Can the Enhanced Transtheoretical Model Intervention (ETMI) be Implemented in a Public Health Organization

Completed

• Conditions: Low Back Pain
• Interventions: Other: the Enhanced Transtheoretical Model Intervention (ETMI)

• Registration Number: NCT04819009
• Lead Sponsor: Ariel University

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.

Study Timeline

• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-26
• Study Start: 2022-01-01
• Status Verified: 2023-01
• Primary Completion: 2023-08-30
• Study Completion: 2024-01-02
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1463

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Central District	the Enhanced Transtheoretical Model Intervention (ETMI)	The ETMI method will be implemented in this group

Primary Outcome Measures

Name	Time	Method
ETMI Code	baseline

Secondary Outcome Measures

Name	Time	Method
Lumbar Computerized Adaptive Test (LCAT)	baseline	LCAT is a computerized adaptive test, meaning that the administration selects items from the item bank one at a time based on an administrative algorithm. The final calculated functional score ranges on a linear scale of 0-100, higher measures representing higher function. Additionally, the system predicts a risk-adjusted functional score at discharge. The adjusting is on: functional score at admission, age, sex, chronicity as number of days from onset of the treated condition, number of related surgeries, exercise history and use of medication to treat LBP.MCID for the LCAT is 3-9 points depending on the first score. LCAT has been tested for validity by comparing it to the Oswestry Low Back Pain Disability Questionnaire and has a high level of reliability in the English version (α = 0.92).Several studies have been published using the LCAT's Hebrew version.

Trial Locations

Locations (1)

Ariel University; 🇮🇱 Ariel, Israel