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Trial record 11 of 3539 for:    Facility

Palliative Care Consultations in the Skilled Nursing Facility (SNF) Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03958552
Recruitment Status : Enrolling by invitation
First Posted : May 22, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Joan Carpenter, PhD, CRNP, University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Palliative Care Advance Care Planning Skilled Nursing Facilities Other: Palliative Care Consultation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pre-post design where control data will be collected prior to intervention being implemented
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Palliative Care Consultations for Persons in the Medicare Skilled Nursing Facility (SNF) Setting
Actual Study Start Date : October 3, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard Care
Participants will receive the standard Medicare Skilled Nursing Facility care.
Experimental: Palliative Care Consult
Participants will receive the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider.
Other: Palliative Care Consultation
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.




Primary Outcome Measures :
  1. Patient/Caregiver Quality of Life [ Time Frame: Collected upon admission to the nursing home and again 15-days post-admission to the nursing home. ]
    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


Secondary Outcome Measures :
  1. Consult Satisfaction [ Time Frame: Collected within 7 days of palliative care consultation ]
    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

  2. Adherence to SNF-PCC recommendations [ Time Frame: 30 Days post-admission ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958552


Locations
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United States, Pennsylvania
Acts Continuing Care Retirement Communities
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania

Additional Information:
Publications:

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Responsible Party: Joan Carpenter, PhD, CRNP, Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03958552    
Other Study ID Numbers: 832287
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared per an agreement between UPenn and participating SNFs

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joan Carpenter, PhD, CRNP, University of Pennsylvania:
Palliative Care Consultation
Medicare
Skilled Nursing