Clinical trial NCT02892968: ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients
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
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fractures
Delirium
Keywords: Regional Anesthesia Ultrasound guided
Emergency Department
Knowledge to Practice Intervention
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 800
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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.

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