NCT03079375

The Pharmacist Follows You and Your Medication From Hospital to Your Daily Life and Investigate What This Means to You

Completed NA Results posted Last updated 2 December 2019

What this trial tests

NA trial testing basic intervention in Cross-Sectional Study in 1,499 participants. Completed in 24 October 2015.

Timeline

1 September 2013

Primary endpoint
24 April 2015

24 October 2015

Quick facts

Lead sponsor	Lene V. Ravn-Nielsen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	supportive care
Enrollment	1,499
Start date	1 September 2013
Primary completion	24 April 2015
Estimated completion	24 October 2015

Drugs / interventions tested

• basic intervention
• extended intervention

Conditions studied

• Cross-Sectional Study — all drugs for Cross-Sectional Study →

Sponsor

Lene V. Ravn-Nielsen

Who can join

18 and older, any sex, with Cross-Sectional Study. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Readmissions Primary · 30 days

number of patients who have been readmitted

Group	Value	95% CI
Usual Care	111
Basic Intervention	98
Extended Intervention	68

Admissions Primary · 180 days

number of patients who have been admitted

Group	Value	95% CI
Usual Care	243
Basic Intervention	233
Extended Intervention	189

Emergency Department Visits Primary · 180 days

number of patients who have emergency department visits

Group	Value	95% CI
Usual Care	21
Basic Intervention	19
Extended Intervention	15

Composite Endpoint, Admissions or Emergency Department Visits Primary · 180 days

number of patients who experience primary composite endpoint, admissions or emergency department visits within 6 month

Group	Value	95% CI
Usual Care	243
Basic Intervention	233
Extended Intervention	193

Drug-related Admissions Secondary · 180 days after the inclusion date

number of patients who have drug related admissions

Group	Value	95% CI
Usual Care	96
Basic Intervention	95
Extended Intervention	75

Drug-related Readmissions Secondary · 30 days after the inclusion date

number of patients who have drug related readmissions

Group	Value	95% CI
Usual Care	38
Basic Intervention	34
Extended Intervention	24

Percentage of Medication Changes Accepted by GPs Secondary · up to 180 days

Acceptance rate in primary care (general practitioner). Medication review data were not collected from the Usual care Group and were collected only for the Basic and Extended Groups.

Group	Value	95% CI
Extended Intervention	66

Medication Review Changes Accepted by Physicians (in Hospital) Secondary · 1 month

Medication review data were not collected from the Usual care Group and were collected only for the Basic and Extended Groups.

Group	Value	95% CI
Basic Intervention	61
Extended Intervention	61

Mortality Secondary · 180 days after the inclusion date

number of patient who died within 6 month after inclusion

Group	Value	95% CI
Usual Care	50
Basic Intervention	42
Extended Intervention	54

Drug Related Mortality Secondary · 180 days after the inclusion date

number of patients who have drug related death

Group	Value	95% CI
Usual Care	6
Basic Intervention	3
Extended Intervention	5

Sponsor's own description

Background

It is well known that the transfer of a patient from hospital to the general practitioner is related with mistakes in the medication of the patient. A report from 2006 measure the number of drug related admissions in Denmark to be 69.000 to 162.000 per year. To reduce these mistakes, more and better communication between the health professionals are suggested. Furthermore medication reviews made by pharmacist seems to reduce the number of drug related readmissions and other drug related issues, which can lead to an economic cost reduction.

Objective

The aim of this study is to investigate the impact of medication review and better communication between the health professionals after discharge of a patient from hospital to the general practitioner. The effect is measured as reducing the number of readmissions and number of visits at the emergency department 30 days and six month after inclusion of the patient.

Method

This study was estimated to include 1500 participants. The patients were randomized to one of three groups; usual care, basic intervention or extended intervention. The usual care received the normal care following the Danish standard procedure. The basic intervention had a medication review by a clinical pharmacist during admission.

The extended interventions group was similar to the basic intervention group plus follow-up with the patient, the general practitioner and if relevant the nursing home and pharmacy one week and six month after discharge by interview with the clinical pharmacist.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of an In-Hospital Multifaceted Clinical Pharmacist Intervention on the Risk of Readmission: A Randomized Clinical Trial.
   Ravn-Nielsen LV, Duckert ML, Lund ML, Henriksen JP, et al · · 2018 · cited 212× · PMID 29379953 · DOI 10.1001/jamainternmed.2017.8274