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NCT Number: NCT03671629

Clinical Pharmacist Intervention to Reduce Drug-related Readmissions Among Older People

This randomized controlled trial primarily investigates if a clinical pharmacist intervention can reduce drug-related readmissions among patients >75 years. The intervention targets the transfer between hospital and primary care. In brief, the intervention includes medical chart reviews and patient interviews during a period of 180 days.

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Key information

Conditions

Drug Use

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

At discharge from the hospital, patients that meet the inclusion criteria are offered to participate in the study. At this point the investigators will also gather baseline data through questionnaires on self-reported adherence (MARS-5) and quality of life (EQ-5D). The participants are randomized to the different study arms according to a stratified procedure based on their cognitive function.

The intervention group will have their charts reviewed every second week and be contacted by the clinical pharmacist through phone within 7 and after 30 and 60 days respectively to discuss their medications. If possible drug-related problems are suspected during the interviews that cannot be solved immediately, the physician is contacted.

Both groups have a follow-up time of 30 and 180 days. After 30 and 180 days, the patients will once again report adherence and quality of life. All other data can be gathered from the medical charts.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Living at home
  • Acutely admitted
  • Registered at one of ten pre-specified primary care health centers

Exclusion criteria

  • Patients unable to communicate or who do not speak Swedish
  • Patients scheduled for palliative care
  • Patients admitted due to intoxication by alcohol or drug (non prescription)

Treatment and study plan

Enhanced clinical pharmacist service

Other

The intervention includes regular medical chart reviews, multiple patient interviews and, if needed, collaboration with the primary care physician.

Primary outcomes

  1. Time from discharge to first drug-related readmission

    Time frame: 180 days

    Survival analysis with drug-related readmission as endpoint

Secondary outcomes

  1. Time from discharge to first drug-related readmission

    Time frame: 30 days

    Survival analysis with drug-related readmission as endpoint

  2. Frequency of drug-related readmissions

    Time frame: 30 and 180 days

    Difference in total number of drug-related readmissions

  3. Time from discharge to first drug-related readmission - subgroups with/without heart failure

    Time frame: 30 and 180 days

    Survival analysis among patients with/without heart failure

  4. Time from discharge to first drug-related readmission - subgroups with/without cognitive impairment

    Time frame: 30 and 180 days

    Survival analysis among patients with/without cognitive impairment

  5. Frequency of drug-related readmissions - subgroups with/without cognitive impairment

    Time frame: 30 and 180 days

    Subgroup analysis among patients with/without cognitive impairment

  6. Frequency of drug-related readmissions - subgroups with/without heart failure

    Time frame: 30 and 180 days

    Subgroup analysis among patients with/without heart failure

  7. Time from discharge to first all-cause hospital visit

    Time frame: 30 and 180 days

    Survival analysis with readmission or visit to the emergency department as endpoint

  8. Frequency of all-cause hospital visits

    Time frame: 30 and 180 days

    Difference in total number of readmissions and visits to the emergency department

  9. Self-reported adherence

    Time frame: 30 and 180 days

    Adherence to medications reported through MARS-5 ( Medication Adherence Rating Scale) and Swedish Prescribed Drug Register

  10. Self assessed quality of life: EQ-5D-questionnaire

    Time frame: 30 and 180 days

    Health-related quality of life reported through the EQ-5D-questionnaire

  11. Health economics

    Time frame: 180 days

    Cost for visits for (drug-related) readmissions and to visits to the Emergency Department compared between patients in the control group and intervention group.

  12. Medication appropriateness

    Time frame: 180 days

    Medication appropriateness using the implicit Medication Appropriateness Index (MAI) and explicit tools in the form of the quality indicators published by the Swedish National Board of Health and Welfare and The European Union (EU)(7)-PIM list

  13. Mortality

    Time frame: 30 and 180 days

    Survival analysis with death as endpoint

Study contacts

Contact information is provided by the study sponsor or research team.

Kindstedt

CONTACT

[email protected]

+46706572422

Maria Gustafsson, Ph.D

CONTACT

[email protected]

+46907853562

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

Involving Clinical Pharmacists in Transitional Care to Reduce Drug-related Readmissions Among the Elderly - a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2018
Registry last updated
Dec 20, 2024

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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