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

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

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

Study Overview

• Status: Unknown
• Conditions: Acute Disease
• Intervention / Treatment: Behavioral: Nurse prescription; Behavioral: Medical prescription

• Study Type: Interventional
• Enrollment (Anticipated): 374
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sonia Fernandez Molero, Nurse; Phone Number: +34637353101; Email: sfernandez@casap.cat
• Study Contact Backup: Name: Andres Baiget Ortega; Phone Number: +34652997848; Email: abaigeto@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nurse prescription; experimental group receiving pharmacological nurse prescription	Behavioral: Nurse prescription; Pharmacological nurse prescription. Subjects are individuals who request a same day consultation for minor acute pathologies and meet the selection criteria
Active Comparator: medical prescription; control group receiving medical prescription	Behavioral: Medical prescription; Pharmacological medical prescription. Subjects are individuals who request a same day consultation for minor acute pathologies and meet the selection criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
no re-attendance during the following 72 hours	Options: Yes / No	During next 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of information and knowledge of the treatment		after 10 days
adverse effects		after 10 days
satisfaction level	Options of survey: Very satisfied, satisfied, ok, dissatisfied, very dissatisfied	after 10 days
resolution of the health problem	Options of survey: Fully resolved, Very resolved, Something solved, A little resolved, Nothing solved	after 10 days
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

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Investigators: Principal Investigator: Sonia Fernandez Molero, Sonia, Institut Universitari d'Investigació en Atenció Primària IDIAP Jordi Gol

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): October 31, 2019
• Study Completion (Anticipated): November 30, 2019

Study Registration Dates

• First Submitted: March 18, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Primary Health Care; Prescriptions; Nurses; Acute Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Acute Disease
• Other Study ID Numbers: 4R18/112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No