Heart FailureGUIDED-HFNCT02519283
Get With the Guidelines in ED Patients With Heart Failure
A study testing GUIDED-HF in people with Heart Failure, run by Vanderbilt University at 15 sites in United States.
Trial summary
Approximately 20-30% of patients presenting with acute heart failure are discharged from the ED. Compared to patients discharged from the hospital, they more frequently return to the ED and hospital for further management. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- GUIDED-HF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 529 participants
- Where
- 15 sitesUnited States
- Study dates
- Oct 2015to Feb 2020
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients deemed by emergency physician to have AHF, who they plan to discharge or hold for brief ED-based observation (less than 23 hours of AHF care)
- Age ≥21 years old
- Prior history of HF
Who cannot join
- Unable to comply with protocol- due to psychiatric disease or distance from the hospital
- Systolic BP <100 mmHg
- Evidence of ACS based on ischemia on ECG or Troponin elevation
- Outpatient inotrope infusion
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Emory University
Atlanta, Georgia, 30307
University of Cincinnati
Cincinnati, Ohio, 45220
MetroHealth
Cleveland, Ohio, 44109
UT Southwestern Medical Center
Dallas, Texas, 75390
Wayne State University
Detroit, Michigan, 48202
Baylor College of Medicine
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
University of Mississippi Medical Center
Jackson, Mississippi, 39216
VA Tennessee Valley Health System
Nashville, Tennessee, 37232
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Virginia Commonwealth University
Richmond, Virginia, 23298
Washington University
St Louis, Missouri, 63130
Stony Brook University
Stony Brook, New York, 11794
About this study
Approximately 20-30% of patients presenting with acute heart failure are discharged from the ED. Compared to patients discharged from the hospital, they more frequently return to the ED and hospital for further management. While inpatient discharges are often enrolled in transitions programs and have their care tailored to evidence-based recommendations, ED discharges do not. The investigators propose to evaluate current standard ED discharge to an ED-based intervention which will transition patients to outpatient follow-up on guideline-recommended therapy.
Read the detailed description
Heart failure (HF) is common and growing healthcare concern. Heart failure affects nearly 6 million Americans. It results in over one million annual hospital discharges as the primary discharge diagnosis and an additional two million hospitalizations where HF contributes to the discharge diagnosis. Despite a relative reduction in the hospitalization rate of HF, the actual number of HF hospitalizations remains over one million annually. This figure is expected to significantly worsen with the aging United States population and the growing HF prevalence. Over 80% of patients who are hospitalized are initially seen in the emergency department (ED). However, not all those seen in the ED for HF are admitted; a sizeable proportion are discharged home without hospitalization. As disposition decisions for those who present to the hospital rest largely with ED providers, the ED will play an even bigger role in the management of HF patients and in avoiding unnecessary hospitalizations.
The ED is the gatekeeper for AHF evaluations. Nearly one million ED visits for acute heart failure (AHF) occur annually in the United States. Importantly, the ED is the safety net for AHF care and often sole provider of AHF care to vulnerable patients. To optimize care and reduce ED and hospital revisits, there has been significant emphasis on improving transitions at the time of hospital discharge for HF patients. Such efforts have been almost exclusively directed at hospitalized patients; individuals with AHF who are discharged from the ED miss the benefits of transitional care initiatives.
Ensuring optimal transitions of care for discharged ED AHF patients is a critical unmet need. Data show AHF patients discharged from the ED receive suboptimal guideline directed medical therapy (GDMT), suggesting interventions to improve AHF transitions are needed in the ED setting. This is particularly true for patients that are in resource limited settings, many of whom have vulnerable characteristics. By default the ED is often the sole or primary provider of HF care to this group of patients who are discharged from the ED.
The proposal, "Get with the Guidelines in ED Patients with Heart Failure (GUIDED-HF)", is designed to answer two fundamental questions about vulnerable patients with AHF discharged from the ED:
- Does GWTG:HF implementation by a transition nurse coordinator directed team (TNC Team) reduce disparities in time to ED/clinic revisit or hospital admission or cardiovascular death over the 3-month period immediately following the index ED visit?
- Does GWTG:HF implementation by a TNC Team reduce disparities in patient satisfaction, HF knowledge and QOL over the 3-month period immediately following the index ED visit?
Patients hospitalized for HF continue to have a high risk of adverse post-discharge outcomes. Although there has been a relative reduction in rehospitalization and mortality rates for AHF patients post-discharge after a significant recent effort by hospitals to avoid CMS financial penalties, the absolute risk remains very high. The one-month post discharge readmission risk is 20-25% and one-year post discharge mortality is 25-30%. These results are from institutions who have implemented significant in-hospital case management programs with a specific focus on transitions of care, including early post-discharge follow-up. ED patients discharged with AHF have more vulnerable characteristics, have a higher risk of readmission, and are not included in hospital programs targeted to help them. This proposal will study a significant unmet need, projected to get worse, and for which no evidence based data currently exist to guide management. Even a modest reduction in the risk for ED revisits or hospital admissions has the potential for significant clinical and patient centric benefits in patients with AHF discharged from the ED.
- Conditions
- Heart Failure
- Being tested
- GUIDED-HF, Standard of Care
- Keywords
- AHF, HF, ED, ER, Emergency Department, Emergency Room
- Medical subject headings
- Heart Failure, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GUIDED-HFBehavioural
Participants in this arm will receive a tailored discharge plan via a transition nurse coordinator directed team (TNC Team).
- Disease education: Health literacy screen will identify barriers to understanding discharge and medication instructions.
- Lifestyle interventions: Includes receiving smoking cessation information and instructions to track daily weights.
- Guideline recommendations for medications and device referral: Includes determining the need for prescriptions for ACEIs, ARBs, beta blockers, aldosterone antagonists, anticoagulants and referral for pacemaker/defibrillator consideration.
- Outpatient follow-up appointment: TNC Team will provide a scheduled appointment within 7 days and will conduct a home visit within 48 hours of ED discharge.
Standard of CareBehavioural
Those in the standard care arm will receive structured ED discharge assessment to include:
- discharge instructions;
- medication reconciliation
- encourage follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | In keeping with the strategy-based pragmatic nature of the trial, the discharge procedures will largely be kept as they are in common practice. Investigators will standardize usual care for ED discharge to include HF medication reconciliation as well as encourage 7-day follow-up. Receives: Behavioral: Standard of Care |
| GUIDED-HF | Active comparator | GWTG:HF has been successfully implemented across multiple inpatient populations and health systems over the last decade and has been shown to improve HF disparities. Receives: Behavioral: GUIDED-HF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Score Reflective of Clinical Status
Participants ranked sequentially. Ranking stratified in 1 of 3 tiers based on:
Lowest tier: CV Death: Ranking based on time to death from original ED discharge date. Participant with the first death = lowest rank in the tier.
Middle tier: ED Re-visit, Hospital Re-admission or Clinic for AHF with IV. For patients alive, ranking based on time to ED Re-visit, Hospital Re-admission or Clinic for AHF with IV from original ED discharge date, whichever occurs first. Participant with first adverse event = lowest rank in the tier.
Highest tier: KCCQ Changes. For patients alive, ranking is based on changes in KCCQ from baseline. Participant with the largest decrease = lowest rank in the tier.
The use of 3 tiers reflects the greater adverse impact of death, followed by adverse impact of Hospital Re-admission, ED Re-visit, clinic for AHF with IV on clinical status, and then health status as measured by KCCQ. The Clinical Events (Composite) updated on 11/19/19 per PCORI study team discussion.
Measured: 90 days from ED discharge
Secondary outcomes (7)
HF Related Quality of Life: Kansas City Cardiomyopathy Questionnaire (KCCQ)
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 12-item self-administered questionnaire developed to independently measure the patient's perception of their health status. Scores range from 0 to 100, with higher scores indicating lower symptom burden and better QOL. Scores were divided into ranges of 0 to 25 (severe), 26 to 50 (moderate), 51 to 75 (fair), and 76 to 100 (little-to-no disability).
Measured: Enrollment, 30 days and 90 days after ED discharge
Adherence to Refills and Medications Scale (ARMS 7) score
The ARMS consists of 7 questions administered verbally by healthcare professionals to assess self-reported adherence to medication for participants. Scores range from 7 to 28 with lower scores indicating better adherence and higher scores indicating worse adherence.
Measured: Enrollment, 30 days and 90 days after ED discharge
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety score
The PROMIS Anxiety short form consists of 8 questions with five response options ranging in value from 1 to 5 to assess self-reported anxiety for participants. Scores range from 8 to 40. Higher scores indicate greater anxiety.
Measured: Enrollment, 30 days and 90 days after ED discharge
Patient Reported Outcomes Measurement Information System (PROMIS) Depression score
The PROMIS Depression short form consists of 8 questions with five response options ranging in value from 1 to 5 to assess self-reported anxiety for participants. Scores range from 8 to 40. Higher scores indicate greater depression.
Measured: Enrollment, 30 days and 90 days after ED discharge
Time spent at clinic office visits
Time spent at clinic office visits after ED discharge will be measured in minutes. Increased minutes indicate lower health status
Measured: 30 days and 90 days after ED discharge
Out-of-pocket costs for work missed
Out-of-pocket costs for time missed at work after ED discharge will be measured in dollars. Increased dollars indicate lower health status
Measured: 30 days and 90 days after ED discharge
Dutch Heart Failure Knowledge score
The Dutch Heart Failure Knowledge Scale is a 15-item, self-administered questionnaire that covers items concerning HF knowledge. Scores range from 0 to 15, where a score between 0 and 7 indicates a lack of awareness and a score between 8 and 15 indicates a complete knowledge of the disease.
Measured: Enrollment, 30 days and 90 days after ED discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2019
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 529 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Stony Brook University, Indiana University, Wayne State University, VA Office of Research and Development, University of Cincinnati, Washington University School of Medicine, Baylor College of Medicine, MetroHealth Medical Center, University of Mississippi Medical Center, Emory University, University of Iowa, Thomas Jefferson University, University of Texas, Virginia Commonwealth University
- Responsible party
- Principal investigator, Sean Collins, Vanderbilt University
- Investigators
- Sean Collins, MD, Principal investigator, Vanderbilt UniversityJaved Butler, MD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519283
- Sponsor's protocol ID
- 150684
- Acronym
- GUIDED-HF
- Status last verified
- Apr 2020
- First submitted
- 31 Jul 2015
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Stubblefield WB, Jenkins CA, Liu D, Storrow AB, Spertus JA, Pang PS, Levy PD, Butler J, Chang AM, Char D, Diercks DB, Fermann GJ, Han JH, Hiestand BC, Hogan CJ, Khan Y, Lee S, Lindenfeld JM, McNaughton CD, Miller K, Peacock WF, Schrock JW, Self WH, Singer AJ, Sterling SA, Collins SP. Improvement in Kansas City Cardiomyopathy Questionnaire Scores After a Self-Care Intervention in Patients With Acute Heart Failure Discharged From the Emergency Department. Circ Cardiovasc Qual Outcomes. 2021 Oct;14(10):e007956. doi: 10.1161/CIRCOUTCOMES.121.007956. Epub 2021 Sep 24.
PubMed 34555929Collins SP, Liu D, Jenkins CA, Storrow AB, Levy PD, Pang PS, Chang AM, Char D, Diercks DJ, Fermann GJ, Han JH, Hiestand B, Hogan C, Kampe CJ, Khan Y, Lee S, Lindenfeld J, Martindale J, McNaughton CD, Miller KF, Miller-Reilly C, Moser K, Peacock WF, Robichaux C, Rothman R, Schrock J, Self WH, Singer AJ, Sterling SA, Ward MJ, Walsh C, Butler J. Effect of a Self-care Intervention on 90-Day Outcomes in Patients With Acute Heart Failure Discharged From the Emergency Department: A Randomized Clinical Trial. JAMA Cardiol. 2021 Feb 1;6(2):200-208. doi: 10.1001/jamacardio.2020.5763.
PubMed 33206126Fermann GJ, Levy PD, Pang P, Butler J, Ayaz SI, Char D, Dunn P, Jenkins CA, Kampe C, Khan Y, Kumar VA, Lindenfeld J, Liu D, Miller K, Peacock WF, Rizk S, Robichaux C, Rothman RL, Schrock J, Singer A, Sterling SA, Storrow AB, Walsh C, Wilburn J, Collins SP. Design and Rationale of a Randomized Trial of a Care Transition Strategy in Patients With Acute Heart Failure Discharged From the Emergency Department: GUIDED-HF (Get With the Guidelines in Emergency Department Patients With Heart Failure). Circ Heart Fail. 2017 Feb;10(2):e003581. doi: 10.1161/CIRCHEARTFAILURE.116.003581.
PubMed 28188268
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Get With the Guidelines in ED Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT02519283
- Acronym / sponsor ID
- GUIDED-HF / 150684
- Conditions
- Heart Failure
- Keywords
- AHF, HF, ED, ER, Emergency Department, Emergency Room
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 529 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Stony Brook University, Indiana University, Wayne State University, VA Office of Research and Development, University of Cincinnati, Washington University School of Medicine, Baylor College of Medicine, MetroHealth Medical Center, University of Mississippi Medical Center, Emory University, University of Iowa, Thomas Jefferson University, University of Texas, Virginia Commonwealth University
- Study start
- Oct 2015 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 10 Aug 2015 (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.
Approximately 20-30% of patients presenting with acute heart failure are discharged from the ED. Compared to patients discharged from the hospital, they more frequently return to the ED and hospital for further management. While inpatient discharges are often enrolled in transitions programs and have their care tailored to evidence-based recommendations, ED discharges do not. The investigators propose to evaluate current standard ED discharge to an ED-based intervention which will transition patients to outpatient follow-up on guideline-recommended therapy.
Detailed description
Heart failure (HF) is common and growing healthcare concern. Heart failure affects nearly 6 million Americans. It results in over one million annual hospital discharges as the primary discharge diagnosis and an additional two million hospitalizations where HF contributes to the discharge diagnosis. Despite a relative reduction in the hospitalization rate of HF, the actual number of HF hospitalizations remains over one million annually. This figure is expected to significantly worsen with the aging United States population and the growing HF prevalence. Over 80% of patients who are hospitalized are initially seen in the emergency department (ED). However, not all those seen in the ED for HF are admitted; a sizeable proportion are discharged home without hospitalization. As disposition decisions for those who present to the hospital rest largely with ED providers, the ED will play an even bigger role in the management of HF patients and in avoiding unnecessary hospitalizations.
The ED is the gatekeeper for AHF evaluations. Nearly one million ED visits for acute heart failure (AHF) occur annually in the United States. Importantly, the ED is the safety net for AHF care and often sole provider of AHF care to vulnerable patients. To optimize care and reduce ED and hospital revisits, there has been significant emphasis on improving transitions at the time of hospital discharge for HF patients. Such efforts have been almost exclusively directed at hospitalized patients; individuals with AHF who are discharged from the ED miss the benefits of transitional care initiatives.
Ensuring optimal transitions of care for discharged ED AHF patients is a critical unmet need. Data show AHF patients discharged from the ED receive suboptimal guideline directed medical therapy (GDMT), suggesting interventions to improve AHF transitions are needed in the ED setting. This is particularly true for patients that are in resource limited settings, many of whom have vulnerable characteristics. By default the ED is often the sole or primary provider of HF care to this group of patients who are discharged from the ED.
The proposal, "Get with the Guidelines in ED Patients with Heart Failure (GUIDED-HF)", is designed to answer two fundamental questions about vulnerable patients with AHF discharged from the ED:
- Does GWTG:HF implementation by a transition nurse coordinator directed team (TNC Team) reduce disparities in time to ED/clinic revisit or hospital admission or cardiovascular death over the 3-month period immediately following the index ED visit?
- Does GWTG:HF implementation by a TNC Team reduce disparities in patient satisfaction, HF knowledge and QOL over the 3-month period immediately following the index ED visit?
Patients hospitalized for HF continue to have a high risk of adverse post-discharge outcomes. Although there has been a relative reduction in rehospitalization and mortality rates for AHF patients post-discharge after a significant recent effort by hospitals to avoid CMS financial penalties, the absolute risk remains very high. The one-month post discharge readmission risk is 20-25% and one-year post discharge mortality is 25-30%. These results are from institutions who have implemented significant in-hospital case management programs with a specific focus on transitions of care, including early post-discharge follow-up. ED patients discharged with AHF have more vulnerable characteristics, have a higher risk of readmission, and are not included in hospital programs targeted to help them. This proposal will study a significant unmet need, projected to get worse, and for which no evidence based data currently exist to guide management. Even a modest reduction in the risk for ED revisits or hospital admissions has the potential for significant clinical and patient centric benefits in patients with AHF discharged from the ED.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Behavioral: Standard of CareIn keeping with the strategy-based pragmatic nature of the trial, the discharge procedures will largely be kept as they are in common practice. Investigators will standardize usual care for ED discharge to include HF medication reconciliation as well as encourage 7-day follow-up. |
| GUIDED-HF | Active comparator | Behavioral: GUIDED-HFGWTG:HF has been successfully implemented across multiple inpatient populations and health systems over the last decade and has been shown to improve HF disparities. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients deemed by emergency physician to have AHF, who they plan to discharge or hold for brief ED-based observation (less than 23 hours of AHF care)
- Age ≥21 years old
- Prior history of HF
Key exclusion criteria (4 listed)
- Unable to comply with protocol- due to psychiatric disease or distance from the hospital
- Systolic BP <100 mmHg
- Evidence of ACS based on ischemia on ECG or Troponin elevation
- Outpatient inotrope infusion
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 |
|---|---|---|
| GUIDED-HFParticipants in this arm will receive a tailored discharge plan via a transition nurse coordinator directed team (TNC Team). 1. Disease education: Health literacy screen will identify barriers to understanding discharge and medication instructions. 2. Lifestyle interventions: Includes receiving smoking cessation information and instructions to track daily weights. 3. Guideline recommendations for medications and device referral: Includes determining the need for prescriptions for ACEIs, ARBs, beta blockers, aldosterone antagonists, anticoagulants and referral for pacemaker/defibrillator consideration. 4. Outpatient follow-up appointment: TNC Team will provide a scheduled appointment within 7 days and will conduct a home visit within 48 hours of ED discharge. | Behavioural | GUIDED-HF |
| Standard of CareThose in the standard care arm will receive structured ED discharge assessment to include: 1. discharge instructions; 2. medication reconciliation 3. encourage follow-up. | Behavioural | Standard of Care |
Primary outcome
Composite Score Reflective of Clinical Status
Time frame: 90 days from ED discharge
Participants ranked sequentially. Ranking stratified in 1 of 3 tiers based on: Lowest tier: CV Death: Ranking based on time to death from original ED discharge date. Participant with the first death = lowest rank in the tier. Middle tier: ED Re-visit, Hospital Re-admission or Clinic for AHF with IV. For patients alive, ranking based on time to ED Re-visit, Hospital Re-admission or Clinic for AHF with IV from original ED discharge date, whichever occurs first. Participant with first adverse event = lowest rank in the tier. Highest tier: KCCQ Changes. For patients alive, ranking is based on changes in KCCQ from baseline. Participant with the largest decrease = lowest rank in the tier. The use of 3 tiers reflects the greater adverse impact of death, followed by adverse impact of Hospital Re-admission, ED Re-visit, clinic for AHF with IV on clinical status, and then health status as measured by KCCQ. The Clinical Events (Composite) updated on 11/19/19 per PCORI study team discussion.
7 secondary outcomes
HF Related Quality of Life: Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Enrollment, 30 days and 90 days after ED discharge
Adherence to Refills and Medications Scale (ARMS 7) score
Time frame: Enrollment, 30 days and 90 days after ED discharge
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety score
Time frame: Enrollment, 30 days and 90 days after ED discharge
Patient Reported Outcomes Measurement Information System (PROMIS) Depression score
Time frame: Enrollment, 30 days and 90 days after ED discharge
Time spent at clinic office visits
Time frame: 30 days and 90 days after ED discharge
Out-of-pocket costs for work missed
Time frame: 30 days and 90 days after ED discharge
Dutch Heart Failure Knowledge score
Time frame: Enrollment, 30 days and 90 days after ED discharge
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 22 Apr 2020.
- Derived from this study: PubMed 34555929Stubblefield WB, Jenkins CA, Liu D, Storrow AB, Spertus JA, Pang PS, Levy PD, Butler J, Chang AM, Char D, Diercks DB, Fermann GJ, Han JH, Hiestand BC, Hogan CJ, Khan Y, Lee S, Lindenfeld JM, McNaughton CD, Miller K, Peacock WF, Schrock JW, Self WH, Singer AJ, Sterling SA, Collins SP. Improvement in Kansas City Cardiomyopathy Questionnaire Scores After a Self-Care Intervention in Patients With Acute Heart Failure Discharged From the Emergency Department. Circ Cardiovasc Qual Outcomes. 2021 Oct;14(10):e007956. doi: 10.1161/CIRCOUTCOMES.121.007956. Epub 2021 Sep 24.
- Derived from this study: PubMed 33206126Collins SP, Liu D, Jenkins CA, Storrow AB, Levy PD, Pang PS, Chang AM, Char D, Diercks DJ, Fermann GJ, Han JH, Hiestand B, Hogan C, Kampe CJ, Khan Y, Lee S, Lindenfeld J, Martindale J, McNaughton CD, Miller KF, Miller-Reilly C, Moser K, Peacock WF, Robichaux C, Rothman R, Schrock J, Self WH, Singer AJ, Sterling SA, Ward MJ, Walsh C, Butler J. Effect of a Self-care Intervention on 90-Day Outcomes in Patients With Acute Heart Failure Discharged From the Emergency Department: A Randomized Clinical Trial. JAMA Cardiol. 2021 Feb 1;6(2):200-208. doi: 10.1001/jamacardio.2020.5763.
- Derived from this study: PubMed 28188268Fermann GJ, Levy PD, Pang P, Butler J, Ayaz SI, Char D, Dunn P, Jenkins CA, Kampe C, Khan Y, Kumar VA, Lindenfeld J, Liu D, Miller K, Peacock WF, Rizk S, Robichaux C, Rothman RL, Schrock J, Singer A, Sterling SA, Storrow AB, Walsh C, Wilburn J, Collins SP. Design and Rationale of a Randomized Trial of a Care Transition Strategy in Patients With Acute Heart Failure Discharged From the Emergency Department: GUIDED-HF (Get With the Guidelines in Emergency Department Patients With Heart Failure). Circ Heart Fail. 2017 Feb;10(2):e003581. doi: 10.1161/CIRCHEARTFAILURE.116.003581.
- Individual participant dataSharing planned: Yes
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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.
Sean Collins, MD principal investigator
Vanderbilt University
Javed Butler, MD principal investigator
Stony Brook University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GUIDED-HF in people with Heart Failure, run by Vanderbilt University at 15 sites 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 3 inclusion and 4 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 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
Composite Score Reflective of Clinical Status (time frame: 90 days from ED discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02519283, which also lists 3 linked publications.
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 22 Apr 2020.