Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05784194 |
| Other study ID # |
TOER2022-03357-01 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2022 |
| Est. completion date |
December 1, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Malmö University |
| Contact |
Tommy Eriksson, PhD Prof |
| Phone |
+46725782210 |
| Email |
tommy.eriksson[@]mau.se |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Medication treatment is not always optimal, and care transitions are problematic with errors
and clinical consequences. The primary aim of this study is to evaluate the effects of an
intervention to reduce errors, in the patient medication list when discharged from hospital
to home. It will be secured that patients have the correct medications available for use
after discharge and, that the information about current medications is correct in the
Electronic Health Register and the pharmacy dispensing system. 100 patients 60 years and
older, handling their own medications, and prescribed at least five continuous medications,
Swedish or Arabic speaking, will be recruited from a hospital in Malmö before discharge.
Discrepancies between the accurate medication list and patients' actual use will be followed
up three weeks after discharge.
Description:
Background
LIMM-studies interventions decreased error rates in the discharge medication lists from 66 to
32% and the risk for clinical negative consequences from 32 to 16%. Patients who manage their
own medication and patients with different cultural background have not been studied in the
LIMM-model. In a pilot study using the same methods as in this planned RCT 22 problems were
identified among 7 patients in the medication list at discharge. All problems were solved and
no remained at follow-up 2 weeks later.
Aim The aim of this study is to evaluate the effects of an intervention to reduce errors in
the patient medication list when discharged from hospital to home. A further aim is to
compare the effects of the intervention in two different patient populations, Swedish- and
Arabic speaking, and the potential clinical and economic consequences of the errors.
Methods
Study design
This is a prospective, RCT with two parallel groups. Patients are randomized to standard care
(control) or an intervention. The investigators want to secure that patients have the correct
medications available for use after discharge and, that the information about current
medications is correct in the EHR and the pharmacy dispensing system, and to ensure that the
accurate medication list is communicated and agreed with the patient. Patients 60 years and
older, handling their own medications, and with at least five continuous medications, Swedish
or Arabic speaking, will be recruited from two departments at Skåne University hospital (SUS)
in Malmö before discharge, during 4-12 months starting from September 2022. Patients will be
given written and verbal information about the trial by a pharmacist (the PhD student), as
well as an invitation to take part. Patients unable to discuss their treatment will be
excluded Patients will be randomised to standard care (control) or standard care plus
research pharmacist activities (intervention). The randomisation will be stratified based on
Swedish speaking or Arabic speaking (requiring an interpreter). The randomisation sequence
will be computer-generated by a researcher not involved in data collection. The researcher (a
PhD student) collects baseline questionnaires and defines the stratum of each patient before
assigning the patient to the intervention or control group according to the serial number. As
described below 100 patients are planned to be included, 60 Swedish and 40 Arabic speaking.
If it proves to be difficult to include 40 Arabic speaking patients, more Swedish speaking
patient will be included.
Assessments and interventions in both intervention and control groups
Baseline assessment data for both intervention and control patients, including demographics,
civil status, social factors (level of education and employment), comorbidities, are
collected from the electronic health care record (EHR) and/or by asking the patient verbally.
Two questionnaires "Beliefs about medicines questionnaire" (BMQ-S) and "Medication adherence
report scale" (MARS) will also be used. Standard medical care including medication
reconciliation and -review according to Swedish constitution will be performed by responsible
physician in both groups . At discharge, a ward physician is supposed to prepare a written
discharge information for the patient including a medication list.
A follow-up telephone meeting with the patient will be booked 3 weeks after discharge.
Changes in the medication list and what the patient really takes are identified.
Intervention group protocol
At discharge, the PhD-student performs activities developed and tested in the described study
and further developed in the pilot study. The intervention includes dispensing the correct
medications to the patient and to correct errors and missunderstandings based on patient
perceptions and usage, pharmacy records, medical notes, and written discharge information.
The investigators aim to make the patients fully informed and conscious about which
medications to take or not, at home, and that the prescriptions are updated to support this.
The discharge information produced by a physician will also be updated to reflect this and
will contain a correct medication list. Based on the medication reconciliation and a brief
medication review, possible problems will be discussed with the responsible physician and the
patient, to finally be corrected. At discharge, the patient will receive a correct medication
list and his/her new medications dispensed by the researcher, bedside.
Identification of errors
If there is a written discharge information including a medication list this will be
considered the correct medication list at discharge. If not, the final medication list in the
EHR on the day at discharge will be considered the correct medication list. These lists are
compared to the medication list stated by the patient 3 weeks after discharge and corrected
for changes performed and documented after discharge when needed. The patient is the main
source on which medications that are really used. The patient´s statement on which
medications are being used is to be compared with the medication list at discharge. EHR and
pharmacy dispensing records will be used to establish and check the list. If investigators
have access to EHR at the primary care system this will be used as a complement to the other
systems. In this way, the investigators make sure that the discharge information from the
hospital has reached the primary care both in intervention and control groups, and that they
have had enough time to take the discharge information and different changes into account and
make their own statements.
Errors during the discharge process will be identified. This will be performed simultaneously
as the identification of clinical risk as described below.
A checklist, including basic clinical patient information, the correct medication list at
discharge and the establishment of a correct medication list 3 weeks after discharge will be
used. The establishment of a correct medication list 3 weeks after discharge will be based on
the following process: 1/ identify new prescriptions (after discharge) and medication
information from pharmacy records and EHR. 2/ let the patient describe their current
medication use. 3/ ask questions based on correct medication list at discharge and new
information from records as above. 4/ask questions from a specific list used for medication
reconciliation.
The definition of medication error proposed by Leape will be applied. With this definition, a
medication error is any error in the process of prescribing, dispensing, or administering a
drug, whether there are adverse consequences or not. The focus will be on what the patients
take. If drugs are added, withdrawn or the dosage had changed without any documentation in
charts, medical records, or medication lists, it will be considered an error.
Evaluation of risk of an error
The clinical risk associated with an error, will be evaluated for each patient and for each
error, separately by two senior researchers. They will receive allocation blinded basic
clinical patient information and documentation on medication lists at and 3 weeks after
discharge. Patients' risks will be classified into one of three groups, (1) without clinical
risk, (2) with moderate clinical risk and (3) with high clinical risk.
Clinical consequences and health economic evaluation
Patients with at least one error classified as moderate or high risk will be evaluated. All
contacts that these patients have with primary care or hospital care within 3 months after
discharge will be documented and evaluated. A regional patient register (RSVD) will be used
to investigate each contact. For all included patients all information on each contact will
be collected and prepared by the PhD student for blind evaluation of errors, risks, and
clinical outcomes. The probability that medication errors had caused the clinical outcome or
need for administrative corrections will be estimated according to the WHO's criteria as
certain, probable, possible, unlikely, and no.
Health economic evaluation will be performed based on time spent in the intervention, costs
for healthcare resources during three months and error rates. Incremental costs will be
calculated by comparing the mean cost of all healthcare during the study period between the
groups. This cost will be compared in an incremental cost-effectiveness ratio using the
number of clinically relevant medication errors reaching the patient as the health outcome.
Statistical methods and sample size
All errors for each patient in intervention and control group will be tabulated based on type
and clinical risk to allow comparisons. Proportion of patients with no errors in the
medication list 3 weeks after discharge, and also no clinical consequences after 3 months
will be the primary outcome measure. Also, the mean number of errors for each group, and
proportions of patients with at least 1, 2, 3, 5 and 10 errors, as well as clinical risk and
consequences will be compared. Also the Swedish and Arabic speaking populations will be
compared. Finally, possible relationship between individual patients BMQ-S and MARS scores,
and the outcomes will be studied. T-test, chi-square test, multiple regression test, etcetera
as appropriate will be used. All tests will be two-sided and a P value of <0.05 will be
considered significant.
Based on previous studies it is anticipated an increase in the number of patients with no
medication errors at follow up from 20% to at least 80% in the intervention group. With a
5%-significance level and power of 80%, 11 patients in each group is needed. Similarily the
number of patients with no clinical consequences is anticipated to increase from 71% to at
least 94% in the intervention group and 43 patients in each group is needed.
