|- candidate number||7871|
|- NTR Number||NTR2258|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-mrt-2010|
|- Secondary IDs||17088.2706 ZonMw|
|- Public Title||The economic and clinical impact of a clinical pharmacy team on surgical patients: the SUREPILL study.|
|- Scientific Title||The economic and clinical impact of a clinical pharmacy team on surgical patients: a randomised cost-effectiveness study.|
|- hypothesis||The active participation of a clinical pharmacy team on the surgical ward will reduce preventable ADE's cost-effectively.|
|- Healt Condition(s) or Problem(s) studied||Adverse Drug Events|
|- Inclusion criteria||1. Study ward: surgical ward;|
2. Elective admitted for surgical procedure;
3. Hospital stay: > 48 hours.
|- Exclusion criteria||1. Patient already included in the study;|
2. Admitted from other department within hospital or other hospital.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2008|
|- planned closingdate||1-okt-2011|
|- Target number of participants||1444|
|- Interventions||Three hospitals will participate. First, baseline assessments (n=480) will be made in each hospital at the surgical wards. Then, in each centre, one unit will randomly be assigned (one-time randomisation) as experimental unit (n= 482) receiving ward-based pharmacy, whereas the other unit will serve as control unit (n= 482) receiving usual pharmaceutical care.
Active participation of a hospital pharmacy team on the surgical ward:
1. Medication reconciliation at admission by pharmacy technicians;
2. Daily review of prescribed medication by hospital pharmacists;
3. Medication reconciliation and couselling at discharge by pharmacy technicians.
|- Primary outcome||Number of preventable ADE's per 100 admissions.
|- Secondary outcome||1. Severity of all preventable ADE's;|
2. Number and clinical relevance of pharmacy interventions;
3. Lenght of hospital stay;
4. Number of readmissions within 3 months after admission;
6. Quality of life within 3 months after admission;
7. Additional quality of pharmaceutical care.
|- Timepoints||1. Medication reconciliation at admission and discharge with questionnairre;|
2. Daily registration of interventions by clinical pharmacy team;
3. Follow -up by questionnairre within 3 months after admission;
4. Retrospective patient chart analysis to detect ADE's and determine quality of care.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. M. Boer, de|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. L. Lie-A-Huen|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam, Onze Lieve Vrouwe Gasthuis (OLVG), Diakonessenhuis Utrecht, Department of Surgery|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale: |
Injuries caused by medication errors are widely agreed to be a problem in hospitalized patients. These injuries are known as preventable Adverse Drug Events (pADE’s). Also in The Netherlands is stated that hundreds of people die each year as a result of pADE’s. Surgical patients are especially at risk for these ADEs because of the frequent transfer moments within the hospital and subsequent changes in medication.
International studies have shown that hospital pharmacists can effectively reduce pADE’s when they actively participate on the ward. This concept is known as ‘ward-based pharmacy’. The activities consist of close review of medication on admission, active participation in rounding teams and counselling patients at discharge. The applicability of these findings to the Dutch setting is unknown as our health care system is differently organized. In The Netherlands hospital pharmacists work from a central pharmacy and they are scarce and more costly.
The aim of the proposed study is to establish whether the active participation of a clinical pharmacy team on the surgical ward reduces pADE's cost-effectively in the Dutch setting.
Three hospitals will participate. First, baseline assessments (n=480) will be made in each hospital at the surgical wards. Then, in each centre, one unit will randomly be assigned (one-time randomisation) as experimental unit (n= 482) receiving ward-based pharmacy, whereas the other unit will serve as control unit (n= 482) receiving usual pharmaceutical care.
Consecutive patients admitted to a surgical ward for elective surgery with an expected length of stay of more than 2 days.
The ward-based pharmacy team assesses medication reconciliation at admission and discharge and daily optimizes the patient medication during hospital stay. Patients admitted to control units receive standard pharmaceutical care.
The number of pADE’s per 100 admissions in experimental unit patients will be compared to that of control unit patients, corrected for differences at baseline. Besides presence, also the severity of the pADE’s will be determined. Additionally, the quality of care will be measured using newly developed quality indicators. The follow-up of 3 months will provide information on the outcomes readmissions, quality of life and additional costs after discharge. All interventions by the clinical pharmacy team will be documented.
|- Main changes (audit trail)|
|- RECORD||24-mrt-2010 - 5-apr-2010|