Clinical trial NCT03892850: Effectiveness and Safety of the Nursing Prescription in Acute Health Problems of Low Complexity
Official title: Effectiveness and Safety of the Nursing Prescription in Acute Health Problems of Low Complexity. Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Disease
Keywords: Prescriptions
Nurses
Primary Health Care
Acute Disease
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Objective: To compare the efficacy/effectiveness of pharmacological nurse prescription with medical prescription in patients attended in a primary care center for minor acute health problems.

Scope of the study: Multicenter study, with the participation of 8 primary care centers of Catalonia.

Methodology: Randomized blind clinical trial, with experimental group receiving pharmacological nurse prescription and a control group receiving medical prescription. Subjects are individuals who request a same day consultation for minor acute pathologies and meet the selection criteria, with random assignment of 374 subjects, 187 per group.

The efficacy/effectiveness of the prescribed treatment will be considered as a no re-attendance during the following 72h and will be completed with the variables: information and knowledge of the treatment, adverse effects, compliance, satisfaction level and resolution of the health problem. The data collection is done 10 days after the visit by an ad-hoc telephone questionnaire of 11 items, previously tested. The analysis is done using the SPSS software version 21.0, obtaining data of descriptive, multivariate and inferential statistics.

Implications for practice: To evidence the equivalence of pharmacological nurse prescription with medical prescription for minor acute health problems


Eligibility criteria: Inclusion Criteria:

* Contusion
* Diarrhea / vomit
* Fever without focality
* Flu
* Urinary distress
* Odinophagy
* Toothache
* Skin Bite
* Upper respiratory symptoms
* Ankle twist

Exclusion Criteria:

* Language barrier
* Cognitive deterioration
* Sensory deficit
* Pregnancy
* Immunosuppression
* Neoplasia in the last 5 years
* Does not participate / Does not sign consent
* Breastfeeding period
* Reconsult
* Resides outside of Spain
* Treatment with glucocorticoids in the last 6 months

Primary outcomes:
measure: no re-attendance during the following 72 hours
timeFrame: During next 72 hours
Secondary outcomes:
measure: Level of information and knowledge of the treatment
timeFrame: after 10 days
measure: adverse effects
timeFrame: after 10 days
measure: satisfaction level
timeFrame: after 10 days
measure: resolution of the health problem
timeFrame: after 10 days
measure: compliance
timeFrame: after 10 days
Other outcomes:
Locations:
Study officials:
affiliation: Institut Universitari d'Investigació en Atenció Primària IDIAP Jordi Gol
name: Sonia Fernandez Molero, Sonia
role: PRINCIPAL_INVESTIGATOR
References: