Effectiveness and Safety of the Nursing Prescription in Acute Health Problems of Low Complexity
1 other identifier
interventional
374
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2019
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2019
CompletedFirst Posted
Study publicly available on registry
March 27, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedMarch 29, 2019
March 1, 2019
7 months
March 18, 2019
March 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
no re-attendance during the following 72 hours
Options: Yes / No
During next 72 hours
Secondary Outcomes (5)
Level of information and knowledge of the treatment
after 10 days
adverse effects
after 10 days
satisfaction level
after 10 days
resolution of the health problem
after 10 days
compliance
after 10 days
Study Arms (2)
nurse prescription
EXPERIMENTALexperimental group receiving pharmacological nurse prescription
medical prescription
ACTIVE COMPARATORcontrol group receiving medical prescription
Interventions
Pharmacological nurse prescription. Subjects are individuals who request a same day consultation for minor acute pathologies and meet the selection criteria
Pharmacological medical prescription. Subjects are individuals who request a same day consultation for minor acute pathologies and meet the selection criteria
Eligibility Criteria
You may qualify if:
- Contusion
- Diarrhea / vomit
- Fever without focality
- Flu
- Urinary distress
- Odinophagy
- Toothache
- Skin Bite
- Upper respiratory symptoms
- Ankle twist
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sonia Fernandez Molero, Sonia
Institut Universitari d'Investigació en Atenció Primària IDIAP Jordi Gol
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2019
First Posted
March 27, 2019
Study Start
April 1, 2019
Primary Completion
October 31, 2019
Study Completion
November 30, 2019
Last Updated
March 29, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share