- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03958552
Palliative Care Consultations in the Skilled Nursing Facility (SNF) Setting
Palliative Care Consultations for Persons in the Medicare Skilled Nursing Facility (SNF) Setting
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Acts Continuing Care Retirement Communities
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Standard Care
Participants will receive the standard Medicare Skilled Nursing Facility care.
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Experimental: Palliative Care Consult
Participants will receive the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider.
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Trained provider will discuss illness trajectories, establish and communicate patient-directed goals that guide health care decisions, identify and treat illness-related symptoms, and identify psycho-spiritual needs and approaches to mitigate suffering.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants Who Completed Patient Quality of Life Surveys
Time Frame: Collected upon admission to the nursing home and enrollment and again 15-21 days after enrollment in the study (control group) or intervention received (intervention group).
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The Patient Outcome Survey (POS) 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).
Higher values represent a worse outcome.
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Collected upon admission to the nursing home and enrollment and again 15-21 days after enrollment in the study (control group) or intervention received (intervention group).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants Who Completed the Consult Satisfaction Survey (CSQ)
Time Frame: Collected within 15-21days of palliative care consultation for the intervention group.
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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).
Higher values represent a worse outcome.
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Collected within 15-21days of palliative care consultation for the intervention group.
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Adherence to SNF-PCC Recommendations
Time Frame: 30 Days post-admission
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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
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Collaborators and Investigators
Investigators
- Principal Investigator: Joan Carpenter, PhD, UMSON
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HP-00099506
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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