From Administration of Oral Medicines by Nurses to Controlled Self-administration: Impact on Safety of Administration During Hospitalisation (AUTOGESTMED)

Evaluation of the Safety of a Change of Practice in the Administration of Oral Medication During Hospitalisation: From Administration by the Nurse to Supervision of Self-administration of Medication in the Locomotor and Polyvalent Rehabilitation Department of the Valenciennes Hospital Centre.

Medication administration practices during patient hospital stay tend to improve patient autonomy. Several studies have concluded that self-administration of medication programs in hospital centers have a beneficial effect on patients' knowledge of their medications, their compliance and the safety of administration. Nevertheless, few studies have been carried out in France on this subject. The aim of this study is to evaluate the impact of the change of nurses administration practices from the administration of each drugs to supervision of self-administration by the patient under a self-administration program.

Study Overview

• Status: Recruiting
• Conditions: Self Administration
• Intervention / Treatment: Behavioral: Self-administration medicines

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Quentin HIVER; Phone Number: 0327143333; Email: hiver-q@ch-valenciennes.fr

Study Locations

• France
  • Valenciennes, France, 59300
    • Recruiting
    • Ch Valenciennes
    • Contact: Hanane FODIL; Phone Number: 0327140665; Email: fodil-h@ch-valenciennes.fr
    • Principal Investigator: Quentin HIVER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Care in the rehabilitation unit of Hospital in Valenciennes, France
• Patient with a planned stay of 7 days or more
• Patient on chronic treatment before admission to hospital ;
• Patients taking their treatment alone at home;

Exclusion Criteria:

• Age < 18 years old
• Patients with poor compliance
• No chronic treatment
• Unstable disease
• Major cognitive, memory or depressive disorders
• Swallowing disorders
• Prehension problems
• Patient under legal protection
• Patient under guardianship or curatorship
• Patient included in another trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self administration of medication by the patient	Behavioral: Self-administration medicines; Management of drugs' administration by the patient
No Intervention: Administration of medication by the nurses; Administration of medication by the nurses during medication administration rounds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of oral medication administration errors in self-administered patients	Total number of oral medication administration errors in self-administered patients	After 7 days of self-administration
Total number of oral medication administration errors in patients receiving administration by nurses	Total number of oral medication administration errors in patients receiving administration by nurses	After 7 days of administration by nurses

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication compliance in self-managed patients	Medication compliance is assessed using the questionnaire "Evaluation of medication compliance" provided by the French health insurance system. This questionnaire consists of 6 questions with "yes" or "no" answers. Each "no" answer is worth 1 point, each "yes" answer is worth 0 points. A patient with poor medication compliance will have a score of 3 or less.	At the beginning of the study
Medication compliance in self-managed patients	Medication compliance is assessed using the questionnaire "Evaluation of medication compliance" provided by the French health insurance system. This questionnaire consists of 6 questions with "yes" or "no" answers. Each "no" answer is worth 1 point, each "yes" answer is worth 0 points. A patient with poor medication compliance will have a score of 3 or less.	15 days after hospital discharge for self-managed patients
Patient satisfaction with self-administration of oral medication	Patient satisfaction was assessed using a questionnaire designed by the investigator, consisting of 9 questions giving a total of 45 points. The higher the total, the higher the level of satisfaction.	Within 24 hours of discharge from hospital
Care staff satisfaction with self-administration	Care staff satisfaction was assessed using a questionnaire designed by the investigator, consisting of 4 questions totalling 20 points. The higher the total, the higher the level of satisfaction.	6 months after the beginning of the study

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Valenciennes
• Investigators: Principal Investigator: Quentin HIVER, PH, Centre Hospitalier de Valenciennes

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: September 5, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Administration; Autonomy; Self-management of medication
• Other Study ID Numbers: 2023-02-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No