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

Primary Purpose

Hip Fractures, Delirium

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Fascia-Iliaca Block(FIB)
Femoral Nerve Block(FNB)
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hip Fractures focused on measuring Regional Anesthesia Ultrasound guided, Emergency Department, Knowledge to Practice Intervention

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sunnybrook Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

U/S Guided Regional Anesthesia

Current Local Standard Analgesia

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Overall rate of incident delirium
Time to onset of incident delirium

Secondary Outcome Measures

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

Full Information

First Posted
August 9, 2016
Last Updated
September 1, 2016
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02892968
Brief Title
ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients
Acronym
EDU-RAPID
Official Title
ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients (EDU-RAPID) Multi-center Stepped Wedge Cluster Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Delirium
Keywords
Regional Anesthesia Ultrasound guided, Emergency Department, Knowledge to Practice Intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
U/S Guided Regional Anesthesia
Arm Type
Experimental
Arm Description
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
Arm Title
Current Local Standard Analgesia
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Fascia-Iliaca Block(FIB)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Femoral Nerve Block(FNB)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall rate of incident delirium
Time Frame
Time of injury to post-injury day 7
Title
Time to onset of incident delirium
Time Frame
Time of injury to post-injury day 7
Secondary Outcome Measure Information:
Title
The rate of regional anesthesia use by intervention physicians for hip fracture patients
Time Frame
Time of injury to operation to maximum of 7 days
Title
Time to perform the block
Time Frame
Time block started to completion to maximum of 2 hours
Title
Pain Severity on 0-10 Numeric Rating Scale as assessed by treating MD or Nurse after administration of regional anesthesia
Time Frame
30 minutes and 60 minutes after administration of regional anesthesia
Title
Numeric Rating Scale (1-5) Effectiveness of block (pain reduction measured)at 30 minutes
Time Frame
30 minutes after administration of regional anesthesia
Title
Supplementary narcotic analgesics used pre-operatively, measured in morphine equivalent units
Time Frame
Time of Injury to operation measured to a maximum of 7 days
Title
Maximum severity of delirium using the validated Delirium Index (DI)
Time Frame
Time of injury to post-injury day 7
Title
Cognitive Assessment Method (CAM) status (CAM + or CAM -) measurement at hospital discharge
Time Frame
Admission to Discharge to a maximum of 100 days
Title
Complications from the regional anesthesia including hematoma and persistent nervous dysfunction
Time Frame
Time of injury to post-injury day 7
Title
Adverse events, including in-hospital falls, cardiovascular events and deaths; Hospital length of stay
Time Frame
Time of injury to 1 year follow-up
Title
Functional status measured using Older Americans' Resources and Services (OARS) Activities of Daily Living Questionnaire at 1 month and 1 year follow-up
Time Frame
1 month and 1 year follow-up from Time of Injury
Title
Proportion of patients who return to independent living at discharge
Time Frame
Admission to Discharge to a maximum of 1 year
Title
Mortality within 1 year post-operatively
Time Frame
1 year follow-up from time of injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Sunnybrook Health Sciences Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4S 3M5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques S Lee, MD
Phone
416-480-6100
Ext
7701
Email
jacques.lee@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Jacques S Lee, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34226222
Citation
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.
Results Reference
derived
PubMed Identifier
33238043
Citation
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.
Results Reference
derived

Learn more about this trial

ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients

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