Engaging patients and families to create a feasible clinical trial integrating palliative and heart failure care: results of the ENABLE CHF-PC pilot clinical trial
Abstract Background Early palliative care (EPC) is recommended but rarely integrated with advanced heart failure (HF) care. We engaged patients and family caregivers to study the feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Compr...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2017-08-01
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| Series: | BMC Palliative Care |
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| Online Access: | http://link.springer.com/article/10.1186/s12904-017-0226-8 |
| _version_ | 1811318480150986752 |
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| author | Marie Bakitas J. Nicholas Dionne-Odom Salpy V. Pamboukian Jose Tallaj Elizabeth Kvale Keith M. Swetz Jennifer Frost Rachel Wells Andres Azuero Konda Keebler Imatullah Akyar Deborah Ejem Karen Steinhauser Tasha Smith Raegan Durant Alan T. Kono |
| author_facet | Marie Bakitas J. Nicholas Dionne-Odom Salpy V. Pamboukian Jose Tallaj Elizabeth Kvale Keith M. Swetz Jennifer Frost Rachel Wells Andres Azuero Konda Keebler Imatullah Akyar Deborah Ejem Karen Steinhauser Tasha Smith Raegan Durant Alan T. Kono |
| author_sort | Marie Bakitas |
| collection | DOAJ |
| description | Abstract Background Early palliative care (EPC) is recommended but rarely integrated with advanced heart failure (HF) care. We engaged patients and family caregivers to study the feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers). Methods We conducted an EPC feasibility study (4/1/14–8/31/15) for patients with NYHA Class III/IV HF and their caregivers in academic medical centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person outpatient palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls. We collected patient- and caregiver-reported outcomes of quality of life (QOL), symptom, health, anxiety, and depression at baseline, 12- and 24-weeks. We used linear mixed-models to assess baseline to week 24 longitudinal changes. Results We enrolled 61 patients and 48 caregivers; between-site demographic differences included age, race, religion, marital, and work status. Most patients (69%) and caregivers (79%) completed all intervention sessions; however, we noted large between-site differences in measurement completion (38% southeast vs. 72% northeast). Patients experienced moderate effect size improvements in QOL, symptoms, physical, and mental health; caregivers experienced moderate effect size improvements in QOL, depression, mental health, and burden. Small-to-moderate effect size improvements were noted in patients’ hospital and ICU days and emergency visits. Conclusions Between-site demographic, attrition, and participant-reported outcomes highlight the importance of intervention pilot-testing in culturally diverse populations. Observations from this pilot feasibility trial allowed us to refine the methodology of an in-progress, full-scale randomized clinical efficacy trial. Trial registration Clinicaltrials.gov NCT03177447 (retrospectively registered, June 2017). |
| first_indexed | 2024-04-13T12:26:57Z |
| format | Article |
| id | doaj.art-614f49abd2f9472ca5fb3807f0f82615 |
| institution | Directory Open Access Journal |
| issn | 1472-684X |
| language | English |
| last_indexed | 2024-04-13T12:26:57Z |
| publishDate | 2017-08-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Palliative Care |
| spelling | doaj.art-614f49abd2f9472ca5fb3807f0f826152022-12-22T02:46:59ZengBMCBMC Palliative Care1472-684X2017-08-0116111310.1186/s12904-017-0226-8Engaging patients and families to create a feasible clinical trial integrating palliative and heart failure care: results of the ENABLE CHF-PC pilot clinical trialMarie Bakitas0J. Nicholas Dionne-Odom1Salpy V. Pamboukian2Jose Tallaj3Elizabeth Kvale4Keith M. Swetz5Jennifer Frost6Rachel Wells7Andres Azuero8Konda Keebler9Imatullah Akyar10Deborah Ejem11Karen Steinhauser12Tasha Smith13Raegan Durant14Alan T. Kono15School of Nursing and Department of Medicine, Division of Gerontology, Geriatrics, and Palliative Care, University of Alabama at BirminghamSchool of Nursing, University of Alabama at BirminghamDepartment of Medicine, Division of Cardiovascular Diseases, University of Alabama at BirminghamDepartment of Medicine, Division of Cardiovascular Diseases, University of Alabama at BirminghamDepartment of Medicine, Division of Gerontology, Geriatrics and Palliative Care, University of Alabama at BirminghamDepartment of Medicine, Division of Gerontology, Geriatrics and Palliative Care, University of Alabama at BirminghamCardiology, Dartmouth-Hitchcock Medical Center/Geisel School of Medicine at DartmouthSchool of Nursing, University of Alabama at BirminghamSchool of Nursing, University of Alabama at BirminghamSchool of Nursing, University of Alabama at BirminghamSchool of Nursing, University of Alabama at BirminghamSchool of Nursing, University of Alabama at BirminghamCenter for Health Services Research in Primary Care, Durham VA Medical Center, Durham, NC, Division of General Internal Medicine, Department of Medicine, Duke UniversitySchool of Nursing, University of Alabama at BirminghamDepartment of Medicine, Division of Preventative Medicine, University of Alabama at BirminghamCardiology, Dartmouth-Hitchcock Medical Center/Geisel School of Medicine at DartmouthAbstract Background Early palliative care (EPC) is recommended but rarely integrated with advanced heart failure (HF) care. We engaged patients and family caregivers to study the feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers). Methods We conducted an EPC feasibility study (4/1/14–8/31/15) for patients with NYHA Class III/IV HF and their caregivers in academic medical centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person outpatient palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls. We collected patient- and caregiver-reported outcomes of quality of life (QOL), symptom, health, anxiety, and depression at baseline, 12- and 24-weeks. We used linear mixed-models to assess baseline to week 24 longitudinal changes. Results We enrolled 61 patients and 48 caregivers; between-site demographic differences included age, race, religion, marital, and work status. Most patients (69%) and caregivers (79%) completed all intervention sessions; however, we noted large between-site differences in measurement completion (38% southeast vs. 72% northeast). Patients experienced moderate effect size improvements in QOL, symptoms, physical, and mental health; caregivers experienced moderate effect size improvements in QOL, depression, mental health, and burden. Small-to-moderate effect size improvements were noted in patients’ hospital and ICU days and emergency visits. Conclusions Between-site demographic, attrition, and participant-reported outcomes highlight the importance of intervention pilot-testing in culturally diverse populations. Observations from this pilot feasibility trial allowed us to refine the methodology of an in-progress, full-scale randomized clinical efficacy trial. Trial registration Clinicaltrials.gov NCT03177447 (retrospectively registered, June 2017).http://link.springer.com/article/10.1186/s12904-017-0226-8Heart failurePalliative careCaregiverTelehealthRuralIntervention development |
| spellingShingle | Marie Bakitas J. Nicholas Dionne-Odom Salpy V. Pamboukian Jose Tallaj Elizabeth Kvale Keith M. Swetz Jennifer Frost Rachel Wells Andres Azuero Konda Keebler Imatullah Akyar Deborah Ejem Karen Steinhauser Tasha Smith Raegan Durant Alan T. Kono Engaging patients and families to create a feasible clinical trial integrating palliative and heart failure care: results of the ENABLE CHF-PC pilot clinical trial BMC Palliative Care Heart failure Palliative care Caregiver Telehealth Rural Intervention development |
| title | Engaging patients and families to create a feasible clinical trial integrating palliative and heart failure care: results of the ENABLE CHF-PC pilot clinical trial |
| title_full | Engaging patients and families to create a feasible clinical trial integrating palliative and heart failure care: results of the ENABLE CHF-PC pilot clinical trial |
| title_fullStr | Engaging patients and families to create a feasible clinical trial integrating palliative and heart failure care: results of the ENABLE CHF-PC pilot clinical trial |
| title_full_unstemmed | Engaging patients and families to create a feasible clinical trial integrating palliative and heart failure care: results of the ENABLE CHF-PC pilot clinical trial |
| title_short | Engaging patients and families to create a feasible clinical trial integrating palliative and heart failure care: results of the ENABLE CHF-PC pilot clinical trial |
| title_sort | engaging patients and families to create a feasible clinical trial integrating palliative and heart failure care results of the enable chf pc pilot clinical trial |
| topic | Heart failure Palliative care Caregiver Telehealth Rural Intervention development |
| url | http://link.springer.com/article/10.1186/s12904-017-0226-8 |
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