The use of a patient ward transfer as a trigger for the application of clinical pharmacy

ISRCTN	ISRCTN40005781
DOI	https://doi.org/10.1186/ISRCTN40005781
Protocol serial number	072010FOD
Sponsor	ZNA Hospital Network Antwerp (Belgium)
Funder	Belgian Goverment

Submission date: 22/03/2011
Registration date: 31/08/2011
Last edited: 31/08/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Dirk Ramaekers
Scientific

Leopoldstraat 26
Antwerp
2000
Belgium

Email	dirk.ramaekers@zna.be

Study information

Primary study design	Interventional
Study design	Prospective randomized two-arm multicenter study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The transfer-trigger as a basic for the application of clinical pharmacy
Study objectives	1. A total inventory and analysis of the communication channels and different types of documents involved in a patient transfer 2. A proposal for improvement and optimization of these documents 3. A comparison of drug therapy before and after each transfer 4. An analysis of the differences of these comparisons 5. A proposal for interventions/recommendations to medication management by the clinical pharmacist following the transfers 6. Acceptance measurement of the interventions / recommendations 7. Discharge management
Ethics approval(s)	The Institutional Review Board ZNA/OCMW Antwerpen OG 031-009 ref: 3754
Health condition(s) or problem(s) studied	The clinical pharmacist receives a signal when an enrolled patient is transferred. This signal is the cue for a total drug analysis of the medication therapy before and after transfer. This happens no later than 2 days after transfer. The patients home medication is studied retrospectively.
Intervention	Implementation Phase: For each enrolled patient the drug therapy before and after each transfer will be compared and any differences will be recorded on a standard document. The following differences will be reported: 1. Differences in dosage 2. Differences in method of administration 3. Dosage adjustments depending on organ function 4. Additions or eliminations of a drug 5. Incorrect medication As it is possible that a patient can transfer several times, after each transfer a new document will be completed. The enrolled patients are followed throughout their stay in the ZNA. 1. The patients are randomised using the last digit of their admissions number: 1.1. Odd number = observation group 1.2. Even number = intervention group 2. Recommendations for intervention (where necessary) are recorded for all patients. 3. The interventions/recommendations are only implemented/proposed in the intervention group. 4. The included patients will be randomized and divided into 2 groups: 4.1. In the control group there will be only observation but no interventions by the clinical pharmacist. Subsequent changes to the medication by other care providers with a positive impact on the drug therapy are also noted. 4.2. The drug therapy of the intervention group will be viewed by the clinical pharmacist who will make interventions or recommendations where appropriate. 4.3. The clinical pharmacist will also examine whether the therapy is consistent with the current medication policy endorsed by the MFC (formulary medication). 5. Interventions can include: 5.1. Stopping or reducing treatment 5.2. Starting or resumption of treatment 5.3. Substitution/replacement 5.4. Change of route of administration/formulation 5.5. Dose adjustment 5.6. Frequency adjustment 5.7. Change of route of administration 5.8. Improvement of monitoring/follow up 5.9. Explanation of the discharge procedure 6. The interventions will be documented using a standard intervention form consisting of the following: 6.1. Reason to intervene 6.2. Intervention 6.3. Outcome 6.4 Medical/economic impact 7. The four parts are completed for both the intervention group and the control group. 8. In the control group the intervention will not be implemented. 9. Both intervention and outcome will be assessed according to their relevance and will be compared 10. When a patient is discharged, the clinical pharmacist will do a proposal for the discharge medication. This proposal takes into account the possible substitutions that would have happened in the hospital and ensures that they are switched back to the original drug. 11. There needs to be clear procedures in place to inform the prescriber which medication substitutions need to be prescribed on discharge 12. Communication between doctor - nurse - pharmacist - patient is crucial. We will investigate how this can be done most efficiently.
Intervention type	Other
Primary outcome measure(s)	1. These are only applicable for the intervention group 2. Determined the day after the intervention 3. Importance of the interventions are evaluated 4. The difference in outcome between the two groups will serve as a measure of the importance of a clinical pharmacist on the ward The possible primary outcome/acceptance among the intervention group is (a) implementation of the intervention or (b) no implementation. Also in the control group, the primary outcome can (a) be positive by implementing interventions or recommendations by other health care providers on their own initiative or (b) negative if no third party has intervened.
Key secondary outcome measure(s)	The degree of relevancy will be determined by an expert group: 1. Medical impact 2. Economic impact
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	600
Key inclusion criteria	1. Hospitalised patients above 15 years of age 2. Patients should have stayed a minimum of three days in intensive care and then undergo a transfer to a ward with surgical, medical or geriatric beds
Key exclusion criteria	Patients with a Do Not Resuscitate (DNR) code of 2 and 3 are excluded (patients where it has been agreed that certain treatments should not be started or should be withdrawn)
Date of first enrolment	06/12/2010
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

Belgium

Study participating centre

Leopoldstraat 26

Antwerp
2000
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes