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

NCT06639113 | Recruiting

• 1 other identifier: 2023-02-04
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Self Administration

Keywords

Rehabilitation; Self-management of medication; Administration; Autonomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Medication compliance in self-managed patients

  At the beginning of the study

• Medication compliance in self-managed patients

  15 days after hospital discharge for self-managed patients

• Patient satisfaction with self-administration of oral medication

  Within 24 hours of discharge from hospital

• Care staff satisfaction with self-administration

  6 months after the beginning of the study

Study Arms (2)

Self administration of medication by the patient

EXPERIMENTAL

Self administration of medication by the patient

Behavioral: Self-administration medicines

Administration of medication by the nurses

NO INTERVENTION

Administration of medication by the nurses during medication administration rounds

Interventions

Self-administration medicines BEHAVIORAL

Management of drugs' administration by the patient

Self administration of medication by the patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Valenciennes: lead

Study Sites (1)

CH Valenciennes

Valenciennes, 59300, France

RECRUITING

Study Officials

• Quentin HIVER, PH

  Centre Hospitalier de Valenciennes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quentin HIVER

CONTACT

0327143333; hiver-q@ch-valenciennes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: October 15, 2024
• Study Start: May 24, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)