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Recruiting NCT06639113

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

No phase Interventional Self Administration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Self-administration medicines.
Who it may be relevant to
Registry conditions: Self Administration. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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.

Overview

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.

Interventions

  • Behavioral Self-administration medicines
    Management of drugs' administration by the patient

Primary outcome measures

  • Total number of oral medication administration errors in self-administered patients [Time frame: After 7 days of self-administration]
  • Total number of oral medication administration errors in patients receiving administration by nurses [Time frame: After 7 days of administration by nurses]
Secondary outcome measures (4)
  • Medication compliance in self-managed patients [Time frame: At the beginning of the study]
  • Medication compliance in self-managed patients [Time frame: 15 days after hospital discharge for self-managed patients]
  • Patient satisfaction with self-administration of oral medication [Time frame: Within 24 hours of discharge from hospital]
  • Care staff satisfaction with self-administration [Time frame: 6 months after the beginning of the study]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • CH Valenciennes — Valenciennes

Identifiers

NCT: NCT06639113 · 2023-02-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗