NCT04040855

Brief Summary

The study is a follow-up of a randomized controlled study performed in 2011-2012 with medication reviews in elderly patients in Sweden. Additional data about mortality and hospital admissions have been collected.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
369

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Status
completed

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 Start

First participant enrolled

September 1, 2011

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
Last Updated

August 1, 2019

Status Verified

July 1, 2019

Enrollment Period

7.3 years

First QC Date

July 29, 2019

Last Update Submit

July 31, 2019

Conditions

Keywords

medication reviews, elderly, primary care

Outcome Measures

Primary Outcomes (4)

  • hospital admission

    time to the first hospital admission

    six months

  • hospital admission

    time to the first hospital admission

    twelve months

  • Survival analysis

    time to death

    six months

  • Survival analysis

    time to death

    twelve months

Secondary Outcomes (4)

  • number of hospital admissions

    six months

  • number of hospital admissions

    twelve months

  • mortality

    six months

  • mortality

    twelve months

Other Outcomes (1)

  • number of drugs

    base-line

Study Arms (2)

Intervention

EXPERIMENTAL

Patients in the intervention groups received multi-professional medication reviews. A nurse performed a symptom evaluation, a pharmacist assessed the drug list and made adjustment suggestions and finally a physician took action and performed medication changes.

Other: Medication review

Control

NO INTERVENTION

Patients were treated according to the usual routine.

Interventions

Multi-professional medication review

Intervention

Eligibility Criteria

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

You may qualify if:

  • age\>75 years, living in nursing homes or community-dwelling with municipality-provided care, with multi-dose drug dispensing

You may not qualify if:

  • lack of multi-dose drug dispensing, living at home with no municipality-provided care, \<75 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Milos Nymberg V, Lenander C, Borgstrom Bolmsjo B. The Impact of Medication Reviews Conducted in Primary Care on Hospital Admissions and Mortality: An Observational Follow-Up of a Randomized Controlled Trial. Drug Healthc Patient Saf. 2021 Jan 27;13:1-9. doi: 10.2147/DHPS.S283708. eCollection 2021.

MeSH Terms

Interventions

Medication Review

Intervention Hierarchy (Ancestors)

Medication SystemsOrganization and AdministrationHealth Services AdministrationPatient Care Management

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Closed envelopes
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Patients were blindly randomized to intervention or control group in 2011. This study is a follow-up with additional data collection for the included patient, a total of 369.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2019

First Posted

August 1, 2019

Study Start

September 1, 2011

Primary Completion

December 31, 2018

Study Completion

March 31, 2019

Last Updated

August 1, 2019

Record last verified: 2019-07