Clinical trial NCT04819009: Can the Enhanced Transtheoretical Model Intervention (ETMI) be Implemented in a Public Health Organization
Official title: Can the Enhanced Transtheoretical Model Intervention (ETMI) be Implemented in a Public Health Organization- an Implementation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: Low Back Pain
implementation study
Enhanced Transtheoretical Model Intervention
Public Health
Lead sponsor: Ariel University
Sponsor class: OTHER
Collaborators: name: Maccabi Healthcare Services, Israel
First posted: 2021-03-26
Enrollment: 1463
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 220 primary care practitioners (100 Physicians and 120 physiotherapists) and their patients (n=7,000) who suffer from back pain and receive treatment.

Brief summary: The aim of this study is to assess whether the ETMI method can be implemented among primary care practitioners in the central district of Maccabi Health Services and examine whether it provides a medical and economic advantage.

Detailed description: An implementation study- a prospective cohort study with pre- and post-intervention by retrieving economic and therapeutic outcome data from MHS databases. The intervention group will be the Central District of MHS, among 220 primary care practitioners (100 Physicians and 120 physiotherapists) and their patients (n=7,000) who suffer from back pain and receive treatment. We will investigate the relationship between the care received and outcomes in terms of healthcare utilization, costs, and patient-relevant outcomes.

Eligibility criteria: Inclusion Criteria:

* primary care practitioners and their patients, who suffer from back pain and receive treatment.
* patients who suffer from back pain and receive treatment with or without leg radiation

Exclusion Criteria:

* no

Primary outcomes:
measure: ETMI Code
timeFrame: baseline
Secondary outcomes:
measure: Lumbar Computerized Adaptive Test (LCAT)
timeFrame: baseline
Other outcomes:
measure: Economic variables and therapeutic results
timeFrame: baseline
measure: Numeric Pain Rate Scale (NPRS)
timeFrame: baseline
measure: Fear Avoidance Belief Questionnaire (FABQ)
timeFrame: baseline
measure: Economic variables and therapeutic results
timeFrame: baseline
measure: Economic variables and therapeutic results
timeFrame: baseline
measure: Economic variables and therapeutic results
timeFrame: baseline
measure: Economic variables and therapeutic results
timeFrame: baseline
measure: Economic variables and therapeutic results
timeFrame: baseline
Locations:
city: Ariel
country: Israel
facility: Ariel University
Study officials:
affiliation: Ariel University
name: Ron Feldman, PhD Candidate
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ben-Ami N, Chodick G, Mirovsky Y, Pincus T, Shapiro Y. Increasing Recreational Physical Activity in Patients With Chronic Low Back Pain: A Pragmatic Controlled Clinical Trial. J Orthop Sports Phys Ther. 2017 Feb;47(2):57-66. doi: 10.2519/jospt.2017.7057.
citation: Canaway A, Pincus T, Underwood M, Shapiro Y, Chodick G, Ben-Ami N. Is an enhanced behaviour change intervention cost-effective compared with physiotherapy for patients with chronic low back pain? Results from a multicentre trial in Israel. BMJ Open. 2018 Apr 10;8(4):e019928. doi: 10.1136/bmjopen-2017-019928.
citation: Simoneau GG. 2017 JOSPT Award Recipients. J Orthop Sports Phys Ther. 2018 May;48(5):348. doi: 10.2519/jospt.2018.0104.