Projected Prognosis as a Predictor of Short-term Outcome After Treatment of Minor Musculoskeletal Injuries in the Emergency Department

January 15, 2020 updated by: Slagelse Hospital

Projected Prognosis as a Predictor of Short-term Outcome After Treatment of Minor Musculoskeletal Injuries in the Emergency Department: A Prospective Cohort Study

This study describes the caseload treated by the extended scope physiotherapists(ESP) working in the emergency department at Slagelse Hospital.

Patients treated by the ESP during a 3 month period will be included in this study.

Furthermore we aim to assess if ESPs treating patients with minor musculoskeletal injuries in the ED can predict the short-term prognosis of recovery. The prediction is made at hospital discharge using a (-7/+7) numerical rating scale (-7=poor prognosis; 7=best prognosis).

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

432

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Region Zealand
      • Slagelse, Region Zealand, Denmark, 4200
        • The Emergency Department, Slagelse Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients treated by an ESP physiotherapist in the emergency room at Slagelse Hospital, Denmark, in a 3 month period +1 month follow-up will be invited to participate in this study.

Description

Inclusion Criteria:

  • 1 Treated by an ESP for a minor musculoskeletal injury in the emergency room
  • 2 Has an email address
  • 3 Signed informed consent form

Exclusion Criteria:

  • 1 A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., not having access to the internet, cognitive impairments etc.)
  • 2 Under the influence of drugs or alcohol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Caseload group
Treatment by an extended scope physiotherapist following Standard Operating Procedures.
Prediction group
Treatment by an extended scope physiotherapist following Standard Operating Procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transition ratings of global perceived effect
Time Frame: 1 month after discharge
Using a transition questionnaire (TRANS-Q) the perceived effect of treatment will be measured by participants answering if their current health status is "unchanged", "worse" or "better" compared to their pre-injury status. "unchanged" equals a transition score of 0. If the participant answers "worse", he/she is asked to rate the degree of worsening on a 7 point Likert scale, with corresponding scores ranging from -1 to -7. If the participant answers "better", he/she is asked to rate the degree of improvement on a 7 point Likert scale, with corresponding scores ranging from 1 to 7. Thus the GPE score range from -7 (worsening) to 7 (improvement), with the mid-point - 0 - representing no change.
1 month after discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient Acceptable Symptom State
Time Frame: 1 month after discharge
1 month after discharge
EuroQoL questionnaire
Time Frame: 1 month after discharge
1 month after discharge

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS Pain
Time Frame: At baseline and 1 month after discharge
The VAS pain is a measure of pain intensity, which has been widely used in diverse adult populations. The scale is a unidimensional continuous scale comprised of a horizontal line, anchored by 2 verbal descriptors, one for each symptom extreme (0 no pain, 10 the worst imaginable pain).
At baseline and 1 month after discharge
Analgesic use
Time Frame: 1 month after discharge
The participants self-reported use of analgesics will be collected at the 1 month follow-up. Participants will be asked to note their use of analgesic drugs, within the week before the follow-up, only related to the treated injury in the emergency room.
1 month after discharge
Follow-up treatments
Time Frame: 1 month after discharge
The participants self-reported use of follow-up visits with other allied health professionals will be recorded. All visits related to the treated injury during the 1-month follow-up period should be noted.
1 month after discharge
Re-injury
Time Frame: 1 month after discharge
The participants self-reported reinjury rate during the 1-month follow-up period will be recorded.
1 month after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Christian P Olsen, PT, Phd candidate, Næstved-Slagelse-Ringsted Hospitals
  • Study Chair: Marius Henriksen, PT, PhD, Department of Physical and Occupational Therapy, Bispebjerg-Frederiksberg Hospital
  • Study Chair: Søren T Skou, PT, PhD, Næstved-Slagelse-Ringsted Hospitals AND University of Southern Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2019

Primary Completion (Actual)

November 15, 2019

Study Completion (Actual)

November 15, 2019

Study Registration Dates

First Submitted

July 4, 2019

First Submitted That Met QC Criteria

July 4, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 15, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Upon finalisation of the prespecified analyses we will share the IPD to other researchers based on an email inquiry.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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