Heart FailureNCT02805712
Focused Palliative Care Intervention in Advanced Heart Failure
A study testing Verbal Information and Discussion in people with Heart Failure and Quality of Life, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This small pilot study will be assessing the the impact of a standardized, social-worker led, longitudinal palliative care intervention on alignment of patient and physician understanding of prognosis and goals of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Quality of Life
- What is being tested?
- Verbal Information and Discussion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 1 Dec 2016
- 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
- Symptomatic Heart Failure (NYHA II-IV)
- Hospitalized or recently for acute decompensation with at least one of the following high-risk features
- Prior hospitalization for Heart Failure (HF) within 1 year
- Age > 80 years
- Chronic Kidney Disease (estimated Glomerular Filtration Rate (eGFR) < 45 mL/min/m2)
- Systolic Blood Pressure < 100 mm Hg
Show all 11Show fewer
- Serum sodium < 130 meq/L
- Cardiogenic Shock (Cardiac Index < 2.0)
- Serious Non-Cardiovascular Illness (e.g. advanced stage cancer, Chronic Obstructive Pulmonary Disease (COPD) , or the like.
- Ability to Provide Informed Consent
- Permission of attending physician
Who cannot join
- Anticipated major cardiac surgery, including Ventricular Assist Device (VAD) or transplant, within 3 months of enrollment
- Already enrolled in hospice or receiving outpatient palliative care
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Pilot Study of a Focused Palliative Care Intervention for Recently Hospitalized High-Risk Patients With Heart Failure
This small pilot study will be assessing the the impact of a standardized, social-worker led, longitudinal palliative care intervention on alignment of patient and physician understanding of prognosis and goals of care. Secondary objectives include assessing the impact of this intervention on documentation of advanced care planning and end of life preferences, symptom burden, quality of life and health care utilization.
Read the detailed description
Patients will be assigned to one of two groups a) longitudinal goals of care discussion led by a palliative care-trained social worker or b) usual care + written information regarding advanced directives. The intervention group will be enrolled in the hospital and then be followed longitudinally for 3 months by a palliative care-trained social worker who will shepherd a conversation around prognosis, expectations, and goals of care. The results of these conversations will be documented in the electronic medical record and shared with the clinical team. Clinical symptoms that are identified during these conversations will be evaluated by a Palliative Care Physician who will relay suggestions regarding management to the primary treating clinician. Baseline surveys will assess prognostic awareness, symptom burden, anxiety, depression, and quality of life for both groups. At the conclusion of the study, an individualized follow-up plan will be devised for each patient based on a needs assessment by the study social worker.
Patients assigned to the control/usual care arm will complete the same series of questionnaires as those assigned to the intervention group and will undergo usual in hospital and post-discharge treatment as directed by their care team. All control subjects will receive written Advanced Care planning and Heart Failure education materials as provided routinely to inpatients at Brigham and Women's Hospital. At the 6 month visit following hospitalization, these patients will be asked to complete follow up questionnaires and then will be given the option to participate in the above verbal intervention and guided "Goals and Values" conversation that was provided to the intervention group.
- Conditions
- Heart Failure, Quality of Life
- Being tested
- Verbal Information and Discussion, Control
- Keywords
- Heart Failure, Palliative Care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal Information and DiscussionOther
Intervention patient will receive a outpatient session with a palliative care social worker in the heart failure clinic two weeks post discharge consent focusing on goals of care.
ControlOther
The control group will receive usual written care material and a palliative care consult if ordered by physician.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participant will receive usual care for Heart Failure patients, which include standard written material on Advanced Care planning and supportive cardiology/palliative care consult if ordered by attending. Receives: Other: Control |
| Verbal Information and Discussion | Experimental | Participants will participate in a guided goals of care conversation and the support of a Palliative Care Social Worker who is working closely with the patients' primary cardiology team. Social worker has ongoing clinical review of participants with a Palliative Care physician who will provide a full medical consult if appropriate. Receives: Other: Verbal Information and Discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is there a change in patient understanding of prognosis with the addition of a palliative care intervention?
Assessment tool: Patient Preferences Questionnaire.
Measured: 6 months
Secondary outcomes (7)
Is there an impact on documentation of advanced care planning documentation with a palliative care intervention?
Chart review of Advanced Care Planning documents and written notes by members of clinical team.
Measured: 6 months
Is there an impact on symptom burden through a palliative care intervention?
Assessment tool: : The Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Measured: Three months
Is there an impact on perceived level of illness through a palliative care intervention?
Assessment tool: EQ visual analogue scale (EQ-VAS)
Measured: 6 months
Is there an impact on overall patient well being through a palliative care intervention?
Assessment tool: The Functional Assessment of Chronic Illness Therapy ( FACIT-Sp)
Measured: Three months
Is there an impact on depression through a palliative care intervention?
Assessment tool: Patient Health Questionnaire (PHQ-8)
Measured: 6 months
Is there an impact on anxiety through a palliative care intervention?
Assessment tool: General Anxiety Disorder (GAD-7)
Measured: 6 months
Is there an impact on cost of treatment through a palliative care intervention?
Focus will be on cost through health care utilization as aggregated by number of hospital days, days in ICU and 30 day re-admissions.
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 posted20 Jun 2016 (estimated)
- Study startSep 2014
- Primary completionJun 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akshay Desai, MD, Brigham and Women's Hospital
- Investigators
- Akshay S Desai, MPH, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805712
- Sponsor's protocol ID
- 2014P001391
- Status last verified
- Jul 2017
- First submitted
- 20 May 2016
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
O'Donnell AE, Schaefer KG, Stevenson LW, DeVoe K, Walsh K, Mehra MR, Desai AS. Social Worker-Aided Palliative Care Intervention in High-risk Patients With Heart Failure (SWAP-HF): A Pilot Randomized Clinical Trial. JAMA Cardiol. 2018 Jun 1;3(6):516-519. doi: 10.1001/jamacardio.2018.0589.
PubMed 29641819
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Focused Palliative Care Intervention for Recently Hospitalized High-Risk Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT02805712
- Acronym / sponsor ID
- 2014P001391
- Conditions
- Heart Failure, Quality of Life
- Keywords
- Heart Failure, Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 20 Jun 2016 (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.
This small pilot study will be assessing the the impact of a standardized, social-worker led, longitudinal palliative care intervention on alignment of patient and physician understanding of prognosis and goals of care. Secondary objectives include assessing the impact of this intervention on documentation of advanced care planning and end of life preferences, symptom burden, quality of life and health care utilization.
Detailed description
Patients will be assigned to one of two groups a) longitudinal goals of care discussion led by a palliative care-trained social worker or b) usual care + written information regarding advanced directives. The intervention group will be enrolled in the hospital and then be followed longitudinally for 3 months by a palliative care-trained social worker who will shepherd a conversation around prognosis, expectations, and goals of care. The results of these conversations will be documented in the electronic medical record and shared with the clinical team. Clinical symptoms that are identified during these conversations will be evaluated by a Palliative Care Physician who will relay suggestions regarding management to the primary treating clinician. Baseline surveys will assess prognostic awareness, symptom burden, anxiety, depression, and quality of life for both groups. At the conclusion of the study, an individualized follow-up plan will be devised for each patient based on a needs assessment by the study social worker.
Patients assigned to the control/usual care arm will complete the same series of questionnaires as those assigned to the intervention group and will undergo usual in hospital and post-discharge treatment as directed by their care team. All control subjects will receive written Advanced Care planning and Heart Failure education materials as provided routinely to inpatients at Brigham and Women's Hospital. At the 6 month visit following hospitalization, these patients will be asked to complete follow up questionnaires and then will be given the option to participate in the above verbal intervention and guided "Goals and Values" conversation that was provided to the intervention group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ControlParticipant will receive usual care for Heart Failure patients, which include standard written material on Advanced Care planning and supportive cardiology/palliative care consult if ordered by attending. |
| Verbal Information and Discussion | Experimental | Other: Verbal Information and DiscussionParticipants will participate in a guided goals of care conversation and the support of a Palliative Care Social Worker who is working closely with the patients' primary cardiology team. Social worker has ongoing clinical review of participants with a Palliative Care physician who will provide a full medical consult if appropriate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Symptomatic Heart Failure (NYHA II-IV)
- Hospitalized or recently for acute decompensation with at least one of the following high-risk features
- Ability to Provide Informed Consent
- Permission of attending physician
Key exclusion criteria (2 listed)
- Anticipated major cardiac surgery, including Ventricular Assist Device (VAD) or transplant, within 3 months of enrollment
- Already enrolled in hospice or receiving outpatient palliative care
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 |
|---|---|---|
| Verbal Information and DiscussionIntervention patient will receive a outpatient session with a palliative care social worker in the heart failure clinic two weeks post discharge consent focusing on goals of care. | Other | Verbal Information and Discussion |
| ControlThe control group will receive usual written care material and a palliative care consult if ordered by physician. | Other | Control |
Primary outcome
Is there a change in patient understanding of prognosis with the addition of a palliative care intervention?
Time frame: 6 months
Assessment tool: Patient Preferences Questionnaire.
7 secondary outcomes
Is there an impact on documentation of advanced care planning documentation with a palliative care intervention?
Time frame: 6 months
Is there an impact on symptom burden through a palliative care intervention?
Time frame: Three months
Is there an impact on perceived level of illness through a palliative care intervention?
Time frame: 6 months
Is there an impact on overall patient well being through a palliative care intervention?
Time frame: Three months
Is there an impact on depression through a palliative care intervention?
Time frame: 6 months
Is there an impact on anxiety through a palliative care intervention?
Time frame: 6 months
Is there an impact on cost of treatment through a palliative care intervention?
Time frame: 6 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 21 Jul 2017.
- Derived from this study: PubMed 29641819O'Donnell AE, Schaefer KG, Stevenson LW, DeVoe K, Walsh K, Mehra MR, Desai AS. Social Worker-Aided Palliative Care Intervention in High-risk Patients With Heart Failure (SWAP-HF): A Pilot Randomized Clinical Trial. JAMA Cardiol. 2018 Jun 1;3(6):516-519. doi: 10.1001/jamacardio.2018.0589.
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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.
Akshay S Desai, MPH, MD principal investigator
Brigham and Women'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 Verbal Information and Discussion in people with Heart Failure and Quality of Life, run by Brigham and Women's Hospital 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 11 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: finished, as of the sponsor's last update on 21 Jul 2017. 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 a change in patient understanding of prognosis with the addition of a palliative care intervention? (time frame: 6 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 NCT02805712, which also lists 1 linked publication.
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 21 Jul 2017.