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Patient InvolvementNCT03541421

Self-administration of Patients Own Drugs During Hospital Stay

A study testing Patient involvement in administration of drugs in people with Patient Involvement and Medication Errors, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Patient involvement in administration of drugs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteDenmark
Study dates
6 Mar 2017to 1 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Medicinsk Sengeafsnit 1, Regionshospitalet Randers

    Randers, 8930

Other trials in Denmark

About this study

Official title: Self-administration of Patients Own Drugs During Hospital Stay - Patient Involvement, Medication Errors and Health Economics

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.

Read more

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.

Read the detailed description

Background When patients are admitted to Danish hospitals, the responsibility for their medication is taken over by the hospital staff.

Medication administration errors occur in approximately 20% of the total opportunities for error.

Patient involvement (PI) is recommended and self-management support is a central component of PI aiming to improve patients' knowledge, skills and confidence into managing their health condition. "Self-administration of patient's own drugs" during hospital stay is considered a central part of self-management support.

Self-administration of patient's own drugs has been tested in the Capital Region of Denmark. Conclusions were that self-administration increase PI, prepare patients to manage their medication after discharge and release resources within the care group. The occurrence of medication errors compared to traditional medication system was not investigated.

Aim The aim is to investigate whether PI in administering drugs during hospital stay affects the number of medication errors, medication adherence and patient satisfaction and whether it is economically advantageously.

Materials and methods The study design is "complex intervention" and a stepwise process is recommended by the UK Medical Research Council. In study 1 the intervention will therefore be developed, investigated for feasibility and pilot-tested in small scale. In study 2 and 3 the intervention will be evaluated within a RCT.

Intervention If the patient is assessed able to self-administer own drugs at admission, the patient will be asked if he has brought (or can get someone to bring) his usual drugs to hospital. The 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. After discharge, the patient can bring the package and an updated medication list back home to ensure continuity in the medical treatment.

Study 1: Feasibility and pilot study The PhD study is performed at the Department of Cardiology, Randers Regional Hospital. By visits in the department it is assessed how many eligible patients there are, how many patients change ability to self-administer own drugs during hospital stay (risk of withdrawal), how many drugs do they receive and how many opportunities for error are there? These numbers will be used to assess the inclusion period and to calculate the sample size for the RCT. The intervention and workflows will be developed in collaboration with nurses, physicians and patients to ensure acceptability, feasibility and high patient safety.

In the pilot study the intervention and tools for study 2 is tested.

Study 2: RCT The study is a randomized controlled trial where patients are randomized for either intervention or control. The intervention group consists of patients who self-administer own drugs at home and are able to self-administer own drugs during hospital stay. The control group consists of patients who self-administer own drugs at home, who is able to self-administer own drugs during hospital stay, but where standard care is used (not self-administration).

Study 3: Health economic evaluation The cost effectiveness of the intervention is assessed from the perspectives of the hospital and the health system. Relevant resource use will be identified and detailed in study 1 and measured alongside the RCT.

The costs incurred in the intervention group will be compared to the control group based on an intention to treat principle. If the intervention costs in the intervention group exceed those in the control group, the costs will be related to an effect measure such as number of medication errors avoided.

Perspectives When the patient plays an active role in their own medication, it is expected that they will have a more comprehensive and adequate understanding of their situation and will be better to manage their own medication. The number of medication errors during the processes of dispensing and administering drugs at the wards is expected to decrease when patients administers their own drugs. PI and the use of patient's own drugs during admission are expected to contribute to a better utilization of the resources of the Health Care System.

Being tested
Patient involvement in administration of drugs
Medical subject headings
Patient Participation, Medication Adherence, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient involvement in administration of drugsOther

    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.

Study groups in NCT03541421
Study groupRoleWhat they receive
InterventionExperimentalThe patients administers own drugs during hospital stay.
Receives: Other: Patient involvement in administration of drugs
ControlNo interventionThe patients receive medications from the medicine room dispensed by a nurse (standard care). No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)
  1. Medication errors after discharge

    Discrepancies in medicationlists 14 days after discharge through interviews

    Measured: 14 days after discharge

  2. Medication Adherence

    The patients medication adherence is assessed through interviews

    Measured: at hospitalization and 14 days after discharge

  3. Patient satisfaction

    The patients satisfaction with the hospital stay is assessed through interviews

    Measured: 14 days after discharge

  4. Health economics

    The cost effectiveness of the intervention is assessed. The costs incurred in the intervention group will be compared to the control group based on an intention to treat principle. If the intervention costs in the intervention group exceed those in the control group, the costs will be related to an effect measure such as number of medication errors avoided.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2018
  2. Study start6 Mar 2017
  3. Primary completion26 Sep 2018
  4. Study completion1 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03541421
Sponsor's protocol ID
SAMRR2016_2019
Status last verified
Dec 2019
First submitted
25 Oct 2017
Last updated
25 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32821422

Questions about this trial

What is this clinical trial studying?

A study testing Patient involvement in administration of drugs in people with Patient Involvement and Medication Errors, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medication administration errors (time frame: on the day of inclusion and the following day. 1-2 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03541421, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.

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