NCT03671629

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Sep 2018Dec 2026

First Submitted

Initial submission to the registry

September 7, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

September 19, 2018

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

8.2 years

First QC Date

September 7, 2018

Last Update Submit

December 17, 2024

Conditions

Drug Use

Keywords

Clinical pharmacistElderlyAdherenceDrug-related readmission

Outcome Measures

Primary Outcomes (1)

  • Time from discharge to first drug-related readmission

    Survival analysis with drug-related readmission as endpoint

    180 days

Secondary Outcomes (13)

  • Time from discharge to first drug-related readmission

    30 days

  • Frequency of drug-related readmissions

    30 and 180 days

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

    30 and 180 days

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

    30 and 180 days

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

    30 and 180 days

  • +8 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

This group receives standard care, which might include a medication review at the hospital.

Interventions

Enhanced clinical pharmacist serviceOTHER

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

Intervention group

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Centre, University Hospital of Umeå

Umeå, 901 85, Sweden

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32345700DERIVED

Study Officials

  • Maria Gustafsson, Ph.D

    Umeå University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kindstedt

CONTACT

+46706572422jonas.kindstedt@umu.se

Maria Gustafsson, Ph.D

CONTACT

+46907853562maria.gustafsson@umu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
A group of physicians and clinical pharmacists will asses whether readmissions are drug-related or not. This group is blinded.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 14, 2018

Study Start

September 19, 2018

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 20, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)