A Multicomponent Nonpharmacological Intervention to Prevent Delirium for Hospitalized People with Advanced Cancer: A Phase II Cluster Randomized Waitlist Controlled Trial (The PRESERVE Pilot Study)

Article


Hosie, Annmarie, Phillips, Jane, Lam, Lawrence, Kochovska, Slavica, Noble, Beverly, Brassil, Meg, Kurrle, Susan, Cumming, Anne, Caplan, Gideon A., Chye, Richard, Ely, Eugene Wesley, Lawlor, Peter G., Bush, Shirley H., Davis, Jan Maree, Lovell, Melanie, Parr, Cynthia, Williams, Sally, Hauser, Katherine, McArdle, Susan, ..., Agar, Meera. 2020. "A Multicomponent Nonpharmacological Intervention to Prevent Delirium for Hospitalized People with Advanced Cancer: A Phase II Cluster Randomized Waitlist Controlled Trial (The PRESERVE Pilot Study)." Journal of Palliative Medicine. 23 (10), pp. 1314-1322. https://doi.org/10.1089/jpm.2019.0632
Article Title

A Multicomponent Nonpharmacological Intervention to Prevent Delirium for Hospitalized People with Advanced Cancer: A Phase II Cluster Randomized Waitlist Controlled Trial (The PRESERVE Pilot Study)

ERA Journal ID40549
Article CategoryArticle
AuthorsHosie, Annmarie (Author), Phillips, Jane (Author), Lam, Lawrence (Author), Kochovska, Slavica (Author), Noble, Beverly (Author), Brassil, Meg (Author), Kurrle, Susan (Author), Cumming, Anne (Author), Caplan, Gideon A. (Author), Chye, Richard (Author), Ely, Eugene Wesley (Author), Lawlor, Peter G. (Author), Bush, Shirley H. (Author), Davis, Jan Maree (Author), Lovell, Melanie (Author), Parr, Cynthia (Author), Williams, Sally (Author), Hauser, Katherine (Author), McArdle, Susan (Author), Jacquier, Karen (Author), Phillipson, Carl (Author), Kuwahata, Lynne (Author), Kerfoot, Jackie (Author), Brown, Linda (Author), Fazekas, Belinda (Author), Cheah, Seong Leang (Author), Edwards, Layla (Author), Green, Anna (Author), Hunt, Jane (Author), Attwood, Robyn (Author), Assen, Teresa (Author), Garcia, Maja (Author), Wilcock, Julie (Author) and Agar, Meera (Author)
Journal TitleJournal of Palliative Medicine
Journal Citation23 (10), pp. 1314-1322
Year2020
PublisherMary Ann Liebert Inc
Place of PublicationUnited States
ISSN1096-6218
1557-7740
Digital Object Identifier (DOI)https://doi.org/10.1089/jpm.2019.0632
Web Address (URL)https://www.liebertpub.com/doi/10.1089/jpm.2019.0632
Abstract

Background: Delirium is a common debilitating complication of advanced cancer. Objective: To determine if a multicomponent nonpharmacological delirium prevention intervention was feasible for adult patients with advanced cancer, before a phase III (efficacy) trial. Design: Phase II (feasibility) cluster randomized controlled trial. All sites implemented delirium screening and diagnostic assessment. Strategies within sleep, vision and hearing, hydration, orientation, mobility, and family domains were delivered to enrolled patients at intervention site admission days 1-7. Control sites then implemented the intervention ('waitlist sites'). Setting: Four Australian palliative care units. Measurements: The primary outcome was adherence, with an a priori endpoint of at least 60% patients achieving full adherence. Secondary outcomes were interdisciplinary care delivery, delirium measures, and adverse events, analyzed descriptively and inferentially. Results: Sixty-five enrolled patients (25 control, 20 intervention, and 20 waitlist) had 98% delirium screens and 75% diagnostic assessments completed. Nurses (67%), physicians (16%), allied health (8.4%), family (7%), patients (1%), and volunteers (0.5%) delivered the intervention. There was full adherence for 5% patients at intervention sites, partial for 25%. Both full and partial adherence were higher at waitlist sites: 25% and 45%, respectively. One-third of control site patients (32%) became delirious within seven days of admission compared to one-fifth (20%) at both intervention and waitlist sites (p = 0.5). Mean (standard deviation) Delirium Rating Scale-Revised-1998 scores were 16.8 + 12.0 control sites versus 18.4 + 8.2 (p = 0.6) intervention and 18.7 + 7.8 (p = 0.5) waitlist sites. The intervention caused no adverse events. Conclusion: The intervention requires modification for optimal adherence in a phase III trial.

Keywordscancer; clinical trial; delirium; inpatients; nonpharmacological; palliative care
ANZSRC Field of Research 2020420316. Palliative care
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Institution of OriginUniversity of Southern Queensland
Byline AffiliationsUniversity of Notre Dame Australia
University of Technology Sydney
University of Sydney
Australian Commission on Safety and Quality in Health Care, Australia
Department of Health, New South Wales
St Vincent’s Private Hospital, Sydney, Australia
Vanderbilt University, United States
University of Ottawa, Canada
Calvary Health Care Kogarah, Australia
Greenwich Hospital, Australia
Department of Health, South Australia
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Phillips, Jane, Heneka, Nicole, Lam, Lawrence and Shaw, Tim. 2014. "Multi-Centre Pre-Post Test Trial of a Complex QStream (c) Pain Assessment Intervention on Cancer Nurses' Pain Screening and Assessment Practices." Asia Pacific Journal of Clinical Oncology. 10, pp. 206-206.
A Complex QStream (R) Pain Assessment Intervention on Cancer Nurses' Pain Screening and Assessment Practices: Results from a Quasi-Experimental Study
Phillips, Jane, Heneka, Nicole, Lam, Lawrence and Shaw, Tim. 2014. "A Complex QStream (R) Pain Assessment Intervention on Cancer Nurses' Pain Screening and Assessment Practices: Results from a Quasi-Experimental Study." Asia Pacific Journal of Clinical Oncology. 10, pp. 136-136.
Impact of a novel online learning module on specialist palliative care nurses’ pain assessment competencies and patients’ reports of pain: Results from a quasiexperimental pilot study
Phillips, Jane L., Heneka, Nicole, Hickman, Louise, Lam, Lawrence and Shaw, Tim. 2014. "Impact of a novel online learning module on specialist palliative care nurses’ pain assessment competencies and patients’ reports of pain: Results from a quasiexperimental pilot study." Palliative Medicine. 28 (6), pp. 521-529. https://doi.org/10.1177/0269216314527780
Exploring opiate errors in the specialist cancer and palliative care setting: perceptions of key stakeholders
Phillips, Jane, Heneka, Nicole and Shaw, Tim. 2013. "Exploring opiate errors in the specialist cancer and palliative care setting: perceptions of key stakeholders." COSA Annual Scientific Meeting 2013. Adelaide, Australia 12 - 14 Nov 2013 Australia.
Mapping cancer pain screening, assessment and reassessment practices within one Australian health district: results from a baseline chart audit
Phillips, Jane, Heneka, Nicole and Shaw, Tim. 2013. "Mapping cancer pain screening, assessment and reassessment practices within one Australian health district: results from a baseline chart audit." COSA Annual Scientific Meeting 2013. Adelaide, Australia 12 - 14 Nov 2013 Australia.
Impact of a Qstream Online Learning Module on Palliative Care Nurses’ Pain Assessment Competencies and Patients’ Reports of Pain: Results from a Quasi-Experimental Pilot Study
Phillips, Jane, Heneka, Nicole, Hickman, Louise, Lam, Lawrence and Shaw, Tim. 2013. "Impact of a Qstream Online Learning Module on Palliative Care Nurses’ Pain Assessment Competencies and Patients’ Reports of Pain: Results from a Quasi-Experimental Pilot Study." COSA Annual Scientific Meeting 2013. Adelaide, Australia 12 - 14 Nov 2013 Australia.