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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04151797
Other study ID # RC31/17/0353
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 19, 2019
Est. completion date March 22, 2021

Study information

Verified date May 2021
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In patients aged 75 years and older, polypathology is frequent and often associated with polypharmacy. This polypharmacy coupled with a lack of proactive elderly care can sometimes lead to hospitalisation. Due to comorbidities and complex problems, management of geriatric patients usually requires a multidisciplinary approach. In Toulouse University Hospital, elderly inpatients can benefit from a geriatric assessment by a Geriatric Mobile Team. Whether this team improve the prescriptions through the advice of a clinical pharmacist has not been demonstrated yet.


Description:

All participants will be identified via the geriatrician of the mobile geriatric team with the following inclusion criteria: age ≥ 75 years, ≥ 5 medications per day and being hospitalised either in emergency room, short-stay medicine unit or in a surgery department. For each patient, the pharmacist will detect potentially inappropriate prescribing (based on explicit criteria and an implicit approach) and liaise with the geriatrician for drug optimisations. The pharmaceutical advice will be added to the geriatrician's written report, and then addressed to the relevant physician. The implementation of the proposals will be evaluated immediately at the end of hospitalisation, and then reassessed three months later by calling the patient and/or his community pharmacist. A total of 250 patients will be enrolled over a 12 month-period. The evolution of potentially inappropriate prescribing will be assessed and their cost evaluated.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date March 22, 2021
Est. primary completion date March 22, 2021
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria: - Patient aged 75 or older - Having 5 medications or more per day - Being hospitalised either in emergency room, short-stay medicine unit or surgery department Exclusion Criteria: - Patient refuses to participate - Patient already included in another study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Medication therapy management
The intervention is in the form of a pharmacist-led medication review aimed at detecting potentially inappropriate prescribing. It includes: Data collection on comorbidities, medication and laboratory results. A pharmacist's evaluation of the prescriptions based on the patient's conditions and on the current recommendations for clinical practice. A detailed feedback to the geriatrician. A written report addressed to the attending physician

Locations

Country Name City State
France Toulouse University Hospital Toulouse Occitanie

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Toulouse Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (1)

Pagès A, Roland C, Qassemi S, Abdeljalil AB, Houles M, Romain M, Toulza O, Belloc A, McCambridge C, Voisin T, Cestac P, Juillard-Condat B; PharMoG study group. Impact of a Pharmacist-included Mobile Geriatrics team intervention on potentially inappropriate drug prescribing: protocol for a prospective feasibility study (PharMoG study). BMJ Open. 2020 Dec 2;10(12):e040917. doi: 10.1136/bmjopen-2020-040917. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline patients' number of potentially inappropriate prescription at the patient discharge after optimization by a mobile geriatric team with pharmacist number of potentially inappropriate prescribing per patient before (month 0) and after the intervention of the mobile geriatric team (at the patient discharge) Month 0 and max Month 2 (At the patient discharge)
Secondary Change from baseline patients' number of potentially inappropriate prescription at 3 months after optimization by a mobile geriatric team with pharmacist number of potentially inappropriate prescribing per patient before (month 0) and after the intervention of the mobile geriatric team (month 3) Month 0, Month 3
Secondary Change from baseline patients' number with at least one potentially inappropriate drug at 3 months after optimization by a mobile geriatric team with pharmacist number of patients with at least one potentially inappropriate drug before (month 0) and after the intervention of the mobile geriatric team (month 3) Month 0, Month 3
Secondary Change from baseline ratio of potentially inappropriate drug per patient at 3 months after optimization by a mobile geriatric team with pharmacist ratio of potentially inappropriate drug per patient before (month 0) and after (month 3) the intervention of the mobile geriatric team. Month 0, Month 3
Secondary Change from baseline mean number of medications per patient at 3 months Mean number of medications per patient Month 0, Month 3
Secondary realisation of a pharmacist-led medication review in primary care Number of pharmacist-led medication review performed in primary care at 3 months Month 3
Secondary number of falls 3 months after pharmacist-led medication review Number of falls Month 3
Secondary mortality 3 months after pharmacist-led medication review Number of deaths Month 3
Secondary re-hospitalisation, including emergency room transfers Number of non-scheduled hospitalisations (including emergency department transfers) Month 3
Secondary The nursing home transfers Number of nursing home transfers Month 3
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