Heart FailureNCT01519479
Palliative Care for Heart Failure Patients
A study testing Palliative Care Consultation in people with Heart Failure, run by Allina Health System at 1 site in United States.
Trial summary
The purpose of this study is to assess the impact of palliative care consultation on quality of life and symptom management for patients hospitalized with acute heart failure with a randomized control trial at Abbott Northwestern Hospital. 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?
- Palliative Care Consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2013
- 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
- Abbott Northwestern Hospital inpatient adults with a diagnosis of acute heart failure
Who cannot join
- Are not an inpatient at Abbott Northwestern Hospital
- Are in the ICU
- On a ventilator
- Are pre-or post heart transplant
- Have a ventricular assist device (VAD)
- Determined to be actively dying
- Have cognitive impairments such that informed consent would not be possible,
- Are not proficient in the English language
Trial locations and contacts
1 site in 1 country.
United States1 site
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
About this study
Official title: An Examination of Palliative Care as Standard Practice for Heart Failure Patients
The purpose of this study is to assess the impact of palliative care consultation on quality of life and symptom management for patients hospitalized with acute heart failure with a randomized control trial at Abbott Northwestern Hospital.
Read the detailed description
Research questions:
Q1. Does the provision of palliative care to heart failure patients yield higher quality of life, increased symptom management, or reduced depression compared to heart failure patients not receiving palliative care?
Q2. Does the provision of palliative care to heart failure patients result in differential use of medical services (lower hospital days and readmission) compared to heart failure patients not receiving systematic palliative care?
- Conditions
- Heart Failure
- Being tested
- Palliative Care Consultation, Control
- Keywords
- Congestive Heart Failure, Heart Failure, Palliative Care, Palliative Medicine
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative Care ConsultationOther
Also called palliative care consults, palliative care medicine
Intervention patient would receive an inpatient palliative care consultation to focus on comprehensive symptom assessment, create goals of care/treatment plan which include recommendations and referrals.
ControlOther
Also called palliative care consult, palliative care medicine
The control group would receive usual care and could receive a palliative consult if ordered by the treating provider
| Study group | Role | What they receive |
|---|---|---|
| Palliative Care Consultation | Experimental | Participant will get one palliative care consultation while in the hospital. The participants desire for subsequent palliative care visits will be determined and mutually agreed upon at the initial consultation. Receives: Other: Palliative Care Consultation |
| Control | Active comparator | Usual care for HF patient which may include a palliative care consult if ordered by treating physician. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is there an impact on quality of life with the addition of palliative care intervention?
Assessment Tools:
*Quality of Life-Minnesota Living with Heart Failure questionnaire (MLHF)
Measured: Change from baseline in quality of life score at 3 months
Secondary outcomes (3)
Differential use of medical services- 30 day readmission
*Number of readmissions in 30 days of discharge from initial enrollment hospitalization.
Measured: 30 Days
Is there an impact on Symptom Severity with the addition of palliative care
Assessment tool:
*Symptom Severity - Edmonton Symptom Assessment scale (ESAS)
Measured: Change from baseline in symptom severity score at 3 months
Is there an impact on depression with the addition of palliative care intervention?
Assessment Tool:
*Depression- Patient Health Questionnaire (PHQ-9)
Measured: Change from baseline in depression score at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)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
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin Kirven, MD, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519479
- Sponsor's protocol ID
- 3601-2
- Status last verified
- Mar 2019
- First submitted
- 19 Jan 2012
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198.
PubMed 19690306Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
PubMed 20818875Smith ER. Heart failure--are we making progress? Can J Cardiol. 2002 Oct;18(10):1124-5. No abstract available.
PubMed 12420047Morrison RS, Dietrich J, Ladwig S, Quill T, Sacco J, Tangeman J, Meier DE. Palliative care consultation teams cut hospital costs for Medicaid beneficiaries. Health Aff (Millwood). 2011 Mar;30(3):454-63. doi: 10.1377/hlthaff.2010.0929.
PubMed 21383364Jovicic A, Holroyd-Leduc JM, Straus SE. Effects of self-management intervention on health outcomes of patients with heart failure: a systematic review of randomized controlled trials. BMC Cardiovasc Disord. 2006 Nov 2;6:43. doi: 10.1186/1471-2261-6-43.
PubMed 17081306Wilson E. Congestive heart failure: A national priority. Can J Cardiol. 2001 Dec;17(12):1243-4. No abstract available. English, French.
PubMed 11773934Wolinsky FD, Overhage JM, Stump TE, Lubitz RM, Smith DM. The risk of hospitalization for congestive heart failure among older adults. Med Care. 1997 Oct;35(10):1031-43. doi: 10.1097/00005650-199710000-00005.
PubMed 9338529Roger VL, Weston SA, Redfield MM, Hellermann-Homan JP, Killian J, Yawn BP, Jacobsen SJ. Trends in heart failure incidence and survival in a community-based population. JAMA. 2004 Jul 21;292(3):344-50. doi: 10.1001/jama.292.3.344.
PubMed 15265849Stuart B. Palliative care and hospice in advanced heart failure. J Palliat Med. 2007 Feb;10(1):210-28. doi: 10.1089/jpm.2006.9988.
PubMed 17298270Goodlin SJ. Palliative care in congestive heart failure. J Am Coll Cardiol. 2009 Jul 28;54(5):386-96. doi: 10.1016/j.jacc.2009.02.078.
PubMed 19628112Stewart S, MacIntyre K, Hole DJ, Capewell S, McMurray JJ. More 'malignant' than cancer? Five-year survival following a first admission for heart failure. Eur J Heart Fail. 2001 Jun;3(3):315-22. doi: 10.1016/s1388-9842(00)00141-0.
PubMed 11378002Enguidanos SM, Cherin D, Brumley R. Home-based palliative care study: site of death, and costs of medical care for patients with congestive heart failure, chronic obstructive pulmonary disease, and cancer. J Soc Work End Life Palliat Care. 2005;1(3):37-56. doi: 10.1300/J457v01n03_04.
PubMed 17387068Rabow MW, Dibble SL, Pantilat SZ, McPhee SJ. The comprehensive care team: a controlled trial of outpatient palliative medicine consultation. Arch Intern Med. 2004 Jan 12;164(1):83-91. doi: 10.1001/archinte.164.1.83.
PubMed 14718327Archana R, Gray D. The quality of life in chronic disease--heart failure is as bad as it gets. Eur Heart J. 2002 Dec;23(23):1806-8. doi: 10.1053/euhj.2002.3309. No abstract available.
PubMed 12445531O'Connor CM, Joynt KE. Depression: are we ignoring an important comorbidity in heart failure? J Am Coll Cardiol. 2004 May 5;43(9):1550-2. doi: 10.1016/j.jacc.2004.02.003. No abstract available.
PubMed 15120810
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Examination of Palliative Care as Standard Practice for Heart Failure Patients
- ClinicalTrials.gov ID
- NCT01519479
- Acronym / sponsor ID
- 3601-2
- Conditions
- Heart Failure
- Keywords
- Congestive Heart Failure, Heart Failure, Palliative Care, Palliative Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Jan 2012 (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 palliative care consultation on quality of life and symptom management for patients hospitalized with acute heart failure with a randomized control trial at Abbott Northwestern Hospital.
Detailed description
Research questions:
Q1. Does the provision of palliative care to heart failure patients yield higher quality of life, increased symptom management, or reduced depression compared to heart failure patients not receiving palliative care?
Q2. Does the provision of palliative care to heart failure patients result in differential use of medical services (lower hospital days and readmission) compared to heart failure patients not receiving systematic palliative care?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palliative Care Consultation | Experimental | Other: Palliative Care ConsultationParticipant will get one palliative care consultation while in the hospital. The participants desire for subsequent palliative care visits will be determined and mutually agreed upon at the initial consultation. |
| Control | Active comparator | Other: ControlUsual care for HF patient which may include a palliative care consult if ordered by 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)
- Abbott Northwestern Hospital inpatient adults with a diagnosis of acute heart failure
Key exclusion criteria (8 listed)
- Are not an inpatient at Abbott Northwestern Hospital
- Are in the ICU
- On a ventilator
- Are pre-or post heart transplant
- Have a ventricular assist device (VAD)
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 |
|---|---|---|
| Palliative Care ConsultationAlso: palliative care consults, palliative care medicineIntervention patient would receive an inpatient palliative care consultation to focus on comprehensive symptom assessment, create goals of care/treatment plan which include recommendations and referrals. | Other | Palliative Care Consultation |
| ControlAlso: palliative care consult, palliative care medicineThe control group would receive usual care and could receive a palliative consult if ordered by the treating provider | Other | Control |
Primary outcome
Is there an impact on quality of life with the addition of palliative care intervention?
Time frame: Change from baseline in quality of life score at 3 months
Assessment Tools: *Quality of Life-Minnesota Living with Heart Failure questionnaire (MLHF)
3 secondary outcomes
Differential use of medical services- 30 day readmission
Time frame: 30 Days
Is there an impact on Symptom Severity with the addition of palliative care
Time frame: Change from baseline in symptom severity score at 3 months
Is there an impact on depression with the addition of palliative care intervention?
Time frame: Change from baseline in depression score at 3 months
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 18 Mar 2019.
- Background: PubMed 19690306Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198.
- Background: PubMed 20818875Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
- Background: PubMed 12420047Smith ER. Heart failure--are we making progress? Can J Cardiol. 2002 Oct;18(10):1124-5. No abstract available.
- Background: PubMed 21383364Morrison RS, Dietrich J, Ladwig S, Quill T, Sacco J, Tangeman J, Meier DE. Palliative care consultation teams cut hospital costs for Medicaid beneficiaries. Health Aff (Millwood). 2011 Mar;30(3):454-63. doi: 10.1377/hlthaff.2010.0929.
- Background: PubMed 17081306Jovicic A, Holroyd-Leduc JM, Straus SE. Effects of self-management intervention on health outcomes of patients with heart failure: a systematic review of randomized controlled trials. BMC Cardiovasc Disord. 2006 Nov 2;6:43. doi: 10.1186/1471-2261-6-43.
- Background: PubMed 11773934Wilson E. Congestive heart failure: A national priority. Can J Cardiol. 2001 Dec;17(12):1243-4. No abstract available. English, French.
- Background: PubMed 9338529Wolinsky FD, Overhage JM, Stump TE, Lubitz RM, Smith DM. The risk of hospitalization for congestive heart failure among older adults. Med Care. 1997 Oct;35(10):1031-43. doi: 10.1097/00005650-199710000-00005.
- Background: PubMed 15265849Roger VL, Weston SA, Redfield MM, Hellermann-Homan JP, Killian J, Yawn BP, Jacobsen SJ. Trends in heart failure incidence and survival in a community-based population. JAMA. 2004 Jul 21;292(3):344-50. doi: 10.1001/jama.292.3.344.
- Background: PubMed 17298270Stuart B. Palliative care and hospice in advanced heart failure. J Palliat Med. 2007 Feb;10(1):210-28. doi: 10.1089/jpm.2006.9988.
- Background: PubMed 19628112Goodlin SJ. Palliative care in congestive heart failure. J Am Coll Cardiol. 2009 Jul 28;54(5):386-96. doi: 10.1016/j.jacc.2009.02.078.
- Background: PubMed 11378002Stewart S, MacIntyre K, Hole DJ, Capewell S, McMurray JJ. More 'malignant' than cancer? Five-year survival following a first admission for heart failure. Eur J Heart Fail. 2001 Jun;3(3):315-22. doi: 10.1016/s1388-9842(00)00141-0.
- Background: PubMed 17387068Enguidanos SM, Cherin D, Brumley R. Home-based palliative care study: site of death, and costs of medical care for patients with congestive heart failure, chronic obstructive pulmonary disease, and cancer. J Soc Work End Life Palliat Care. 2005;1(3):37-56. doi: 10.1300/J457v01n03_04.
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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.
Justin Kirven, MD principal investigator
Allina Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative Care Consultation in people with Heart Failure, run by Allina 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 1 inclusion and 8 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 18 Mar 2019. 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?
Is there an impact on quality of life with the addition of palliative care intervention? (time frame: Change from baseline in quality of life score at 3 months). 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 NCT01519479, which also lists 27 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 18 Mar 2019.