Pharmacist Intervention to Reduce Drug-related Readmissions Among the Elderly

Drug Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03671629
• Other study ID #: UmU-2018-700
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2018
• Est. completion date: December 2023

Study information

• Verified date: August 2021
• Source: Umeå University
• Contact: Kindstedt
• Phone: +46706572422
• Email: jonas.kindstedt[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Drug Use

Intervention

Other:
• Enhanced clinical pharmacist service
The intervention includes regular medical chart reviews, multiple patient interviews and, if needed, collaboration with the primary care physician.

Locations

Country	Name	City	State
Sweden	Medical Centre, University Hospital of Umeå	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from discharge to first drug-related readmission	Survival analysis with drug-related readmission as endpoint	180 days
Secondary	Time from discharge to first drug-related readmission	Survival analysis with drug-related readmission as endpoint	30 days
Secondary	Frequency of drug-related readmissions	Difference in total number of drug-related readmissions	30 and 180 days
Secondary	Time from discharge to first drug-related readmission - subgroups with/without heart failure	Survival analysis among patients with/without heart failure	30 and 180 days
Secondary	Time from discharge to first drug-related readmission - subgroups with/without cognitive impairment	Survival analysis among patients with/without cognitive impairment	30 and 180 days
Secondary	Frequency of drug-related readmissions - subgroups with/without cognitive impairment	Subgroup analysis among patients with/without cognitive impairment	30 and 180 days
Secondary	Frequency of drug-related readmissions - subgroups with/without heart failure	Subgroup analysis among patients with/without heart failure	30 and 180 days
Secondary	Time from discharge to first all-cause hospital visit	Survival analysis with readmission or visit to the emergency department as endpoint	30 and 180 days
Secondary	Frequency of all-cause hospital visits	Difference in total number of readmissions and visits to the emergency department	30 and 180 days
Secondary	Self-reported adherence	Adherence to medications reported through MARS-5 ( Medication Adherence Rating Scale) and Swedish Prescribed Drug Register	30 and 180 days
Secondary	Self assessed quality of life: EQ-5D-questionnaire	Health-related quality of life reported through the EQ-5D-questionnaire	30 and 180 days
Secondary	Health economics	Cost for visits for (drug-related) readmissions and to visits to the Emergency Department compared between patients in the control group and intervention group.	180 days
Secondary	Medication appropriateness	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	180 days
Secondary	Mortality	Survival analysis with death as endpoint	30 and 180 days