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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Drug Use
• Intervention / Treatment: Other: Enhanced clinical pharmacist service

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kindstedt; Phone Number: +46706572422; Email: jonas.kindstedt@umu.se
• Study Contact Backup: Name: Maria Gustafsson, Ph.D; Phone Number: +46907853562; Email: maria.gustafsson@umu.se

Study Locations

• Sweden
  • Umeå, Sweden, 901 85
    • Recruiting
    • Medical Centre, University Hospital of Umeå
    • Contact: Matsson; Phone Number: +4690-785 84 02; Email: cecilia.mattsson@vll.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; In addition to a standard medication review at the hospital, this group also receives an enhanced clinical pharmacist service during 180 days after discharge from the hospital.	Other: Enhanced clinical pharmacist service; The intervention includes regular medical chart reviews, multiple patient interviews and, if needed, collaboration with the primary care physician.
No Intervention: Control group; This group receives standard care, which might include a medication review at the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from discharge to first drug-related readmission	Survival analysis with drug-related readmission as endpoint	180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from discharge to first drug-related readmission	Survival analysis with drug-related readmission as endpoint	30 days
Frequency of drug-related readmissions	Difference in total number of drug-related readmissions	30 and 180 days
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
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
Frequency of drug-related readmissions - subgroups with/without cognitive impairment	Subgroup analysis among patients with/without cognitive impairment	30 and 180 days
Frequency of drug-related readmissions - subgroups with/without heart failure	Subgroup analysis among patients with/without heart failure	30 and 180 days
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
Frequency of all-cause hospital visits	Difference in total number of readmissions and visits to the emergency department	30 and 180 days
Self-reported adherence	Adherence to medications reported through MARS-5 ( Medication Adherence Rating Scale) and Swedish Prescribed Drug Register	30 and 180 days
Self assessed quality of life: EQ-5D-questionnaire	Health-related quality of life reported through the EQ-5D-questionnaire	30 and 180 days
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
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
Mortality	Survival analysis with death as endpoint	30 and 180 days

Collaborators and Investigators

• Sponsor: Umeå University
• Investigators: Principal Investigator: Maria Gustafsson, Ph.D, Umeå University

Publications and helpful links

General Publications

• Kindstedt J, Svahn S, Sjolander M, Glader EL, Lovheim H, Gustafsson M. Investigating the effect of clinical pharmacist intervention in transitions of care on drug-related hospital readmissions among the elderly: study protocol for a randomised controlled trial. BMJ Open. 2020 Apr 27;10(4):e036650. doi: 10.1136/bmjopen-2019-036650.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 7, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Elderly; Adherence; Clinical pharmacist; Drug-related readmission
• Other Study ID Numbers: UmU-2018-700

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No