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

Primary Purpose

Acute Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nurse prescription
Medical prescription
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Disease focused on measuring Prescriptions, Nurses, Primary Health Care, Acute Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    nurse prescription

    medical prescription

    Arm Description

    experimental group receiving pharmacological nurse prescription

    control group receiving medical prescription

    Outcomes

    Primary Outcome Measures

    no re-attendance during the following 72 hours
    Options: Yes / No

    Secondary Outcome Measures

    Level of information and knowledge of the treatment
    adverse effects
    satisfaction level
    Options of survey: Very satisfied, satisfied, ok, dissatisfied, very dissatisfied
    resolution of the health problem
    Options of survey: Fully resolved, Very resolved, Something solved, A little resolved, Nothing solved
    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)

    Full Information

    First Posted
    March 18, 2019
    Last Updated
    March 27, 2019
    Sponsor
    Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03892850
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2019 (Anticipated)
    Primary Completion Date
    October 31, 2019 (Anticipated)
    Study Completion Date
    November 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Disease
    Keywords
    Prescriptions, Nurses, Primary Health Care, Acute Disease

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    374 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    nurse prescription
    Arm Type
    Experimental
    Arm Description
    experimental group receiving pharmacological nurse prescription
    Arm Title
    medical prescription
    Arm Type
    Active Comparator
    Arm Description
    control group receiving medical prescription
    Intervention Type
    Behavioral
    Intervention Name(s)
    Nurse prescription
    Intervention Description
    Pharmacological nurse prescription. Subjects are individuals who request a same day consultation for minor acute pathologies and meet the selection criteria
    Intervention Type
    Behavioral
    Intervention Name(s)
    Medical prescription
    Intervention Description
    Pharmacological medical prescription. Subjects are individuals who request a same day consultation for minor acute pathologies and meet the selection criteria
    Primary Outcome Measure Information:
    Title
    no re-attendance during the following 72 hours
    Description
    Options: Yes / No
    Time Frame
    During next 72 hours
    Secondary Outcome Measure Information:
    Title
    Level of information and knowledge of the treatment
    Time Frame
    after 10 days
    Title
    adverse effects
    Time Frame
    after 10 days
    Title
    satisfaction level
    Description
    Options of survey: Very satisfied, satisfied, ok, dissatisfied, very dissatisfied
    Time Frame
    after 10 days
    Title
    resolution of the health problem
    Description
    Options of survey: Fully resolved, Very resolved, Something solved, A little resolved, Nothing solved
    Time Frame
    after 10 days
    Title
    compliance
    Description
    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)
    Time Frame
    after 10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sonia Fernandez Molero, Nurse
    Phone
    +34637353101
    Email
    sfernandez@casap.cat
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andres Baiget Ortega
    Phone
    +34652997848
    Email
    abaigeto@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sonia Fernandez Molero, Sonia
    Organizational Affiliation
    Institut Universitari d'Investigació en Atenció Primària IDIAP Jordi Gol
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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