Heart Failure, CongestiveNCT00355511
Heart Failure Evaluation Acute Referral Team Trial (HEARTT)
A study testing education: disease, medication, self-care, diet in people with Heart Failure, Congestive, run by University of Alberta at 1 site in Canada.
Trial summary
The purpose of this study is to assess the impact of a multidisciplinary team clinic including a clinical pharmacist, a registered nurse (RN), dietician and physician providing short-term sub-acute management of patients with heart failure on patient outcomes and the quality of medication use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- education: disease, medication, self-care, diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2007to Feb 2009
- 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 presenting to the emergency department (ED) with signs and symptoms of heart failure with a plan to discharge home from the ED .
Who cannot join
- < 18 years of age
- planned follow-up with Cardiology or Internal Medicine post discharge from ED
- heart transplant candidate or recipient
- current Heart Function Clinic patient
- left ventricular ejection fraction >0.40
- unable or unwilling to attend clinic visits
Show all 9Show fewer
- heart failure requiring admission to hospital
- patients living outside the Capital Health catchment area
- participation in another heart failure clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the impact of a multidisciplinary team clinic including a clinical pharmacist, a registered nurse (RN), dietician and physician providing short-term sub-acute management of patients with heart failure on patient outcomes and the quality of medication use. Patients being discharged from the emergency department with a diagnosis of heart failure will be eligible for this study. We believe that emergency room visits, hospitalization and deaths secondary to heart failure will decrease secondary to this program.
Read the detailed description
BACKGROUND: Heart failure (HF)accounts for morbidity and mortality in Canada. In contrast to coronary heart disease, the mortality rate attributed to HF has decreased minimally, only 14%, over the last 35 years. This is despite a plethora of new therapeutic modalities proven to decrease mortality in HF. HF is also one of the leading causes of hospitalizations accounting for the second highest total number of hospital days and the third highest number of patients affected. It has been estimated that approximately 20-50% of patients will be readmitted to hospital with one year. Patients seen in the emergency department (ED)and discharged home from the ED are also at high risk for readmissions. A local study by our group indicated that 44% of patients seen for HF in the ED have this disposition and as such have a strikingly 50% higher readmission rate at 30 days compared to those admitted to hospital. This difference could be explained by a "care gap" as evidence by a low utilization of both angiotensin converting enzyme inhibitors and beta-blockers in this group. However, a lack of patient education on self-care and follow-up post ED discharge could also attribute to these rates. We propose testing a intervention employing a multidisciplinary team to facilitate follow-up, provide HF education, including self-care, and improve utilization of proven drug-therapy in patients discharged with HF from the ED on the outcomes of hospitalizations and mortality.
PURPOSE: To improve the quality of care for patient with HF
HYPOTHESIS: Multidisciplinary team management of patients with HF has be shown to decrease both morbidity and mortality in HF patients. A multifaceted program including rapid referral, early short-term follow-up, medication initiation and titration and HF education in collaboration with a dietician, nurse, pharmacist and physician will improve HF patient care in terms of clinical outcomes, quality of life and evidence-based medication utilization.
STUDY DESIGN: The study will utilize an unblinded randomized controlled trial (RCT) design. Eligible patients will included patient discharged from the ED with a diagnosis of heart failure. All patients referred from the ED will be seen in a rapid referral clinic within 1 week. Eligible patients will then randomized to an intervention arm or usual care. The usual care group will have a consultation letter with recommendations sent their family doctor and will receive a booklet on heart failure. The intervention arm will be followed in clinic monthly by the multidisciplinary team. Medication will be initiated and titrated to target dose. Patients will receive education regarding heart failure, medications, lifestyle, diet and self-management. Communication will the patient's primary care provider will also be enhanced.
SIGNIFICANCE: The literature describes a plethora of therapeutic modalities aimed at improving the care of patients with HF. However, in terms of multifaceted disease management interventions, the majority of HF studies have examined high risk patients that were admitted to hospital or stable outpatients. This proposed study would examine a unique population of patients being discharged from the emergency department.
- Conditions
- Heart Failure, Congestive
- Being tested
- education: disease, medication, self-care, diet
- Keywords
- heart failure, congestive, patient care team, randomized controlled trial, disease management, drug therapy, diet therapy, hospitalization, mortality
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education: disease, medication, self-care, dietBehavioural
education on heart failure self care; medication initiation and titration, frequent follow-up
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the composite endpoint of emergency room visits, hospitalizations, and mortality at 6 months between the intervention and usual care group.
Measured: 6 months
Secondary outcomes (3)
Difference in the following between the intervention and usual care groups at 6 months: emergency room visits, hospitalizations, mortality, proportion of patients utilizing evidence-based therapies, quality of life
Measured: 6 months
Description of the implementation of the rapid assessment clinic
Measured: 6 months
Patient satisfaction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2006 (estimated)
- Study startJul 2007
- Primary completionFeb 2009
- Study completionFeb 2009 (estimated)
Why it stopped: unable to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Investigators
- Ross T Tsuyuki, PharmD, MSc, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355511
- Sponsor's protocol ID
- EPICORE2006-002
- Status last verified
- Apr 2015
- First submitted
- 18 Jul 2006
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Evaluation Acute Referral Team Trial (HEARTT)
- ClinicalTrials.gov ID
- NCT00355511
- Acronym / sponsor ID
- EPICORE2006-002
- Conditions
- Heart Failure, Congestive
- Keywords
- heart failure, congestive, patient care team, randomized controlled trial, disease management, drug therapy, diet therapy, hospitalization, mortality
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to recruit patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (estimated)
- First posted
- 24 Jul 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.
The purpose of this study is to assess the impact of a multidisciplinary team clinic including a clinical pharmacist, a registered nurse (RN), dietician and physician providing short-term sub-acute management of patients with heart failure on patient outcomes and the quality of medication use. Patients being discharged from the emergency department with a diagnosis of heart failure will be eligible for this study. We believe that emergency room visits, hospitalization and deaths secondary to heart failure will decrease secondary to this program.
Detailed description
BACKGROUND: Heart failure (HF)accounts for morbidity and mortality in Canada. In contrast to coronary heart disease, the mortality rate attributed to HF has decreased minimally, only 14%, over the last 35 years. This is despite a plethora of new therapeutic modalities proven to decrease mortality in HF. HF is also one of the leading causes of hospitalizations accounting for the second highest total number of hospital days and the third highest number of patients affected. It has been estimated that approximately 20-50% of patients will be readmitted to hospital with one year. Patients seen in the emergency department (ED)and discharged home from the ED are also at high risk for readmissions. A local study by our group indicated that 44% of patients seen for HF in the ED have this disposition and as such have a strikingly 50% higher readmission rate at 30 days compared to those admitted to hospital. This difference could be explained by a "care gap" as evidence by a low utilization of both angiotensin converting enzyme inhibitors and beta-blockers in this group. However, a lack of patient education on self-care and follow-up post ED discharge could also attribute to these rates. We propose testing a intervention employing a multidisciplinary team to facilitate follow-up, provide HF education, including self-care, and improve utilization of proven drug-therapy in patients discharged with HF from the ED on the outcomes of hospitalizations and mortality.
PURPOSE: To improve the quality of care for patient with HF
HYPOTHESIS: Multidisciplinary team management of patients with HF has be shown to decrease both morbidity and mortality in HF patients. A multifaceted program including rapid referral, early short-term follow-up, medication initiation and titration and HF education in collaboration with a dietician, nurse, pharmacist and physician will improve HF patient care in terms of clinical outcomes, quality of life and evidence-based medication utilization.
STUDY DESIGN: The study will utilize an unblinded randomized controlled trial (RCT) design. Eligible patients will included patient discharged from the ED with a diagnosis of heart failure. All patients referred from the ED will be seen in a rapid referral clinic within 1 week. Eligible patients will then randomized to an intervention arm or usual care. The usual care group will have a consultation letter with recommendations sent their family doctor and will receive a booklet on heart failure. The intervention arm will be followed in clinic monthly by the multidisciplinary team. Medication will be initiated and titrated to target dose. Patients will receive education regarding heart failure, medications, lifestyle, diet and self-management. Communication will the patient's primary care provider will also be enhanced.
SIGNIFICANCE: The literature describes a plethora of therapeutic modalities aimed at improving the care of patients with HF. However, in terms of multifaceted disease management interventions, the majority of HF studies have examined high risk patients that were admitted to hospital or stable outpatients. This proposed study would examine a unique population of patients being discharged from the emergency department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
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 presenting to the emergency department (ED) with signs and symptoms of heart failure with a plan to discharge home from the ED .
Key exclusion criteria (9 listed)
- < 18 years of age
- planned follow-up with Cardiology or Internal Medicine post discharge from ED
- heart transplant candidate or recipient
- current Heart Function Clinic patient
- left ventricular ejection fraction >0.40
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 |
|---|---|---|
| education: disease, medication, self-care, dieteducation on heart failure self care; medication initiation and titration, frequent follow-up | Behavioural | – |
Primary outcome
Difference in the composite endpoint of emergency room visits, hospitalizations, and mortality at 6 months between the intervention and usual care group.
Time frame: 6 months
3 secondary outcomes
Difference in the following between the intervention and usual care groups at 6 months: emergency room visits, hospitalizations, mortality, proportion of patients utilizing evidence-based therapies, quality of life
Time frame: 6 months
Description of the implementation of the rapid assessment clinic
Time frame: 6 months
Patient satisfaction
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Related InfoLink provided by the sponsor.
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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.
Ross T Tsuyuki, PharmD, MSc principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education: disease, medication, self-care, diet in people with Heart Failure, Congestive, run by University of Alberta at 1 site in Canada.
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 9 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: withdrawn, as of the sponsor's last update on 28 Apr 2015. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Difference in the composite endpoint of emergency room visits, hospitalizations, and mortality at 6 months between the intervention and usual care group. (time frame: 6 months). 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 28 Apr 2015.