NCT03958552

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2022

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 11, 2024

Completed
Last Updated

July 11, 2024

Status Verified

June 1, 2024

Enrollment Period

3.2 years

First QC Date

May 16, 2019

Results QC Date

December 14, 2023

Last Update Submit

June 12, 2024

Conditions

Keywords

Palliative Care ConsultationMedicareSkilled Nursing

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Completed Patient Quality of Life Surveys

    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.

    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).

Secondary Outcomes (2)

  • Number of Participants Who Completed the Consult Satisfaction Survey (CSQ)

    Collected within 15-21days of palliative care consultation for the intervention group.

  • Adherence to SNF-PCC Recommendations

    30 Days post-admission

Study Arms (2)

Standard Care

NO INTERVENTION

Participants will receive the standard Medicare Skilled Nursing Facility care.

Palliative Care Consult

EXPERIMENTAL

Participants will receive the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider.

Other: Palliative Care Consultation

Interventions

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.

Palliative Care Consult

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Patients who have previously received or are referred for a SNF-based PCC by their primary care team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acts Continuing Care Retirement Communities

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (13)

  • 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.

    PMID: 23026981BACKGROUND
  • 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.

    PMID: 26159824BACKGROUND
  • 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.

    PMID: 28457493BACKGROUND
  • 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.

    PMID: 24117283BACKGROUND
  • 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.

    PMID: 22175816BACKGROUND
  • 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.

    PMID: 20048361BACKGROUND
  • 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.

    PMID: 15006832BACKGROUND
  • 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.

    PMID: 20439041BACKGROUND
  • 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.

    PMID: 15817003BACKGROUND
  • 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.

    PMID: 27641157BACKGROUND
  • 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.

    PMID: 27650008BACKGROUND
  • 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.

    PMID: 21903662BACKGROUND
  • 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.

    PMID: 23984636BACKGROUND

Related Links

Results Point of Contact

Title
Dr. Joan Carpenter
Organization
University of Maryland School of Nursing

Study Officials

  • Joan Carpenter, PhD

    UMSON

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Pre-post design where control data will be collected prior to intervention being implemented
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 22, 2019

Study Start

October 1, 2019

Primary Completion

December 7, 2022

Study Completion

December 31, 2022

Last Updated

July 11, 2024

Results First Posted

July 11, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

IPD will not be shared per an agreement between UPenn and participating SNFs

Locations