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Clinical Trials/NCT03079375
NCT03079375
Completed
Not Applicable

The Impact of Pharmaceutical Medication Review, Medication Interview Before Discharge and Follow-up: A Randomized Controlled Trial

Lene V. Ravn-Nielsen0 sites1,499 target enrollmentSeptember 1, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cross-Sectional Study
Sponsor
Lene V. Ravn-Nielsen
Enrollment
1499
Primary Endpoint
Emergency Department Visits
Status
Completed
Last Updated
6 years ago

Overview

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.

Detailed Description

The aim of this study is to determine if a multifaceted pharmacist intervention based on medication review, medication interview and follow up with patient, general practitioner and pharmacy can reduce the number of readmissions and death and or if the time to next admission can be postponed. The combination of the full pharmacist intervention is compared with medication review alone in comparison to non-intervention. Pharmacist intervention: Usual care group: the patients received no intervention by the clinical pharmacist. Basic intervention group: A structured, patient centered medication review (MR) was conducted by the clinical pharmacist. The following was considered during MR: Were there untreated diagnoses, has the goal of treatment been reached, was the treatment compliant with current national guidelines regarding dose, choice of drug and time of treatment. Focus was at certain drugs most commonly implicated in causing admission. Furthermore, all drugs on the medication list were assessed according to the following: Indication for treatment, drug dose, considering i.e. kidney insufficiency, age, etc., adverse drug events, therapeutic duplication, dosage time and interval, drug formulation and strength, interactions, contraindications, precautions and specific patient characteristics. Advice on drug selection, dosages, monitoring needs and possibly side effects were given to the physician in charge of the patient, and written in the electronic patient journal (EPJ). Extended intervention group: MR was conducted according to the same terms and conditions as for the basic intervention group. Upon discharge medication reconciliation was conducted. The pharmacist provided a motivational interview (MI)-based patient interview including a comprehensive summary of changes in the drug therapy during the hospitalization. Post discharge any drug related problem not dealt with during hospitalization was mailed or faxed to the general practitioner (GP). When needed, the GP, care giver and primary care pharmacy were contacted by phone (approximately five working days after discharge). Follow-up interview by phone was performed twice. The first was conducted one week post discharge and the second six months after discharge. When needed additional follow-ups could be made. The follow-up interviews had an motivational interview approach. All interventions were conducted according to a defined standard operating procedure and all interventions were performed by qualified clinical pharmacists from the involved sites. In order to minimize the risk of cultural differences and variations in routine's the regions in between, all data pharmacists were trained prior to entering the study. Data was analysed after the intention-to-treat method. Data was analyzed after a proportional hazard cox regression with the randomization group as the only variable.

Registry
clinicaltrials.gov
Start Date
September 1, 2013
End Date
October 24, 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Lene V. Ravn-Nielsen
Responsible Party
Sponsor Investigator
Principal Investigator

Lene V. Ravn-Nielsen

Clinical pharmacist

Odense University Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Emergency Department Visits

Time Frame: 180 days

number of patients who have emergency department visits

Composite Endpoint, Admissions or Emergency Department Visits

Time Frame: 180 days

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

Readmissions

Time Frame: 30 days

number of patients who have been readmitted

Admissions

Time Frame: 180 days

number of patients who have been admitted

Secondary Outcomes

  • Drug Related Mortality(180 days after the inclusion date)
  • Percentage of Medication Changes Accepted by GPs(up to 180 days)
  • Drug-related Readmissions(30 days after the inclusion date)
  • Drug-related Admissions(180 days after the inclusion date)
  • Medication Review Changes Accepted by Physicians (in Hospital)(1 month)
  • Mortality(180 days after the inclusion date)

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