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

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.

Study Overview

• Status: Completed
• Conditions: Cross-Sectional Study
• Intervention / Treatment: Other: basic intervention; Other: extended intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 1499
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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
• Suicidal
• In custody
• Isolated at the hospital
• Im- and/or expressive aphasia
• Severe dementia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: usual care; no pharmaceutical intervention.
Sham Comparator: basic intervention; Medication review	Other: basic intervention; medication review
Sham Comparator: extended intervention; medication review, medication interview before discharge and follow-up with patient, GP and if relevant pharmacy and nursing home.	Other: extended intervention; medication review, medication interview before discharge and follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug-related Admissions	number of patients who have drug related admissions	180 days after the inclusion date
Drug-related Readmissions	number of patients who have drug related readmissions	30 days after the inclusion date
Percentage of Medication Changes Accepted by GPs	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.	up to 180 days
Medication Review Changes Accepted by Physicians (in Hospital)	Medication review data were not collected from the Usual care Group and were collected only for the Basic and Extended Groups.	1 month
Mortality	number of patient who died within 6 month after inclusion	180 days after the inclusion date
Drug Related Mortality	number of patients who have drug related death	180 days after the inclusion date

Collaborators and Investigators

• Sponsor: Lene V. Ravn-Nielsen
• Collaborators: University of Southern Denmark; The Hospitals Pharmacies' and Amgros' Research Development Foundation; Two public Regional foundations; The Actavis Foundation
• Investigators: Study Director: Lene V. Ravn-Nielsen, M.Sc.Pharm, Hospital Pharmacy of Funen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): April 24, 2015
• Study Completion (Actual): October 24, 2015

Study Registration Dates

• First Submitted: March 1, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (Actual): March 14, 2017

Study Record Updates

• Last Update Posted (Actual): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 11, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: follow-up; readmissions; medication review; cross sectional
• Other Study ID Numbers: Cross-sectorial medicine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only during data analysis between clinical pharmacists. Personal identification number is converted to an anonymous identification number.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No