Congestive Heart FailureNCT01446536
Effect of Quality Improvement Tools in Congestive Heart Failure (CHF)
A study testing Checklist cohort in people with Congestive Heart Failure, run by St. Joseph Mercy Oakland Hospital at 1 site in United States.
Trial summary
Hypothesis: Quality Improvement tools like "Heart Failure Discharge Checklist" which emphasizes on proper education to patients, ensure appropriate dose titration and counselling improve outcome in congestive heart failure (CHF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Checklist cohort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jun 2010
- 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
- Patients admitted to SJMO with principal diagnosis of acute decompensated heart failure
Who cannot join
- Age less than 18 years
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
About this study
Official title: Decreased Readmissions and Improved Quality of Care With Use of Inexpensive Checklist in Heart Failure
Hypothesis: Quality Improvement tools like "Heart Failure Discharge Checklist" which emphasizes on proper education to patients, ensure appropriate dose titration and counselling improve outcome in congestive heart failure (CHF).
- Conditions
- Congestive Heart Failure
- Being tested
- Checklist cohort
- Keywords
- Quality, Improvement
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Checklist cohortOther
CHF discharge checklist was used arbitrarily by their treating physicians in addition to the standard therapy
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | This arm which was control group, was randomly selected among patients with acute decompensated heart failure in whom the checklist was not used. This group was managed as per the standard guidelines. |
| Checklist (intervention) cohort | Active comparator | checklist was used in this group arbitrarily by their treating physician Receives: Other: Checklist cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmissions
Readmission to the hospital for CHF within 6 months of discharge
Measured: 6 months
Dose titration
up titration of medications including Beta blocer, ACE inhibitor or ARB was assessed during the hospital stay
Measured: patients were followed during the time of hospital stay, average of 5 days
Secondary outcomes (1)
Medications prescribed
during the hospital stay and at discharge this outcome is measured/assessed
Measured: patients were followed during their hospital stay from admission to discharge, on an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startAug 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph Mercy Oakland Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abhijeet Basoor, St. Joseph Mercy Oakland Hospital
- Investigators
- Abhijeet Basoor, MD, Principal investigator, St. Joseph Mercy Oakland Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446536
- Sponsor's protocol ID
- 11-09-02
- Status last verified
- Mar 2012
- First submitted
- 30 Sep 2011
- Last updated
- 20 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreased Readmissions and Improved Quality of Care With Use of Inexpensive Checklist in Heart Failure
- ClinicalTrials.gov ID
- NCT01446536
- Acronym / sponsor ID
- 11-09-02
- Conditions
- Congestive Heart Failure
- Keywords
- Quality, Improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- St. Joseph Mercy Oakland HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 Oct 2011 (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.
Hypothesis: Quality Improvement tools like "Heart Failure Discharge Checklist" which emphasizes on proper education to patients, ensure appropriate dose titration and counselling improve outcome in congestive heart failure (CHF).
Study design
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –This arm which was control group, was randomly selected among patients with acute decompensated heart failure in whom the checklist was not used. This group was managed as per the standard guidelines. |
| Checklist (intervention) cohort | Active comparator | Other: Checklist cohortchecklist was used in this group arbitrarily by their treating physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to SJMO with principal diagnosis of acute decompensated heart failure
Key exclusion criteria (2 listed)
- Age less than 18 years
- Pregnant women
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 |
|---|---|---|
| Checklist cohortCHF discharge checklist was used arbitrarily by their treating physicians in addition to the standard therapy | Other | Checklist (intervention) cohort |
Primary outcome
Readmissions
Time frame: 6 months
Readmission to the hospital for CHF within 6 months of discharge
Dose titration
Time frame: patients were followed during the time of hospital stay, average of 5 days
up titration of medications including Beta blocer, ACE inhibitor or ARB was assessed during the hospital stay
1 secondary outcome
Medications prescribed
Time frame: patients were followed during their hospital stay from admission to discharge, on an average of 5 days
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 20 Mar 2012.
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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.
Abhijeet Basoor, MD principal investigator
St. Joseph Mercy Oakland Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Checklist cohort in people with Congestive Heart Failure, run by St. Joseph Mercy Oakland Hospital 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?
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 20 Mar 2012. 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.
What does the primary outcome measure?
Readmissions (time frame: 6 months). The study lists 2 primary outcomes in all. 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 20 Mar 2012.