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| Name | Class |
|---|---|
| The Hospitals Pharmacies' and Amgros' Research Development Foundation | UNKNOWN |
| University of Southern Denmark | OTHER |
| Two public Regional foundations | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual care | No Intervention | no pharmaceutical intervention. | |
| basic intervention | Sham Comparator | Medication review |
|
| extended intervention | Sham Comparator | medication review, medication interview before discharge and follow-up with patient, GP and if relevant pharmacy and nursing home. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| basic intervention | Other | medication review |
| |
| extended intervention |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lene V. Ravn-Nielsen, M.Sc.Pharm | Hospital Pharmacy of Funen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29379953 | Derived | 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. |
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Only during data analysis between clinical pharmacists. Personal identification number is converted to an anonymous identification number.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | no pharmaceutical intervention. |
| FG001 | Basic Intervention | Medication review basic intervention: medication review |
| FG002 | Extended Intervention | medication review, medication interview before discharge and follow-up with patient, general practitioner and if relevant pharmacy and nursing home. extended intervention: medication review, medication interview before discharge and follow-up |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | no pharmaceutical intervention. |
| BG001 | Basic Intervention | Medication review basic intervention: medication review |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Readmissions | number of patients who have been readmitted | Posted | Count of Participants | Participants | 30 days |
|
6 months
The adverse event data was not collected because the Danish medicines agency found that the study did not require registration of adverse events according to Danish law.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | no pharmaceutical intervention. | 50 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lene V. Ravn-Nielsen clinical pharmacist | OdenseUH | +4523467925 | lene.ravn-nielsen@rsyd.dk |
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| The Actavis Foundation |
| UNKNOWN |
The combination of pharmacist interventions are compared with medication review alone in comparison to non-intervention (a control group).
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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.
| Other |
medication review, medication interview before discharge and follow-up |
|
| 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | Admissions | number of patients who have been admitted | Posted | Count of Participants | Participants | 180 days |
|
|
|
| Primary | Emergency Department Visits | number of patients who have emergency department visits | Posted | Count of Participants | Participants | 180 days |
|
|
|
| Primary | Composite Endpoint, Admissions or Emergency Department Visits | number of patients who experience primary composite endpoint, admissions or emergency department visits within 6 month | Posted | Count of Participants | Participants | 180 days |
|
|
|
| Secondary | Drug-related Admissions | number of patients who have drug related admissions | Posted | Count of Participants | Participants | 180 days after the inclusion date |
|
|
|
| Secondary | Drug-related Readmissions | number of patients who have drug related readmissions | Posted | Count of Participants | Participants | 30 days after the inclusion date |
|
|
|
| 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. | 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. | Posted | Number | percentage of medication changes | up to 180 days |
|
|
|
| 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. | 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. | Posted | Number | percentage of medication changes | 1 month |
|
|
|
| Secondary | Mortality | number of patient who died within 6 month after inclusion | Posted | Count of Participants | Participants | 180 days after the inclusion date |
|
|
|
| Secondary | Drug Related Mortality | number of patients who have drug related death | Posted | Count of Participants | Participants | 180 days after the inclusion date |
|
|
|
| 498 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Basic Intervention | Medication review basic intervention: medication review | 42 | 493 | 0 | 0 | 0 | 0 |
| EG002 | 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 | 54 | 476 | 0 | 0 | 0 | 0 |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|