Acute DiseaseNCT00461201
Nurse vs General Practitioner Care for Patients Requesting Same Day Consultations in Primary Care
A study testing Nurse practitioner care of patients in people with Acute Disease and Nursing Care, run by Catalan Institute of Health.
Trial summary
The purpose of this study is to compare the effectiveness of nursing care in relation to usual medical care in adult patients who demand to be visited the same day in Primary Care Teams in Catalonia, as it is suggested in other countries. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Acute Disease, Nursing Care, Ambulatory Care
- What is being tested?
- Nurse practitioner care of patients
- Type of treatment
- Surgery or procedure
- How many people
- 1,640 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to not given
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients requesting same day consultations in primary care
- assigned to the practice
Who cannot join
- do not want to participate
- difficulties to follow-up
- serious illness that makes the intervention impossible
- home visits
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of an Intervention in Primary Care: Randomized Controlled Trial Comparing Care for Patients Requesting Same Day Consultations by Nurse Practitioner vs General Practitioners
The purpose of this study is to compare the effectiveness of nursing care in relation to usual medical care in adult patients who demand to be visited the same day in Primary Care Teams in Catalonia, as it is suggested in other countries.
Read the detailed description
The primary care demand is rapidly growing and the family physicians feel overflowed by the demand and their capacity to solve things is limited by lack of time. Many organizational interventions have been planned to solve this problem. One of these is to imply the nurse professional to solve and control health problems that traditionally were the doctor's job. So, to demonstrate the nursing care is as effective as the medical care, we will compare, among both collectives, the 'quality' of care received by patients who ask an appointment for the same day.
- Conditions
- Acute Disease, Nursing Care, Ambulatory Care, Family Practice
- Being tested
- Nurse practitioner care of patients
- Keywords
- Health Services Research, Nurse Practitioners, Outcome and Process Assessment (Health Care), Patient Acceptance of Health Care, Patient Satisfaction, Primary Health Care, Professional Autonomy
- Medical subject headings
- Acute Disease, Patient Acceptance of Health Care, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse practitioner care of patientsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the capacity of resolution of the nurse:
To determine if there are differences in the proportion of patients that make a second appointment for the same reason in the next 2 weeks, comparing the two groups.
To determine if there are differences in the resolution of symptoms in 2 weeks after the visit comparing the two groups.
To determine if there are differences in the proportion of admission to hospital or to emergency room the next 2 weeks comparing the two groups.
To determine if there are differences in the satisfaction and resolution of the worries about the users state of health in 2 weeks after the visit comparing the two groups.
To determine if there are differences comparing the two groups in the perceived status of health, perception of the information, received attention, resource utilization and future intention to consult again with the same professional.
Secondary outcomes (3)
Description of the clinical demands of the users and their demographic characteristics.
To identify if there is a type of user in which the effectiveness of the intervention is higher.
To determine the proportion of users visited by the nurse not having to be visited by the doctor afterwards for that reason.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2007 (estimated)
- Study startJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- 1,640 participants
Sponsor and investigators
- Lead sponsor
- Catalan Institute of Health
- Sponsor type
- Other government
- Collaborators
- Carlos III Health Institute, Ministry of Health, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Investigators
- Begoña Iglesias, Physician, Principal investigator, Catalan Institute of HealthMaria Teresa Grifell, Nurse, Study chair, Catalan Institute of HealthJosep Maria Vidal, Physician, Study chair, Catalan Institute of HealthSandra Pons, Physician, Study chair, Catalan Institute of HealthJosep Casajuana, Physician, Study chair, Catalan Institute of HealthRosa Aragonès, Physician, Study chair, Catalan Institute of HealthMireia Fàbregas, Physician, Study chair, Catalan Institute of HealthNeus Esgueva, Nurse, Study chair, Catalan Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461201
- Sponsor's protocol ID
- PI060715
- Status last verified
- Apr 2007
- First submitted
- 16 Apr 2007
- Last updated
- 17 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Effectiveness of health checks conducted by nurses in primary care: final results of the OXCHECK study. Imperial Cancer Research Fund OXCHECK Study Group. BMJ. 1995 Apr 29;310(6987):1099-104.
PubMed 7742676Mundinger MO, Kane RL, Lenz ER, Totten AM, Tsai WY, Cleary PD, Friedewald WT, Siu AL, Shelanski ML. Primary care outcomes in patients treated by nurse practitioners or physicians: a randomized trial. JAMA. 2000 Jan 5;283(1):59-68. doi: 10.1001/jama.283.1.59.
PubMed 10632281Kinnersley P, Anderson E, Parry K, Clement J, Archard L, Turton P, Stainthorpe A, Fraser A, Butler CC, Rogers C. Randomised controlled trial of nurse practitioner versus general practitioner care for patients requesting "same day" consultations in primary care. BMJ. 2000 Apr 15;320(7241):1043-8. doi: 10.1136/bmj.320.7241.1043.
PubMed 10764366Venning P, Durie A, Roland M, Roberts C, Leese B. Randomised controlled trial comparing cost effectiveness of general practitioners and nurse practitioners in primary care. BMJ. 2000 Apr 15;320(7241):1048-53. doi: 10.1136/bmj.320.7241.1048.
PubMed 10764367Shum C, Humphreys A, Wheeler D, Cochrane MA, Skoda S, Clement S. Nurse management of patients with minor illnesses in general practice: multicentre, randomised controlled trial. BMJ. 2000 Apr 15;320(7241):1038-43. doi: 10.1136/bmj.320.7241.1038.
PubMed 10764365Horrocks S, Anderson E, Salisbury C. Systematic review of whether nurse practitioners working in primary care can provide equivalent care to doctors. BMJ. 2002 Apr 6;324(7341):819-23. doi: 10.1136/bmj.324.7341.819.
PubMed 11934775Zwarenstein M, Bryant W. Interventions to promote collaboration between nurses and doctors. Cochrane Database Syst Rev. 2000;(2):CD000072. doi: 10.1002/14651858.CD000072.
PubMed 10796485
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Intervention in Primary Care: Randomized Controlled Trial Comparing Care for Patients Requesting Same Day Consultations by Nurse Practitioner vs General Practitioners
- ClinicalTrials.gov ID
- NCT00461201
- Acronym / sponsor ID
- PI060715
- Conditions
- Acute Disease, Nursing Care, Ambulatory Care, Family Practice
- Keywords
- Health Services Research, Nurse Practitioners, Outcome and Process Assessment (Health Care), Patient Acceptance of Health Care, Patient Satisfaction, Primary Health Care, Professional Autonomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,640 participants
- Lead sponsor
- Catalan Institute of HealthOther government
- Collaborators
- Carlos III Health Institute, Ministry of Health, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Study start
- Jan 2009
- First posted
- 17 Apr 2007 (estimated)
- 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.
The purpose of this study is to compare the effectiveness of nursing care in relation to usual medical care in adult patients who demand to be visited the same day in Primary Care Teams in Catalonia, as it is suggested in other countries.
Detailed description
The primary care demand is rapidly growing and the family physicians feel overflowed by the demand and their capacity to solve things is limited by lack of time. Many organizational interventions have been planned to solve this problem. One of these is to imply the nurse professional to solve and control health problems that traditionally were the doctor's job. So, to demonstrate the nursing care is as effective as the medical care, we will compare, among both collectives, the 'quality' of care received by patients who ask an appointment for the same day.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients requesting same day consultations in primary care
- assigned to the practice
Key exclusion criteria (4 listed)
- do not want to participate
- difficulties to follow-up
- serious illness that makes the intervention impossible
- home visits
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 practitioner care of patients | Procedure or surgery | – |
Primary outcome
Description of the capacity of resolution of the nurse:
To determine if there are differences in the proportion of patients that make a second appointment for the same reason in the next 2 weeks, comparing the two groups.
To determine if there are differences in the resolution of symptoms in 2 weeks after the visit comparing the two groups.
To determine if there are differences in the proportion of admission to hospital or to emergency room the next 2 weeks comparing the two groups.
To determine if there are differences in the satisfaction and resolution of the worries about the users state of health in 2 weeks after the visit comparing the two groups.
To determine if there are differences comparing the two groups in the perceived status of health, perception of the information, received attention, resource utilization and future intention to consult again with the same professional.
3 secondary outcomes
Description of the clinical demands of the users and their demographic characteristics.
To identify if there is a type of user in which the effectiveness of the intervention is higher.
To determine the proportion of users visited by the nurse not having to be visited by the doctor afterwards for that reason.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2007.
- Background: PubMed 7742676Effectiveness of health checks conducted by nurses in primary care: final results of the OXCHECK study. Imperial Cancer Research Fund OXCHECK Study Group. BMJ. 1995 Apr 29;310(6987):1099-104.
- Background: PubMed 10632281Mundinger MO, Kane RL, Lenz ER, Totten AM, Tsai WY, Cleary PD, Friedewald WT, Siu AL, Shelanski ML. Primary care outcomes in patients treated by nurse practitioners or physicians: a randomized trial. JAMA. 2000 Jan 5;283(1):59-68. doi: 10.1001/jama.283.1.59.
- Background: PubMed 10764366Kinnersley P, Anderson E, Parry K, Clement J, Archard L, Turton P, Stainthorpe A, Fraser A, Butler CC, Rogers C. Randomised controlled trial of nurse practitioner versus general practitioner care for patients requesting "same day" consultations in primary care. BMJ. 2000 Apr 15;320(7241):1043-8. doi: 10.1136/bmj.320.7241.1043.
- Background: PubMed 10764367Venning P, Durie A, Roland M, Roberts C, Leese B. Randomised controlled trial comparing cost effectiveness of general practitioners and nurse practitioners in primary care. BMJ. 2000 Apr 15;320(7241):1048-53. doi: 10.1136/bmj.320.7241.1048.
- Background: PubMed 10764365Shum C, Humphreys A, Wheeler D, Cochrane MA, Skoda S, Clement S. Nurse management of patients with minor illnesses in general practice: multicentre, randomised controlled trial. BMJ. 2000 Apr 15;320(7241):1038-43. doi: 10.1136/bmj.320.7241.1038.
- Background: PubMed 11934775Horrocks S, Anderson E, Salisbury C. Systematic review of whether nurse practitioners working in primary care can provide equivalent care to doctors. BMJ. 2002 Apr 6;324(7341):819-23. doi: 10.1136/bmj.324.7341.819.
- Background: PubMed 10796485Zwarenstein M, Bryant W. Interventions to promote collaboration between nurses and doctors. Cochrane Database Syst Rev. 2000;(2):CD000072. doi: 10.1002/14651858.CD000072.
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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.
Begoña Iglesias, Physician principal investigator
Catalan Institute of Health
Maria Teresa Grifell, Nurse study chair
Catalan Institute of Health
Josep Maria Vidal, Physician study chair
Catalan Institute of Health
Questions about this trial
What is this clinical trial studying?
A study testing Nurse practitioner care of patients in people with Acute Disease and Nursing Care, run by Catalan Institute of Health.
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 2 inclusion and 4 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 17 Apr 2007. 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 Begoña Iglesias, Physician (0034938931216, biglesias@ambitcp.catsalut.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the capacity of resolution of the nurse:. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00461201, which also lists 7 linked publications.
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 17 Apr 2007; AzTrials last refreshed its copy on 26 Oct 2026.