Condition category
Not Applicable
Date applied
22/03/2011
Date assigned
31/08/2011
Last edited
31/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Dirk Ramaekers

ORCID ID

Contact details

Leopoldstraat 26
Antwerp
2000
Belgium
dirk.ramaekers@zna.be

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

072010FOD

Study information

Scientific title

The transfer-trigger as a basic for the application of clinical pharmacy

Acronym

Study hypothesis

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

The Institutional Review Board ZNA/OCMW Antwerpen OG 031-009 ref: 3754

Study design

Prospective randomized two-arm multicenter study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 patient’s ‘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

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

The degree of relevancy will be determined by an expert group:
1. Medical impact
2. Economic impact

Overall trial start date

06/12/2010

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant 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)

Recruitment start date

06/12/2010

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Belgium

Trial participating centre

Leopoldstraat 26
Antwerp
2000
Belgium

Sponsor information

Organisation

ZNA Hospital Network Antwerp (Belgium)

Sponsor details

c/o Ms Sarah De Broe
Lange Beeldekensstraat 267
Antwerp
2060
Belgium
sarah.debroe@zna.be

Sponsor type

Hospital/treatment centre

Website

http://www.zna.be/

Funders

Funder type

Government

Funder name

Belgian Goverment

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes