Effectiveness of a complex regional advance care planning intervention to improve care consistency with care preferences

TY - JOUR

T1 - Effectiveness of a complex regional advance care planning intervention to improve care consistency with care preferences

AU - Götze, Kornelia

AU - Bausewein, Claudia

AU - Feddersen, Behrend

AU - Fuchs, Angela

AU - Hot, Amra

AU - Hummers, Eva

AU - Icks, Andrea

AU - Kirchner, Änne

AU - Kleinert, Evelyn

AU - Klosterhalfen, Stephanie

AU - Kolbe, Henrike

AU - Laag, Sonja

AU - Langner, Henriette

AU - Lezius, Susanne

AU - Meyer, Gabriele

AU - Montalbo, Joseph

AU - Nauck, Friedemann

AU - Reisinger, Christine

AU - Rieder, Nicola

AU - Schildmann, Jan

AU - Schunk, Michaela

AU - Stanze, Henrikje

AU - Vogel, Christiane

AU - Wegscheider, Karl

AU - Zapf, Antonia

AU - Marckmann, Georg

AU - in der Schmitten, Jürgen

AU - BEVOR study group

PY - 2022/9/12

Y1 - 2022/9/12

N2 - BackgroundAccording to recent legislation, facilitated advance care planning (ACP) for nursing home (NH) residents is covered by German sickness funds. However, the effects of ACP on patient-relevant outcomes have not been studied in Germany yet. This study investigates whether implementing a complex regional ACP intervention improves care consistency with care preferences in NH residents.MethodsThis is a parallel-group cluster-randomized controlled trial (cRCT) with 48 NHs (≈ 3840 resident beds) between 09/2019 and 02/2023. The intervention group will receive a complex, regional ACP intervention aiming at sustainable systems redesign at all levels (individual, institutional, regional). The intervention comprises comprehensive training of ACP facilitators, implementation of reliable ACP processes, organizational development in the NH and other relevant institutions of the regional healthcare system, and education of health professionals caring for the residents. Control group NHs will deliver care as usual.Primary outcome is the hospitalization rate during the 12-months observation period. Secondary outcomes include the rate of residents whose preferences were known and honored in potentially life-threatening events, hospital days, index treatments like resuscitation and artificial ventilation, advance directives, quality of life, psychological burden on bereaved families, and costs of care.The NHs will provide anonymous, aggregated data of all their residents on the primary outcome and several secondary outcomes (data collection 1). For residents who have given informed consent, we will evaluate care consistency with care preferences and further secondary outcomes, based on chart reviews and short interviews with residents, surrogates, and carers (data collection 2). Process evaluation will aim to explain barriers and facilitators, economic evaluation the cost implications.DiscussionThis study has the potential for high-quality evidence on the effects of a complex regional ACP intervention on NH residents, their families and surrogates, NH staff, and health care utilization in Germany. It is the first cRCT investigating a comprehensive regional ACP intervention that aims at improving patient-relevant clinical outcomes, addressing and educating multiple institutions and health care providers, besides qualification of ACP facilitators. Thereby, it can generate evidence on the potential of ACP to effectively promote patient-centered care in the vulnerable population of frail and often chronically ill elderly.Trial registrationClinicalTrials.gov ID NCT04333303. Registered 30 March 2020.

AB - BackgroundAccording to recent legislation, facilitated advance care planning (ACP) for nursing home (NH) residents is covered by German sickness funds. However, the effects of ACP on patient-relevant outcomes have not been studied in Germany yet. This study investigates whether implementing a complex regional ACP intervention improves care consistency with care preferences in NH residents.MethodsThis is a parallel-group cluster-randomized controlled trial (cRCT) with 48 NHs (≈ 3840 resident beds) between 09/2019 and 02/2023. The intervention group will receive a complex, regional ACP intervention aiming at sustainable systems redesign at all levels (individual, institutional, regional). The intervention comprises comprehensive training of ACP facilitators, implementation of reliable ACP processes, organizational development in the NH and other relevant institutions of the regional healthcare system, and education of health professionals caring for the residents. Control group NHs will deliver care as usual.Primary outcome is the hospitalization rate during the 12-months observation period. Secondary outcomes include the rate of residents whose preferences were known and honored in potentially life-threatening events, hospital days, index treatments like resuscitation and artificial ventilation, advance directives, quality of life, psychological burden on bereaved families, and costs of care.The NHs will provide anonymous, aggregated data of all their residents on the primary outcome and several secondary outcomes (data collection 1). For residents who have given informed consent, we will evaluate care consistency with care preferences and further secondary outcomes, based on chart reviews and short interviews with residents, surrogates, and carers (data collection 2). Process evaluation will aim to explain barriers and facilitators, economic evaluation the cost implications.DiscussionThis study has the potential for high-quality evidence on the effects of a complex regional ACP intervention on NH residents, their families and surrogates, NH staff, and health care utilization in Germany. It is the first cRCT investigating a comprehensive regional ACP intervention that aims at improving patient-relevant clinical outcomes, addressing and educating multiple institutions and health care providers, besides qualification of ACP facilitators. Thereby, it can generate evidence on the potential of ACP to effectively promote patient-centered care in the vulnerable population of frail and often chronically ill elderly.Trial registrationClinicalTrials.gov ID NCT04333303. Registered 30 March 2020.

KW - Advance Care Planning

KW - Aged

KW - Germany

KW - Health Personnel

KW - Humans

KW - Multicenter Studies as Topic

KW - Nursing Homes

KW - Quality of Life

KW - Randomized Controlled Trials as Topic

U2 - 10.1186/s13063-022-06576-3

DO - 10.1186/s13063-022-06576-3

M3 - SCORING: Journal article

C2 - 36096948

VL - 23

JO - TRIALS

JF - TRIALS

SN - 1745-6215

IS - 1

M1 - 770

ER -