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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03079375
Enrollment
1499
Registered
2017-03-14
Start date
2013-09-01
Completion date
2015-10-24
Last updated
2019-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cross-Sectional Study

Keywords

cross sectional, medication review, readmissions, follow-up

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.

Interventions

medication review

OTHERextended intervention

medication review, medication interview before discharge and follow-up

Sponsors

The Hospitals Pharmacies' and Amgros' Research Development Foundation
CollaboratorUNKNOWN
University of Southern Denmark
CollaboratorOTHER
Two public Regional foundations
CollaboratorUNKNOWN
The Actavis Foundation
CollaboratorUNKNOWN
Lene V. Ravn-Nielsen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, 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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Readmissions30 daysnumber of patients who have been readmitted
Admissions180 daysnumber of patients who have been admitted
Emergency Department Visits180 daysnumber of patients who have emergency department visits
Composite Endpoint, Admissions or Emergency Department Visits180 daysnumber of patients who experience primary composite endpoint, admissions or emergency department visits within 6 month

Secondary

MeasureTime frameDescription
Mortality180 days after the inclusion datenumber of patient who died within 6 month after inclusion
Drug-related Admissions180 days after the inclusion datenumber of patients who have drug related admissions
Drug Related Mortality180 days after the inclusion datenumber of patients who have drug related death
Drug-related Readmissions30 days after the inclusion datenumber of patients who have drug related readmissions
Percentage of Medication Changes Accepted by GPsup to 180 daysAcceptance 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.
Medication Review Changes Accepted by Physicians (in Hospital)1 monthMedication review data were not collected from the Usual care Group and were collected only for the Basic and Extended Groups.

Participant flow

Participants by arm

ArmCount
Usual Care
no pharmaceutical intervention.
498
Basic Intervention
Medication review basic intervention: medication review
493
Extended Intervention
medication review, medication interview before discharge and follow-up with patient, GP and if relevant pharmacy and nursing home. extended intervention: medication review, medication interview before discharge and follow-up
476
Total1,467

Baseline characteristics

CharacteristicUsual CareBasic InterventionExtended InterventionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
377 Participants352 Participants346 Participants1075 Participants
Age, Categorical
Between 18 and 65 years
121 Participants141 Participants130 Participants392 Participants
Age, Continuous73 years72 years71 years72 years
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
278 Participants248 Participants262 Participants788 Participants
Sex: Female, Male
Male
220 Participants245 Participants214 Participants679 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
50 / 49842 / 49354 / 476
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 0

Outcome results

Primary

Admissions

number of patients who have been admitted

Time frame: 180 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareAdmissions243 Participants
Basic InterventionAdmissions233 Participants
Extended InterventionAdmissions189 Participants
Primary

Composite Endpoint, Admissions or Emergency Department Visits

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

Time frame: 180 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareComposite Endpoint, Admissions or Emergency Department Visits243 Participants
Basic InterventionComposite Endpoint, Admissions or Emergency Department Visits233 Participants
Extended InterventionComposite Endpoint, Admissions or Emergency Department Visits193 Participants
Primary

Emergency Department Visits

number of patients who have emergency department visits

Time frame: 180 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareEmergency Department Visits21 Participants
Basic InterventionEmergency Department Visits19 Participants
Extended InterventionEmergency Department Visits15 Participants
Primary

Readmissions

number of patients who have been readmitted

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareReadmissions111 Participants
Basic InterventionReadmissions98 Participants
Extended InterventionReadmissions68 Participants
Secondary

Drug-related Admissions

number of patients who have drug related admissions

Time frame: 180 days after the inclusion date

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareDrug-related Admissions96 Participants
Basic InterventionDrug-related Admissions95 Participants
Extended InterventionDrug-related Admissions75 Participants
Secondary

Drug Related Mortality

number of patients who have drug related death

Time frame: 180 days after the inclusion date

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareDrug Related Mortality6 Participants
Basic InterventionDrug Related Mortality3 Participants
Extended InterventionDrug Related Mortality5 Participants
Secondary

Drug-related Readmissions

number of patients who have drug related readmissions

Time frame: 30 days after the inclusion date

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareDrug-related Readmissions38 Participants
Basic InterventionDrug-related Readmissions34 Participants
Extended InterventionDrug-related Readmissions24 Participants
Secondary

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.

Time frame: 1 month

Population: Medication review data were not collected from the Usual care Group and were collected only for the Basic and Extended Groups. The acceptance rate is only analyzed for of the basic intervention and the extended intervention in total.

ArmMeasureValue (NUMBER)
Usual CareMedication Review Changes Accepted by Physicians (in Hospital)61 percentage of medication changes
Basic InterventionMedication Review Changes Accepted by Physicians (in Hospital)61 percentage of medication changes
Secondary

Mortality

number of patient who died within 6 month after inclusion

Time frame: 180 days after the inclusion date

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareMortality50 Participants
Basic InterventionMortality42 Participants
Extended InterventionMortality54 Participants
Secondary

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.

Time frame: up to 180 days

Population: Medication review data were not collected from the Usual care Group and were collected only for the Basic and Extended Groups. No interventions were sent to the general practitioner for the Usual care and the Basic intervention Groups.

ArmMeasureValue (NUMBER)
Usual CarePercentage of Medication Changes Accepted by GPs66 percentage of medication changes

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026