NCT01513265

Brief Summary

The aim of this study is to determine whether a clinical pharmacist using the RASP list (RASP = Rationalisation of home medication by an adjusted STOPP-list in older patients; STOPP = Screening Tool of Older Persons' potentially inappropriate Prescriptions) can optimise the drug use in elderly inpatients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2011

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

May 22, 2014

Status Verified

December 1, 2011

Enrollment Period

8 months

First QC Date

December 27, 2011

Last Update Submit

May 21, 2014

Conditions

Healthy

Keywords

reduction polypharmacyclinical outcomespharmaceutical careclinical pharmacygeriatricsmedication reviewpotentially inappropriate drugs

Outcome Measures

Primary Outcomes (1)

  • Number of actually stopped or adjusted drugs

    At hospital discharge the number of stopped or adjusted drugs will be determined. This variable will be compared between the two arms.

    Patients will be followed for the duration of hospital stay, an expected average of 14 days.

Secondary Outcomes (10)

  • Number of potentially inappropriate drug prescriptions as defined by the RASP.

    Patients will be followed for the duration of hospital stay, an expected average of 14 days.

  • Actual drug use

    Measured on 30 and 90 days post-discharge.

  • Number and category of drugs adjusted on recommendations of the clinical pharmacist independent of RASP

    Patients will be followed for the duration of hospital stay, an expected average of 14 days.

  • Mortality

    Measured during hospitalisation, an expected average of 14 days and within 90 days after discharge.

  • Number of falls

    Measured during hospitalisation, an expected average of 14 days and within 90 days after discharge

  • +5 more secondary outcomes

Study Arms (2)

RASP

ACTIVE COMPARATOR
Other: Pharmaceutical care plan, mostly based on the RASP

Control group

NO INTERVENTION

Subjects enrolled in this arm will undergo usual medical and pharmaceutical care with registration of drug use at admission and discharge without interference of RASP or clinical pharmacist.

Interventions

Pharmaceutical care plan, mostly based on the RASPOTHER

Drug use of subjects enrolled in this arm will be systematically evaluated by a clinical pharmacist, using the RASP list. Potentially inappropriate drug use will be pointed out to the treating physician. The pharmaceutical advice is not limited to the RASP list. Any actual change in drug prescription will be decided by the treating physician based upon comprehensive medical evaluations in each individual patient.

RASP

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Signed informed consent by the patient or a caregiver if the patient is incompetent to sign

You may not qualify if:

  • Patients not admitted to the hospital from home or a nursing home
  • Patients unable to communicate in Dutch
  • Patients admitted for palliative care
  • Patients who do not take any drugs at admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitaire Ziekenhuizen Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (1)

  • Van der Linden L, Decoutere L, Walgraeve K, Milisen K, Flamaing J, Spriet I, Tournoy J. Combined Use of the Rationalization of Home Medication by an Adjusted STOPP in Older Patients (RASP) List and a Pharmacist-Led Medication Review in Very Old Inpatients: Impact on Quality of Prescribing and Clinical Outcome. Drugs Aging. 2017 Feb;34(2):123-133. doi: 10.1007/s40266-016-0424-8.

    PMID: 27915457DERIVED

Study Officials

  • Lorenz Van der Linden, PharmD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2011

First Posted

January 20, 2012

Study Start

December 1, 2011

Primary Completion

August 1, 2012

Study Completion

October 1, 2012

Last Updated

May 22, 2014

Record last verified: 2011-12

Locations

BE(1)