArticle

Abstract

Background Delirium is an acute change in mental status characterized by sudden onset, fluctuating course, inattention, disorganized thinking, and abnormal level of consciousness. The objective of the randomized controlled trial "A STrategy to Reduce the Incidence of Postoperative Delirium in Elderly Patients" (STRIDE) is to assess the effectiveness of light versus heavy sedation on delirium and other outcomes in elderly patients undergoing hip fracture repair surgery. Our goal is to describe the design considerations and lessons learned in planning and implementing the STRIDE trial. Methods Discussed are challenges encountered including (1) how to ensure that we quickly identify, assess the eligibility of, and randomize traumatic hip fracture patients; (2) how to implement interventions that involve continuous monitoring and adjustment during the surgery; and (3) how to measure and ascertain the primary outcome, delirium. Results To address the first challenge, we monitored the operating room schedule more actively than anticipated. We constructed and organized eligibility assessment data collection forms by purpose and by source of information needed to complete them. We decided that randomization needs to take place in the operating room. To address the second challenge, we designed and implemented a treatment protocol and covered the bispectral index monitor to prevent the Anesthesiologist/Anesthetist from being influenced by the bispectral index reading while administering the intervention. Finally, clinical assessment of delirium consisted of standardized interviews of the patient using validated instruments, interviews of those caring for the patient, and review of the medical record. A consensus panel made the final determination of a delirium diagnosis. We note that STRIDE is a single-center trial. The decisions we took may have different implications for multi-center trials. Conclusions Lessons learned are likely to provide useful information to others designing trials in emergency and surgical setting and for those who are interested in unbiased assessment of delirium.

Original languageEnglish (US)
Pages (from-to)299-307
Number of pages9
JournalClinical Trials
Volume14
Issue number3
DOIs
StatePublished - Jun 1 2017

Fingerprint

Delirium
Hip Fractures
Randomized Controlled Trials
Incidence
Operating Rooms
Consciousness Monitors
Interviews
Social Adjustment
Clinical Protocols
Random Allocation
Consciousness
Medical Records
Reading
Consensus
Appointments and Schedules
Emergencies
Light

Keywords

  • delirium
  • design considerations
  • hip fracture repair
  • propofol
  • Sedation

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology

Cite this

@article{acb51f918d65469d952f813c4a860cb3,
title = "Design considerations of a randomized controlled trial of sedation level during hip fracture repair surgery: A strategy to reduce the incidence of postoperative delirium in elderly patients",
abstract = "Background Delirium is an acute change in mental status characterized by sudden onset, fluctuating course, inattention, disorganized thinking, and abnormal level of consciousness. The objective of the randomized controlled trial {"}A STrategy to Reduce the Incidence of Postoperative Delirium in Elderly Patients{"} (STRIDE) is to assess the effectiveness of light versus heavy sedation on delirium and other outcomes in elderly patients undergoing hip fracture repair surgery. Our goal is to describe the design considerations and lessons learned in planning and implementing the STRIDE trial. Methods Discussed are challenges encountered including (1) how to ensure that we quickly identify, assess the eligibility of, and randomize traumatic hip fracture patients; (2) how to implement interventions that involve continuous monitoring and adjustment during the surgery; and (3) how to measure and ascertain the primary outcome, delirium. Results To address the first challenge, we monitored the operating room schedule more actively than anticipated. We constructed and organized eligibility assessment data collection forms by purpose and by source of information needed to complete them. We decided that randomization needs to take place in the operating room. To address the second challenge, we designed and implemented a treatment protocol and covered the bispectral index monitor to prevent the Anesthesiologist/Anesthetist from being influenced by the bispectral index reading while administering the intervention. Finally, clinical assessment of delirium consisted of standardized interviews of the patient using validated instruments, interviews of those caring for the patient, and review of the medical record. A consensus panel made the final determination of a delirium diagnosis. We note that STRIDE is a single-center trial. The decisions we took may have different implications for multi-center trials. Conclusions Lessons learned are likely to provide useful information to others designing trials in emergency and surgical setting and for those who are interested in unbiased assessment of delirium.",
keywords = "delirium, design considerations, hip fracture repair, propofol, Sedation",
author = "Tianjing Li and Wieland, {L. Susan} and Esther Oh and Neufeld, {Karin Jane} and Wang, {Nae Yuh} and Kay Dickersin and Frederick Sieber",
year = "2017",
month = "6",
day = "1",
doi = "10.1177/1740774516687253",
language = "English (US)",
volume = "14",
pages = "299--307",
journal = "Clinical Trials",
issn = "1740-7745",
publisher = "SAGE Publications Ltd",
number = "3",

}

TY - JOUR

T1 - Design considerations of a randomized controlled trial of sedation level during hip fracture repair surgery

T2 - A strategy to reduce the incidence of postoperative delirium in elderly patients

AU - Li, Tianjing

AU - Wieland, L. Susan

AU - Oh, Esther

AU - Neufeld, Karin Jane

AU - Wang, Nae Yuh

AU - Dickersin, Kay

AU - Sieber, Frederick

PY - 2017/6/1

Y1 - 2017/6/1

N2 - Background Delirium is an acute change in mental status characterized by sudden onset, fluctuating course, inattention, disorganized thinking, and abnormal level of consciousness. The objective of the randomized controlled trial "A STrategy to Reduce the Incidence of Postoperative Delirium in Elderly Patients" (STRIDE) is to assess the effectiveness of light versus heavy sedation on delirium and other outcomes in elderly patients undergoing hip fracture repair surgery. Our goal is to describe the design considerations and lessons learned in planning and implementing the STRIDE trial. Methods Discussed are challenges encountered including (1) how to ensure that we quickly identify, assess the eligibility of, and randomize traumatic hip fracture patients; (2) how to implement interventions that involve continuous monitoring and adjustment during the surgery; and (3) how to measure and ascertain the primary outcome, delirium. Results To address the first challenge, we monitored the operating room schedule more actively than anticipated. We constructed and organized eligibility assessment data collection forms by purpose and by source of information needed to complete them. We decided that randomization needs to take place in the operating room. To address the second challenge, we designed and implemented a treatment protocol and covered the bispectral index monitor to prevent the Anesthesiologist/Anesthetist from being influenced by the bispectral index reading while administering the intervention. Finally, clinical assessment of delirium consisted of standardized interviews of the patient using validated instruments, interviews of those caring for the patient, and review of the medical record. A consensus panel made the final determination of a delirium diagnosis. We note that STRIDE is a single-center trial. The decisions we took may have different implications for multi-center trials. Conclusions Lessons learned are likely to provide useful information to others designing trials in emergency and surgical setting and for those who are interested in unbiased assessment of delirium.

AB - Background Delirium is an acute change in mental status characterized by sudden onset, fluctuating course, inattention, disorganized thinking, and abnormal level of consciousness. The objective of the randomized controlled trial "A STrategy to Reduce the Incidence of Postoperative Delirium in Elderly Patients" (STRIDE) is to assess the effectiveness of light versus heavy sedation on delirium and other outcomes in elderly patients undergoing hip fracture repair surgery. Our goal is to describe the design considerations and lessons learned in planning and implementing the STRIDE trial. Methods Discussed are challenges encountered including (1) how to ensure that we quickly identify, assess the eligibility of, and randomize traumatic hip fracture patients; (2) how to implement interventions that involve continuous monitoring and adjustment during the surgery; and (3) how to measure and ascertain the primary outcome, delirium. Results To address the first challenge, we monitored the operating room schedule more actively than anticipated. We constructed and organized eligibility assessment data collection forms by purpose and by source of information needed to complete them. We decided that randomization needs to take place in the operating room. To address the second challenge, we designed and implemented a treatment protocol and covered the bispectral index monitor to prevent the Anesthesiologist/Anesthetist from being influenced by the bispectral index reading while administering the intervention. Finally, clinical assessment of delirium consisted of standardized interviews of the patient using validated instruments, interviews of those caring for the patient, and review of the medical record. A consensus panel made the final determination of a delirium diagnosis. We note that STRIDE is a single-center trial. The decisions we took may have different implications for multi-center trials. Conclusions Lessons learned are likely to provide useful information to others designing trials in emergency and surgical setting and for those who are interested in unbiased assessment of delirium.

KW - delirium

KW - design considerations

KW - hip fracture repair

KW - propofol

KW - Sedation

UR - http://www.scopus.com/inward/record.url?scp=85019675191&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85019675191&partnerID=8YFLogxK

U2 - 10.1177/1740774516687253

DO - 10.1177/1740774516687253

M3 - Article

C2 - 28068834

AN - SCOPUS:85019675191

VL - 14

SP - 299

EP - 307

JO - Clinical Trials

JF - Clinical Trials

SN - 1740-7745

IS - 3

ER -