Acute DiseaseNCT03892850
Effectiveness and Safety of the Nursing Prescription in Acute Health Problems of Low Complexity
A study testing Nurse prescription and Medical prescription in people with Acute Disease, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Disease
- What is being tested?
- Nurse prescription and Medical prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Contusion
- Diarrhea / vomit
- Fever without focality
- Flu
- Urinary distress
- Odinophagy
Show all 10Show fewer
- Toothache
- Skin Bite
- Upper respiratory symptoms
- Ankle twist
Who cannot join
- Language barrier
- Cognitive deterioration
- Sensory deficit
- Pregnancy
- Immunosuppression
- Neoplasia in the last 5 years
Show all 11Show fewer
- Does not participate / Does not sign consent
- Breastfeeding period
- Reconsult
- Resides outside of Spain
- Treatment with glucocorticoids in the last 6 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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
- Conditions
- Acute Disease
- Being tested
- Nurse prescription, Medical prescription
- Keywords
- Prescriptions, Nurses, Primary Health Care, Acute Disease
- Medical subject headings
- Acute Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse prescriptionBehavioural
Pharmacological nurse prescription. Subjects are individuals who request a same day consultation for minor acute pathologies and meet the selection criteria
Medical prescriptionBehavioural
Pharmacological medical prescription. Subjects are individuals who request a same day consultation for minor acute pathologies and meet the selection criteria
| Study group | Role | What they receive |
|---|---|---|
| nurse prescription | Experimental | experimental group receiving pharmacological nurse prescription Receives: Behavioral: Nurse prescription |
| medical prescription | Active comparator | control group receiving medical prescription Receives: Behavioral: Medical prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
no re-attendance during the following 72 hours
Options: Yes / No
Measured: During next 72 hours
Secondary outcomes (5)
Level of information and knowledge of the treatment
Measured: after 10 days
adverse effects
Measured: after 10 days
satisfaction level
Options of survey: Very satisfied, satisfied, ok, dissatisfied, very dissatisfied
Measured: after 10 days
resolution of the health problem
Options of survey: Fully resolved, Very resolved, Something solved, A little resolved, Nothing solved
Measured: 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)
Measured: after 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion31 Oct 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonia Fernandez Molero, Sonia, Principal investigator, Institut Universitari d'Investigació en Atenció Primària IDIAP Jordi Gol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892850
- Sponsor's protocol ID
- 4R18/112
- Status last verified
- Mar 2019
- First submitted
- 18 Mar 2019
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of the Nursing Prescription in Acute Health Problems of Low Complexity. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03892850
- Acronym / sponsor ID
- 4R18/112
- Conditions
- Acute Disease
- Keywords
- Prescriptions, Nurses, Primary Health Care, Acute Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nurse prescription | Experimental | Behavioral: Nurse prescriptionexperimental group receiving pharmacological nurse prescription |
| medical prescription | Active comparator | Behavioral: Medical prescriptioncontrol group receiving medical prescription |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Contusion
- Diarrhea / vomit
- Fever without focality
- Flu
- Urinary distress
Key exclusion criteria (11 listed)
- Language barrier
- Cognitive deterioration
- Sensory deficit
- Pregnancy
- Immunosuppression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse prescriptionPharmacological nurse prescription. Subjects are individuals who request a same day consultation for minor acute pathologies and meet the selection criteria | Behavioural | nurse prescription |
| Medical prescriptionPharmacological medical prescription. Subjects are individuals who request a same day consultation for minor acute pathologies and meet the selection criteria | Behavioural | medical prescription |
Primary outcome
no re-attendance during the following 72 hours
Time frame: During next 72 hours
Options: Yes / No
5 secondary outcomes
Level of information and knowledge of the treatment
Time frame: after 10 days
adverse effects
Time frame: after 10 days
satisfaction level
Time frame: after 10 days
resolution of the health problem
Time frame: after 10 days
compliance
Time frame: after 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia Fernandez Molero, Sonia principal investigator
Institut Universitari d'Investigació en Atenció Primària IDIAP Jordi Gol
Questions about this trial
What is this clinical trial studying?
A study testing Nurse prescription and Medical prescription in people with Acute Disease, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sonia Fernandez Molero, Nurse (+34637353101, sfernandez@casap.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
no re-attendance during the following 72 hours (time frame: During next 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.