Self-administration of Patients Own Drugs During Hospital Stay

NCT03541421 | Completed DMC

• 1 other identifier: SAMRR2016_2019
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Background Medication administration errors occur in around 20% of administrations. Patient involvement (PI) is recommended and self-management support e.g. as self-administration of patient's own drugs during hospital stay is a central component of practising PI. Aim To investigate whether PI in administering drugs in hospital affects the number of medication errors, medication adherence and patient satisfaction and whether it is economically advantageously. Materials and methods The PhD Study is performed at the Department of Cardiology, Randers Regional Hospital. The study design is "complex intervention" and the PhD study therefore consists of three studies. In study 1 the intervention is developed, investigated for feasibility and pilot-tested in small scale. In study 2 and 3 the intervention is evaluated within a RCT with outcomes as medication errors, medication adherence, patient satisfaction and cost-effectiveness.

Conditions

Patient Involvement; Medication Errors; Self Administration; Medication Adherence; Patient Satisfaction; Health Economics

Outcome Measures

Primary Outcomes (1)

• Medication administration errors

  The total number of medication administration errors observed compared to the total opportunities for error. Direct observation of nurses (control group) and patients (intervention group) dispensing drugs.

  on the day of inclusion and the following day. 1-2 days.

Secondary Outcomes (4)

• Medication errors after discharge

  14 days after discharge

• Medication Adherence

  at hospitalization and 14 days after discharge

• Patient satisfaction

  14 days after discharge

• Health economics

  from day of inclusion to day of discharge (1-31 days).

Study Arms (2)

Intervention

EXPERIMENTAL

The patients administers own drugs during hospital stay.

Other: Patient involvement in administration of drugs

Control

NO INTERVENTION

The patients receive medications from the medicine room dispensed by a nurse (standard care). No intervention

Interventions

Patient involvement in administration of drugs OTHER

The patient´s own drugs and an updated medication list will be placed in a lockable bedside table. During hospitalization the patient is responsible for taking his own medication. If a new drug is prescribed, the patient will be involved and instructed about it. Furthermore the smallest package will be delivered so that the patient can begin self-administration of the new drug during hospitalization.

Intervention

Eligibility Criteria

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

You may qualify if:

• Patients admitted to the department "Medicinsk sengeafsnit 1", at Randers Regional Hospital Monday to Friday from 8.00 am to 6.00 pm
• Patients who are self-administering own drugs at home

You may not qualify if:

• Patients under 18 years old
• Patients who are not able to self-administer own drugs during hospital stay
• Patients who do not speak Danish
• Patients who can not or will not give informed consent

Sponsors & Collaborators

• University of Aarhus: lead
• Randers Regional Hospital: collaborator
• Hospital Pharmacy Central Denmark Region: collaborator

Study Sites (1)

Medicinsk Sengeafsnit 1, Regionshospitalet Randers

Randers, 8930, Denmark

Location

Related Publications (1)

• Sorensen CA, Olesen C, Lisby M, Enemark U, de Thurah A. Self-administration of medication during hospitalization-a randomized pilot study. Pilot Feasibility Stud. 2020 Aug 18;6:116. doi: 10.1186/s40814-020-00665-3. eCollection 2020.

  PMID: 32821422 DERIVED

MeSH Terms

Conditions

Patient Participation; Medication Adherence; Patient Satisfaction

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Patient Compliance

Study Officials

• Charlotte A. Sørensen, Ph.d.student

  Health, Aarhus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: May 30, 2018
• Study Start: March 6, 2017
• Primary Completion: September 26, 2018
• Study Completion: May 1, 2019
• Last Updated: March 25, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)