NCT03393299

Brief Summary

Assess the impact of the systematic use of STOPP/START tool during medication conciliation on the evolution of hospitalised elderly people's quality of life at 2 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for not_applicable quality-of-life

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

January 16, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

January 2, 2018

Last Update Submit

August 4, 2020

Conditions

Quality of LifeDrug Use

Keywords

elderly peoplegeriatric short-staySTOPP/START criteria

Outcome Measures

Primary Outcomes (1)

  • SF-12 Quality of life scale

    The evolution of the hospitalised elderly people's quality of life at 2 months will be measured by the SF-12 scale.

    at inclusion and at 2 months

Secondary Outcomes (3)

  • Number of falls

    at 2 months

  • Proportion of patients rehospitalized

    at 2 months

  • Mortality

    at 2 months

Study Arms (2)

STOPP/START

EXPERIMENTAL

Use of STOPP/START criteria during medication reconciliation

Procedure: STOPP/START criteria

CONTROL

NO INTERVENTION

Medication reconciliation done as usual, without the consideration of the STOPP/START criteria

Interventions

STOPP/START criteriaPROCEDURE

software which helps to do the drug reconciliation

STOPP/START

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patient with more than 75 years old
  • Hospitalized in geriatrics short-stay
  • Patient with a written informed consent
  • Patient with a social security scheme

You may not qualify if:

  • Severe dementia
  • Not able to respond to SF-12
  • Disease at final stage
  • Patient under legal protection (maintenance of justice, tutelage, legal guardianship)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital La Porte Verte

Versailles, 78004, France

Location

MeSH Terms

Interventions

Potentially Inappropriate Medication List

Intervention Hierarchy (Ancestors)

Quality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2018

First Posted

January 8, 2018

Study Start

January 16, 2018

Primary Completion

July 17, 2018

Study Completion

October 30, 2018

Last Updated

August 5, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)