Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative Care Consultation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Completed the Consult Satisfaction Survey (CSQ) | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joan Carpenter, PhD | UMSON | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acts Continuing Care Retirement Communities | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23026981 | Background | 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. | |
| 26159824 | Background | 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. |
| Label | URL |
|---|---|
| The National Consensus Project for Quality Palliative Care. Clinical Practice Guidelines for Quality Palliative Care, 3rd edition | View source |
Not provided
IPD will not be shared per an agreement between UPenn and participating SNFs
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care (Control) | Participants received the standard Medicare Skilled Nursing Facility care, Patient Outcome Survey (POS) at enrollment and follow-up 15-21 days later. |
| FG001 | Palliative Care Consult | Participants received the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation. They also received a Patient Outcome Survey (POS) at enrollment and followup POS and Consultation Satisfaction Questionnaire (CSQ) 15-21 later. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | Participants received the standard Medicare Skilled Nursing Facility care. |
| BG001 | Palliative Care Consult | Participants received the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider. Palliative Care Consultation: Trained provider discussed 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Both intervention and control groups are administered a baseline POS and follow up POS. | Posted | Number | participants | 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). |
|
up to 21 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Care | Participants received the standard Medicare Skilled Nursing Facility care. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joan Carpenter | University of Maryland School of Nursing | 443-880-1430 | joan.carpenter@umaryland.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2022 | Jun 11, 2024 | Prot_SAP_000.pdf |
Not provided
Pre-post design where control data will be collected prior to intervention being implemented
Not provided
Not provided
Not provided
Not provided
|
| Collected within 15-21days of palliative care consultation for the intervention group. |
| 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 |
| 28457493 | Background | 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. |
| 24117283 | Background | 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. |
| 22175816 | Background | 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. |
| 20048361 | Background | 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. |
| 15006832 | Background | 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. |
| 20439041 | Background | 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. |
| 15817003 | Background | 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. |
| 27641157 | Background | 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. |
| 27650008 | Background | 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. |
| 21903662 | Background | 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. |
| 23984636 | Background | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Palliative Care Consult (Intervention Group) | Participants received the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider. Palliative Care Consultation: Trained provider discussed 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. |
|
|
| Secondary | Number of Participants Who Completed the Consult Satisfaction Survey (CSQ) | 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. | Participants in the Control arm were not administered the CSQ survey. Only participants in the intervention group were administered the CSQ survey | Posted | Number | participants | Collected within 15-21days of palliative care consultation for the intervention group. |
|
|
|
| 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. | Data were not collected due to study teams limited access to the medical records to review Adherence to SNF-PCC recommendations (due to Covid 19) | Posted | 30 Days post-admission |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Palliative Care Consult | Participants received the standard Medicare Skilled Nursing Facility care plus a Palliative Care Consultation with a trained provider. Palliative Care Consultation: Trained provider discussed 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. | 0 | 35 | 0 | 35 | 0 | 35 |
Not provided
Not provided
Not provided