Palliative Care Clinical Trial
Official title:
Palliative Care Consultations for Persons in the Medicare Skilled Nursing Facility (SNF) Setting
Verified date | March 2023 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Close to one-third of Medicare decedents use the Medicare skilled nursing facility (SNF) benefit in the 6 months prior to death. SNF care often increases the risk for more aggressive, potentially burdensome treatments and unrecognized or undertreated symptoms. Palliative care is goal-directed, patient and family-centered care that focuses on a wide range of physical, psychosocial, and spiritual needs for persons with serious, life-limiting illnesses. Effective palliative care relieves suffering, enhances communication, and improves end-of-life care and decision making for seriously ill older adults. Despite its association with improved quality of care, higher satisfaction, and better symptom management at the end of life, palliative care is not widely available to Medicare patients in the Skilled Nursing Facility (SNF) setting. Palliative care consultation (PCC) is one approach that can potentially improve care for older adults with advanced illness in SNFs. This pilot study will test an evidence-based palliative care consult intervention for older adult SNF patients in nursing homes by comparing the patient/family caregiver reported quality of life in two participant groups: one receiving a PCC and the other receiving standard care.
Status | Completed |
Enrollment | 45 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 7, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - Admitted to a participating nursing home under the Medicare SNF benefit - English speaking - If non-verbal or unable to participate in a conversation, a legally authorized representative(LAR) or surrogate decision maker who can participate in the study - A diagnosis of one or more advanced serious illness using established criteria - One global indicator for a PCC at SNF admission (i.e., primary provider would not be surprised if patient died in 12 months; frequent hospital or SNF admissions; complex care requirements; decline in function; feeding intolerance; or unintended decline in weight) Exclusion Criteria: - Patients who have previously received or are referred for a SNF-based PCC by their primary care team |
Country | Name | City | State |
---|---|---|---|
United States | Acts Continuing Care Retirement Communities | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore |
United States,
Aragon K, Covinsky K, Miao Y, Boscardin WJ, Flint L, Smith AK. Use of the Medicare posthospitalization skilled nursing benefit in the last 6 months of life. Arch Intern Med. 2012 Nov 12;172(20):1573-9. doi: 10.1001/archinternmed.2012.4451. — View Citation
Boockvar K, Fishman E, Kyriacou CK, Monias A, Gavi S, Cortes T. Adverse events due to discontinuations in drug use and dose changes in patients transferred between acute and long-term care facilities. Arch Intern Med. 2004 Mar 8;164(5):545-50. doi: 10.1001/archinte.164.5.545. — View Citation
Boockvar KS, Gruber-Baldini AL, Burton L, Zimmerman S, May C, Magaziner J. Outcomes of infection in nursing home residents with and without early hospital transfer. J Am Geriatr Soc. 2005 Apr;53(4):590-6. doi: 10.1111/j.1532-5415.2005.53205.x. — View Citation
Carpenter JG, Berry PH, Ersek M. Nursing home care trajectories for older adults following in-hospital palliative care consultation. Geriatr Nurs. 2017 Nov-Dec;38(6):531-536. doi: 10.1016/j.gerinurse.2017.03.016. Epub 2017 Apr 28. — View Citation
Ersek M, Carpenter JG. Geriatric palliative care in long-term care settings with a focus on nursing homes. J Palliat Med. 2013 Oct;16(10):1180-7. doi: 10.1089/jpm.2013.9474. Epub 2013 Aug 28. — View Citation
Givens JL, Mitchell SL, Kuo S, Gozalo P, Mor V, Teno J. Skilled nursing facility admissions of nursing home residents with advanced dementia. J Am Geriatr Soc. 2013 Oct;61(10):1645-50. doi: 10.1111/jgs.12476. Epub 2013 Oct 1. — View Citation
Huskamp HA, Kaufmann C, Stevenson DG. The intersection of long-term care and end-of-life care. Med Care Res Rev. 2012 Feb;69(1):3-44. doi: 10.1177/1077558711418518. Epub 2011 Sep 8. — View Citation
Miller SC, Dahal R, Lima JC, Intrator O, Martin E, Bull J, Hanson LC. Palliative Care Consultations in Nursing Homes and End-of-Life Hospitalizations. J Pain Symptom Manage. 2016 Dec;52(6):878-883. doi: 10.1016/j.jpainsymman.2016.05.017. Epub 2016 Sep 17. — View Citation
Miller SC, Lima JC, Intrator O, Martin E, Bull J, Hanson LC. Palliative Care Consultations in Nursing Homes and Reductions in Acute Care Use and Potentially Burdensome End-of-Life Transitions. J Am Geriatr Soc. 2016 Nov;64(11):2280-2287. doi: 10.1111/jgs.14469. Epub 2016 Sep 19. — View Citation
Miller SC, Lima JC, Looze J, Mitchell SL. Dying in U.S. nursing homes with advanced dementia: how does health care use differ for residents with, versus without, end-of-life Medicare skilled nursing facility care? J Palliat Med. 2012 Jan;15(1):43-50. doi: 10.1089/jpm.2011.0210. Epub 2011 Dec 16. — View Citation
Mor V, Intrator O, Feng Z, Grabowski DC. The revolving door of rehospitalization from skilled nursing facilities. Health Aff (Millwood). 2010 Jan-Feb;29(1):57-64. doi: 10.1377/hlthaff.2009.0629. — View Citation
Murray LM, Laditka SB. Care transitions by older adults from nursing homes to hospitals: implications for long-term care practice, geriatrics education, and research. J Am Med Dir Assoc. 2010 May;11(4):231-8. doi: 10.1016/j.jamda.2009.09.007. Epub 2010 Mar 24. — View Citation
Retrum JH, Gozansky WS, Lahoff DG, Rosenberg EL, Tropeano LE, Owens BA, Fischer SM. A Need for More Palliative Focused Care: A Survey of Colorado Skilled Care Facilities. J Am Med Dir Assoc. 2015 Aug 1;16(8):712-3. doi: 10.1016/j.jamda.2015.05.011. Epub 2015 Jul 6. No abstract available. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient/Caregiver Quality of Life | 10 item Survey that measures quality of life in five dimensions: 1) physical; 2) emotional; 3) psychological; 4) spiritual needs, and 5) provision of information and support. Items scored on a 5 point Likert Scale (0=not at all, 4= overwhelmingly) based on symptom/need in the past week. Overall profile score is calculated by summing responses (range 0-40). Source: patient or family caregiver; Time to complete: 5-7 minutes | Collected upon admission to the nursing home and again 15-days post-admission to the nursing home. | |
Secondary | Consult Satisfaction | Measured using the Consultation Satisfaction Questionnaire (CSQ). The CSQ is an 18 item patient/caregiver-reported instrument that measures communication and satisfaction of a consult in four domains: 1) general satisfaction, 2) professional care, 3) depth of relationship, 4) perceived length of consultation.(scale format: 5-point Likert Scale (0= strongly disagree, 4=strongly agree).Overall score is calculated by summing responses (range 0-72) Source: patient or family caregiver; Time to complete: 3-5 minutes | Collected within 15 days of palliative care consultation | |
Secondary | Adherence to SNF-PCC recommendations | Adherence Protocol. Medical record review and/or phone interview with patient/caregiver
We will determine a recommendation adherence score after each participants' SNF-PCC. Each recommendation will be assigned 2 points, then we will define full (2 points), partial (1 point) and no adherence (0 point) to each recommendation. We will sum the points for each SNF-PCC recommendation and use this as the denominator. We will sum each recommendation with full, partial, no adherence and use this as the numerator. The fraction will be converted to a percentage ranging from 0-100% reflecting the recommendation adherence score. |
30 Days post-admission |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04673760 -
The PROAKTIV Study
|
N/A | |
Completed |
NCT03520023 -
Critical Care and Palliative Care Medicine Together in the ICU
|
N/A | |
Completed |
NCT01990742 -
Improving Palliative Care Through Teamwork
|
N/A | |
Not yet recruiting |
NCT05434208 -
Effects of Nurse-led Telephone Based Service for Early Palliative Care (PALTEL)
|
N/A | |
Not yet recruiting |
NCT03267706 -
Introducing the Palliative Care Comprehensive Tool in Family Medicine
|
N/A | |
Completed |
NCT02845817 -
Requests for Euthanasia and Assisted Suicide
|
N/A | |
Recruiting |
NCT02778347 -
Development and Validation of a Comprehensive Standardised Clinical Assessment Tool for Patient Needs
|
N/A | |
Completed |
NCT01934413 -
Technology-enhanced Transitional Care for Rural Palliative Care Patients: A Pilot Study
|
N/A | |
Completed |
NCT01933789 -
Improving Communication About Serious Illness
|
N/A | |
Recruiting |
NCT01170000 -
Timely End-of-Life Communication to Parents of Children With Brain Tumors
|
N/A | |
Recruiting |
NCT04052074 -
Complementary Therapy in Home Palliative Care Patients and Their Caregivers
|
N/A | |
Recruiting |
NCT05935540 -
ACP-Family Programme for Palliative Care Patients and Their Family Member
|
N/A | |
Active, not recruiting |
NCT02689375 -
A Prospective, Open Label, Pilot Study of Patient OutcoMes Following Successful TriAl of High Frequency SpInal CorD Stimulation at 10kHz (HF10™) Leading to Permanent Implant Compared to Trial Failure and Standard CarE for the TreatmeNt of Persistent Low BACK Pain of Neuropathic Origin
|
N/A | |
Recruiting |
NCT05520281 -
Short-term Psychodynamic Psychotherapy in Serious Physical Illness
|
N/A | |
Completed |
NCT06140004 -
Home-Based Palliative Care Impact on Providers
|
||
Completed |
NCT04333719 -
Prevalence of Deep Sedation in Terminal Palliative Phase
|
||
Recruiting |
NCT03286127 -
Palliative Outcome Evaluation Muenster I
|
||
Completed |
NCT06211816 -
Efficacy of End-of-life Communication Strategies on Nurses in the Intensive Care Unit
|
N/A | |
Completed |
NCT04857060 -
Palliative Care Educator
|
N/A | |
Completed |
NCT04491110 -
Intervention to Improve Quality of Sleep of Palliative Patient Carers in the Community: Clinical Trial
|
N/A |