Clinical trial NCT02962817: The Influence of an Educational Intervention in the Beliefs and Attitudes of Primary Care Professionals
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Nonspecific Low Back Pain
Lead sponsor: Universitat de Lleida
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 60
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knowledge about the pain neurophysiology
timeFrame: 2 weeks
Secondary outcomes:
measure: Fear-avoidance beliefs
timeFrame: 2 weeks
measure: Fear-avoidance beliefs and attitudes
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Primary care
Study officials:
affiliation: Universitat de Lleida
name: Francesc Valenzuela Pascual, BSc(PT)
role: STUDY_DIRECTOR
affiliation: Universitat de Lleida
name: Jorge Soler Gonzalez, MD
role: STUDY_DIRECTOR
affiliation: Universitat de Lleida
name: Ester García Martínez, BSc(PT)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia-Martinez E, Soler-Gonzalez J, Blanco-Blanco J, Rubi-Carnacea F, Masbernat-Almenara M, Valenzuela-Pascual F. Misbeliefs about non-specific low back pain and attitudes towards treatment by primary care providers in Spain: a qualitative study. BMC Prim Care. 2022 Jan 14;23(1):9. doi: 10.1186/s12875-021-01617-3.
citation: Garcia-Martinez E, Soler-Gonzalez J, Rubi-Carnacea F, Garcia-Martinez B, Climent-Sanz C, Blanco-Blanco J, Valenzuela-Pascual F. 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. BMC Fam Pract. 2019 Feb 21;20(1):31. doi: 10.1186/s12875-019-0919-6.