ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients (EDU-RAPID)

ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients (EDU-RAPID) Multi-center Stepped Wedge Cluster Randomized Trial

Hip fractures are common, costly and affect older people - Canadians spend 1 billion dollars to treat hip fractures each year. Unfortunately, as many as two-thirds of hip fracture cases suffer a complication known as delirium, or acute confusion. Patients with delirium may become frightened and agitated. This in turn leads to other serious problems. Having delirium doubles the chances of dying or can increase the need for admission into a nursing home. People with delirium spend an extra week in hospital on average.

Using ultrasound to locate and 'freeze' or block specific nerves can stop hip fracture pain almost immediately, and use of this technique is known to reduce delirium when administered by Anaesthetists to patients at the time of their hip operation. Unfortunately, patients with hip fractures commonly wait hours or even days in the Emergency Department (ED) prior to their operation. Currently, these patients are given narcotic pain killers like morphine to dull their pain, as most ED physicians have not been trained in using this 'freezing' technique and Anaesthetists are rarely able to leave the operating room to administer freezing to patient in the ED.

The EDU-RAPID study will test whether training ED physicians on how to use the nerve freezing technique will reduce the number of patients who develop delirium after a hip fracture. To study this, ED physicians will be trained at 6 hospitals in small groups every 6 weeks over 18 months. The study will look at how patients who are treated by ED physician who has been trained compare to patients treated by a ED physician who has not yet been trained. Also, the study will see if the training motivates ED physicians to use the block regularly.

If correct, this study could significantly improve the comfort, quality of life, and independence of patients who suffer a hip fracture. In addition, if the study shows a reduction in delirium rates, this could represent a significant cost reduction to the health care system.

Study Overview

• Status: Unknown
• Conditions: Delirium; Hip Fractures
• Intervention / Treatment: Procedure: Fascia-Iliaca Block(FIB); Procedure: Femoral Nerve Block(FNB)

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4S 3M5
      • Sunnybrook Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At the cluster level, ED physicians practicing at a participating site will be eligible.
• At the patient level, all hip fractures seen by a participating ED physician will be eligible

Exclusion Criteria:

• ED physicians who work casually (less than 0.25 Full Time Equivalent)
• ED Physicians who are routinely using U/S guided RA for hip fracture patients, or decline participation in the trial.
• Patients' age less than 65 years;
• Patients who are delirious on initial assessment by ED physician or severe dementia
• Patients with communication problems (critically ill, unconscious, language barrier despite use of secure telephone-based translation service)
• Patients with allergies to narcotics or local anesthetic; or anticoagulant use (e.g. warfarin, dabigatran, rivaroxaban).
• Patients with hip fractures not requiring surgery (e.g. greater trochanter avulsion) will also be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: U/S Guided Regional Anesthesia; Fascia-Iliaca Block(FIB) Femoral Nerve Block(FNB) All participating emergency physicians (EPs) will be randomly assigned to the order they receive training in a stepped wedge design. Thus all EPs will begin the trial as "control physicians". EPs will then be trained to use two approaches to ultrasound (U/S) guided regional anesthesia, the fascia iliaca and femoral nerve blocks. Which block that will be used will be randomly determined at the individual patient level	Procedure: Fascia-Iliaca Block(FIB); The target of the FIB is the potential space between the fascia iliaca and the iliacus muscle, at least 4 cm lateral to the Femoral artery. This is neither a drug nor a device.; Procedure: Femoral Nerve Block(FNB); The target of the FNB technique is the intersection of the fascia iliaca and the femoral nerve. This is neither a drug nor a device.
No Intervention: Current Local Standard Analgesia; All participating emergency physicians (EPs) will be randomly assigned to the order they receive training in a stepped wedge design. Thus all EPs will begin the trial as "control physicians". Physicians who are in the control group will provide current local standard of analgesic care for hip fracture patients such as the use of IV opiods with supplemental acetaminophen and non-steroidal anti-inflammatory agents until they receive training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall rate of incident delirium	Time of injury to post-injury day 7
Time to onset of incident delirium	Time of injury to post-injury day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
The rate of regional anesthesia use by intervention physicians for hip fracture patients	Time of injury to operation to maximum of 7 days
Time to perform the block	Time block started to completion to maximum of 2 hours
Pain Severity on 0-10 Numeric Rating Scale as assessed by treating MD or Nurse after administration of regional anesthesia	30 minutes and 60 minutes after administration of regional anesthesia
Numeric Rating Scale (1-5) Effectiveness of block (pain reduction measured)at 30 minutes	30 minutes after administration of regional anesthesia
Supplementary narcotic analgesics used pre-operatively, measured in morphine equivalent units	Time of Injury to operation measured to a maximum of 7 days
Maximum severity of delirium using the validated Delirium Index (DI)	Time of injury to post-injury day 7
Cognitive Assessment Method (CAM) status (CAM + or CAM -) measurement at hospital discharge	Admission to Discharge to a maximum of 100 days
Complications from the regional anesthesia including hematoma and persistent nervous dysfunction	Time of injury to post-injury day 7
Adverse events, including in-hospital falls, cardiovascular events and deaths; Hospital length of stay	Time of injury to 1 year follow-up
Functional status measured using Older Americans' Resources and Services (OARS) Activities of Daily Living Questionnaire at 1 month and 1 year follow-up	1 month and 1 year follow-up from Time of Injury
Proportion of patients who return to independent living at discharge	Admission to Discharge to a maximum of 1 year
Mortality within 1 year post-operatively	1 year follow-up from time of injury

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre

Publications and helpful links

General Publications

• Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
• Lee JS, Bhandari T, Simard R, Emond M, Topping C, Woo M, Perry J, Eagles D, McRae AD, Lang E, Wong C, Sivilotti M, Newbigging J, Borgundvaag B, McLeod SL, Melady D, Chernoff L, Kiss A, Chenkin J. Point-of-care ultrasound-guided regional anaesthesia in older ED patients with hip fractures: a study to test the feasibility of a training programme and time needed to complete nerve blocks by ED physicians after training. BMJ Open. 2021 Jul 5;11(7):e047113. doi: 10.1136/bmjopen-2020-047113.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 9, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimate): September 8, 2016

Study Record Updates

• Last Update Posted (Estimate): September 8, 2016
• Last Update Submitted That Met QC Criteria: September 1, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Emergency Department; Regional Anesthesia Ultrasound guided; Knowledge to Practice Intervention
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Leg Injuries; Femoral Fractures; Hip Injuries; Delirium; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 201503MOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No