The Influence of an Educational Intervention in the Beliefs and Attitudes of Primary Care Professionals

December 2, 2021 updated by: Ester García Martínez, Universitat de Lleida

The Influence of an Educational Internet-based Intervention in the Beliefs and Attitudes of Primary Care Professionals on Non-specific Chronic Low Back Pain: Study Protocol of a Mixed Methods Approach

Aim: The primary aim of this project is to identify the fear-avoidance beliefs and attitudes of primary care physicians and nurses towards the treatment of chronic nonspecific low back pain to subsequently develop a biopsychosocial educational tool using a web platform. The secondary aim of this project is to evaluate the effectiveness of this educational intervention about pain neurophysiology and fear-avoidance beliefs, using a web platform for primary care physicians and nurses.

Methods: Exploratory sequential mixed method design. For the qualitative phase of this study, researchers will use personal semistructured interviews. For the quantitative phase the authors will use an experimental study design.

Subjects: medical and nursing staff working in primary care centers in the city of Lleida, Spain.

Expected outcomes: the authors expect to change and modify wrong beliefs and attitudes about chronic low back pain of physicians and nurses working in primary care settings, using a web-based educational tool with the additional result of increasing knowledge on pain neurophysiology and reducing fear-avoidance beliefs.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

HYPOTHESIS AND OUTCOMES

Hypothesis:

  1. The beliefs and attitudes of fear-avoidance of primary care professionals are held by lack of knowledge about the origin and meaning of pain.
  2. The neurophysiology of pain as a biopsychosocial educational intervention using a web platform for primary care professionals will change their knowledge about the origin and meaning of pain, with the result of reducing the beliefs and attitudes of fear avoidance.

Outcomes:

  • Qualitative:

    1. To identify the fear-avoidance beliefs and attitudes of primary care professionals towards the treatment of chronic nonspecific low back pain in relation to the origin and meaning of pain.
    2. To build and develop using a web platform a biopsychosocial educational intervention based on the results obtained in the qualitative phase.

  • Quantitative:

    1. To evaluate the effectiveness of a biopsychosocial educational intervention about pain neurophysiology and fear-avoidance beliefs related to non-specific chronic low back pain, using a web platform for primary care professionals.

METHODOLOGY DESING To answer the research question a mixted-method sequential exploratory design will be used. This mixed-method design consists of two stages, where the results of the methodology used in the first phase of the study, in this case qualitative, contribute to the development of the second quantitative phase. In this project, both phases should have the same relevance for the development of an educational tool for primary care professionals. Using a mixed design methodology is justified in this protocol because the integration of both (qualitative and quantitative) methodologies occurs when data from the qualitative phase contributes to the construction of an educational tool.

The process to be followed is:

  • Qualitative: Semistructured personal interviews.
  • Quantitative: An experimental study design in which a sample of specialized physicians in family and community care and nurses working in primary care health centers will be randomly assigned to the experimental group and the control group.

SUBJECTS:

- Qualitative and quantitative: To start the recruitment process, the principal investigator will do a presentation of the project in each of the primary care centers in the city of Lleida addressed to the medical and nursing staff. Professionals will be invited to participate in the study, either in the qualitative or quantitative phase, and will be provided a phone number and an email address through which they can contact the researcher and agree on the interview date. In the quantitative phase, health professionals who meet the inclusion criteria will be informed about the intervention and the author will answer any questions or concerns that may arise. At the end of this first contact the professionals will be asked to read and sign the informed consent.

  • Qualitative: Subjects who agree to be part of the qualitative study will be contacted by the author and invited to participate in a deep semistructured interview. Individual interviews will be conducted in Spanish or Catalan and will be audio recorded with the consent of interviewed professionals. To increase participation, interviews will be conducted in designated areas in the primary health centers, during working hours. The duration of the interview will be approximately 1 hour.
  • Quantitative: Subjects will be randomly allocated to either intervention or control group using a simple randomization method.

Intervention group: This group will have access to the web platform where they will find information related to nonspecific chronic low back pain. This information will be presented using dynamic explanatory videos made by the author.

Control group: They will have access to a video where medical staff and primary care nurses explain the content of the clinical practice guidelines for addressing back pain.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

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

  • Spain
      • Lleida, Spain, 25198
        • Primary Care

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

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Graduated in medicine and specialized in family and community medicine.
  2. Graduates in nursing.
  3. Registered health professionals.
  4. Professionals working in any of the primary care centers.
  5. Accept and sign the informed consent form.

Exclusion Criteria: nothing

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Educational intervention through a web platform

This group will have access to our web platform where they will find information related to nonspecific chronic low back pain. This information will be presented through dynamic explanatory 3D videos made by the author.

The aim of this intervention is to change and modify wrong beliefs and attitudes about chronic low back pain of physicians and nurses working in primary care settings, using a web-based educational tool with the additional result of increasing knowledge on pain neurophysiology and reducing fear-avoidance beliefs.
Other: Educational intervention
Active Comparator: Clinical practice guidelines on low back pain
Control group: They will have access to a video where medical staff and primary care nurses explain the content of the clinical practice guideline for addressing back pain.
Other: Video explaining the clinical practice guidelines on low back pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge about the pain neurophysiology
Time Frame: 2 weeks
Using the pain neurophysiology questionnaire. This self-administered questionnaire was developed by Lorimer Moseley in 2003 to assess how an individual conceptualizes pain. An acceptable internal consistency and good test-retest reliability was demonstrated. The original English version was translated into Spanish by the Language Service of the Rovira and Virgili University. The questionnaire consists of 19 statements that refer to the origin and meaning of pain with three possible answers: true, false or doubtful. Each correct answer is scored with 1 point, while incorrect, doubtful or unanswered responses are scored with 0 points.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear-avoidance beliefs
Time Frame: 2 weeks
Using the Health Care Providers Pain and Impairment Relationship Scale. This self-administered questionnaire was designed to assess attitudes and beliefs of primary care physicians on chronic nonspecific low back pain. Domenech et al. translated into Spanish the original English version in 2013. After the cross-cultural adaptation, the Spanish version of HC-PAIRS proved to be a reliable, valid and sensitive instrument. The questionnaire consists of 15 statements that suggest a direct link between pain and functional limitation and disability. Each statement is followed by a 7 point Likert scale (1 = strongly disagree, 4 = neither agree nor disagree and 7 = strongly agree). The total score ranges from 1 to 105. Higher scores indicate strong beliefs.
2 weeks
Fear-avoidance beliefs and attitudes
Time Frame: 2 weeks
Using the Fear Avoidance Beliefs Questionnaire. This self-administered questionnaire was developed to measure the beliefs and attitudes of fear-avoidance in patients with low back pain towards physical and / or occupational activities. The questionnaire is divided into two subscales: FABQ-physical activity and FABQ-work. It consists of a total of 16 statements about the beliefs of patients with low back pain about the relationship between pain and physical and labor activity. Each statement is followed by a 6 point Likert scale (0 = strongly disagree and 6 = strongly agree). For both subscales high scores indicate strong fear-avoidance beliefs. This questionnaire has been validated in Spanish. The Spanish version of the FABQ has good internal consistency and reliability. Although it was created to assess fear-avoidance beliefs of patients, this questionnaire has also been used to measure the beliefs of general practitioners and rheumatologists.
2 weeks

Collaborators and Investigators

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

Sponsor

Universitat de Lleida

Investigators

  • Study Director: Francesc Valenzuela Pascual, BSc(PT), Universitat de Lleida
  • Study Director: Jorge Soler Gonzalez, MD, Universitat de Lleida
  • Principal Investigator: Ester García Martínez, BSc(PT), Universitat de Lleida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

November 9, 2016

First Submitted That Met QC Criteria

November 10, 2016

First Posted (Estimate)

November 11, 2016

Study Record Updates

Last Update Posted (Actual)

December 10, 2021

Last Update Submitted That Met QC Criteria

December 2, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULleida P16/124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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