ElderlyPAINFREENCT03082417

The PAINFREE Initiative, a Stepped Wedge Cluster Randomized Trial

A study testing Implementation in people with Elderly and Older Adults, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The PAINFREE (Improving PAIN control following FRactures; towards an Elder-friendly Emergency department) Initiative is a patient-centered multifaceted intervention which aims to improve pain management in patients 75 years and older presenting with a fracture at 7 Emergency Department of participating Montreal… Read more about this study

Who is it for?: Ages 75 years and older
Conditions the study is for: Elderly, Older Adults, Bone Fracture
What is being tested?: Implementation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,375 participants
Where: 1 siteCanada
Study dates: 1 Mar 2016to 1 Oct 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 75 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Age 75 years old or older
Visiting Emergency Departments for a fracture

Who cannot join

Having a skull fracture
Having only fingers or toes fractures

Trial locations and contacts

1 site in 1 country.

Canada1 site

Department of Internal Medicine, Montreal General Hospital
Montreal, Quebec, H3G 1A4

Other trials in Canada

About this study

Official title: Improving PAIN Control Following FRactures; Towards an Elder-friendly Emergency Department

Montreal General Hospital
Royal Victoria Hospital
Ste Mary's Hospital
Hôpital de Verdun
Hôpital du Sacré-Coeur de Montréal
Jewish General Hospital
Lakeshore General Hospital

Read the detailed description

Using a stepped-wedge cluster randomized trial design, we will implement PAINFREE sequentially in 7 Emergency Departments (EDs) in the greater Montreal area where as each ED site acts as its own control and provides data in both pre- and post-implementation periods. Mixed methods analysis will be used to link quantitative (pain management indicators pre- and post-implementation) to qualitative (feasibility, fidelity and acceptability of implementation) data sets to facilitate data triangulation to evaluate the effects of PAINFREE in real world settings.

PAINFREE Initiative at each site includes 3 phases: pre-implementation, implementation, and post-implementation. The approach is patient-centered and is composed of three complementary components: a patient component, a physician component, and a nursing component.

Each program phases include the following steps:

Pre-implementation (2 months):
In all study sites, distribution and analysis of a web-based survey for nurses to document factors that can impact PAINFREE implementation in their environment
Review of medical records of the target population for extraction of selected variables
PAINFREE implementation (6 months):
Awareness campaigns will be organized throughout the institution of each study site (posters, brochures, billboards, lanyards)
Profession-specific educational presentations (1 hour) for physicians and nurses, accredited as part of continued professional development programs
Distribution of standardized point-of-care tools to improve pain assessment and documentation (pocket cards, use of validated pain scales), treatment (standardized prescription) and re-assessment
Distribution of educational material and tools targeting pain care literacy (pain scale interpretation, pamphlet) for patients and their families
Post-implementation (4 months):
Review of medical records of target population for extraction of selected variables
Distribution of report cards comparing each ED's post- and pre-intervention performance on pain management indicators and comparing their performance to that of other sites
Phone call interviews with patients
Focus group interviews (physicians and nurses)

Conditions: Elderly, Older Adults, Bone Fracture, Emergency Department, Pain, Acute
Being tested: Implementation
Keywords: Bone Fracture, 75 years old, Elderly, Older adults, Pain scale, Pain documentation, Analgesics, Acetaminophen, Opioid, Nonsteroidal anti-inflammatory drugs, Emergency Department
Medical subject headings: Fractures, Bone, Emergencies, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ImplementationOther
The PAINFREE Initiative is a Multifaceted intervention:
1. Educating and providing point-of-care tools to nurses working at Emergency Department to improve pain management in older adults with fractures
2. Educating and providing point of care tools to Emergency Departments physicians working at Emergency Department to improve pain management in older adults with fractures
3. Inform the patients and their family about how to better manage the pain after a fracture

Study groups in NCT03082417
Study group	Role	What they receive
Pre-Implementation	No intervention	Medical records of patients with a fracture visiting the Emergency departments will be reviewed. Data will be collected as a baseline prior to the intervention regarding how nurses and physicians working at Emergency Departments manage acute pain in targeted population.
Implementation	Experimental	In this stepped-wedge trial design, the experimental arm refers to the time period during patients advertising and educational interventions. It consists in: Informing patients visiting Emergency department for fracture about Pain Management Nurses and physicians working at the Emergency Departments will receive an educational interventions focused on optimal acute pain management in older adults with fracture. Receives: Other: Implementation
Post-Implementation	No intervention	Data will be collected after the intervention regarding how the intervention impacted nurses' and physicians' work in the pain management in older adults with fracture visiting Emergency Departments manage acute pain in older adults.

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to achieve pain score documentation, and/or administration of an analgesic, within 2 hours of triage, in at least 80% of patients.
Measured: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)

Secondary outcomes (7)

Documentation of pain score
Measured: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Time to first pain score documentation
Measured: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Effectiveness of analgesia
Patients with pain score ≥7 who have pain score reduced by ≥ 3 points within 1 hour
Measured: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Type of analgesia used
Measured: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Mean length of stay in Emergency Department
Measured: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Return to the Emergency Department within 7 days after the first Visit with an uncontrolled pain due to the fracture
Measured: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Evidence of worsening of Patients mental status while in Emergency Department
Measured: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20161 Oct 2018

First posted17 Mar 2017
Study start1 Mar 2016
Primary completion1 Feb 2018
Study completion1 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ElderlyStudies of the same condition, open and under way.
More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Model description: Pragmatic Stepped Wedge Cluster Randomized Trial
Masking: None (open label)
Enrolment: 1,375 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03082417
Sponsor's protocol ID: MP-CUSM-13-054
Acronym: PAINFREE
Status last verified: Mar 2019
First submitted: 6 Mar 2017
Last updated: 8 Mar 2019
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving PAIN Control Following FRactures; Towards an Elder-friendly Emergency Department
ClinicalTrials.gov ID: NCT03082417
Acronym / sponsor ID: PAINFREE / MP-CUSM-13-054
Conditions: Elderly, Older Adults, Bone Fracture, Emergency Department, Pain, Acute
Keywords: Bone Fracture, 75 years old, Elderly, Older adults, Pain scale, Pain documentation, Analgesics, Acetaminophen
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,375 participants (actual)
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
Collaborators: Canadian Institutes of Health Research (CIHR)
Study start: 1 Mar 2016 (actual)
Primary completion: 1 Feb 2018 (actual)
Study completion: 1 Oct 2018 (actual)
First posted: 17 Mar 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Montreal General Hospital
Royal Victoria Hospital
Ste Mary's Hospital
Hôpital de Verdun
Hôpital du Sacré-Coeur de Montréal
Jewish General Hospital
Lakeshore General Hospital

Detailed description

Each program phases include the following steps:

Pre-implementation (2 months):
In all study sites, distribution and analysis of a web-based survey for nurses to document factors that can impact PAINFREE implementation in their environment
Review of medical records of the target population for extraction of selected variables
PAINFREE implementation (6 months):
Awareness campaigns will be organized throughout the institution of each study site (posters, brochures, billboards, lanyards)
Profession-specific educational presentations (1 hour) for physicians and nurses, accredited as part of continued professional development programs
Distribution of standardized point-of-care tools to improve pain assessment and documentation (pocket cards, use of validated pain scales), treatment (standardized prescription) and re-assessment
Distribution of educational material and tools targeting pain care literacy (pain scale interpretation, pamphlet) for patients and their families
Post-implementation (4 months):
Review of medical records of target population for extraction of selected variables
Distribution of report cards comparing each ED's post- and pre-intervention performance on pain management indicators and comparing their performance to that of other sites
Phone call interviews with patients
Focus group interviews (physicians and nurses)

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3
Model description: Pragmatic Stepped Wedge Cluster Randomized Trial

Arm	Type	Receives
Pre-Implementation	No intervention	–Medical records of patients with a fracture visiting the Emergency departments will be reviewed. Data will be collected as a baseline prior to the intervention regarding how nurses and physicians working at Emergency Departments manage acute pain in targeted population.
Implementation	Experimental	Other: ImplementationIn this stepped-wedge trial design, the experimental arm refers to the time period during patients advertising and educational interventions. It consists in: Informing patients visiting Emergency department for fracture about Pain Management Nurses and physicians working at the Emergency Departments will receive an educational interventions focused on optimal acute pain management in older adults with fracture.
Post-Implementation	No intervention	–Data will be collected after the intervention regarding how the intervention impacted nurses' and physicians' work in the pain management in older adults with fracture visiting Emergency Departments manage acute pain in older adults.

Who may qualify

Ages: 75 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (2 listed)

Age 75 years old or older
Visiting Emergency Departments for a fracture

Key exclusion criteria (2 listed)

Having a skull fracture
Having only fingers or toes fractures

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ImplementationThe PAINFREE Initiative is a Multifaceted intervention: 1. Educating and providing point-of-care tools to nurses working at Emergency Department to improve pain management in older adults with fractures 2. Educating and providing point of care tools to Emergency Departments physicians working at Emergency Department to improve pain management in older adults with fractures 3. Inform the patients and their family about how to better manage the pain after a fracture	Other	Implementation

Primary outcome

Time to achieve pain score documentation, and/or administration of an analgesic, within 2 hours of triage, in at least 80% of patients.
Time frame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)

7 secondary outcomes

Documentation of pain score
Time frame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Time to first pain score documentation
Time frame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Effectiveness of analgesia
Time frame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Type of analgesia used
Time frame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Mean length of stay in Emergency Department
Time frame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Return to the Emergency Department within 7 days after the first Visit with an uncontrolled pain due to the fracture
Time frame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)
Evidence of worsening of Patients mental status while in Emergency Department
Time frame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Suzanne Morin, Dr principal investigator

McGill University Hospital Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Implementation in people with Elderly and Older Adults, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to achieve pain score documentation, and/or administration of an analgesic, within 2 hours of triage, in at least 80% of patients. (time frame: Pre-implementation (baseline) and at 6 to 8 months (post-implementation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03082417.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019.