NCT01446536

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

August 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

Enrollment Period

1.8 years

First QC Date

September 30, 2011

Last Update Submit

March 18, 2012

Conditions

Congestive Heart Failure

Keywords

QualityImprovement

Outcome Measures

Primary Outcomes (2)

  • Readmissions

    Readmission to the hospital for CHF within 6 months of discharge

    6 months

  • Dose titration

    up titration of medications including Beta blocer, ACE inhibitor or ARB was assessed during the hospital stay

    patients were followed during the time of hospital stay, average of 5 days

Secondary Outcomes (1)

  • Medications prescribed

    patients were followed during their hospital stay from admission to discharge, on an average of 5 days

Study Arms (2)

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

Other: Checklist cohort

Interventions

Checklist cohortOTHER

CHF discharge checklist was used arbitrarily by their treating physicians in addition to the standard therapy

Checklist (intervention) cohort

Eligibility Criteria

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

You may qualify if:

  • Patients admitted to SJMO with principal diagnosis of acute decompensated heart failure

You may not qualify if:

  • Age less than 18 years
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Abhijeet Basoor, MD

    St. Joseph Mercy Oakland Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Who Masked
INVESTIGATOR
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiology Fellow

Study Record Dates

First Submitted

September 30, 2011

First Posted

October 5, 2011

Study Start

August 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

March 20, 2012

Record last verified: 2012-03

Locations

US(1)