Improving Palliative Care Access Through Technology (ImPAcTT)
7 июля 2021 г. обновлено: 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.
Обзор исследования
Статус
Приостановленный
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Ожидаемый)
81
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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California
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San Francisco, California, Соединенные Штаты, 94143
- University of California San Francisco - UCSF
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Utah
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Salt Lake City, Utah, Соединенные Штаты, 84112
- University of Utah
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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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Без вмешательства: Usual care
Participants will receive the standard of care established at the NH.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Symptom distress (composite measure)
Временное ограничение: 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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in number of completed POLST forms
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Следователи
- Главный следователь: Caroline E Stephens, PhD, RN, University of Utah
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
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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/
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- 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.
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- 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.
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- 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.
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- 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.
- Ding J, Saunders C, Cook A, Johnson CE. End-of-life care in rural general practice: how best to support commitment and meet challenges? BMC Palliat Care. 2019 Jun 25;18(1):51. doi: 10.1186/s12904-019-0435-4.
- Carlson MD, Lim B, Meier DE. Strategies and innovative models for delivering palliative care in nursing homes. J Am Med Dir Assoc. 2011 Feb;12(2):91-8. doi: 10.1016/j.jamda.2010.07.016. Epub 2010 Nov 10.
- 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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- Collier A, Morgan DD, Swetenham K, To TH, Currow DC, Tieman JJ. Implementation of a pilot telehealth programme in community palliative care: A qualitative study of clinicians' perspectives. Palliat Med. 2016 Apr;30(4):409-17. doi: 10.1177/0269216315600113. Epub 2015 Aug 19.
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- Steinhauser KE, Clipp EC, Bosworth HB, McNeilly M, Christakis NA, Voils CI, Tulsky JA. Measuring quality of life at the end of life: validation of the QUAL-E. Palliat Support Care. 2004 Mar;2(1):3-14. doi: 10.1017/s1478951504040027.
Полезные ссылки
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
19 февраля 2018 г.
Первичное завершение (Ожидаемый)
30 июня 2022 г.
Завершение исследования (Ожидаемый)
30 июня 2022 г.
Даты регистрации исследования
Первый отправленный
4 мая 2021 г.
Впервые представлено, что соответствует критериям контроля качества
7 июля 2021 г.
Первый опубликованный (Действительный)
20 июля 2021 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
20 июля 2021 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
7 июля 2021 г.
Последняя проверка
1 июля 2021 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- IRB_00129094
- 5K76AG054862-05 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана 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.
Сроки обмена IPD
Data will be made available by the online publication date unless the NIH policy specifies an earlier date.
Критерии совместного доступа к 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.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
- АНАЛИТИЧЕСКИЙ_КОД
- КСО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .