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NCT Number: NCT01504672

An Intervention Study to Reduce Drug-related Problems and Readmissions Among Old People With Dementia

The aim of this randomized controlled study is to investigate if medication reviews performed by a clinical pharmacist as part of a ward team can reduce drug related problems and reduce readmissions to hospital among elderly patients (≥65 years) with dementia and cognitive failure.

Four hundred and sixty patients will be recruited and randomized to control (usual care) and intervention group (enhanced service in which a pharmacist is part of the health care team).

Six months after the last patient of the 460 has been discharged the study will be closed. Data about the number of readmissions and visits to the emergency room will be collected during the six-month follow-up and also, the costs associated with each visit or admission. Time until institutionalization will be compared between intervention group and control group.

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Key information

Conditions

Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

County hospital of Skellefteå, Skellefteå, Sweden

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with dementia or cognitive impairment
  • Patients ≥ 65 years

Exclusion criteria

  • Patients previously admitted to the study wards during the study period

Treatment and study plan

Medication review

Other

In the intervention, the pharmacist will evaluate:

  • Is there an indication for the drug?
  • Has the drug desired effect?
  • Is the dose correct and dosing scheme correct?
  • Side effects, contraindications, inappropriate drugs
  • Interactions
  • Treatment time
  • Cost effectiveness
  • Adherence to recommendation list
  • Problems with handling the drugs (for example crushing of the tablets)
  • Untreated indication
  • Double medications
  • Administration of drugs

Primary outcomes

  1. Number of Patients Readmitted Because of Drug Related Reasons

    Time frame: Six months follow-up

Secondary outcomes

  1. Cost for Visits for Readmissions and to the Emergency Department Compared Between Patients in the Control Group and Intervention Group.

    Time frame: Six months follow-up

    To evaluate the economic impact of clinical pharmacist engagement in hospital ward teams for medication therapy management in older patients with dementia or cognitive impairments.

  2. Number of Participants Institutionalized After Discharge, in Control Group and Intervention Group.

    Time frame: Six months follow-up

  3. Frequency of Emergency Department Visits During the 6-month Follow-up.

    Time frame: Six months follow-up

  4. Change in the Number of Participants With Potentially Inappropriate Medications, According to the Swedish National Board of Health and Welfare, at Admission and Discharge Between Intervention and Control Group

    Time frame: Index admission (at randomization) and index discharge (duration of index admission, mean days 8.7)

    Six drug-specific quality indicators as defined by the Swedish National Board of Health and Welfare were used to define use of Potentially inappropriate medications (PIMs) in this study. Four out of the six selected indicators belong to a group where drug-use should be as low as possible regardless of indication: anticholinergic drugs (as defined by the Swedish National Board of Health and Welfare, propiomazine, tramadol, and long-acting benzodiazepines. The two remaining indicators are classified as preparations for which correct and current indication is of particular importance: antipsychotic drugs (N05A except lithium) and Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). In the present study, a PIM was defined as exposure to at least one of the drugs mentioned among the six quality indicators.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

A Randomized Controlled Pharmacist Intervention Study to Reduce Drug-related Problems and Readmissions Among Old People With Dementia

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 5, 2012
Registry last updated
Nov 9, 2021

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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