Medication SafetySAMENCT04990986
Co-Development and Evaluation of a Complex Intervention to Increase Medication Safety in Nursing Homes
A study testing Complex intervention in people with Medication Safety and Patient Safety, run by Anne Estrup Olesen at 1 site in Denmark.
Trial summary
The study aims to develop and evaluate a new, multifaceted (complex) intervention in a mixed methods study-design to increase medication safety in nursing homes. The SAME-study will be locally anchored, including investigation of patient safety culture, in a mixed methods design, including both in depth qualitative… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Medication Safety, Patient Safety
- What is being tested?
- Complex intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2020to 31 Oct 2023
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- involved directly or indirectly in the medication process
- employment of at least two months in a nursing-home within the municipality of Aalborg, sufficient spoken and written Danish language
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Co-Development and Evaluation of a Complex Intervention to Increase Medication Safety in Nursing Homes - A Mixed Methods Study Embedding a Cluster Randomised Controlled Trial, Guided by Safety Theory With Participatory Approach
The study aims to develop and evaluate a new, multifaceted (complex) intervention in a mixed methods study-design to increase medication safety in nursing homes. The SAME-study will be locally anchored, including investigation of patient safety culture, in a mixed methods design, including both in depth qualitative and organizational-focused quantitative methods.
Read the detailed description
In the SAME-study, we aim to develop and evaluate a new, multifaceted (complex) intervention in a mixed methods study-design to increase medication safety in nursing homes. The SAME-study will be locally anchored, including investigation of patient safety culture, in a mixed methods design, including both in depth qualitative and organizational-focused quantitative methods. This study will be guided by the following main research questions and hypothesis:
- Can we elucidate new areas susceptible for intervention to increase medication safety in nursing homes through qualitative in-depth investigation of patient safety culture in nursing homes guided by safety theory with participatory approach?
- Is it possible to develop a multifaceted intervention fit to context within actual resource-frame to increase medication safety in nursing homes based on patient safety culture, guided by safety theory with participatory approach?
- A complex intervention developed within a participatory framework will lead to positive change of care-staff self-reported perceptions of patient safety climate culture in nursing homes in the intervention group compared with the control group of this study?
Study design This study applies mixed-methods pragmatic paradigm led by Safety 1 and 2 theory, with participatory approach to an exploratory sequential three-phased study-design, embedding a randomized controlled trial (cRCT). Overall study-settings will be nursing homes within the municipality of Aalborg, North Denmark Region, Denmark.
- Conditions
- Medication Safety, Patient Safety
- Being tested
- Complex intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex interventionOther
Will be co-developed during the study.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | The complex intervention will be co-developed during first phase of the study. Receives: Other: Complex intervention |
| Control | No intervention | Half of the group will be included as control and thus not exposed to the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care staff's perceptions of patient safety culture
Safety Attitudes Questionnaire (SAQ)
Measured: One year
Secondary outcomes (1)
Perceptions of patient safety culture of relatives of residents and nursing home doctors.
Qualitative data will be collected through individual interviews with relatives and GPs
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Oct 2020
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
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 Medication SafetyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study applies mixed-methods pragmatic paradigm led by Safety 1 and 2 theory, with participatory approach to an exploratory sequential three-phased study-design, embedding a randomized controlled trial (cRCT).
- Masking
- None (open label)
- Enrolment
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anne Estrup Olesen
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University, Aalborg Municipality, University College of Northern Denmark
- Responsible party
- Sponsor-investigator, Anne Estrup Olesen, Aalborg University Hospital
- Investigators
- Anne E Olesen, Ph.D., Study director, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990986
- Sponsor's protocol ID
- AalborgH2021-015
- Acronym
- SAME
- Status last verified
- Apr 2024
- First submitted
- 30 Jun 2021
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to publish the protocol
Publications
Juhl MH, Soerensen AL, Kristensen JK, Johnsen SP, Olesen AE. Safe Medication in Nursing Home Residents Through the Development and Evaluation of an Intervention (SAME): Protocol for a Fully Integrated Mixed Methods Study With a Cocreative Approach. JMIR Res Protoc. 2023 Mar 31;12:e43538. doi: 10.2196/43538.
PubMed 37000508
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-Development and Evaluation of a Complex Intervention to Increase Medication Safety in Nursing Homes - A Mixed Methods Study Embedding a Cluster Randomised Controlled Trial, Guided by Safety Theory With Participatory Approach
- ClinicalTrials.gov ID
- NCT04990986
- Acronym / sponsor ID
- SAME / AalborgH2021-015
- Conditions
- Medication Safety, Patient Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- Anne Estrup OlesenUniversity, hospital or other
- Collaborators
- Aalborg University, Aalborg Municipality, University College of Northern Denmark
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 5 Aug 2021 (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.
The study aims to develop and evaluate a new, multifaceted (complex) intervention in a mixed methods study-design to increase medication safety in nursing homes. The SAME-study will be locally anchored, including investigation of patient safety culture, in a mixed methods design, including both in depth qualitative and organizational-focused quantitative methods.
Detailed description
In the SAME-study, we aim to develop and evaluate a new, multifaceted (complex) intervention in a mixed methods study-design to increase medication safety in nursing homes. The SAME-study will be locally anchored, including investigation of patient safety culture, in a mixed methods design, including both in depth qualitative and organizational-focused quantitative methods. This study will be guided by the following main research questions and hypothesis:
- Can we elucidate new areas susceptible for intervention to increase medication safety in nursing homes through qualitative in-depth investigation of patient safety culture in nursing homes guided by safety theory with participatory approach?
- Is it possible to develop a multifaceted intervention fit to context within actual resource-frame to increase medication safety in nursing homes based on patient safety culture, guided by safety theory with participatory approach?
- A complex intervention developed within a participatory framework will lead to positive change of care-staff self-reported perceptions of patient safety climate culture in nursing homes in the intervention group compared with the control group of this study?
Study design This study applies mixed-methods pragmatic paradigm led by Safety 1 and 2 theory, with participatory approach to an exploratory sequential three-phased study-design, embedding a randomized controlled trial (cRCT). Overall study-settings will be nursing homes within the municipality of Aalborg, North Denmark Region, Denmark.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study applies mixed-methods pragmatic paradigm led by Safety 1 and 2 theory, with participatory approach to an exploratory sequential three-phased study-design, embedding a randomized controlled trial (cRCT).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Complex interventionThe complex intervention will be co-developed during first phase of the study. |
| Control | No intervention | –Half of the group will be included as control and thus not exposed to the intervention. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- involved directly or indirectly in the medication process
- employment of at least two months in a nursing-home within the municipality of Aalborg, sufficient spoken and written Danish language
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Complex interventionWill be co-developed during the study. | Other | Intervention |
Primary outcome
Care staff's perceptions of patient safety culture
Time frame: One year
Safety Attitudes Questionnaire (SAQ)
1 secondary outcome
Perceptions of patient safety culture of relatives of residents and nursing home doctors.
Time frame: One year
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 1 May 2024.
- Derived from this study: PubMed 37000508Juhl MH, Soerensen AL, Kristensen JK, Johnsen SP, Olesen AE. Safe Medication in Nursing Home Residents Through the Development and Evaluation of an Intervention (SAME): Protocol for a Fully Integrated Mixed Methods Study With a Cocreative Approach. JMIR Res Protoc. 2023 Mar 31;12:e43538. doi: 10.2196/43538.
- Individual participant dataSharing planned: Yes. We plan to publish the protocol
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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.
Anne E Olesen, Ph.D. study director
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex intervention in people with Medication Safety and Patient Safety, run by Anne Estrup Olesen 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 1 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 1 May 2024. 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?
Care staff's perceptions of patient safety culture (time frame: One year). 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 NCT04990986, 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 1 May 2024.