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

Sponsor
Jordi Gol i Gurina Foundation (Other)
Overall Status
Unknown status
CT.gov ID
NCT03892850
Collaborator
(none)
374
Enrollment
2
Arms
8
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Nurse prescription
  • Behavioral: Medical prescription
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
374 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Effectiveness and Safety of the Nursing Prescription in Acute Health Problems of Low Complexity. Randomized Clinical Trial
Anticipated Study Start Date :
Apr 1, 2019
Anticipated Primary Completion Date :
Oct 31, 2019
Anticipated Study Completion Date :
Nov 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. no re-attendance during the following 72 hours [During next 72 hours]

    Options: Yes / No

Secondary Outcome Measures

  1. Level of information and knowledge of the treatment [after 10 days]

  2. adverse effects [after 10 days]

  3. satisfaction level [after 10 days]

    Options of survey: Very satisfied, satisfied, ok, dissatisfied, very dissatisfied

  4. resolution of the health problem [after 10 days]

    Options of survey: Fully resolved, Very resolved, Something solved, A little resolved, Nothing solved

  5. compliance [after 10 days]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Jordi Gol i Gurina Foundation

Investigators

  • Principal Investigator: Sonia Fernandez Molero, Sonia, Institut Universitari d'Investigació en Atenció Primària IDIAP Jordi Gol

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT03892850
Other Study ID Numbers:
  • 4R18/112
First Posted:
Mar 27, 2019
Last Update Posted:
Mar 29, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jordi Gol i Gurina Foundation
Prescriptions
Nurses
Primary Health Care
Acute Disease
Additional relevant MeSH terms:
Acute Disease

Study Results

No Results Posted as of Mar 29, 2019