Effectiveness and Safety of the Nursing Prescription in Acute Health Problems of Low Complexity

Acute Disease Clinical Trial

Official title:

Effectiveness and Safety of the Nursing Prescription in Acute Health Problems of Low Complexity. Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03892850
• Other study ID #: 4R18/112
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: March 2019
• Source: Jordi Gol i Gurina Foundation
• Contact: Sonia Fernandez Molero, Nurse
• Phone: +34637353101
• Email: sfernandez[@]casap.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 374
• Est. completion date: November 30, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease

Intervention

Behavioral:
• Nurse prescription
Pharmacological nurse prescription. Subjects are individuals who request a same day consultation for minor acute pathologies and meet the selection criteria
• Medical prescription
Pharmacological medical prescription. Subjects are individuals who request a same day consultation for minor acute pathologies and meet the selection criteria

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	no re-attendance during the following 72 hours	Options: Yes / No	During next 72 hours
Secondary	Level of information and knowledge of the treatment		after 10 days
Secondary	adverse effects		after 10 days
Secondary	satisfaction level	Options of survey: Very satisfied, satisfied, ok, dissatisfied, very dissatisfied	after 10 days
Secondary	resolution of the health problem	Options of survey: Fully resolved, Very resolved, Something solved, A little resolved, Nothing solved	after 10 days
Secondary	compliance	Options: Yes / No (Reason for answered no: Appearance of side effects, Disappearance of symptoms, Distrust of tto, Complicated dosage, No improvement of symptoms, I forget)	after 10 days