A Pilot Randomized Controlled Trial of Integrated Palliative Care and Nephrology Care.

Background

There has been a call by both patients and health professionals for the integration of palliative care with nephrology care, yet there is little evidence describing the effect of this approach. The objective of this paper is to report the feasibility and acceptability of a pilot randomized controlled trial testing the efficacy of integrated palliative and nephrology care.

Methods

English speaking patients with CKD stage 5 were randomized to monthly palliative care visits for 3 months in addition to their usual care, as compared with usual nephrology care. Feasibility of recruitment, retention, completion of intervention processes, and feedback on participation was measured. Other outcomes included differences in symptom burden change, measured by the Integrated Palliative Outcome Scale-Renal, and change in quality of life, measured by the Kidney Disease Quality of Life questionnaire and completion of advance care planning documents.

Results

Of the 67 patients approached, 45 (67%) provided informed consent. Of these, 27 patients completed the study (60%), and 14 (74%) of those in the intervention group completed all visits. We found small improvements in overall symptom burden (-2.92 versus 1.57) and physical symptom burden scores (-1.92 versus 1.79) in the intervention group. We did not see improvements in the quality-of-life scores, with the exception of the physical component score. The intervention group completed more advance care planning documents than controls (five health care proxy forms completed versus one, nine Medical Orders for Life Sustaining Treatment forms versus none).

Conclusions

We found that pilot testing through a randomized controlled trial of an ambulatory integrated palliative and nephrology care clinical program was feasible and acceptable to participants. This intervention has the potential to improve the disease experience for those with nondialysis CKD and should be tested in other CKD populations with longer follow-up.

Clinical Trials registry name and registration number

Pilot Randomized-controlled Trial of Integrated Palliative and Nephrology Care Versus Usual Nephrology Care, NCT04520984.

Informations de copyright

Copyright © 2022 by the American Society of Nephrology.

Déclaration de conflit d'intérêts

A. Brody reports having ownership interest in Accomplish Health, and having consultancy agreements with David Horowitz (PC), Ryan Ryan Deluca, and Victoria Crown Law (PC). D.M. Charytan reports having consultancy agreements with Allena Pharmaceuticals (data and safety monitoring board), Amgen, AstraZeneca, CSL Behring, Eli Lilly/Boehringer Ingelheim, GlaxoSmithKline, Janssen (steering committee), Fresenius, Gilead, Medtronic, Merck, Novo Nordisk, PLC medical (clinical events committee), Renalytix, and Zogenix; receiving grants and personal fees from Amgen, Gilead, Medtronic, and Novo Nordisk; receiving personal fees from AstraZeneca, Boehringer/Eli Lily, CSL Behring, Fresenius, GlaxoSmithKline, Merck, and Zoll; serving in an advisory or leadership role for CJASN; receiving personal fees and other from Janssen; and receiving expert witness fees related to proton pump inhibitors. J. Chodosh reports serving in an advisory or leadership role for the Journal of American Geriatrics Society. M.E. Rau reports having ownership interest in Doximity. J.S. Scherer reports serving in an advisory or leadership role for Cara Pharmaceuticals and Monogram Health (clinical advisory board), and receiving honoraria from Vifor Pharmaceuticals. All remaining authors have nothing to disclose. H. Zhong receives funding from National Institute of Aging grants 1R011AG065330-01, 5R01AG 054467-04, and 3R01AG54467-04S1All remaining authors have nothing to disclose.