Clinical trial NCT03671278: Implementation of the STarT Back Screening Tool
Official title: Implementing the STarT Back Model of Stratifying Care for Patients With Low Back Pain Seeking Care in an Emergency Department: a Prospective Longitudinal Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
emergency
feasibility
implementation
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The STarT Back Screening Tool (SBST) has been used in different healthcare settings in order to stratify the management of patients with low back pain. However, to date, no study has investigated the feasibility of implementing the SBST in emergency departments. The objective of this study will be to test the implementation of the SBST in the stratification of patients seeking care in emergency departments.

Detailed description: The Start Back Screening Tool (SBST) aims to identify and stratify primary care patients by using modifiable prognostic indicators that are relevant in clinical decision making. The objective of this study will be to test the feasibility of the implementation of the SBST in the stratification of patients seeking care in emergency departments. Study design: A prospective longitudinal cohort study with a 6-month follow-up. Intervention: At 6-weeks after baseline consultation, patients will be targeted to the specific treatment according to their subclassification in the SBST tool: education about pain neurophysiology and physical therapy. This is the first study that will provide results about logistic processes of the implementation of the SBST in the emergency sector, present feasibility data for the conduction of a large randomized controlled trial of subgroups of low back pain.

Eligibility criteria: Inclusion Criteria:

* We will include patients with back pain seeking care in emergency departments

Exclusion Criteria:

* We will exclude patients with serious spinal pathologies (such as cancer, fractures, inflammatory and infectious diseases) as well as pregnant patients and patients with nerve root compromise.

Primary outcomes:
measure: Feasibility from the perspective of the patient
timeFrame: Adoption at 6 weeks (i.e. at the implementation of treatment after stratification)
measure: Feasibility from the perspective of the patient
timeFrame: Adequacy at 3 months.
measure: Feasibility from the perspective of the patient
timeFrame: Fidelity at 3 months.
measure: Feasibility from the perspective of the patient
timeFrame: Feasibility at 3 months.
Secondary outcomes:
measure: Pain intensity measured by a 0-10 Pain Numerical Rating Scale
timeFrame: 1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.
measure: Disability measured by the 0-24 Roland Morris Disability Questionnaire
timeFrame: 6 weeks and 3 and 6 months after first consultation at the emergency department.
measure: Risk of persistent disability measured by the 0-9 Start Back Screening Tool.
timeFrame: 1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.
measure: Global Impression of Recovery measured by the -5 to + 5 Global Perceived Effect Scale.
timeFrame: 1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.
measure: Recovery from pain
timeFrame: 1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.
measure: Depressive symptoms over the last week.
timeFrame: 1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.
measure: Recurrence of low back pain symptoms
timeFrame: 6 weeks and 3 and 6 months after first consultation at the emergency department.
Other outcomes:
measure: Out of pocket costs associated with low back pain
timeFrame: 6 weeks and 3 and 6 months after first consultation at the emergency department.
Locations:
Study officials:
affiliation: Universidade Cidade de São Paulo
name: Luciola Costa, PhD
role: PRINCIPAL_INVESTIGATOR
References: