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Randomized Controlled Trial
. 2020 Nov:98:106163.
doi: 10.1016/j.cct.2020.106163. Epub 2020 Sep 29.

Operationalizing needs-focused palliative care for older adults in intensive care units: Design of and rationale for the PCplanner randomized clinical trial

Christopher E Cox  1 , Maren K Olsen  2 , David Casarett  3 , Krista Haines  4 , Mashael Al-Hegelan  5 , Raquel R Bartz  6 , Jason N Katz  7 , Colleen Naglee  8 , Deepshikha Ashana  9 , Daniel Gilstrap  10 , Jessie Gu  11 , Alice Parish  12 , Allie Frear  13 , Deepthi Krishnamaneni  14 , Andrew Corcoran  15 , Sharron L Docherty  16
Affiliations
Randomized Controlled Trial

Operationalizing needs-focused palliative care for older adults in intensive care units: Design of and rationale for the PCplanner randomized clinical trial

Christopher E Cox et al. Contemp Clin Trials. 2020 Nov.

Abstract

Introduction: The number of older adults who receive life support in an intensive care unit (ICU), now 2 million per year, is increasing while survival remains unchanged. Because the quality of ICU-based palliative care is highly variable, we developed a mobile app intervention that integrates into the electronic health records (EHR) system called PCplanner (Palliative Care planner) with the goal of improving collaborative primary and specialist palliative care delivery in ICU settings.

Objective: To describe the methods of a randomized clinical trial (RCT) being conducted to compare PCplanner vs. usual care.

Methods and analysis: The goal of this two-arm, parallel group mixed methods RCT is to determine the clinical impact of the PCplanner intervention on outcomes of interest to patients, family members, clinicians, and policymakers over a 3-month follow up period. The primary outcome is change in unmet palliative care needs measured by the NEST instrument between baseline and 1 week post-randomization. Secondary outcomes include goal concordance of care, patient-centeredness of care, and quality of communication at 1 week post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder at 3 months post-randomization. We will use general linear models for repeated measures to compare outcomes across the main effects and interactions of the factors. We hypothesize that compared to usual care, PCplanner will have a greater impact on the quality of ICU-based palliative care delivery across domains of core palliative care needs, psychological distress, patient-centeredness, and healthcare resource utilization.

Keywords: Critical illness; Electronic health record (EHR) systems; Intensive care units; Mobile app; Palliative care; Randomized clinical trial (RCT).

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Conflict of interest statement

Competing interests statement

No author has conflicts of interest to report relevant to this manuscript.

Figures

Fig. 1.
Fig. 1.
RCT flow.
Fig. 2.
Fig. 2.
Screenshots from the PCplanner mobile app.
See this image and copyright information in PMC

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