Impact of "ASAP" Multidisciplinary Optimization Care Protocol on Clinical Outcome in Elderly Inpatients for Hip Fracture

Sponsor

University of Liege (Other)

Overall Status

Completed

CT.gov ID

NCT04771364

Collaborator

(none)

300

Enrollment

Location

Actual Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the impact of ASAP protocol (geriatric advice, early surgery, loco-regional anesthesia and pharmacological adaptation) on elderly patients with hip fracture and clinical outcome.

Condition or Disease	Intervention/Treatment	Phase
Hip Fractures	Other: ASAP care's protocol

Detailed Description

Retrospective double cohort analysis for ASA physical status 1, 2 and 3 elderly patients >65 years old, scheduled to undergo surgery for hip fracture between January 1st 2019 and January 1st 2021.

The investigator want to confirm the better outcome on 30-days mortality after surgery in patients where the ASAP protocol was applied, starting from 1 January 2020.

ASAP protocol follow the latest international guidelines about hip fracture in elderly patient. The investigator focuses the research about the impact of ASAP protocol on clinical outcome: geriatrician's advice, impact of loco-regional techniques on intra-operative and postoperative pain control, chronic pharmacological therapy's adaptation and 30-days postoperative mortality.

Study Design

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Impact of "ASAP" Multidisciplinary Optimization Care Protocol on Clinical Outcome in Elderly Inpatients for Hip Fracture: Retrospective Cohort Study

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Jan 1, 2021

Actual Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Standard care Patients aged >65 years old scheduled for hip fracture between January 1st 2019 and December 31th 2019. Standard anesthesiology cares were performed, as usual in our hospital institution.
ASAP cohort Patients aged >65 years old scheduled for hip fracture between January 1st 2020 and December 31th 2020. Standard anesthesiology cares were performed, as usual in our hospital institution, but the investigator focused the attention on these cares' adaptation: early geriatrician's advice, prefer locoregional anesthesia techniques where possible, early surgical therapy and medical adaptation on chronic therapy.	Other: ASAP care's protocol Early geriatrician's advice, prefer locoregional anesthesia techniques where possible, early surgical therapy and medical adaptation on chronic patient's therapy (in particular with regard to sedative, anticholinergic and psychotropic drugs).

Arm

Intervention/Treatment

Standard care

Patients aged >65 years old scheduled for hip fracture between January 1st 2019 and December 31th 2019. Standard anesthesiology cares were performed, as usual in our hospital institution.

ASAP cohort

Patients aged >65 years old scheduled for hip fracture between January 1st 2020 and December 31th 2020. Standard anesthesiology cares were performed, as usual in our hospital institution, but the investigator focused the attention on these cares' adaptation: early geriatrician's advice, prefer locoregional anesthesia techniques where possible, early surgical therapy and medical adaptation on chronic therapy.

Other: ASAP care's protocol

Early geriatrician's advice, prefer locoregional anesthesia techniques where possible, early surgical therapy and medical adaptation on chronic patient's therapy (in particular with regard to sedative, anticholinergic and psychotropic drugs).

Outcome Measures

Primary Outcome Measures

Postoperative complications [7 days]
Neurological, cardiovascular, pulmonary, renal, infectious and gastrointestinal complications after surgery.

Secondary Outcome Measures

Days of hospitalisation [30 days]
Total hospitalisation days
30-days postoperative mortality [30 days]
Mortality 1 month after surgery
1-year postoperative mortality [1 year]
Mortality 1 year after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Over 65 years old patients with hip fractures between January 1st 2019 and December 31th 2020

Exclusion Criteria:

Fracture without indication for surgery
Death before surgery
Intensive care's or polytrauma patients (> 2 fracture sites) or under pharmacological coma needed before and after surgery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Liège	Liège		Belgium	4000

Sponsors and Collaborators

University of Liege

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Borges FK, Bhandari M, Patel A, Avram V, Guerra-Farfán E, Sigamani A, Umer M, Tiboni M, Adili A, Neary J, Tandon V, Sancheti PK, Lawendy A, Jenkinson R, Ramokgopa M, Biccard BM, Szczeklik W, Wang CY, Landoni G, Forget P, Popova E, Wood G, Nabi Nur A, John B, Ślęczka P, Feibel RJ, Balaguer-Castro M, Deheshi B, Winemaker M, de Beer J, Kolesar R, Teixidor-Serra J, Tomas-Hernandez J, McGillion M, Shanthanna H, Moppett I, Vincent J, Pettit S, Harvey V, Gauthier L, Alvarado K, Devereaux PJ. Rationale and design of the HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) Trial: a protocol for an international randomised controlled trial evaluating early surgery for hip fracture patients. BMJ Open. 2019 May 1;9(4):e028537. doi: 10.1136/bmjopen-2018-028537.

Responsible Party:

Jean François Brichant, Head of Anesthesiology Departement, University of Liege

ClinicalTrials.gov Identifier:

NCT04771364

Other Study ID Numbers:

ASAP

First Posted:

Feb 25, 2021

Last Update Posted:

Mar 2, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fractures, Bone

Hip Fractures

Study Results

No Results Posted as of Mar 2, 2022