NCT04011917

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
432

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

August 15, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

July 4, 2019

Last Update Submit

January 15, 2020

Conditions

Keywords

Minor Musculoskeletal InjuriesEmergency DepartmentPrediction outcomeExtended Scope Physiotherapists

Outcome Measures

Primary Outcomes (1)

  • Transition ratings of global perceived effect

    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 Outcomes (2)

  • Patient Acceptable Symptom State

    1 month after discharge

  • EuroQoL questionnaire

    1 month after discharge

Other Outcomes (4)

  • VAS Pain

    At baseline and 1 month after discharge

  • Analgesic use

    1 month after discharge

  • Follow-up treatments

    1 month after discharge

  • +1 more other outcomes

Study Arms (2)

Caseload group

Behavioral: Standard care

Prediction group

Behavioral: Standard care

Interventions

Standard careBEHAVIORAL

Treatment by an extended scope physiotherapist following Standard Operating Procedures.

Caseload groupPrediction group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.)
  • Under the influence of drugs or alcohol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Emergency Department, Slagelse Hospital

Slagelse, Region Sjælland, 4200, Denmark

Location

MeSH Terms

Conditions

Musculoskeletal DiseasesEmergencies

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Christian P Olsen, PT, Phd candidate

    Næstved-Slagelse-Ringsted Hospitals

    PRINCIPAL INVESTIGATOR
  • 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 CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2019

First Posted

July 9, 2019

Study Start

August 15, 2019

Primary Completion

November 15, 2019

Study Completion

November 15, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

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

Locations