TY - JOUR

T1 - Compassionate Communication and Advance Care Planning to improve End-of-life Care in Treatment of Haematological Disease 'ACT'

T2 - Study Protocol for a Cluster-randomized trial

AU - Borregaard Myrhøj, Cæcilie

AU - Clemmensen, Stine Novrup

AU - Jarden, Mary

AU - Johansen, Christoffer

AU - Von Heymann, Annika

N1 - Publisher Copyright: © 2024 Author(s) (or their employer(s)).

PY - 2024

Y1 - 2024

N2 - Introduction To support the implementation of advance care planning and serious illness conversations in haematology, a previously developed conversation intervention titled 'Advance Consultations Concerning your Life and Treatment' (ACT) was found feasible. This study aims to investigate the effect of ACT on the quality of end-of-life care in patients with haematological malignancy and their informal caregivers. Methods and analysis The study is a nationwide 2-arm cluster randomised trial randomising 40 physician-nurse clusters across seven haematological departments in Denmark to provide standard care or ACT intervention. A total of 400 patients with haematological malignancies and their informal caregivers will be included. The ACT intervention includes an ACT conversation that centres on discussing the patient's prognosis, worries, hopes and preferences for future treatment. The intervention is supported by clinician training and supervision, preparatory materials for patients and informal caregivers, and system changes including dedicated ACT-conversation timeslots and templates for documentation in medical records. This study includes two primary outcomes: (1) the proportion of patients receiving chemotherapy within the last 30 days of death and (2) patients' and informal caregivers' symptoms of anxiety (General Anxiety Disorder-7) at 3 6, 9, 12 and 18 months follow-up. Mixed effects models accounting for clusters will be used. Ethics and dissemination The Declaration of Helsinki and the European GDPR regulations as practised in Denmark are followed through all aspects of the study. Findings will be made available to the participants, patient organisations, funding bodies, healthcare professionals and researchers at national and international conferences and through publication in peer-reviewed international journals.

AB - Introduction To support the implementation of advance care planning and serious illness conversations in haematology, a previously developed conversation intervention titled 'Advance Consultations Concerning your Life and Treatment' (ACT) was found feasible. This study aims to investigate the effect of ACT on the quality of end-of-life care in patients with haematological malignancy and their informal caregivers. Methods and analysis The study is a nationwide 2-arm cluster randomised trial randomising 40 physician-nurse clusters across seven haematological departments in Denmark to provide standard care or ACT intervention. A total of 400 patients with haematological malignancies and their informal caregivers will be included. The ACT intervention includes an ACT conversation that centres on discussing the patient's prognosis, worries, hopes and preferences for future treatment. The intervention is supported by clinician training and supervision, preparatory materials for patients and informal caregivers, and system changes including dedicated ACT-conversation timeslots and templates for documentation in medical records. This study includes two primary outcomes: (1) the proportion of patients receiving chemotherapy within the last 30 days of death and (2) patients' and informal caregivers' symptoms of anxiety (General Anxiety Disorder-7) at 3 6, 9, 12 and 18 months follow-up. Mixed effects models accounting for clusters will be used. Ethics and dissemination The Declaration of Helsinki and the European GDPR regulations as practised in Denmark are followed through all aspects of the study. Findings will be made available to the participants, patient organisations, funding bodies, healthcare professionals and researchers at national and international conferences and through publication in peer-reviewed international journals.

KW - HAEMATOLOGY

KW - PALLIATIVE CARE

KW - Psychosocial Intervention

KW - Randomized Controlled Trial

U2 - 10.1136/bmjopen-2024-085163

DO - 10.1136/bmjopen-2024-085163

M3 - Journal article

C2 - 38772898

AN - SCOPUS:85194024112

VL - 14

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 5

M1 - e085163

ER -