Safety IssuesMedRecNCT03654963
Study to Assess the Impact of Medication Reconciliation at Hospital Admission on Healthcare Outcomes
A study testing Medication reconciliation in people with Safety Issues, run by Ente Ospedaliero Cantonale, Bellinzona at 2 sites in Switzerland.
Trial summary
Medication reconciliation is a systematic process by which health care professionals obtain the most complete and accurate information about the drugs regularly taken by patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Safety Issues
- What is being tested?
- Medication reconciliation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,702 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 5 Nov 2018to 8 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients admitted to the inpatient wards of the two regional hospitals Beata Vergine in Mendrisio and La Carità in Locarno, fulfilling one of the following inclusion criteria, will be eligible for the study:
- patients aged ≥ 85 years
- patients with > 10 drugs at admission
- Patients with home care as well as patients from elderly homes, meeting the inclusion criteria, will be factored in the study population.
- Eligible patients will be included one-time only.
Who cannot join
- The presence of any of the following exclusion criteria will lead to patient exclusion:
- patients admitted to intensive care unit who do not reach inpatient wards
- patients who are planned to stay within inpatient wards for less than 48 hours
- patients who have been admitted to any of the EOC hospital wards within the previous 3 months and have been discharged at home
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Regional Hospital La Carità
Locarno, 6600
Regional Hospital Beata Vergine
Mendrisio, 6850
About this study
Official title: Parallel Group Randomized Controlled Trial to Assess the Impact of Medication Reconciliation at Hospital Admission on Healthcare Outcomes
Medication reconciliation is a systematic process by which health care professionals obtain the most complete and accurate information about the drugs regularly taken by patients. Internationally, the value of this procedure is mainly attributed to the reduction in the number of adverse drug events, which can cause drug-related morbidity and mortality, as well as unnecessary health care costs.
As part of the Progress! Pilot project Safe Pharmacotherapy at the interface points, promoted by the Federal Office of Public Health, coordinated by the Swiss Patients Safety Foundation and held in several Swiss hospitals, medication reconciliation at hospital admission was introduced at the regional hospital Beata Vergine in Mendrisio, from 2014 to 2016. During this pilot project it was shown that medication reconciliation after obtaining the best possible medication history by a pharmacist at hospital admission, in comparison with the standard medication history obtained by the physician at admission, reduced the number of clinically relevant drug discrepancies.
Read more
A structured, well-established and practicable procedure of medication reconciliation that improves patient safety assuring a better quality of care at hospital admission might provide evidence that medication reconciliation could be a valuable intervention to be applied systematically in all EOC hospitals at admission, as well as subsequently potentially at the other hospital interfaces.
The purpose of this study is to evaluate whether obtaining the best possible medication history and performing medication reconciliation at hospital admission results in improving some specific healthcare outcomes.
The study seeks primarily to determine if obtaining the best possible medication history and performing medication reconciliation, in comparison with the standard medication history, reduces the number of subsequent unplanned all-cause hospital visits (readmissions and emergency department visits within 30 days after initial discharge). As secondary objectives, the study aims at assessing if best possible medication history with medication reconciliation, in comparison with the standard medication history, reduces the incidence of adverse drug reactions during hospital stay, shortens length of stay, leads to a reduction in the use of hospital resources, and/or is associated with a decreased number of deaths.
Read the detailed description
Patients of the control group will not receive the best possible medication history with medication reconciliation at admission. The standard physician-acquired medication history will be performed as usual.
Eligible patients, randomized within the intervention arm, will receive medication reconciliation according to the following steps:
- The pharmacy assistant will obtain the best possible medication history by compiling a comprehensive list of the medications the patient is taking and details about how the drugs are taken. In order to confirm the accuracy of the history, the pharmacy assistant will use at least two sources of information, one of which being, when possible, the interview with the patient and/or family members, in addition to referral letters, prescriptions and drug lists from primary care centres, and other.
- The clinical pharmacist will reconcile best possible medication history with prescribed medicines and, to resolve unclear or ambiguous discrepancies between the two lists and/or to propose any adaptations of the pharmacotherapy, the clinical pharmacist will refer to the medical doctor.
- The medical doctor will decide potential changes in pharmacotherapy and communicate them to the patient providing complete information on medicines.
- Conditions
- Safety Issues
- Being tested
- Medication reconciliation
- Keywords
- medication reconciliation, safe pharmacotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication reconciliationProcedure or surgery
Medication reconciliation is the systematic process described above.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients of the control group will not receive the best possible medication history with medication reconciliation at admission. The standard physician-acquired medication history will be performed as usual. |
| Medication reconciliation | Experimental | The pharmacy assistant will obtain the best possible medication history by compiling a comprehensive list of the medications the patient is taking. To confirm the accuracy of the history, the pharmacy assistant will use at least two sources of information, one of which being, when possible, the interview with the patient and/or family members. The clinical pharmacist will reconcile the best possible medication history with prescribed medicines and, to resolve unclear or ambiguous discrepancies between the two lists and/or to propose any adaptations of the pharmacotherapy, the clinical pharmacist will refer to the medical doctor. The medical doctor will decide potential changes in pharmacotherapy and communicate them to the patient. Receives: Procedure: Medication reconciliation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite post-discharge healthcare use variable
Total number of unplanned all-cause hospital visits (readmissions and emergency department visits within 30 days after initial discharge).
Measured: Within 30 days after initial discharge
Secondary outcomes (4)
Incidence of ADRs during hospital stay
To measure the incidence of ADRs developed by patients during the hospital stay, the active pharmacovigilance system currently in use at the Centro Regionale di Farmacovigilanza del Canton Ticino, will be exploited. EMRs identified through this system and referring to patients from both the two study sites, aged ≥85 years or with more than 10 medications at admission, will be manually validated (to discard false positive cases). Subsequently, ADRs will be categorized as not serious or serious (according to the WHO seriousness criteria, for resulting in death, being life threatening, prolonging hospitalization, resulting in persistent disability or incapacity and other). Outcome assessor will be masked to group allocation. At the end of the analysis, ADRs will be matched to either the intervention or the control group
Measured: 1 year
Length of hospital stay
Measured: 1 year
Death during hospital stay
Measured: 1 year
Number of resources used during hospital stay
Laboratory tests, radiologic exams, echocardiography, electrocardiograms
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start5 Nov 2018
- Primary completion8 Jan 2020
- Study completion8 Jan 2020
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 Safety IssuesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation: centralized randomization; a unique list of randomization will be generated by the clinical trial unit (CTU) of the EOC with an ad hoc software, and patients will be allocated 1:1 in either the intervention or the control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,702 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Ceschi, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Dr med Alessandro Ceschi, PD, FEAPCCT, Principal investigator, Institute of Pharmacological Science of Southern Switzerland, Ente Ospedaliero Cantonale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654963
- Sponsor's protocol ID
- 01
- Acronym
- MedRec
- Status last verified
- Jul 2020
- First submitted
- 29 Aug 2018
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ceschi A, Noseda R, Pironi M, Lazzeri N, Eberhardt-Gianella O, Imelli S, Ghidossi S, Bruni S, Pagnamenta A, Ferrari P. Effect of Medication Reconciliation at Hospital Admission on 30-Day Returns to Hospital: A Randomized Clinical Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2124672. doi: 10.1001/jamanetworkopen.2021.24672.
PubMed 34529065
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel Group Randomized Controlled Trial to Assess the Impact of Medication Reconciliation at Hospital Admission on Healthcare Outcomes
- ClinicalTrials.gov ID
- NCT03654963
- Acronym / sponsor ID
- MedRec / 01
- Conditions
- Safety Issues
- Keywords
- medication reconciliation, safe pharmacotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,702 participants (actual)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 31 Aug 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.
Medication reconciliation is a systematic process by which health care professionals obtain the most complete and accurate information about the drugs regularly taken by patients. Internationally, the value of this procedure is mainly attributed to the reduction in the number of adverse drug events, which can cause drug-related morbidity and mortality, as well as unnecessary health care costs.
As part of the Progress! Pilot project Safe Pharmacotherapy at the interface points, promoted by the Federal Office of Public Health, coordinated by the Swiss Patients Safety Foundation and held in several Swiss hospitals, medication reconciliation at hospital admission was introduced at the regional hospital Beata Vergine in Mendrisio, from 2014 to 2016. During this pilot project it was shown that medication reconciliation after obtaining the best possible medication history by a pharmacist at hospital admission, in comparison with the standard medication history obtained by the physician at admission, reduced the number of clinically relevant drug discrepancies.
A structured, well-established and practicable procedure of medication reconciliation that improves patient safety assuring a better quality of care at hospital admission might provide evidence that medication reconciliation could be a valuable intervention to be applied systematically in all EOC hospitals at admission, as well as subsequently potentially at the other hospital interfaces.
The purpose of this study is to evaluate whether obtaining the best possible medication history and performing medication reconciliation at hospital admission results in improving some specific healthcare outcomes.
The study seeks primarily to determine if obtaining the best possible medication history and performing medication reconciliation, in comparison with the standard medication history, reduces the number of subsequent unplanned all-cause hospital visits (readmissions and emergency department visits within 30 days after initial discharge). As secondary objectives, the study aims at assessing if best possible medication history with medication reconciliation, in comparison with the standard medication history, reduces the incidence of adverse drug reactions during hospital stay, shortens length of stay, leads to a reduction in the use of hospital resources, and/or is associated with a decreased number of deaths.
Detailed description
Patients of the control group will not receive the best possible medication history with medication reconciliation at admission. The standard physician-acquired medication history will be performed as usual.
Eligible patients, randomized within the intervention arm, will receive medication reconciliation according to the following steps:
- The pharmacy assistant will obtain the best possible medication history by compiling a comprehensive list of the medications the patient is taking and details about how the drugs are taken. In order to confirm the accuracy of the history, the pharmacy assistant will use at least two sources of information, one of which being, when possible, the interview with the patient and/or family members, in addition to referral letters, prescriptions and drug lists from primary care centres, and other.
- The clinical pharmacist will reconcile best possible medication history with prescribed medicines and, to resolve unclear or ambiguous discrepancies between the two lists and/or to propose any adaptations of the pharmacotherapy, the clinical pharmacist will refer to the medical doctor.
- The medical doctor will decide potential changes in pharmacotherapy and communicate them to the patient providing complete information on medicines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Allocation: centralized randomization; a unique list of randomization will be generated by the clinical trial unit (CTU) of the EOC with an ad hoc software, and patients will be allocated 1:1 in either the intervention or the control group.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients of the control group will not receive the best possible medication history with medication reconciliation at admission. The standard physician-acquired medication history will be performed as usual. |
| Medication reconciliation | Experimental | Procedure: Medication reconciliationThe pharmacy assistant will obtain the best possible medication history by compiling a comprehensive list of the medications the patient is taking. To confirm the accuracy of the history, the pharmacy assistant will use at least two sources of information, one of which being, when possible, the interview with the patient and/or family members. The clinical pharmacist will reconcile the best possible medication history with prescribed medicines and, to resolve unclear or ambiguous discrepancies between the two lists and/or to propose any adaptations of the pharmacotherapy, the clinical pharmacist will refer to the medical doctor. The medical doctor will decide potential changes in pharmacotherapy and communicate them to the patient. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients admitted to the inpatient wards of the two regional hospitals Beata Vergine in Mendrisio and La Carità in Locarno, fulfilling one of the following inclusion criteria, will be eligible for the study:
- patients aged ≥ 85 years
- patients with > 10 drugs at admission
- Patients with home care as well as patients from elderly homes, meeting the inclusion criteria, will be factored in the study population.
- Eligible patients will be included one-time only.
Key exclusion criteria (4 listed)
- patients admitted to intensive care unit who do not reach inpatient wards
- patients who are planned to stay within inpatient wards for less than 48 hours
- patients who have been admitted to any of the EOC hospital wards within the previous 3 months and have been discharged at home
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 |
|---|---|---|
| Medication reconciliationMedication reconciliation is the systematic process described above. | Procedure or surgery | Medication reconciliation |
Primary outcome
Composite post-discharge healthcare use variable
Time frame: Within 30 days after initial discharge
Total number of unplanned all-cause hospital visits (readmissions and emergency department visits within 30 days after initial discharge).
4 secondary outcomes
Incidence of ADRs during hospital stay
Time frame: 1 year
Length of hospital stay
Time frame: 1 year
Death during hospital stay
Time frame: 1 year
Number of resources used during hospital stay
Time frame: 1 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 23 Jul 2020.
- Derived from this study: PubMed 34529065Ceschi A, Noseda R, Pironi M, Lazzeri N, Eberhardt-Gianella O, Imelli S, Ghidossi S, Bruni S, Pagnamenta A, Ferrari P. Effect of Medication Reconciliation at Hospital Admission on 30-Day Returns to Hospital: A Randomized Clinical Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2124672. doi: 10.1001/jamanetworkopen.2021.24672.
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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.
Dr med Alessandro Ceschi, PD, FEAPCCT principal investigator
Institute of Pharmacological Science of Southern Switzerland, Ente Ospedaliero Cantonale
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication reconciliation in people with Safety Issues, run by Ente Ospedaliero Cantonale, Bellinzona at 2 sites in Switzerland.
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 5 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 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Composite post-discharge healthcare use variable (time frame: Within 30 days after initial 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 NCT03654963, 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 23 Jul 2020.