Early geriatric assessment and management in older patients with Clostridioides difficile infection in Denmark (CLODIfrail): a randomised trial

Tone Rubak; Simon Mark Dahl Baunwall; Merete Gregersen; Sara Ellegaard Paaske; Malene Asferg; Ishay Barat; Joanna Secher-Johnsen; Mikael Groth Riis; Jeppe Bakkestrøm Rosenbæk; Troels Kjærskov Hansen; Marianne Ørum; Claire J Steves; Hanne Veilbæk; Christian Lodberg Hvas; Else Marie Skjøde Damsgaard

doi:10.1016/j.lanhl.2024.100648

Early geriatric assessment and management in older patients with Clostridioides difficile infection in Denmark (CLODIfrail): a randomised trial

Tone Rubak^*, Simon Mark Dahl Baunwall, Merete Gregersen, Sara Ellegaard Paaske, Malene Asferg, Ishay Barat, Joanna Secher-Johnsen, Mikael Groth Riis, Jeppe Bakkestrøm Rosenbæk, Troels Kjærskov Hansen, Marianne Ørum, Claire J Steves, Hanne Veilbæk, Christian Lodberg Hvas, Else Marie Skjøde Damsgaard

^*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

Abstract

BACKGROUND: Clostridioides difficile infection causes diarrhoea and colitis. Older patients with C difficile infection are often frail and have comorbidities, leading to high mortality rates. The frailty burden in older people might restrict access to treatments, such as C difficile infection-specific antibiotics and faecal microbiota transplantation. We aimed to investigate the clinical effects of early comprehensive geriatric assessment (CGA) and frailty evaluation, including home visits and assessment for faecal microbiota transplantation, in older patients with C difficile infection.

METHODS: In this randomised, quality improvement trial with a pragmatic design, patients from the Central Denmark Region aged 70 years or older with a positive PCR test for C difficile toxin were randomly assigned (1:1) to CGA or standard care, both with equal access to faecal microbiota transplantation. Patients and investigators were unmasked to treatment. The primary outcome was 90-day mortality, and was compared in the study groups according to the intention-to-treat principle. The study is registered with ClinicalTrials.gov, NCT05447533.

FINDINGS: Between Sept 1, 2022, and May 3, 2023, we randomly assigned 217 patients to CGA (n=109) or standard care (n=108). The median patient age was 78 years (IQR 74-84). 116 (53%) of 217 patients were female and 101 (47%) were male. 16 (15%; 95% CI 9-23) of 109 patients in the CGA group and 22 (20%; 14-29) of 108 patients in the standard-care group died within 90 days (odds ratio 0·66, 95% CI 0·32-1·38. No serious adverse events or deaths related to patient assessment or faecal microbiota transplantation were recorded in either group. Deaths directly attributable to C difficile infection were lower in the CGA group (seven [44%] of 16 deaths vs 18 [82%] of 22 deaths in the standard-care group; p=0·020).

INTERPRETATION: Older patients who received CGA had a 90-day mortality rate similar to that of patients who received standard care, but with fewer deaths directly attributable to C difficile infection.

FUNDING: Innovation Fund Denmark, Novo Nordisk Foundation, and Helsefonden.

Originalsprog	Engelsk
Artikelnummer	100648
Tidsskrift	The Lancet Healthy Longevity
Vol/bind	5
Nummer	12
Sider (fra-til)	100648
ISSN	2666-7568
DOI	https://doi.org/10.1016/j.lanhl.2024.100648
Status	Udgivet - dec. 2024

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10.1016/j.lanhl.2024.100648

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Rubak, T., Baunwall, S. M. D., Gregersen, M., Paaske, S. E., Asferg, M., Barat, I., Secher-Johnsen, J., Riis, M. G., Rosenbæk, J. B., Hansen, T. K., Ørum, M., Steves, C. J., Veilbæk, H., Hvas, C. L., & Damsgaard, E. M. S. (2024). Early geriatric assessment and management in older patients with Clostridioides difficile infection in Denmark (CLODIfrail): a randomised trial. The Lancet Healthy Longevity, 5(12), 100648. Artikel 100648. https://doi.org/10.1016/j.lanhl.2024.100648

@article{5ff2db88610e4a788362d5596aaf450d,

title = "Early geriatric assessment and management in older patients with Clostridioides difficile infection in Denmark (CLODIfrail): a randomised trial",

abstract = "BACKGROUND: Clostridioides difficile infection causes diarrhoea and colitis. Older patients with C difficile infection are often frail and have comorbidities, leading to high mortality rates. The frailty burden in older people might restrict access to treatments, such as C difficile infection-specific antibiotics and faecal microbiota transplantation. We aimed to investigate the clinical effects of early comprehensive geriatric assessment (CGA) and frailty evaluation, including home visits and assessment for faecal microbiota transplantation, in older patients with C difficile infection.METHODS: In this randomised, quality improvement trial with a pragmatic design, patients from the Central Denmark Region aged 70 years or older with a positive PCR test for C difficile toxin were randomly assigned (1:1) to CGA or standard care, both with equal access to faecal microbiota transplantation. Patients and investigators were unmasked to treatment. The primary outcome was 90-day mortality, and was compared in the study groups according to the intention-to-treat principle. The study is registered with ClinicalTrials.gov, NCT05447533.FINDINGS: Between Sept 1, 2022, and May 3, 2023, we randomly assigned 217 patients to CGA (n=109) or standard care (n=108). The median patient age was 78 years (IQR 74-84). 116 (53%) of 217 patients were female and 101 (47%) were male. 16 (15%; 95% CI 9-23) of 109 patients in the CGA group and 22 (20%; 14-29) of 108 patients in the standard-care group died within 90 days (odds ratio 0·66, 95% CI 0·32-1·38. No serious adverse events or deaths related to patient assessment or faecal microbiota transplantation were recorded in either group. Deaths directly attributable to C difficile infection were lower in the CGA group (seven [44%] of 16 deaths vs 18 [82%] of 22 deaths in the standard-care group; p=0·020).INTERPRETATION: Older patients who received CGA had a 90-day mortality rate similar to that of patients who received standard care, but with fewer deaths directly attributable to C difficile infection.FUNDING: Innovation Fund Denmark, Novo Nordisk Foundation, and Helsefonden.",

author = "Tone Rubak and Baunwall, {Simon Mark Dahl} and Merete Gregersen and Paaske, {Sara Ellegaard} and Malene Asferg and Ishay Barat and Joanna Secher-Johnsen and Riis, {Mikael Groth} and Rosenb{\ae}k, {Jeppe Bakkestr{\o}m} and Hansen, {Troels Kj{\ae}rskov} and Marianne {\O}rum and Steves, {Claire J} and Hanne Veilb{\ae}k and Hvas, {Christian Lodberg} and Damsgaard, {Else Marie Skj{\o}de}",

year = "2024",

month = dec,

doi = "10.1016/j.lanhl.2024.100648",

language = "English",

volume = "5",

pages = "100648",

journal = "The Lancet Healthy Longevity",

issn = "2666-7568",

publisher = "Elsevier Ltd",

number = "12",

}

Rubak, T , Baunwall, SMD , Gregersen, M , Paaske, SE, Asferg, M, Barat, I, Secher-Johnsen, J, Riis, MG, Rosenbæk, JB, Hansen, TK, Ørum, M, Steves, CJ, Veilbæk, H, Hvas, CL & Damsgaard, EMS 2024, 'Early geriatric assessment and management in older patients with Clostridioides difficile infection in Denmark (CLODIfrail): a randomised trial', The Lancet Healthy Longevity, bind 5, nr. 12, 100648, s. 100648. https://doi.org/10.1016/j.lanhl.2024.100648

Early geriatric assessment and management in older patients with Clostridioides difficile infection in Denmark (CLODIfrail): a randomised trial. / Rubak, Tone ; Baunwall, Simon Mark Dahl ; Gregersen, Merete et al.
I: The Lancet Healthy Longevity, Bind 5, Nr. 12, 100648, 12.2024, s. 100648.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

TY - JOUR

T1 - Early geriatric assessment and management in older patients with Clostridioides difficile infection in Denmark (CLODIfrail)

T2 - a randomised trial

AU - Rubak, Tone

AU - Baunwall, Simon Mark Dahl

AU - Gregersen, Merete

AU - Paaske, Sara Ellegaard

AU - Asferg, Malene

AU - Barat, Ishay

AU - Secher-Johnsen, Joanna

AU - Riis, Mikael Groth

AU - Rosenbæk, Jeppe Bakkestrøm

AU - Hansen, Troels Kjærskov

AU - Ørum, Marianne

AU - Steves, Claire J

AU - Veilbæk, Hanne

AU - Hvas, Christian Lodberg

AU - Damsgaard, Else Marie Skjøde

PY - 2024/12

Y1 - 2024/12

N2 - BACKGROUND: Clostridioides difficile infection causes diarrhoea and colitis. Older patients with C difficile infection are often frail and have comorbidities, leading to high mortality rates. The frailty burden in older people might restrict access to treatments, such as C difficile infection-specific antibiotics and faecal microbiota transplantation. We aimed to investigate the clinical effects of early comprehensive geriatric assessment (CGA) and frailty evaluation, including home visits and assessment for faecal microbiota transplantation, in older patients with C difficile infection.METHODS: In this randomised, quality improvement trial with a pragmatic design, patients from the Central Denmark Region aged 70 years or older with a positive PCR test for C difficile toxin were randomly assigned (1:1) to CGA or standard care, both with equal access to faecal microbiota transplantation. Patients and investigators were unmasked to treatment. The primary outcome was 90-day mortality, and was compared in the study groups according to the intention-to-treat principle. The study is registered with ClinicalTrials.gov, NCT05447533.FINDINGS: Between Sept 1, 2022, and May 3, 2023, we randomly assigned 217 patients to CGA (n=109) or standard care (n=108). The median patient age was 78 years (IQR 74-84). 116 (53%) of 217 patients were female and 101 (47%) were male. 16 (15%; 95% CI 9-23) of 109 patients in the CGA group and 22 (20%; 14-29) of 108 patients in the standard-care group died within 90 days (odds ratio 0·66, 95% CI 0·32-1·38. No serious adverse events or deaths related to patient assessment or faecal microbiota transplantation were recorded in either group. Deaths directly attributable to C difficile infection were lower in the CGA group (seven [44%] of 16 deaths vs 18 [82%] of 22 deaths in the standard-care group; p=0·020).INTERPRETATION: Older patients who received CGA had a 90-day mortality rate similar to that of patients who received standard care, but with fewer deaths directly attributable to C difficile infection.FUNDING: Innovation Fund Denmark, Novo Nordisk Foundation, and Helsefonden.

AB - BACKGROUND: Clostridioides difficile infection causes diarrhoea and colitis. Older patients with C difficile infection are often frail and have comorbidities, leading to high mortality rates. The frailty burden in older people might restrict access to treatments, such as C difficile infection-specific antibiotics and faecal microbiota transplantation. We aimed to investigate the clinical effects of early comprehensive geriatric assessment (CGA) and frailty evaluation, including home visits and assessment for faecal microbiota transplantation, in older patients with C difficile infection.METHODS: In this randomised, quality improvement trial with a pragmatic design, patients from the Central Denmark Region aged 70 years or older with a positive PCR test for C difficile toxin were randomly assigned (1:1) to CGA or standard care, both with equal access to faecal microbiota transplantation. Patients and investigators were unmasked to treatment. The primary outcome was 90-day mortality, and was compared in the study groups according to the intention-to-treat principle. The study is registered with ClinicalTrials.gov, NCT05447533.FINDINGS: Between Sept 1, 2022, and May 3, 2023, we randomly assigned 217 patients to CGA (n=109) or standard care (n=108). The median patient age was 78 years (IQR 74-84). 116 (53%) of 217 patients were female and 101 (47%) were male. 16 (15%; 95% CI 9-23) of 109 patients in the CGA group and 22 (20%; 14-29) of 108 patients in the standard-care group died within 90 days (odds ratio 0·66, 95% CI 0·32-1·38. No serious adverse events or deaths related to patient assessment or faecal microbiota transplantation were recorded in either group. Deaths directly attributable to C difficile infection were lower in the CGA group (seven [44%] of 16 deaths vs 18 [82%] of 22 deaths in the standard-care group; p=0·020).INTERPRETATION: Older patients who received CGA had a 90-day mortality rate similar to that of patients who received standard care, but with fewer deaths directly attributable to C difficile infection.FUNDING: Innovation Fund Denmark, Novo Nordisk Foundation, and Helsefonden.

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U2 - 10.1016/j.lanhl.2024.100648

DO - 10.1016/j.lanhl.2024.100648

M3 - Journal article

C2 - 39488230

SN - 2666-7568

VL - 5

SP - 100648

JO - The Lancet Healthy Longevity

JF - The Lancet Healthy Longevity

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ER -

Early geriatric assessment and management in older patients with Clostridioides difficile infection in Denmark (CLODIfrail): a randomised trial

Abstract

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