Medication ReconciliationNCT06207500
Evaluation of Pharmacist-led Medication Reconciliation Service Benefits in Hospitalised Medical Patients
A study testing Pharmacist-led Medication Reconciliation in people with Medication Reconciliation, run by The University Clinic of Pulmonary and Allergic Diseases Golnik at 1 site in Slovenia.
Trial summary
Background: Transitions of care often lead to medication errors and unnecessary healthcare utilisation. It has been repeatedly shown that medication reconciliation can at least partially reduce this risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Reconciliation
- What is being tested?
- Pharmacist-led Medication Reconciliation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 553 participants
- Where
- 1 siteSlovenia
- Study dates
- 30 Sep 2019to 31 Dec 2020
- 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
- All adult medical patients admitted to the study wards
Who cannot join
- patients who do not speak Slovenian,
- transferred from another ward,
- previously included in the same study.
- Subsequent exclusion from the analysis:
- patients hospitalised only for diagnostic purposes,
- patients transferred to another ward or hospital,
- patients that died during hospitalisation,
- patients from the control group who were offered medication reconciliation
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Clinic of Respiratory and Allergic Diseases Golnik
Golnik, Select State, 4202
About this study
Official title: Impact of Routine Pharmacist-led Medication Reconciliation on Medication Discrepancies and Post-hospital Healthcare Utilisation
Background:
Transitions of care often lead to medication errors and unnecessary healthcare utilisation. It has been repeatedly shown that medication reconciliation can at least partially reduce this risk.
Read more
Objective:
The aim of this prospective pragmatic trial was to evaluate the effectiveness of pharmacist-led medication reconciliation offered to medical patients as part of routine clinical practise.
The main questions to be answered were:
- the effectiveness of pharmacist-led medication reconciliation on medication discrepancies at discharge and 30 days after discharge
- the effectiveness of pharmacist-led medication reconciliation on healthcare utilisation within 30 days after discharge.
Participants in the intervention group were offered the following:
- medication reconciliation on admission
- medication reconciliation on discharge, coupled with patient counselling, provided by clinical pharmacists.
Participants in the control group were offered standard care.
Read the detailed description
Design: pragmatic, prospective, controlled clinical trial
Setting: Five general medical wards at the University Clinic of Respiratory and Allergic Diseases in Slovenia:
- one intervention ward with a routine pharmacist-led medication reconciliation service
- four control wards
Data collection:
- Data collection and outcome assessment were performed by research pharmacists who were clinical pharmacists or final year clinical pharmacy residents not involved in the treatment of the included patients.
- Data for the assessment of medication errors at discharge were obtained from the patients' medical records and the study documentation.
- The reason for the patient's hospitalisation was obtained from the discharge letter and divided into acute or planned admissions. The main diagnosis was the reason for admission, while all other patient diagnoses listed were used to assess comorbidity.
- Patient comorbidity was assessed using the Charlson Comorbidity Index
- For patients in the control group the BPMH was collected in the same way as in the intervention group. However, it was only used for study purposes and was not documented in the patients' medical records
- Data on healthcare utilisation and medication discrepancies after hospital discharge were collected through patients or caregivers' phone interview.
- Conditions
- Medication Reconciliation
- Being tested
- Pharmacist-led Medication Reconciliation
- Keywords
- medication error, unplanned healthcare utilisation, transitions of care, pharmacist, patient discharge, patient counselling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-led Medication ReconciliationProcedure or surgery
The best possible medication history (BPMH) at hospital admission was obtained from medical and pharmacy records and by interviewing the patient or carers. The BPMH - an accurate and complete (or as close as possible) list of medications the patient is currently taking - was documented in the medication information system. At hospital admission the BPMH was compared with the therapy in hospital to identify discrepancies. All discrepancies were discussed with the treating physician, unintentional discrepancies were reconciled. Intentional discrepancies were documented in the medical records. Prior to discharge from hospital, the BPMH and the medications planned in the discharge therapy were compared again to ensure that all unintentional discrepancies were corrected. Intentional discrepancies were explained in the discharge letter. Individual patient counselling on discharge medications and pharmacotherapy changes was conducted and coupled with written instructions in lay language.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | Patients were offered pharmacist- led medication reconciliation on admission and discharge coupled with patient counselling. Receives: Procedure: Pharmacist-led Medication Reconciliation |
| Control Group | No intervention | Patients received standard care - only written instructions on discharge medications in the discharge letter, according to the standard practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned healthcare utilisation within 30 days after discharge
Unplanned healthcare utilisation within 30 days of hospital discharge was defined as any unplanned visit to a general practitioner, specialist, emergency department (ED), or hospitalisation or death. The visits were classified as unplanned, if sudden health problems required medical attention, and planned, if scheduled. Data on mortality due to any reason were also collected 30 days after discharge. For each patient, only the most detrimental outcome was classified.
Measured: within 30 (±5) days after hospital discharge
Secondary outcomes (4)
Serious unplanned healthcare utilisation within 30 days after discharge
Serious unplanned healthcare utilisation were defined as any unplanned ED visit or hospitalisation or death within 30 days from hospital discharge.
Measured: within 30 (±5) days after hospital discharge
Clinically important medication errors at discharge
Unintentional discrepancies and undocumented intentional discrepancies between the therapy the patient was taking before admission (BMPH) and the therapy recommended in the discharge letter were defined as medication errors. Their clinical importance was assessed using a 4-point Likert scale ranging from not important, not very important, very important to life-threatening medication errors. Very important and life-threatening medication errors represent clinically important medication errors.
Measured: On the day of hospital discharge (up to 365 days from hospital admission)
Medication discrepancies at 30 days
Medication discrepancies 30 (±5) days after hospital discharge were defined as the discrepancies between the discharge therapy and the therapy the patient was taking 30 (±5) days after hospital discharge.
The discrepancies were defined as intentional if the patient intentionally took the therapy differently than recommended in the discharge letter. The reason for the discrepancy was also recorded - the patient's own informed decision or due to instructions from the treating physician (general practitioner, specialist).
Unintentional discrepancies were defined as discrepancies from the therapy recommended in the discharge letter of which the patients were unaware. The clinical importance of unintentional discrepancies was assessed using a 4-point Likert scale, ranging from not important, not very important, very important, to life- threatening.
Measured: At 30 (±5) days after hospital discharge
All healthcare utilisation within 30 days after discharge
Healthcare visits within 30 days of hospital discharge were defined as any visit to a general practitioner, specialist, emergency department (ED), or hospitalisation. These visits were classified as unplanned, if sudden health problems required medical attention, and planned, if scheduled. Data on mortality due to any reason were also collected 30 days after discharge. For each patient, only the most detrimental outcome was classified.
Measured: within 30 (±5) days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start30 Sep 2019
- Primary completion18 Oct 2020
- Study completion31 Dec 2020
Why it stopped: Due to COVID 19 declaration in Slovenia for the second time and subsequent reorganization of intervention ward
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 ReconciliationStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic prospective controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 553 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University Clinic of Pulmonary and Allergic Diseases Golnik
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana
- Responsible party
- Principal investigator, Maja Jošt, The University Clinic of Pulmonary and Allergic Diseases Golnik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207500
- Sponsor's protocol ID
- 8019163
- Status last verified
- Jan 2024
- First submitted
- 22 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jost M, Kerec Kos M, Kos M, Knez L. Effectiveness of pharmacist-led medication reconciliation on medication errors at hospital discharge and healthcare utilization in the next 30 days: a pragmatic clinical trial. Front Pharmacol. 2024 Mar 28;15:1377781. doi: 10.3389/fphar.2024.1377781. eCollection 2024.
PubMed 38606174
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Routine Pharmacist-led Medication Reconciliation on Medication Discrepancies and Post-hospital Healthcare Utilisation
- ClinicalTrials.gov ID
- NCT06207500
- Acronym / sponsor ID
- 8019163
- Conditions
- Medication Reconciliation
- Keywords
- medication error, unplanned healthcare utilisation, transitions of care, pharmacist, patient discharge, patient counselling
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID 19 declaration in Slovenia for the second time and subsequent reorganization of intervention ward
- Enrolment
- 553 participants (actual)
- Lead sponsor
- The University Clinic of Pulmonary and Allergic Diseases GolnikUniversity, hospital or other
- Collaborators
- University of Ljubljana
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 18 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 17 Jan 2024 (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:
Transitions of care often lead to medication errors and unnecessary healthcare utilisation. It has been repeatedly shown that medication reconciliation can at least partially reduce this risk.
Objective:
The aim of this prospective pragmatic trial was to evaluate the effectiveness of pharmacist-led medication reconciliation offered to medical patients as part of routine clinical practise.
The main questions to be answered were:
- the effectiveness of pharmacist-led medication reconciliation on medication discrepancies at discharge and 30 days after discharge
- the effectiveness of pharmacist-led medication reconciliation on healthcare utilisation within 30 days after discharge.
Participants in the intervention group were offered the following:
- medication reconciliation on admission
- medication reconciliation on discharge, coupled with patient counselling, provided by clinical pharmacists.
Participants in the control group were offered standard care.
Detailed description
Design: pragmatic, prospective, controlled clinical trial
Setting: Five general medical wards at the University Clinic of Respiratory and Allergic Diseases in Slovenia:
- one intervention ward with a routine pharmacist-led medication reconciliation service
- four control wards
Data collection:
- Data collection and outcome assessment were performed by research pharmacists who were clinical pharmacists or final year clinical pharmacy residents not involved in the treatment of the included patients.
- Data for the assessment of medication errors at discharge were obtained from the patients' medical records and the study documentation.
- The reason for the patient's hospitalisation was obtained from the discharge letter and divided into acute or planned admissions. The main diagnosis was the reason for admission, while all other patient diagnoses listed were used to assess comorbidity.
- Patient comorbidity was assessed using the Charlson Comorbidity Index
- For patients in the control group the BPMH was collected in the same way as in the intervention group. However, it was only used for study purposes and was not documented in the patients' medical records
- Data on healthcare utilisation and medication discrepancies after hospital discharge were collected through patients or caregivers' phone interview.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic prospective controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Procedure: Pharmacist-led Medication ReconciliationPatients were offered pharmacist- led medication reconciliation on admission and discharge coupled with patient counselling. |
| Control Group | No intervention | –Patients received standard care - only written instructions on discharge medications in the discharge letter, according to the standard practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult medical patients admitted to the study wards
Key exclusion criteria (8 listed)
- patients who do not speak Slovenian,
- transferred from another ward,
- previously included in the same study.
- patients hospitalised only for diagnostic purposes,
- patients transferred to another ward or hospital,
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 |
|---|---|---|
| Pharmacist-led Medication ReconciliationThe best possible medication history (BPMH) at hospital admission was obtained from medical and pharmacy records and by interviewing the patient or carers. The BPMH - an accurate and complete (or as close as possible) list of medications the patient is currently taking - was documented in the medication information system. At hospital admission the BPMH was compared with the therapy in hospital to identify discrepancies. All discrepancies were discussed with the treating physician, unintentional discrepancies were reconciled. Intentional discrepancies were documented in the medical records. Prior to discharge from hospital, the BPMH and the medications planned in the discharge therapy were compared again to ensure that all unintentional discrepancies were corrected. Intentional discrepancies were explained in the discharge letter. Individual patient counselling on discharge medications and pharmacotherapy changes was conducted and coupled with written instructions in lay language. | Procedure or surgery | Intervention Group |
Primary outcome
Unplanned healthcare utilisation within 30 days after discharge
Time frame: within 30 (±5) days after hospital discharge
Unplanned healthcare utilisation within 30 days of hospital discharge was defined as any unplanned visit to a general practitioner, specialist, emergency department (ED), or hospitalisation or death. The visits were classified as unplanned, if sudden health problems required medical attention, and planned, if scheduled. Data on mortality due to any reason were also collected 30 days after discharge. For each patient, only the most detrimental outcome was classified.
4 secondary outcomes
Serious unplanned healthcare utilisation within 30 days after discharge
Time frame: within 30 (±5) days after hospital discharge
Clinically important medication errors at discharge
Time frame: On the day of hospital discharge (up to 365 days from hospital admission)
Medication discrepancies at 30 days
Time frame: At 30 (±5) days after hospital discharge
All healthcare utilisation within 30 days after discharge
Time frame: within 30 (±5) days after hospital discharge
Results and safety
The study was stopped early (reason given: Due to COVID 19 declaration in Slovenia for the second time and subsequent reorganization of intervention ward). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Derived from this study: PubMed 38606174Jost M, Kerec Kos M, Kos M, Knez L. Effectiveness of pharmacist-led medication reconciliation on medication errors at hospital discharge and healthcare utilization in the next 30 days: a pragmatic clinical trial. Front Pharmacol. 2024 Mar 28;15:1377781. doi: 10.3389/fphar.2024.1377781. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-led Medication Reconciliation in people with Medication Reconciliation, run by The University Clinic of Pulmonary and Allergic Diseases Golnik at 1 site in Slovenia.
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 1 inclusion and 8 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: stopped early, as of the sponsor's last update on 17 Jan 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 Slovenia. 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 was stopped early (reason given: Due to COVID 19 declaration in Slovenia for the second time and subsequent reorganization of intervention ward). Results are not available in the source record.
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?
Unplanned healthcare utilisation within 30 days after discharge (time frame: within 30 (±5) days after hospital discharge). 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 NCT06207500, 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 17 Jan 2024.