Heart FailureNCT02398617
End-Of-Life Decision Making and Preparedness Planning Among Heart Failure Patients Hospitalized for Advanced Disease
A study testing Decision Making Intervention in people with Heart Failure, run by Saint Luke's Health System at 1 site in United States.
Trial summary
Heart failure is a chronic and frequently terminal illness associated with poor quality of life and high burden of morbidity, re-hospitalization, and cost. Accordingly, recent guideline updates have highlighted the need for improved focus on end-of-life and palliative care of advanced heart failure patients, in whom… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Decision Making Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2015
- 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
- advanced heart failure
- ineligible for advanced therapies
- 50% risk of death or continued poor heart failure-related health status at 6 months from hospital discharge, based on validated risk score
Who cannot join
- Hospice enrollment
- Previous heart transplant or left ventricular assist device placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Facilitating End-Of-Life Decision Making and Preparedness Planning Among Heart Failure Patients Hospitalized for Advanced Disease
Heart failure is a chronic and frequently terminal illness associated with poor quality of life and high burden of morbidity, re-hospitalization, and cost. Accordingly, recent guideline updates have highlighted the need for improved focus on end-of-life and palliative care of advanced heart failure patients, in whom symptom burden can be high and treatment options are often limited. The aims of this study are to evaluate the feasibility of implementing a semi-structured, outpatient, nurse practitioner-led, educational supportive care intervention concerning multiple domains of end-of-life care not often included in regular, outpatient clinic visits.
Read the detailed description
This study will be a prospective pilot enrolling 10 patients with advanced disease admitted to the heart failure service at St. Luke's Mid America Heart Institute and who are not candidates for advanced therapies such as heart transplant or mechanical circulatory support (left ventricular assist device). Potential enrollees will be identified using a validated risk model that predicts death or poor quality of life in the six months after discharge from the hospital for heart failure exacerbation. Enrolled patients will complete validated questionnaires while still hospitalized, regarding health-related quality of life, illness acceptance, prioritization of different life goals, and confidence in decision-making regarding their terminal heart failure. Patients will then be given a paper exercise regarding delineation of an end-of-life plan and appointment of a surrogate medical decision-maker, to be completed after discharge. At their regularly scheduled admission follow-up visit with seven days of discharge, participants will be asked to bring their medical decision maker and participate in a semi-structured supplemental palliative care/education session facilitated by a heart failure nurse practitioner trained in palliative care discussions. Domains included in the intervention will include disease literacy and understanding, goals of care, legal issues for patients with terminal illness, symptom management, health-related quality of life, caregiver burden, patient autonomy, healthcare utilization, and establishment of end-of-life plans.
Outcomes to be measured after the intervention include repeated validated questionnaires and unstructured patient interviews at 1 month and, at 6 months, creation of a formalized end-of-life plan, change in code status, obtainment of an advanced directive, designation of a durable power of attorney, frequency of re-hospitalizations, emergency room visits and unscheduled clinic visits with providers, and death. These will be obtained at the time of regularly scheduled heart failure clinic follow-up visits or over the phone.
- Conditions
- Heart Failure
- Being tested
- Decision Making Intervention
- Keywords
- Heart Failure, End of Life Care, Decision Making
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Making InterventionOther
At their regularly scheduled admission follow-up visit with seven days of discharge, participants will be asked to bring their medical decision maker and participate in a semi-structured supplemental palliative care/education session facilitated by a heart failure nurse practitioner trained in palliative care discussions. Domains included in the intervention will include disease literacy and understanding, goals of care, legal issues for patients with terminal illness, symptom management, health-related quality of life, caregiver burden, patient autonomy, healthcare utilization, and establishment of end-of-life plans.
| Study group | Role | What they receive |
|---|---|---|
| Decision Making Intervention | Other | At their regularly scheduled admission follow-up visit with seven days of discharge, participants will be asked to bring their medical decision maker and participate in a semi-structured supplemental palliative care/education session facilitated by a heart failure nurse practitioner trained in palliative care discussions. Domains included in the intervention will include disease literacy and understanding, goals of care, legal issues for patients with terminal illness, symptom management, health-related quality of life, caregiver burden, patient autonomy, healthcare utilization, and establishment of end-of-life plans. Receives: Other: Decision Making Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Heart failure-related quality of life
Measured: 1 month
Decisional Conflict Scale
Decision-making confidence/readiness
Measured: 1 month
Peace, Equanimity, and Acceptance in Cancer Experience (PEACE) Scale
Illness Acceptance
Measured: 1 month
Kaldjian's Goals of Care at End of Life
Patient-ranked importance for different goals of care
Measured: 1 month
Secondary outcomes (5)
Death
Mortality
Measured: 6 months
Code Status Change
Measured: 6 months
Advance Directive creation
Measured: 6 months
Durable Power of Attorney appointment
Measured: 6 months
Unscheduled Healthcare Encounter
Composite of re-hospitalizations, emergency department visits, urgent care visits, and unscheduled outpatient heart failure clinic visits
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 posted25 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionJun 2015
- Study completionDec 2015 (estimated)
Why it stopped: Low enrollment and need to refine protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Luke's Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John A Spertus, MD, MPH, Principal investigator, Saint Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398617
- Sponsor's protocol ID
- 14-192
- Status last verified
- Oct 2021
- First submitted
- 20 Feb 2015
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating End-Of-Life Decision Making and Preparedness Planning Among Heart Failure Patients Hospitalized for Advanced Disease
- ClinicalTrials.gov ID
- NCT02398617
- Acronym / sponsor ID
- 14-192
- Conditions
- Heart Failure
- Keywords
- Heart Failure, End of Life Care, Decision Making
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low enrollment and need to refine protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Saint Luke's Health SystemUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Mar 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.
Heart failure is a chronic and frequently terminal illness associated with poor quality of life and high burden of morbidity, re-hospitalization, and cost. Accordingly, recent guideline updates have highlighted the need for improved focus on end-of-life and palliative care of advanced heart failure patients, in whom symptom burden can be high and treatment options are often limited. The aims of this study are to evaluate the feasibility of implementing a semi-structured, outpatient, nurse practitioner-led, educational supportive care intervention concerning multiple domains of end-of-life care not often included in regular, outpatient clinic visits.
Detailed description
This study will be a prospective pilot enrolling 10 patients with advanced disease admitted to the heart failure service at St. Luke's Mid America Heart Institute and who are not candidates for advanced therapies such as heart transplant or mechanical circulatory support (left ventricular assist device). Potential enrollees will be identified using a validated risk model that predicts death or poor quality of life in the six months after discharge from the hospital for heart failure exacerbation. Enrolled patients will complete validated questionnaires while still hospitalized, regarding health-related quality of life, illness acceptance, prioritization of different life goals, and confidence in decision-making regarding their terminal heart failure. Patients will then be given a paper exercise regarding delineation of an end-of-life plan and appointment of a surrogate medical decision-maker, to be completed after discharge. At their regularly scheduled admission follow-up visit with seven days of discharge, participants will be asked to bring their medical decision maker and participate in a semi-structured supplemental palliative care/education session facilitated by a heart failure nurse practitioner trained in palliative care discussions. Domains included in the intervention will include disease literacy and understanding, goals of care, legal issues for patients with terminal illness, symptom management, health-related quality of life, caregiver burden, patient autonomy, healthcare utilization, and establishment of end-of-life plans.
Outcomes to be measured after the intervention include repeated validated questionnaires and unstructured patient interviews at 1 month and, at 6 months, creation of a formalized end-of-life plan, change in code status, obtainment of an advanced directive, designation of a durable power of attorney, frequency of re-hospitalizations, emergency room visits and unscheduled clinic visits with providers, and death. These will be obtained at the time of regularly scheduled heart failure clinic follow-up visits or over the phone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decision Making Intervention | Other | Other: Decision Making InterventionAt their regularly scheduled admission follow-up visit with seven days of discharge, participants will be asked to bring their medical decision maker and participate in a semi-structured supplemental palliative care/education session facilitated by a heart failure nurse practitioner trained in palliative care discussions. Domains included in the intervention will include disease literacy and understanding, goals of care, legal issues for patients with terminal illness, symptom management, health-related quality of life, caregiver burden, patient autonomy, healthcare utilization, and establishment of end-of-life plans. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- advanced heart failure
- ineligible for advanced therapies
- 50% risk of death or continued poor heart failure-related health status at 6 months from hospital discharge, based on validated risk score
Key exclusion criteria (2 listed)
- Hospice enrollment
- Previous heart transplant or left ventricular assist device placement
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 |
|---|---|---|
| Decision Making InterventionAt their regularly scheduled admission follow-up visit with seven days of discharge, participants will be asked to bring their medical decision maker and participate in a semi-structured supplemental palliative care/education session facilitated by a heart failure nurse practitioner trained in palliative care discussions. Domains included in the intervention will include disease literacy and understanding, goals of care, legal issues for patients with terminal illness, symptom management, health-related quality of life, caregiver burden, patient autonomy, healthcare utilization, and establishment of end-of-life plans. | Other | Decision Making Intervention |
Primary outcome
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 1 month
Heart failure-related quality of life
Decisional Conflict Scale
Time frame: 1 month
Decision-making confidence/readiness
Peace, Equanimity, and Acceptance in Cancer Experience (PEACE) Scale
Time frame: 1 month
Illness Acceptance
Kaldjian's Goals of Care at End of Life
Time frame: 1 month
Patient-ranked importance for different goals of care
5 secondary outcomes
Death
Time frame: 6 months
Code Status Change
Time frame: 6 months
Advance Directive creation
Time frame: 6 months
Durable Power of Attorney appointment
Time frame: 6 months
Unscheduled Healthcare Encounter
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 19 Oct 2021.
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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.
John A Spertus, MD, MPH principal investigator
Saint Luke's 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 Decision Making Intervention in people with Heart Failure, run by Saint Luke's Health System 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 3 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: withdrawn, as of the sponsor's last update on 19 Oct 2021. 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 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?
Kansas City Cardiomyopathy Questionnaire (KCCQ) (time frame: 1 month). The study lists 4 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 19 Oct 2021.