Critical PathwaysNCT00275587
Development of a Hospital Service That Uses Critical Pathway (Protocolized) Care Plans to Provide High-Quality, High-Reliability, Evidence-Based Medical Care
An observational study of Critical Pathways, run by Mayo Clinic at 1 site in United States.
Trial summary
Our broad, long-term objective is to create a new non-resident (non-teaching) hospital service that uses patient-centered critical pathway care plans for treating patients in St. Marys Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Pathways
- How many people
- 348 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jan 2008
- Phase
- Observational
- 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
Study population: Patients hospitalized at St. Marys Hospital in Rochester, MN with with one of six medical diagnoses: community-acquired pneumonia, deep venous thrombosis or pulmonary embolism, cellulitis, alcohol withdrawal, pyelonephritis, low back pain.
- Hospitalized patient with one of six medical diagnoses: community-acquired pneumonia, deep venous thrombosis or pulmonary embolism, cellulitis, alcohol withdrawal, pyelonephritis, low back pain.
- Ability and agreement to consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Critical Pathway Care for Hospitalized Patients Using Principles of Patient-Centered Quality Care, Evidence-Based Medicine, and High Reliability Organizational Structure
Our broad, long-term objective is to create a new non-resident (non-teaching) hospital service that uses patient-centered critical pathway care plans for treating patients in St. Marys Hospital. This innovative service, the Hospital Medicine (HOME) Team, will integrate three timely, high-priority concepts in healthcare: patient-centered quality care, evidence-based medicine, and principles that define high reliability organizations. The target populations for the new model of service are patients hospitalized with pre-defined admission diagnoses who are expected to require only a brief, focused hospital stay of four days or less. Specifically, we will 1) Design the prototypical approach to be used for developing all critical pathway care plans by integrating patient-centered quality care, evidence-based medicine, and principles that define high reliability organizations, 2) Systematically design the critical pathway care plans for two pre-defined admission diagnoses (community-acquired pneumonia and non-surgical low-back pain), and 3) Compare outcomes of this new service against respective historical patient cohorts for patients admitted with community-acquired pneumonia and non-surgical low-back pain. We anticipate that the prototypic methodology used to develop this patient-centered service will be replicated for other new hospital-service models. To our knowledge, there are currently no existing hospital services in the U.S. that have intentionally integrated principles of high reliability organizations into evidence-based critical pathways founded on patient-centered principles of uncompromising quality.
- Conditions
- Critical Pathways
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startJan 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical PathwaysStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- A. Scott Keller, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275587
- Sponsor's protocol ID
- 164-05
- Status last verified
- Mar 2011
- First submitted
- 10 Jan 2006
- Last updated
- 23 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Critical Pathway Care for Hospitalized Patients Using Principles of Patient-Centered Quality Care, Evidence-Based Medicine, and High Reliability Organizational Structure
- ClinicalTrials.gov ID
- NCT00275587
- Acronym / sponsor ID
- 164-05
- Conditions
- Critical Pathways
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 12 Jan 2006 (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.
Our broad, long-term objective is to create a new non-resident (non-teaching) hospital service that uses patient-centered critical pathway care plans for treating patients in St. Marys Hospital. This innovative service, the Hospital Medicine (HOME) Team, will integrate three timely, high-priority concepts in healthcare: patient-centered quality care, evidence-based medicine, and principles that define high reliability organizations. The target populations for the new model of service are patients hospitalized with pre-defined admission diagnoses who are expected to require only a brief, focused hospital stay of four days or less. Specifically, we will 1) Design the prototypical approach to be used for developing all critical pathway care plans by integrating patient-centered quality care, evidence-based medicine, and principles that define high reliability organizations, 2) Systematically design the critical pathway care plans for two pre-defined admission diagnoses (community-acquired pneumonia and non-surgical low-back pain), and 3) Compare outcomes of this new service against respective historical patient cohorts for patients admitted with community-acquired pneumonia and non-surgical low-back pain. We anticipate that the prototypic methodology used to develop this patient-centered service will be replicated for other new hospital-service models. To our knowledge, there are currently no existing hospital services in the U.S. that have intentionally integrated principles of high reliability organizations into evidence-based critical pathways founded on patient-centered principles of uncompromising quality.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized at St. Marys Hospital in Rochester, MN with with one of six medical diagnoses: community-acquired pneumonia, deep venous thrombosis or pulmonary embolism, cellulitis, alcohol withdrawal, pyelonephritis, low back pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 23 Mar 2011.
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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.
A. Scott Keller, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Pathways, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 23 Mar 2011.