NCT00673491

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
448

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jul 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 5, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
Last Updated

May 7, 2008

Status Verified

May 1, 2008

Enrollment Period

1.8 years

First QC Date

May 5, 2008

Last Update Submit

May 6, 2008

Conditions

Keywords

Critical PathwaysStrokeRandomized Controlled TrialEffectiveness

Outcome Measures

Primary Outcomes (1)

  • Mortality

    30 days after hospital admission

Secondary Outcomes (1)

  • Disability

    At hospital discharge

Study Arms (2)

1

EXPERIMENTAL

Patients treated according to clinical pathways

Other: Clinical Pathways

2

NO INTERVENTION

Patients treated according to usual care

Interventions

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.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Principal diagnosis of Ischemic Stroke (ICD9CM code 434.91)

You may not qualify if:

  • Transient cerebral ischemia (ICD9CM code 435.9)
  • Intracerebral hemorrhage (ICD9CM codes 431.xx)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • Panella 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.

MeSH Terms

Conditions

Stroke

Interventions

Critical Pathways

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Francesco Di Stanislao, MD

    Agenzia Regionale Sanitaria delle Marche

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 5, 2008

First Posted

May 7, 2008

Study Start

July 1, 2005

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

May 7, 2008

Record last verified: 2008-05