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NCT Number: NCT06639113

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

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.

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Key information

Conditions

Self Administration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Valenciennes

Valenciennes, 59300, France

Location status: Recruiting

Location contact

Hanane FODIL

CONTACT

[email protected]

0327140665

Quentin HIVER

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-administration medicines

Behavioral

Management of drugs' administration by the patient

Primary outcomes

  1. 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 self-administered patients

  2. Total number of oral medication administration errors in patients receiving administration by nurses

    Time frame: After 7 days of administration by nurses

    Total number of oral medication administration errors in patients receiving administration by nurses

Secondary outcomes

  1. Medication compliance in self-managed patients

    Time frame: At the beginning of the study

    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.

  2. Medication compliance in self-managed patients

    Time frame: 15 days after hospital discharge for 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.

  3. Patient satisfaction with self-administration of oral medication

    Time frame: Within 24 hours of discharge from hospital

    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.

  4. Care staff satisfaction with self-administration

    Time frame: 6 months after the beginning of the study

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Quentin HIVER

CONTACT

[email protected]

0327143333

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Valenciennes

Network

Registry information

Official study 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.

Acronym: AUTOGESTMED

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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