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

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ClinicalTrials.gov Identifier: NCT03079375
Recruitment Status : Completed
First Posted : March 14, 2017
Results First Posted : December 2, 2019
Last Update Posted : December 2, 2019
Sponsor:
Collaborators:
The Hospitals Pharmacies’ and Amgros’ Research Development Foundation
University of Southern Denmark
Two public Regional foundations
The Actavis Foundation
Information provided by (Responsible Party):
Lene V. Ravn-Nielsen, Odense University Hospital

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.


Condition or disease Intervention/treatment Phase
Cross-Sectional Study Other: basic intervention Other: extended intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1499 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: The combination of pharmacist interventions are compared with medication review alone in comparison to non-intervention (a control group).
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Supportive Care
Official Title: The Impact of Pharmaceutical Medication Review, Medication Interview Before Discharge and Follow-up: A Randomized Controlled Trial
Actual Study Start Date : September 1, 2013
Actual Primary Completion Date : April 24, 2015
Actual Study Completion Date : October 24, 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Readmissions [ Time Frame: 30 days ]
    number of patients who have been readmitted

  2. Admissions [ Time Frame: 180 days ]
    number of patients who have been admitted

  3. Emergency Department Visits [ Time Frame: 180 days ]
    number of patients who have emergency department visits

  4. 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


Secondary Outcome Measures :
  1. Drug-related Admissions [ Time Frame: 180 days after the inclusion date ]
    number of patients who have drug related admissions

  2. Drug-related Readmissions [ Time Frame: 30 days after the inclusion date ]
    number of patients who have drug related readmissions

  3. Percentage of Medication Changes Accepted by GPs [ Time Frame: 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.

  4. Medication Review Changes Accepted by Physicians (in Hospital) [ Time Frame: 1 month ]
    Medication review data were not collected from the Usual care Group and were collected only for the Basic and Extended Groups.

  5. Mortality [ Time Frame: 180 days after the inclusion date ]
    number of patient who died within 6 month after inclusion

  6. Drug Related Mortality [ Time Frame: 180 days after the inclusion date ]
    number of patients who have drug related death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • Suicidal
  • In custody
  • Isolated at the hospital
  • Im- and/or expressive aphasia
  • Severe dementia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079375


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lene V. Ravn-Nielsen, Clinical pharmacist, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03079375     History of Changes
Other Study ID Numbers: Cross-sectorial medicine
First Posted: March 14, 2017    Key Record Dates
Results First Posted: December 2, 2019
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Only during data analysis between clinical pharmacists. Personal identification number is converted to an anonymous identification number.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lene V. Ravn-Nielsen, Odense University Hospital:
cross sectional
medication review
readmissions
follow-up