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

NCT03079375 | Completed Results

• 1 other identifier: Cross-sectorial medicine
• Study Type: interventional
• Target: 1,499
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cross-Sectional Study

Keywords

cross sectional; medication review; readmissions; follow-up

Outcome Measures

Primary Outcomes (4)

• Readmissions

  number of patients who have been readmitted

  30 days

• Admissions

  number of patients who have been admitted

  180 days

• Emergency Department Visits

  number of patients who have emergency department visits

  180 days

• Composite Endpoint, Admissions or Emergency Department Visits

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

  180 days

Secondary Outcomes (6)

• Drug-related Admissions

  180 days after the inclusion date

• Drug-related Readmissions

  30 days after the inclusion date

• Percentage of Medication Changes Accepted by GPs

  up to 180 days

• Medication Review Changes Accepted by Physicians (in Hospital)

  1 month

• Mortality

  180 days after the inclusion date

Study Arms (3)

usual care

NO INTERVENTION

no pharmaceutical intervention.

basic intervention

SHAM COMPARATOR

Medication review

Other: basic intervention

extended intervention

SHAM COMPARATOR

medication review, medication interview before discharge and follow-up with patient, GP and if relevant pharmacy and nursing home.

Other: extended intervention

Interventions

basic intervention OTHER

medication review

basic intervention

extended intervention OTHER

medication review, medication interview before discharge and follow-up

extended intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Usual medicine of five drugs or above
• Speak and understand Danish
• Admitted via the Acute Medicine Admission Ward
• Are able to give informed consent

You may not qualify if:

• Patients included in a similar study
• Declared terminal
• Suicidal
• In custody
• Isolated at the hospital
• Im- and/or expressive aphasia
• Severe dementia

Sponsors & Collaborators

• Lene V. Ravn-Nielsen: lead
• The Hospitals Pharmacies' and Amgros' Research Development Foundation: collaborator
• University of Southern Denmark: collaborator
• Two public Regional foundations: collaborator
• The Actavis Foundation: collaborator

Related Publications (1)

• Ravn-Nielsen LV, Duckert ML, Lund ML, Henriksen JP, Nielsen ML, Eriksen CS, Buck TC, Pottegard A, Hansen MR, Hallas J. Effect of an In-Hospital Multifaceted Clinical Pharmacist Intervention on the Risk of Readmission: A Randomized Clinical Trial. JAMA Intern Med. 2018 Mar 1;178(3):375-382. doi: 10.1001/jamainternmed.2017.8274.

  PMID: 29379953 DERIVED

Results Point of Contact

• Title: Lene V. Ravn-Nielsen clinical pharmacist
• Organization: OdenseUH

lene.ravn-nielsen@rsyd.dk

+4523467925

Study Officials

• Lene V. Ravn-Nielsen, M.Sc.Pharm

  Hospital Pharmacy of Funen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The study is double blinded. The pharmacist do not know, whether the patient is randomized to the basic or to the extended intervention before they conduct the medication review. That is why the patients in the intervention group are randomized two times.
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical pharmacist

Model Details: The combination of pharmacist interventions are compared with medication review alone in comparison to non-intervention (a control group).

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 14, 2017
• Study Start: September 1, 2013
• Primary Completion: April 24, 2015
• Study Completion: October 24, 2015
• Last Updated: December 2, 2019
• Results First Posted: December 2, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share