StrokeNCT00673491
Clinical Pathways for Effective and Appropriate Care
A study testing Clinical Pathways in people with Stroke, run by Agenzia Regionale Sanitaria delle Marche.
Trial summary
The purposes of this study are to determine whether clinical pathways: 1)improve the quality of the care provided to patients affected by stroke in terms of clinical outcomes, efficiency continuity of care and patients' satisfaction; 2) facilitate the use of evidence based medicine in clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Clinical Pathways
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to May 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Principal diagnosis of Ischemic Stroke (ICD9CM code 434.91)
Who cannot join
- Transient cerebral ischemia (ICD9CM code 435.9)
- Intracerebral hemorrhage (ICD9CM codes 431.xx)
About this study
Official title: Diffusion of Clinical Pathways for the Implementation of Effective and Appropriate Care
The purposes of this study are to determine whether clinical pathways: 1)improve the quality of the care provided to patients affected by stroke in terms of clinical outcomes, efficiency continuity of care and patients' satisfaction; 2) facilitate the use of evidence based medicine in clinical practice.
Read the detailed description
The coordination of care has been proved to be able to improve prognosis in acute stroke patients. Prompt identification of symptoms, organised timely and efficient transportation towards appropriate facilities, has become essential part of effective treatment, as well as organized rehabilitation. The importance of organized stroke care in facilitating recovery has been recognized for the last 10 years, but it is still unclear how organized care contributes to improved outcomes. Since clinical pathways aim to promote evidence- and guideline-based care, improve the organisation and efficiency of care, and reduce cost, their implementation may be a method for achieving the organizational standards required to grant appropriate care in stroke. Even though in the past decade, care pathways have been increasingly implemented as a tool in acute stroke care and stroke rehabilitation the evidence supports partially the use of clinical pathways in stroke because very little prospective controlled data demonstrated their effectiveness through the continuum of the care. Our study was designed in order to conduct a rigorous evaluation of clinical pathways for treatment of acute stroke patients in different types of organized stroke care.
- Conditions
- Stroke
- Being tested
- Clinical Pathways
- Keywords
- Critical Pathways, Stroke, Randomized Controlled Trial, Effectiveness
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical PathwaysOther
Clinical pathways are a methodology for the mutual decision making and organization of care for a well-defined group of patients during a well-defined period. Defining characteristics of clinical pathways includes: an explicit statement of the goals and key elements of care based on evidence, best practice, and patient expectations; the facilitation of the communication, coordination of roles, and sequencing the activities of the multidisciplinary care team, patients and their relatives; the documentation, monitoring, and evaluation of variances and outcomes; and the identification of the appropriate resources.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients treated according to clinical pathways Receives: Other: Clinical Pathways |
| 2 | No intervention | Patients treated according to usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 30 days after hospital admission
Secondary outcomes (1)
Disability
Measured: At hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startJul 2005
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agenzia Regionale Sanitaria delle Marche
- Sponsor type
- Other government
- Collaborators
- Agenzia Nazionale per i Servizi Sanitari Regionali, Regione Friuli Venezia Giulia, Reggio Calabria, Forum della Solidarieta, IRCCS Besta, Regione Molise, Regione Puglia, Regione Siciliana, Regione Umbria, University of Eastern Piedmont
- Investigators
- Francesco Di Stanislao, MD, Study chair, Agenzia Regionale Sanitaria delle Marche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673491
- Sponsor's protocol ID
- DCPIEAC-EXART12MARCHE
- Status last verified
- May 2008
- First submitted
- 5 May 2008
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Panella M, Marchisio S, Brambilla R, Vanhaecht K, Di Stanislao F. A cluster randomized trial to assess the effect of clinical pathways for patients with stroke: results of the clinical pathways for effective and appropriate care study. BMC Med. 2012 Jul 10;10:71. doi: 10.1186/1741-7015-10-71.
PubMed 22781160Panella M, Marchisio S, Barbieri A, Di Stanislao F. A cluster randomized trial to assess the impact of clinical pathways for patients with stroke: rationale and design of the Clinical Pathways for Effective and Appropriate Care Study [NCT00673491]. BMC Health Serv Res. 2008 Nov 3;8:223. doi: 10.1186/1472-6963-8-223.
PubMed 18980664
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion of Clinical Pathways for the Implementation of Effective and Appropriate Care
- ClinicalTrials.gov ID
- NCT00673491
- Acronym / sponsor ID
- DCPIEAC-EXART12MARCHE
- Conditions
- Stroke
- Keywords
- Critical Pathways, Stroke, Randomized Controlled Trial, Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Agenzia Regionale Sanitaria delle MarcheOther government
- Collaborators
- Agenzia Nazionale per i Servizi Sanitari Regionali, Regione Friuli Venezia Giulia, Reggio Calabria, Forum della Solidarieta, IRCCS Besta, Regione Molise, Regione Puglia, Regione Siciliana, Regione Umbria, University of Eastern Piedmont
- Study start
- Jul 2005
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 7 May 2008 (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 purposes of this study are to determine whether clinical pathways: 1)improve the quality of the care provided to patients affected by stroke in terms of clinical outcomes, efficiency continuity of care and patients' satisfaction; 2) facilitate the use of evidence based medicine in clinical practice.
Detailed description
The coordination of care has been proved to be able to improve prognosis in acute stroke patients. Prompt identification of symptoms, organised timely and efficient transportation towards appropriate facilities, has become essential part of effective treatment, as well as organized rehabilitation. The importance of organized stroke care in facilitating recovery has been recognized for the last 10 years, but it is still unclear how organized care contributes to improved outcomes. Since clinical pathways aim to promote evidence- and guideline-based care, improve the organisation and efficiency of care, and reduce cost, their implementation may be a method for achieving the organizational standards required to grant appropriate care in stroke. Even though in the past decade, care pathways have been increasingly implemented as a tool in acute stroke care and stroke rehabilitation the evidence supports partially the use of clinical pathways in stroke because very little prospective controlled data demonstrated their effectiveness through the continuum of the care. Our study was designed in order to conduct a rigorous evaluation of clinical pathways for treatment of acute stroke patients in different types of organized stroke care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Clinical PathwaysPatients treated according to clinical pathways |
| 2 | No intervention | –Patients treated according to usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Principal diagnosis of Ischemic Stroke (ICD9CM code 434.91)
Key exclusion criteria (2 listed)
- Transient cerebral ischemia (ICD9CM code 435.9)
- Intracerebral hemorrhage (ICD9CM codes 431.xx)
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 |
|---|---|---|
| Clinical PathwaysClinical pathways are a methodology for the mutual decision making and organization of care for a well-defined group of patients during a well-defined period. Defining characteristics of clinical pathways includes: an explicit statement of the goals and key elements of care based on evidence, best practice, and patient expectations; the facilitation of the communication, coordination of roles, and sequencing the activities of the multidisciplinary care team, patients and their relatives; the documentation, monitoring, and evaluation of variances and outcomes; and the identification of the appropriate resources. | Other | 1 |
Primary outcome
Mortality
Time frame: 30 days after hospital admission
1 secondary outcome
Disability
Time frame: At hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2008.
- Derived from this study: PubMed 22781160Panella M, Marchisio S, Brambilla R, Vanhaecht K, Di Stanislao F. A cluster randomized trial to assess the effect of clinical pathways for patients with stroke: results of the clinical pathways for effective and appropriate care study. BMC Med. 2012 Jul 10;10:71. doi: 10.1186/1741-7015-10-71.
- Derived from this study: PubMed 18980664Panella M, Marchisio S, Barbieri A, Di Stanislao F. A cluster randomized trial to assess the impact of clinical pathways for patients with stroke: rationale and design of the Clinical Pathways for Effective and Appropriate Care Study [NCT00673491]. BMC Health Serv Res. 2008 Nov 3;8:223. doi: 10.1186/1472-6963-8-223.
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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.
Francesco Di Stanislao, MD study chair
Agenzia Regionale Sanitaria delle Marche
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Pathways in people with Stroke, run by Agenzia Regionale Sanitaria delle Marche.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 7 May 2008. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days after hospital admission). 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 NCT00673491, which also lists 2 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 7 May 2008.