Clinical trial NCT06258512: Impact of an Intervention with a Narrative Approach in Overusers: a Clinical Trial
Official title: Impact of an Intervention with a Narrative Approach in Overusers in Primary Health Care: a Controlled and Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overuse Syndrome
Keywords: Healthcare utilisation
Psychosocial determinants of health
Primary care
Affective social support
Frequent attenders
Lead sponsor: Catalan Institute of Health
Sponsor class: OTHER_GOV
First posted: 2024-02-14
Enrollment: 264
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The interventions of the health social workers rely on listening in the clinical interview, They give space to the patient's subjective complaint, they locate the understanding of the discomfort and the symbolic meaning of the symptoms. The difficulties are focused as elements of the relationship between the professional and the user and does not refer to pharmacological treatments. Since social work identifies discomfort psychosocial as an object of study, we would like to demonstrate that, establishing locally an intervention with a narrative approach implemented in the area of primary health care with the aim of improving the perception of emotional support of users with excessive use of self-initiated consultation, we can reduce the use of medical consultations, and, most importantly, the suffering and discontent of said users who do not find an answer appropriate to your discomforts.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare an intervention with a narrative therapy-based approach with standard care in overusers in general practice . The main question it aims to answer are:

• An intervention with an approach based on narrative therapy can improve the perception of emotional support, and reduce the probability of suffering from anxiety and/or depression, the number of consultations, and the number of medications in primary care overusers.

Participants will 10 individual sessions carried out over five months. The interval between sessions will be two weeks with a specific duration of fifty minutes per session..

If there is a comparison group: Researchers will compare two groups of overusers to see if reduces the number of visits to the primary care doctor.

Detailed description: Background: The best treatment for the excessive use of the consultation is currently being discussed.

Hypothesis: An intervention with an approach based on narrative therapy, compared to standard care, leads to reducing psychosocial distress and reducing the number of consultations with the family doctor.

Objective: To evaluate the effectiveness of an intervention based on co-constructing a new narrative of symptoms of non-organic origin compared to usual clinical care, with respect to affective social support, the probability of suffering from anxiety and/or depression, and the use of the medical consultation.

Methodology: Pragmatic, controlled and randomized, non-masked clinical trial. Study subjects: 264 users (132 in each group, intervention and control) with excessive use of the consultation (95th percentile of the distribution of appointment-type and/or urgent visits to the medicine service). Intervention will be compared with narrative approach + standard care / standard care.

Determinations: Symptoms of anxiety and depression, social support, number of consultations, age, sex, marital status, educational level, income level, employment status.

Statistical analysis: In order to determine the discriminant capacity of the variables associated with the intervention, we will build a multiple regression model in which we will include those that were statistically significant in the bivariate analysis and those that are relevant according to the bibliography.

Expected results: The results will provide evidence on the effectiveness of said intervention.

Application and Relevance: This type of intervention would most likely reduce the pressure on medical-health professionals.

Eligibility criteria: Inclusion Criteria:

* Users in the 95th percentile in the distribution of consultations face-to-face, patient self-initiated consultations with PHC services within the period of 1 year.

Exclusion Criteria:

* Drug abuse or dependence, except for nicotine and tetrahydrocannabinol.
* Comorbidity with DSM-IV-TR (American Psychiatric Association, 2000) severe mental disorders.
* Comorbidity with ICD-10 (World Health Organization, 2008) severe cognitive disorders or sensory disabilities.
* Major locomotor mobility limitations or terminal illness

Primary outcomes:
measure: Change from baseline in affective social support at 1 month, 6 months, and 18 months
timeFrame: Before randomization and at the end of treatment at 1 month, six months and 18 months
Secondary outcomes:
measure: Change from baseline in probability of having an anxiety or depressive at 1 month, 6 months, and 18 months
timeFrame: Before randomization and at the end of treatment at 1 month, six months and 18 months
measure: Change from baseline in variables related to drug exposure at 1 month, 6 months, and 18 months
timeFrame: Before randomization and at the end of treatment at 1 month, six months and 18 months
measure: Number of visits patient self-initiated consultations with PHC services, and totals, per year
timeFrame: Before randomization and at the end of treatment at 1 month, six months and 18 months
Other outcomes:
measure: Sociodemographic data
timeFrame: Before randomization
measure: Clinical variables
timeFrame: Before randomization
Locations:
city: Barcelona
country: Spain
facility: Centre d'Atenció Primària Montnegre, Institut Català de la Salut, Barcelona, Catalonia, Spain
state: Catalonia
Study officials:
References: