Cost-effectiveness of prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO) versus usual care – Protocol for a health economic evaluation alongside a randomized controlled trial
Abstract Background Prehabilitation aims to improve patients' functional capacity before surgery to reduce perioperative complications, promote recovery and decrease probability of disability. The planned economic evaluation is performed alongside a large German multi-centre pragmatic, two-arm...
Main Authors: | , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
BMC
2024-03-01
|
Series: | BMC Geriatrics |
Subjects: | |
Online Access: | https://doi.org/10.1186/s12877-024-04833-5 |
_version_ | 1797266668392546304 |
---|---|
author | Helene Eckhardt Wilm Quentin Julia Silzle Reinhard Busse Tanja Rombey |
author_facet | Helene Eckhardt Wilm Quentin Julia Silzle Reinhard Busse Tanja Rombey |
author_sort | Helene Eckhardt |
collection | DOAJ |
description | Abstract Background Prehabilitation aims to improve patients' functional capacity before surgery to reduce perioperative complications, promote recovery and decrease probability of disability. The planned economic evaluation is performed alongside a large German multi-centre pragmatic, two-arm parallel-group, randomized controlled trial on prehabilitation for frail elderly patients before elective surgery compared to standard care (PRAEP-GO RCT). The aim is to determine the cost-effectiveness and cost-utility of prehabilitation for frail elderly before an elective surgery. Methods The planned health economic evaluation comprises cost-effectiveness, and cost-utility analyses. Analyses are conducted in the German context from different perspectives including the payer perspective, i.e. the statutory health insurance, the societal perspective and the health care provider perspective. Data on outcomes and costs, are collected alongside the ongoing PRAEP-GO RCT. The trial population includes frail or pre-frail patients aged ≥70 years with planned elective surgery. The intervention consists of frailty screening (Fried phenotype), a shared decision-making conference determining modality (physiotherapy and unsupervised physical exercises, nutrition counselling, etc.) and setting (inpatient, day care, outpatient etc.) of a 3-week individual multimodal prehabilitation prior to surgery. The control group receives standard preoperative care. Costs include the intervention costs, the costs of the index hospital stay for surgery, and health care resources consumed during a 12-month follow-up. Clinical effectiveness outcomes included in the economic evaluation are the level of care dependency, the degree of disability as measured by the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), quality-adjusted life years (QALY) derived from the EQ-5D-5L and the German utility set, and complications occurring during the index hospital stay. Each adopted perspective considers different types of costs and outcomes as outlined in the protocol. All analyses will feature Intention-To-Treat analysis. To explore methodological and parametric uncertainties, we will conduct probabilistic and deterministic sensitivity analyses. Subgroup analyses will be performed as secondary analyses. Discussion The health economic evaluation will provide insights into the cost-effectiveness of prehabilitation in older frail populations, informing decision-making processes and contributing to the evidence base in this field. Potential limitation includes a highly heterogeneous trial population. Trial registration PRAEP-GO RCT: NCT04418271; economic evaluation: OSF ( https://osf.io/ecm74 ). |
first_indexed | 2024-04-25T01:04:21Z |
format | Article |
id | doaj.art-e876749c0985414886fb7fa6b1c1c3c8 |
institution | Directory Open Access Journal |
issn | 1471-2318 |
language | English |
last_indexed | 2024-04-25T01:04:21Z |
publishDate | 2024-03-01 |
publisher | BMC |
record_format | Article |
series | BMC Geriatrics |
spelling | doaj.art-e876749c0985414886fb7fa6b1c1c3c82024-03-10T12:21:41ZengBMCBMC Geriatrics1471-23182024-03-0124111410.1186/s12877-024-04833-5Cost-effectiveness of prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO) versus usual care – Protocol for a health economic evaluation alongside a randomized controlled trialHelene Eckhardt0Wilm Quentin1Julia Silzle2Reinhard Busse3Tanja Rombey4Department of Health Care Management, Institute of Technology and Management, Technische Universität BerlinDepartment of Health Care Management, Institute of Technology and Management, Technische Universität BerlinDepartment of Health Care Management, Institute of Technology and Management, Technische Universität BerlinDepartment of Health Care Management, Institute of Technology and Management, Technische Universität BerlinDepartment of Health Care Management, Institute of Technology and Management, Technische Universität BerlinAbstract Background Prehabilitation aims to improve patients' functional capacity before surgery to reduce perioperative complications, promote recovery and decrease probability of disability. The planned economic evaluation is performed alongside a large German multi-centre pragmatic, two-arm parallel-group, randomized controlled trial on prehabilitation for frail elderly patients before elective surgery compared to standard care (PRAEP-GO RCT). The aim is to determine the cost-effectiveness and cost-utility of prehabilitation for frail elderly before an elective surgery. Methods The planned health economic evaluation comprises cost-effectiveness, and cost-utility analyses. Analyses are conducted in the German context from different perspectives including the payer perspective, i.e. the statutory health insurance, the societal perspective and the health care provider perspective. Data on outcomes and costs, are collected alongside the ongoing PRAEP-GO RCT. The trial population includes frail or pre-frail patients aged ≥70 years with planned elective surgery. The intervention consists of frailty screening (Fried phenotype), a shared decision-making conference determining modality (physiotherapy and unsupervised physical exercises, nutrition counselling, etc.) and setting (inpatient, day care, outpatient etc.) of a 3-week individual multimodal prehabilitation prior to surgery. The control group receives standard preoperative care. Costs include the intervention costs, the costs of the index hospital stay for surgery, and health care resources consumed during a 12-month follow-up. Clinical effectiveness outcomes included in the economic evaluation are the level of care dependency, the degree of disability as measured by the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), quality-adjusted life years (QALY) derived from the EQ-5D-5L and the German utility set, and complications occurring during the index hospital stay. Each adopted perspective considers different types of costs and outcomes as outlined in the protocol. All analyses will feature Intention-To-Treat analysis. To explore methodological and parametric uncertainties, we will conduct probabilistic and deterministic sensitivity analyses. Subgroup analyses will be performed as secondary analyses. Discussion The health economic evaluation will provide insights into the cost-effectiveness of prehabilitation in older frail populations, informing decision-making processes and contributing to the evidence base in this field. Potential limitation includes a highly heterogeneous trial population. Trial registration PRAEP-GO RCT: NCT04418271; economic evaluation: OSF ( https://osf.io/ecm74 ).https://doi.org/10.1186/s12877-024-04833-5Health care economicsHealth care evaluation mechanismsCost-effectiveness analysisTrial-based health economic evaluationPrehabilitationPreoperative exercise |
spellingShingle | Helene Eckhardt Wilm Quentin Julia Silzle Reinhard Busse Tanja Rombey Cost-effectiveness of prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO) versus usual care – Protocol for a health economic evaluation alongside a randomized controlled trial BMC Geriatrics Health care economics Health care evaluation mechanisms Cost-effectiveness analysis Trial-based health economic evaluation Prehabilitation Preoperative exercise |
title | Cost-effectiveness of prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO) versus usual care – Protocol for a health economic evaluation alongside a randomized controlled trial |
title_full | Cost-effectiveness of prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO) versus usual care – Protocol for a health economic evaluation alongside a randomized controlled trial |
title_fullStr | Cost-effectiveness of prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO) versus usual care – Protocol for a health economic evaluation alongside a randomized controlled trial |
title_full_unstemmed | Cost-effectiveness of prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO) versus usual care – Protocol for a health economic evaluation alongside a randomized controlled trial |
title_short | Cost-effectiveness of prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO) versus usual care – Protocol for a health economic evaluation alongside a randomized controlled trial |
title_sort | cost effectiveness of prehabilitation of elderly frail or pre frail patients prior to elective surgery praep go versus usual care protocol for a health economic evaluation alongside a randomized controlled trial |
topic | Health care economics Health care evaluation mechanisms Cost-effectiveness analysis Trial-based health economic evaluation Prehabilitation Preoperative exercise |
url | https://doi.org/10.1186/s12877-024-04833-5 |
work_keys_str_mv | AT heleneeckhardt costeffectivenessofprehabilitationofelderlyfrailorprefrailpatientspriortoelectivesurgerypraepgoversususualcareprotocolforahealtheconomicevaluationalongsidearandomizedcontrolledtrial AT wilmquentin costeffectivenessofprehabilitationofelderlyfrailorprefrailpatientspriortoelectivesurgerypraepgoversususualcareprotocolforahealtheconomicevaluationalongsidearandomizedcontrolledtrial AT juliasilzle costeffectivenessofprehabilitationofelderlyfrailorprefrailpatientspriortoelectivesurgerypraepgoversususualcareprotocolforahealtheconomicevaluationalongsidearandomizedcontrolledtrial AT reinhardbusse costeffectivenessofprehabilitationofelderlyfrailorprefrailpatientspriortoelectivesurgerypraepgoversususualcareprotocolforahealtheconomicevaluationalongsidearandomizedcontrolledtrial AT tanjarombey costeffectivenessofprehabilitationofelderlyfrailorprefrailpatientspriortoelectivesurgerypraepgoversususualcareprotocolforahealtheconomicevaluationalongsidearandomizedcontrolledtrial |