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NCT Number: NCT01513265

Rationalisation of Polypharmacy in the Elderly by the RASP Instrument

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.

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Key information

Conditions

Healthy

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitaire Ziekenhuizen Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

Older persons take on average multiple drugs. As people age, there is an apparent increase in pharmacodynamic sensitivity to different making the patient more prone to experience side effects. Alterations in body composition and concomitant changes in pharmacokinetic parameters can also result in a higher risk for adverse drug events. All these factors make the older person, notwithstanding the heterogeneity of this population, more vulnerable for the negative consequences of polypharmacy.

Polypharmacy is a cause of negative clinical outcomes but it still remains unclear which intervention or set of interventions should be used to optimize the prescription of pharmacotherapy in the elderly patient. Therefore, the investigators developed the RASP (RASP = Rationalisation of home medication by an adjusted STOPP-list in older patients; STOPP = Screening Tool of Older Persons' potentially inappropriate Prescriptions), a list as tool to reduce polypharmacy adapted to Belgian national prescribing tendencies within geriatric wards. Content and reliability of the RASP have been validated and the investigators aim to further study the impact of the systematic implementation of this RASP on geriatric wards in a prospective cluster randomized controlled trial.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent by the patient or a caregiver if the patient is incompetent to sign
  • Consecutive inclusion of all newly admitted patients to the wards coming from home or the emergency room department

Exclusion criteria

  • 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

Treatment and study plan

Pharmaceutical care plan, mostly based on the RASP

Other

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.

Primary outcomes

  1. Number of actually stopped or adjusted drugs

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

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

Secondary outcomes

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

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

  2. Actual drug use

    Time frame: Measured on 30 and 90 days post-discharge.

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

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

  4. Mortality

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

  5. Number of falls

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

  6. Quality of Life (EQ-5D-3L)

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

  7. Length of stay

    Time frame: Determined at discharge, on average after 14 days

  8. Rehospitalisation

    Time frame: Within 90 days post-discharge.

  9. Incidence of delirium

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

  10. Number of falls post-discharge

    Time frame: Within 90 days post-discharge

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Rationalisation of Polypharmacy in the Elderly by the RASP Instrument (Rationalisation of Home Medication by an Adjusted STOPP-list in Older Patients): a Prospective, Clinical Trial.

Acronym: RASP

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 20, 2012
Registry last updated
May 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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