Improving Palliative Care Access Through Technology (ImPAcTT)
7 de julho de 2021 atualizado por: Caroline Stephens, University of Utah
Improving Palliative Care Access Through Technology (ImPAcTT): A Multi- Component Pilot Study
This project will focus on developing, optimizing and pilot-testing a multi-component Improving Access Through Technology (ImPAcTT) intervention that leverages existing telehealth technologies to provide staff education; family outreach, engagement and support; care coordination; and resident symptom management and facilitation of goals-of-care discussion.
Visão geral do estudo
Status
Suspenso
Condições
Intervenção / Tratamento
Descrição detalhada
Almost 1.8 million older Americans live in nursing homes (NH), with estimates that this number will grow to more than 3 million by 2050. NHs are increasingly becoming the place of care and site of death for frail older adults dying from multiple chronic illnesses. Unfortunately, most residents die without the benefit of palliative care (PC) or with palliation delayed until the last days of life.
Unfortunately, hospice services are often the only formal end of life care service available in NHs, and access to hospice enrollment is complicated by financial implications for both NHs and residents.
Telehealth, or remote monitoring of patients through information and communication technologies, is an effective mechanism for addressing the increased demand on health services and has much to offer to people living with and dying from advanced illness. Moreover, numerous studies have demonstrated positive benefits of using telehealth in the NH to improve access to consultants (e.g., neurology, dermatology, psychiatry).
Little is known, however, about the effect of using Telehealth on improving access to PC specialists in the NH setting.
The proposed ImPAcTT intervention employs a secure communications platform that permits multi-person live video, audio, and text message consultations; real-time document sharing and documentation for advanced care planning discussions; and remote virtual assessment capabilities.
The investigator will conduct a pilot implementation trial of ImPAcTT in 3 study nursing homes to evaluate our ability to safely recruit and retain study participants, collect appropriate and accurate data, and determine preliminary estimates of an effect size of the intervention.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
81
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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California
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San Francisco, California, Estados Unidos, 94143
- University of California San Francisco - UCSF
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Utah
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Salt Lake City, Utah, Estados Unidos, 84112
- University of Utah
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Purposeful sampling will take place in an attempt to collect data from a range of ethnically and racially diverse participants.
INCLUSION CRITERIA:
Primary participant
- Age >= 18 years
- English language fluency
- Palliative Care Consult Screening Tool (PCCS) scoring 9 or above
- If participant does not demonstrate capacity to consent, he/she must be able to assent to study procedures, be told of plan to approach surrogate and have a legally authorized representative available to provide consent
Family/friend caregivers:
- Closest relative/next of kin/friend who is involved in the care of his/her loved one before and during the study period
- English fluency
EXCLUSION CRITERIA:
Primary participant:
- Enrolled in hospice
- Unable to assent to study procedures
- Expresses resistance or dissent to participation or the use of surrogate consent
Family/friend caregiver:
- Life expectancy < 1 year (e.g., metastatic cancer)
- Evidence of cognitive impairment or inability to consent to study procedures
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: ImPAcTT intervention
Within 48-72 hours of enrollment in the study, the primary participant and family will receive an ImPAcTT Telehealth visit with the PC provider.
The provider will conduct a comprehensive PC assessment aligned with the National Consensus Project for Quality Palliative Care guidelines.
Visits, which may include remote physical assessment using a digital stethoscope, dermatoscope, etc., will be documented and transmitted to the NH.
Advanced Care Planning (ACP) and goals of care discussions will be facilitated by the ability to virtually share and edit documents, such as the Physician Orders for Life Sustaining Treatment (POLST), in real time with primary participants and/or family.
The PC provider will conduct follow-up visits 1 week following the initial visit, then on a case-by-case basis.
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ImPACTT Telehealth visit with the PC provider
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Sem intervenção: Usual care
Participants will receive the standard of care established at the NH.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in Symptom distress (composite measure)
Prazo: Baseline and Last visit -12 weeks
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Symptom distress as measured by the Edmonton Symptom Assessment Scale - ESAS
For all symptom distress scores: High score means: worst outcome Low score means: better outcome |
Baseline and Last visit -12 weeks
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Change in Symptom impact
Prazo: Baseline and Last visit -12 weeks
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Symptom impact as measured by the "Quality of Life at the End of Life" - QUAL-E Symptom impact subscale: Minimum value: 3 Maximum value: 15 High score means: worst outcome Low score means: better outcome |
Baseline and Last visit -12 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in number of completed POLST forms
Prazo: Baseline and Last visit -12 weeks
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Number of Physician's Orders for Life-Sustaining Treatment - POLST forms completed
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Baseline and Last visit -12 weeks
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Type of changes in POLST forms
Prazo: Baseline and Last visit -12 weeks
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Type of changes in Physician's Orders for Life-Sustaining Treatment -POLST forms
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Baseline and Last visit -12 weeks
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Number of In-hospital death
Prazo: Baseline and Last visit -12 weeks
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Number of In-hospital death
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Baseline and Last visit -12 weeks
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Change in Family Satisfaction
Prazo: Baseline and Last visit -12 weeks
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Family Satisfaction as measured by the "Quality of Life at the End of Life - Family" - QUAL-E Fam Subscale: Relationship with Healthcare Provider [Questions #5-8 with 5 item Likert scales, average of 4 scores] Minimum value: 1 Maximum value: 5 High score means: worst outcome Low score means: better outcome |
Baseline and Last visit -12 weeks
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Number of residents transitioned to hospice
Prazo: Last visit - week 12
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Number of residents transitioned to hospice
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Last visit - week 12
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Change in acute care utilization (composite measure)
Prazo: Baseline and Last visit -12 weeks
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Number of ED Visits and number of Hospitalizations
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Baseline and Last visit -12 weeks
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Change in Functional Status
Prazo: Baseline and Last visit -12 weeks
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Functional Status as measured by the PalliativePerformance Scale (PPSv2) Minimum value: 0% Maximum value: 100% High score means: better outcome Low score means: worst outcome |
Baseline and Last visit -12 weeks
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Change in Depression Status
Prazo: Baseline and Last visit -12 weeks
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Depression as measured by the Patient Health Questionnaire-9 (PHQ-9) Subscales: - Question 1: Minimum value: 0 Maximum value: 27 High score means: worst outcome Low score means: better outcome - Question 2: Minimum value: 1 Maximum value: 4 High score means: worst outcome Low score means: better outcome |
Baseline and Last visit -12 weeks
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Change in Cognitive Status
Prazo: Baseline and Last visit -12 weeks
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Cognition as measured by the Montreal - Cognitive Assessment (MoCA) Minimum value: 0 Maximum value: 30 High score means: better outcome Low score means: worst outcome |
Baseline and Last visit -12 weeks
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Change in Mortality
Prazo: Baseline and Last visit -12 weeks
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Risk for dying within one year as measured by the Flacker Mortality Score Minimum value: 0 Maximum value: 15.21 High score means: worst outcome Low score means: better outcome |
Baseline and Last visit -12 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Caroline E Stephens, PhD, RN, University of Utah
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Stephens C, Halifax E, Bui N, Lee SJ, Harrington C, Shim J, Ritchie C. Provider Perspectives on the Influence of Family on Nursing Home Resident Transfers to the Emergency Department: Crises at the End of Life. Curr Gerontol Geriatr Res. 2015;2015:893062. doi: 10.1155/2015/893062. Epub 2015 Aug 24.
- Levy C, Morris M, Kramer A. Improving end-of-life outcomes in nursing homes by targeting residents at high-risk of mortality for palliative care: program description and evaluation. J Palliat Med. 2008 Mar;11(2):217-25. doi: 10.1089/jpm.2007.0147.
- Casarett D, Karlawish J, Morales K, Crowley R, Mirsch T, Asch DA. Improving the use of hospice services in nursing homes: a randomized controlled trial. JAMA. 2005 Jul 13;294(2):211-7. doi: 10.1001/jama.294.2.211.
- Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.
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- National Center for Health Statistics (US). Health, United States, 2010: With Special Feature on Death and Dying. Hyattsville (MD): National Center for Health Statistics (US); 2011 Feb. Report No.: 2011-1232. Available from http://www.ncbi.nlm.nih.gov/books/NBK54381/
- Brock DB, Foley DJ. Demography and epidemiology of dying in the U.S. with emphasis on deaths of older persons. Hosp J. 1998;13(1-2):49-60. doi: 10.1080/0742-969x.1998.11882887.
- Bercovitz A, Decker FH, Jones A, Remsburg RE. End-of-life care in nursing homes: 2004 National Nursing Home Survey. Natl Health Stat Report. 2008 Oct 8;(9):1-23.
- Kaye HS, Harrington C, LaPlante MP. Long-term care: who gets it, who provides it, who pays, and how much? Health Aff (Millwood). 2010 Jan-Feb;29(1):11-21. doi: 10.1377/hlthaff.2009.0535. Erratum In: Health Aff (Millwood). 2010 Mar-Apr;29(3):567.
- Stephens CE, Halifax E, David D, Bui N, Lee SJ, Shim J, Ritchie CS. "They Don't Trust Us": The Influence of Perceptions of Inadequate Nursing Home Care on Emergency Department Transfers and the Potential Role for Telehealth. Clin Nurs Res. 2020 Mar;29(3):157-168. doi: 10.1177/1054773819835015. Epub 2019 Apr 21.
- Gozalo P, Teno JM, Mitchell SL, Skinner J, Bynum J, Tyler D, Mor V. End-of-life transitions among nursing home residents with cognitive issues. N Engl J Med. 2011 Sep 29;365(13):1212-21. doi: 10.1056/NEJMsa1100347.
- 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.
- Cohen A, Bulanda JR. Social Supports as Enabling Factors in Nursing Home Admissions: Rural, Suburban, and Urban Differences. J Appl Gerontol. 2016 Jul;35(7):721-43. doi: 10.1177/0733464814566677. Epub 2015 Jan 11.
- Bolin JN, Phillips CD, Hawes C. Urban and rural differences in end-of-life pain and treatment status on admission to a nursing facility. Am J Hosp Palliat Care. 2006 Jan-Feb;23(1):51-7. doi: 10.1177/104990910602300109.
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- 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.
- 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.
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- Hall S, Kolliakou A, Petkova H, Froggatt K, Higginson IJ. Interventions for improving palliative care for older people living in nursing care homes. Cochrane Database Syst Rev. 2011 Mar 16;2011(3):CD007132. doi: 10.1002/14651858.CD007132.pub2.
- Berkowitz RE, Jones RN, Rieder R, Bryan M, Schreiber R, Verney S, Paasche-Orlow MK. Improving disposition outcomes for patients in a geriatric skilled nursing facility. J Am Geriatr Soc. 2011 Jun;59(6):1130-6. doi: 10.1111/j.1532-5415.2011.03417.x. Epub 2011 Jun 7.
- 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.
- 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.
- Stephens CE, Hunt LJ, Bui N, Halifax E, Ritchie CS, Lee SJ. Palliative Care Eligibility, Symptom Burden, and Quality-of-Life Ratings in Nursing Home Residents. JAMA Intern Med. 2018 Jan 1;178(1):141-142. doi: 10.1001/jamainternmed.2017.6299.
- Zerzan J, Stearns S, Hanson L. Access to palliative care and hospice in nursing homes. JAMA. 2000 Nov 15;284(19):2489-94. doi: 10.1001/jama.284.19.2489.
- Happ MB, Capezuti E, Strumpf NE, Wagner L, Cunningham S, Evans L, Maislin G. Advance care planning and end-of-life care for hospitalized nursing home residents. J Am Geriatr Soc. 2002 May;50(5):829-35. doi: 10.1046/j.1532-5415.2002.50207.x.
- Johnston B, Kidd L, Wengstrom Y, Kearney N. An evaluation of the use of Telehealth within palliative care settings across Scotland. Palliat Med. 2012 Mar;26(2):152-61. doi: 10.1177/0269216311398698. Epub 2011 Mar 4.
- Low JA, Beins G, Lee KK, Koh E. Last moments of life: can telemedicine play a role? Palliat Support Care. 2013 Aug;11(4):353-5. doi: 10.1017/S1478951512000995. Epub 2013 Feb 7.
- Wowchuk SM, McClement S, Bond J Jr. The challenge of providing palliative care in the nursing home part II: internal factors. Int J Palliat Nurs. 2007 Jul;13(7):345-50. doi: 10.12968/ijpn.2007.13.7.24346.
- Travis SS, Loving G, McClanahan L, Bernard M. Hospitalization patterns and palliation in the last year of life among residents in long-term care. Gerontologist. 2001 Apr;41(2):153-60. doi: 10.1093/geront/41.2.153.
- Teno JM, Branco KJ, Mor V, Phillips CD, Hawes C, Morris J, Fries BE. Changes in advance care planning in nursing homes before and after the patient Self-Determination Act: report of a 10-state survey. J Am Geriatr Soc. 1997 Aug;45(8):939-44. doi: 10.1111/j.1532-5415.1997.tb02963.x.
- Teno JM, Clarridge BR, Casey V, Welch LC, Wetle T, Shield R, Mor V. Family perspectives on end-of-life care at the last place of care. JAMA. 2004 Jan 7;291(1):88-93. doi: 10.1001/jama.291.1.88.
- Miller SC, Teno JM, Mor V. Hospice and palliative care in nursing homes. Clin Geriatr Med. 2004 Nov;20(4):717-34, vii. doi: 10.1016/j.cger.2004.07.005.
- Huskamp HA, Stevenson DG, Chernew ME, Newhouse JP. A new medicare end-of-life benefit for nursing home residents. Health Aff (Millwood). 2010 Jan-Feb;29(1):130-5. doi: 10.1377/hlthaff.2009.0523.
- Stevenson DG, Bramson JS. Hospice care in the nursing home setting: a review of the literature. J Pain Symptom Manage. 2009 Sep;38(3):440-51. doi: 10.1016/j.jpainsymman.2009.05.006.
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- Lupu D; American Academy of Hospice and Palliative Medicine Workforce Task Force. Estimate of current hospice and palliative medicine physician workforce shortage. J Pain Symptom Manage. 2010 Dec;40(6):899-911. doi: 10.1016/j.jpainsymman.2010.07.004.
- Edirippulige S, Martin-Khan M, Beattie E, Smith AC, Gray LC. A systematic review of telemedicine services for residents in long term care facilities. J Telemed Telecare. 2013 Apr;19(3):127-132. doi: 10.1177/1357633X13483256. Epub 2013 May 23.
- Rogante M, Giacomozzi C, Grigioni M, Kairy D. Telemedicine in palliative care: a review of systematic reviews. Ann Ist Super Sanita. 2016 Jul-Sep;52(3):434-442. doi: 10.4415/ANN_16_03_16.
- Oliver DP, Demiris G, Wittenberg-Lyles E, Washington K, Day T, Novak H. A systematic review of the evidence base for telehospice. Telemed J E Health. 2012 Jan-Feb;18(1):38-47. doi: 10.1089/tmj.2011.0061. Epub 2011 Nov 15.
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- McCall K, Keen J, Farrer K, Maguire R, McCann L, Johnston B, McGill M, Sage M, Kearney N. Perceptions of the use of a remote monitoring system in patients receiving palliative care at home. Int J Palliat Nurs. 2008 Sep;14(9):426-31. doi: 10.12968/ijpn.2008.14.9.31121.
- Roglieri JL, Futterman R, McDonough KL, Malya G, Karwath KR, Bowman D, Skelly J, Warburton SW Jr. Disease management interventions to improve outcomes in congestive heart failure. Am J Manag Care. 1997 Dec;3(12):1831-9.
- Lind L, Karlsson D. A system for symptom assessment in advanced palliative home healthcare using digital pens. Med Inform Internet Med. 2004 Sep-Dec;29(3-4):199-210. doi: 10.1080/14639230400005966.
- Mair F, Whitten P. Systematic review of studies of patient satisfaction with telemedicine. BMJ. 2000 Jun 3;320(7248):1517-20. doi: 10.1136/bmj.320.7248.1517.
- Hammett L, Harvath TA, Flaherty-Robb M, Sawyer G, Olson D. Remote wound care consultation for nursing homes: using a web-based assessment and care planning tool. J Gerontol Nurs. 2007 Nov;33(11):27-35; quiz 36-7. doi: 10.3928/00989134-20071101-09.
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Links úteis
- National Consensus Project for Quality Palliative Care. Clinical practice guidelines for quality palliative care, 3rd ed., Pittsburgh, PA. 2013.
- Improving palliative care in nursing homes [online report]. New York: Center to Advance Palliative Care. 2008.
- Corbin J, Strauss A, Strauss AL. Basics of qualitative research. Sage; 2014.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
19 de fevereiro de 2018
Conclusão Primária (Antecipado)
30 de junho de 2022
Conclusão do estudo (Antecipado)
30 de junho de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
4 de maio de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de julho de 2021
Primeira postagem (Real)
20 de julho de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de julho de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de julho de 2021
Última verificação
1 de julho de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- IRB_00129094
- 5K76AG054862-05 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Data (complete dataset with full documentation including metadata, protocols, etc) will be made available by the online publication date unless the NIH policy specifies an earlier date. The PI will work the primary mentor to ensure that the study data are submitted to the PCRC De-identified Data Repository. (https://palliativecareresearch.org/corescenters/data-informatics-statistics-core-disc/pcrc-de-identified-data-repository-didr).
This would allow for secondary data analyses of the data to be conducted and support those who need access to these datasets for preliminary data and/or grant proposal preparation. Human subject data will be shared with other investigators within the limits of HIPAA and other patient confidentiality requirements, including the removal of all participant identifiers from all source documents and the use of unique participant identification numbers, and in accordance with PCRC protocols.
Prazo de Compartilhamento de IPD
Data will be made available by the online publication date unless the NIH policy specifies an earlier date.
Critérios de acesso de compartilhamento IPD
This study has specific data and resource sharing plans to make data available both to the community of scientists interested in palliative care and nursing home research to avoid unintentional duplication of research.
Moreover, the investigator would welcome collaboration with others who could make use of the Telehealth visit protocols developed in this ImPAcTT project.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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