ProPACC: Protocol for a Trial of Integrated Specialty Palliative Care for Critically Ill Older Adults

Sarah K Andersen; Grace Vincent; Rachel A Butler; Elke H P Brown; Dave Maloney; Sana Khalid; Rae Oanesa; James Yun; Carrie Pidro; Valerie N Davis; Judith Resick; Aaron Richardson; Kimberly Rak; Jackie Barnes; Karl B Bezak; Andrew Thurston; Eva Reitschuler-Cross; Linda A King; Ian Barbash; Ali Al-Khafaji; Emily Brant; Jonathan Bishop; Jennifer McComb; Chung-Chou H Chang; Jennifer Seaman; Jennifer S Temel; Derek C Angus; Robert Arnold; Yael Schenker; Douglas B White

doi:10.1016/j.jpainsymman.2022.02.344

ProPACC: Protocol for a Trial of Integrated Specialty Palliative Care for Critically Ill Older Adults

J Pain Symptom Manage. 2022 Jun;63(6):e601-e610. doi: 10.1016/j.jpainsymman.2022.02.344.

Authors

Sarah K Andersen¹, Grace Vincent¹, Rachel A Butler², Elke H P Brown¹, Dave Maloney¹, Sana Khalid¹, Rae Oanesa¹, James Yun³, Carrie Pidro³, Valerie N Davis³, Judith Resick⁴, Aaron Richardson³, Kimberly Rak³, Jackie Barnes³, Karl B Bezak⁴, Andrew Thurston⁵, Eva Reitschuler-Cross⁶, Linda A King⁵, Ian Barbash⁷, Ali Al-Khafaji⁸, Emily Brant⁸, Jonathan Bishop⁸, Jennifer McComb⁹, Chung-Chou H Chang¹⁰, Jennifer Seaman¹¹, Jennifer S Temel¹², Derek C Angus³, Robert Arnold¹³, Yael Schenker⁴, Douglas B White¹⁴

Affiliations

¹ Program on Ethics and Decision Making, The Clinical Research, Investigation, and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine (S.K.A., G.V., R.A.B., E.H.P.B., D.M., S.K., R.O., J.S., D.B.W.), University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
² Program on Ethics and Decision Making, The Clinical Research, Investigation, and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine (S.K.A., G.V., R.A.B., E.H.P.B., D.M., S.K., R.O., J.S., D.B.W.), University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA; Palliative Research Center (PaRC) (R.A.B., J.R., K.B.B., A.T., L.A.K., J.S., R.A., Y.S., D.B.W.), University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
³ The CRISMA Center, Department of Critical Care Medicine (I.B., C.-C.H.C.), University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
⁴ Palliative Research Center (PaRC) (R.A.B., J.R., K.B.B., A.T., L.A.K., J.S., R.A., Y.S., D.B.W.), University of Pittsburgh, Pittsburgh, Pennsylvania, USA; Department of Medicine, Division of General Internal Medicine, Section of Palliative Care and Medical Ethics (J.R., K.B.B., R.A., Y.S.), University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
⁵ Palliative Research Center (PaRC) (R.A.B., J.R., K.B.B., A.T., L.A.K., J.S., R.A., Y.S., D.B.W.), University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
⁶ Department of Medicine, Division of General Internal Medicine (E.R.-C., C.-C.H.C.), University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
⁷ Department of Critical Care Medicine (I.B., A.-K., E.B., J.B.), University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA; Department of Medicine, Division of Pulmonary, Allergy and Critical Care (I.B., J.M.), University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA; The CRISMA Center, Department of Critical Care Medicine (I.B., C.-C.H.C.), University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
⁸ Department of Critical Care Medicine (I.B., A.-K., E.B., J.B.), University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
⁹ Department of Medicine, Division of Pulmonary, Allergy and Critical Care (I.B., J.M.), University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
¹⁰ Department of Medicine, Division of General Internal Medicine (E.R.-C., C.-C.H.C.), University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA; The CRISMA Center, Department of Critical Care Medicine (I.B., C.-C.H.C.), University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
¹¹ Program on Ethics and Decision Making, The Clinical Research, Investigation, and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine (S.K.A., G.V., R.A.B., E.H.P.B., D.M., S.K., R.O., J.S., D.B.W.), University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA; Palliative Research Center (PaRC) (R.A.B., J.R., K.B.B., A.T., L.A.K., J.S., R.A., Y.S., D.B.W.), University of Pittsburgh, Pittsburgh, Pennsylvania, USA; Department of Acute and Tertiary Care (J.S.), University of Pittsburgh School of Nursing, Pittsburgh, Pennsylvania, USA.
¹² Division of Hematology/Oncology, Massachusetts General Hospital, Boston (J.S.T.), Massachusetts, USA.
¹³ Palliative Research Center (PaRC) (R.A.B., J.R., K.B.B., A.T., L.A.K., J.S., R.A., Y.S., D.B.W.), University of Pittsburgh, Pittsburgh, Pennsylvania, USA; The CRISMA Center, Department of Critical Care Medicine (I.B., C.-C.H.C.), University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
¹⁴ Program on Ethics and Decision Making, The Clinical Research, Investigation, and Systems Modeling of Acute Illness (CRISMA) Center, Department of Critical Care Medicine (S.K.A., G.V., R.A.B., E.H.P.B., D.M., S.K., R.O., J.S., D.B.W.), University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA; Palliative Research Center (PaRC) (R.A.B., J.R., K.B.B., A.T., L.A.K., J.S., R.A., Y.S., D.B.W.), University of Pittsburgh, Pittsburgh, Pennsylvania, USA. Electronic address: douglas.white@pitt.edu.

Abstract

Background: Each year, approximately one million older adults die in American intensive care units (ICUs) or survive with significant functional impairment. Inadequate symptom management, surrogates' psychological distress and inappropriate healthcare use are major concerns. Pioneering work by Dr. J. Randall Curtis paved the way for integrating palliative care (PC) specialists to address these needs, but convincing proof of efficacy has not yet been demonstrated.

Design: We will conduct a multicenter patient-randomized efficacy trial of integrated specialty PC (SPC) vs. usual care for 500 high-risk ICU patients over age 60 and their surrogate decision-makers from five hospitals in Pennsylvania.

Intervention: The intervention will follow recommended best practices for inpatient PC consultation. Patients will receive care from a multidisciplinary SPC team within 24 hours of enrollment that continues until hospital discharge or death. SPC clinicians will meet with patients, families, and the ICU team every weekday. SPC and ICU clinicians will jointly participate in proactive family meetings according to a predefined schedule. Patients in the control arm will receive routine ICU care.

Outcomes: Our primary outcome is patient-centeredness of care, measured using the modified Patient Perceived Patient-Centeredness of Care scale. Secondary outcomes include surrogates' psychological symptom burden and health resource utilization. Other outcomes include patient survival, as well as interprofessional collaboration. We will also conduct prespecified subgroup analyses using variables such as PC needs, measured by the Needs of Social Nature, Existential Concerns, Symptoms, and Therapeutic Interaction scale.

Conclusions: This trial will provide robust evidence about the impact of integrating SPC with critical care on patient, family, and health system outcomes.

Trial registration: ClinicalTrials.gov NCT04921631.

Keywords: Intensive care; clinical trial; palliative care; patient-centered care; quality of communication; surrogate decision-making.

Publication types

Clinical Trial Protocol
Research Support, N.I.H., Extramural

MeSH terms

Aged
Critical Care
Critical Illness* / therapy
Hospice and Palliative Care Nursing*
Humans
Intensive Care Units
Middle Aged
Multicenter Studies as Topic
Palliative Care / methods
Randomized Controlled Trials as Topic

Associated data

ClinicalTrials.gov/NCT04921631

Abstract

Publication types

MeSH terms

Associated data

Grants and funding