Improving time to palliative care review with predictive modeling in an inpatient adult population: study protocol for a stepped-wedge, pragmatic randomized controlled trial

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Abstract

Background

Palliative care is a medical specialty centered on improving the quality of life (QOL) of patients with complex or life-threatening illnesses. The need for palliative care is increasing and with that the rigorous testing of triage tools that can be used quickly and reliably to identify patients that may benefit from palliative care.

Methods

To that aim, we will conduct a two-armed stepped-wedge cluster randomized trial rolled out to two inpatient hospitals to evaluate whether a machine learning algorithm accurately identifies patients who may benefit from a comprehensive review by a palliative care specialist and decreases time to receiving a palliative care consult in hospital. This is a single-center study which will be conducted from August 2019 to November 2020 at Saint Mary’s Hospital & Methodist Hospital both within Mayo Clinic Rochester in Minnesota. Clusters will be nursing units which will be chosen to be a mix of complex patients from Cardiology, Critical Care, and Oncology and had previously established relationships with palliative medicine. The stepped wedge design will have 12 units allocated to a design matrix of 5 treatment wedges. Each wedge will last 75 days resulting in a study period of 12 months of recruitment unless otherwise specified. Data will be analyzed with Bayesian hierarchical models with credible intervals denoting statistical significance.

Discussion

This intervention offers a pragmatic approach to delivering specialty palliative care to hospital patients in need using machine learning, thereby leading to high value care and improved outcomes. It is not enough for AI to be utilized by simply publishing research showing predictive performance; clinical trials demonstrating better outcomes are critically needed. Furthermore, the deployment of an AI algorithm is a complex process that requires multiple teams with varying skill sets. To evaluate a deployed AI, a pragmatic clinical trial can accommodate the difficulties of clinical practice while retaining scientific rigor.

Trial registration

ClinicalTrials.gov NCT03976297. Registered on 6 June 2019, prior to trial start.

Supplementary Information

The online version contains supplementary material available at 10.1186/s13063-021-05546-5.

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Most cited references 22

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Early palliative care for patients with metastatic non-small-cell lung cancer.

Jennifer Temel, Joseph A. Greer, Alona Muzikansky … (2010)

Patients with metastatic non-small-cell lung cancer have a substantial symptom burden and may receive aggressive care at the end of life. We examined the effect of introducing palliative care early after diagnosis on patient-reported outcomes and end-of-life care among ambulatory patients with newly diagnosed disease. We randomly assigned patients with newly diagnosed metastatic non-small-cell lung cancer to receive either early palliative care integrated with standard oncologic care or standard oncologic care alone. Quality of life and mood were assessed at baseline and at 12 weeks with the use of the Functional Assessment of Cancer Therapy-Lung (FACT-L) scale and the Hospital Anxiety and Depression Scale, respectively. The primary outcome was the change in the quality of life at 12 weeks. Data on end-of-life care were collected from electronic medical records. Of the 151 patients who underwent randomization, 27 died by 12 weeks and 107 (86% of the remaining patients) completed assessments. Patients assigned to early palliative care had a better quality of life than did patients assigned to standard care (mean score on the FACT-L scale [in which scores range from 0 to 136, with higher scores indicating better quality of life], 98.0 vs. 91.5; P=0.03). In addition, fewer patients in the palliative care group than in the standard care group had depressive symptoms (16% vs. 38%, P=0.01). Despite the fact that fewer patients in the early palliative care group than in the standard care group received aggressive end-of-life care (33% vs. 54%, P=0.05), median survival was longer among patients receiving early palliative care (11.6 months vs. 8.9 months, P=0.02). Among patients with metastatic non-small-cell lung cancer, early palliative care led to significant improvements in both quality of life and mood. As compared with patients receiving standard care, patients receiving early palliative care had less aggressive care at the end of life but longer survival. (Funded by an American Society of Clinical Oncology Career Development Award and philanthropic gifts; ClinicalTrials.gov number, NCT01038271.)

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Health care costs in the last week of life: associations with end-of-life conversations.

Baohui Zhang, Alexi A Wright, Haiden Huskamp … (2009)

Life-sustaining medical care of patients with advanced cancer at the end of life (EOL) is costly. Patient-physician discussions about EOL wishes are associated with lower rates of intensive interventions. Funded by the National Institute of Mental Health and the National Cancer Institute, Coping With Cancer is a longitudinal multi-institutional study of 627 patients with advanced cancer. Patients were interviewed at baseline and were followed up through death. Costs for intensive care unit and hospital stays, hospice care, and life-sustaining procedures (eg, mechanical ventilator use and resuscitation) received in the last week of life were aggregated. Generalized linear models were applied to test for cost differences in EOL care. Propensity score matching was used to reduce selection biases. Of 603 participants, 188 (31.2%) reported EOL discussions at baseline. After propensity score matching, the remaining 415 patients did not differ in sociodemographic characteristics, recruitment sites, illness acknowledgment, or treatment preferences. Further analyses, adjusted by quintiles of propensity scores and significant confounders, revealed that the mean (SE) aggregate costs of care (in 2008 US dollars) were $1876 ($177) for patients who reported EOL discussions compared with $2917 ($285) for patients who did not, a cost difference of $1041 (35.7% lower among patients who reported EOL discussions) (P =.002). Patients with higher costs had worse quality of death in their final week (Pearson production moment correlation partial r = -0.17, P =.006). Patients with advanced cancer who reported having EOL conversations with physicians had significantly lower health care costs in their final week of life. Higher costs were associated with worse quality of death.

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Effect of early palliative care on chemotherapy use and end-of-life care in patients with metastatic non-small-cell lung cancer.

Alona Muzikansky, E. Gallagher, Ian Greer … (2012)

Prior research shows that introducing palliative care soon after diagnosis for patients with metastatic non-small-cell lung cancer (NSCLC) is associated with improvements in quality of life, mood, and survival. We sought to investigate whether early palliative care also affects the frequency and timing of chemotherapy use and hospice care for these patients. This secondary analysis is based on a randomized controlled trial of 151 patients with newly diagnosed metastatic NSCLC presenting to an outpatient clinic at a tertiary cancer center from June 2006 to July 2009. Participants received either early palliative care integrated with standard oncology care or standard oncology care alone. By 18-month follow-up, 133 participants (88.1%) had died. Outcome measures included: first, number and types of chemotherapy regimens, and second, frequency and timing of chemotherapy administration and hospice referral. The overall number of chemotherapy regimens did not differ significantly by study group. However, compared with those in the standard care group, participants receiving early palliative care had half the odds of receiving chemotherapy within 60 days of death (odds ratio, 0.47; 95% CI, 0.23 to 0.99; P = .05), a longer interval between the last dose of intravenous chemotherapy and death (median, 64.00 days [range, 3 to 406 days] v 40.50 days [range, 6 to 287 days]; P = .02), and higher enrollment in hospice care for longer than 1 week (60.0% [36 of 60 patients] v 33.3% [21 of 63 patients]; P = .004). Although patients with metastatic NSCLC received similar numbers of chemotherapy regimens in the sample, early palliative care optimized the timing of final chemotherapy administration and transition to hospice services, key measures of quality end-of-life care.

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Author and article information

Contributors

Patrick M. Wilson:

ORCID: http://orcid.org/0000-0002-6604-444X

wilson.patrick@mayo.edu

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 16 September 2021

Publication date PMC-release: 16 September 2021

Publication date Collection: 2021

Volume: 22

Electronic Location Identifier: 635

Affiliations

[1 ]GRID grid.66875.3a, ISNI 0000 0004 0459 167X, Kern Center for the Science of Health Care Delivery, , Mayo Clinic, ; Rochester, MN USA

[2 ]GRID grid.66875.3a, ISNI 0000 0004 0459 167X, Department of Quantitative Health Sciences, , Mayo Clinic, ; MN 55905 Rochester, USA

[3 ]GRID grid.66875.3a, ISNI 0000 0004 0459 167X, Department of Medicine, , Mayo Clinic, ; Rochester, MN 55905 USA

[4 ]GRID grid.66875.3a, ISNI 0000 0004 0459 167X, Center for Palliative Medicine, , Mayo Clinic, ; Rochester, MN USA

[5 ]GRID grid.66875.3a, ISNI 0000 0004 0459 167X, Department of Anesthesiology, , Mayo Clinic, ; Rochester, MN 55905 USA

Author information

Patrick M. Wilson http://orcid.org/0000-0002-6604-444X

Article

Publisher ID: 5546

DOI: 10.1186/s13063-021-05546-5

PMC ID: 8444160

PubMed ID: 34530871

SO-VID: 8b1166ac-8f6e-4709-8720-fd75a9ed7577

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 2 November 2020

Date accepted : 16 August 2021

Funding

Funded by: kern center & cpc (mayo clinic)

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: palliative care,electronic medical record,artificial intelligence,ai,pragmatic clinical trials,stepped wedge trials

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ScienceOpen disciplines: Medicine

Keywords: palliative care, electronic medical record, artificial intelligence, ai, pragmatic clinical trials, stepped wedge trials

Improving time to palliative care review with predictive modeling in an inpatient adult population: study protocol for a stepped-wedge, pragmatic randomized controlled trial

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Abstract

Background

Methods

Discussion

Trial registration

Supplementary Information

Related collections

Artificial Intelligence in Medicine

Most cited references 22

Early palliative care for patients with metastatic non-small-cell lung cancer.

Health care costs in the last week of life: associations with end-of-life conversations.

Effect of early palliative care on chemotherapy use and end-of-life care in patients with metastatic non-small-cell lung cancer.

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