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.
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
- Conditions the study is for
- Patient Involvement, Medication Errors, Self Administration
- 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
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.
- Conditions
- Patient Involvement, Medication Errors, Self Administration, Medication Adherence, Patient Satisfaction, Health Economics
- 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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The patients administers own drugs during hospital stay. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Medication errors after discharge
Discrepancies in medicationlists 14 days after discharge through interviews
Measured: 14 days after discharge
Medication Adherence
The patients medication adherence is assessed through interviews
Measured: at hospitalization and 14 days after discharge
Patient satisfaction
The patients satisfaction with the hospital stay is assessed through interviews
Measured: 14 days after discharge
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.
- First posted30 May 2018
- Study start6 Mar 2017
- Primary completion26 Sep 2018
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient InvolvementStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Randers Regional Hospital, Hospital Pharmacy Central Denmark Region
- Responsible party
- Sponsor
- Investigators
- Charlotte A. Sørensen, Ph.d.student, Principal investigator, Health, Aarhus University
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-administration of Patients Own Drugs During Hospital Stay - Patient Involvement, Medication Errors and Health Economics
- ClinicalTrials.gov ID
- NCT03541421
- Acronym / sponsor ID
- SAMRR2016_2019
- Conditions
- Patient Involvement, Medication Errors, Self Administration, Medication Adherence, Patient Satisfaction, Health Economics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Randers Regional Hospital, Hospital Pharmacy Central Denmark Region
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 30 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Patient involvement in administration of drugsThe patients administers own drugs during hospital stay. |
| Control | No intervention | –The patients receive medications from the medicine room dispensed by a nurse (standard care). No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient involvement in administration of drugsThe 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. | Other | Intervention |
Primary outcome
Medication administration errors
Time frame: on the day of inclusion and the following day. 1-2 days.
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.
4 secondary outcomes
Medication errors after discharge
Time frame: 14 days after discharge
Medication Adherence
Time frame: at hospitalization and 14 days after discharge
Patient satisfaction
Time frame: 14 days after discharge
Health economics
Time frame: from day of inclusion to day of discharge (1-31 days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 32821422Sorensen 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.
- Individual participant dataSharing planned: No
Related trials for Patient Involvement
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Not yet recruitingObservational study
Implementing Dynamic Consent for Rare Disease Patients
Rare Disorders
Recruiting
Impact and Experiences of Using Patient Decisions Aids in Hospital Outpatient Mental Health Settings.
Shared Decision Making
Recruiting
Designing a Large Language Model Architecture for Shared Decision Making and Informed Intentions
Shared Decision Making, Health Literacy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte A. Sørensen, Ph.d.student principal investigator
Health, Aarhus University
1 site in 1 country: see every site and its status.
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.