Cross-Sectional Study
Conditions
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
medication review, medication interview before discharge and follow-up
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Readmissions | 30 days | number of patients who have been readmitted |
| Admissions | 180 days | number of patients who have been admitted |
| Emergency Department Visits | 180 days | number of patients who have emergency department visits |
| Composite Endpoint, Admissions or Emergency Department Visits | 180 days | number of patients who experience primary composite endpoint, admissions or emergency department visits within 6 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 180 days after the inclusion date | number of patient who died within 6 month after inclusion |
| Drug-related Admissions | 180 days after the inclusion date | number of patients who have drug related admissions |
| Drug Related Mortality | 180 days after the inclusion date | number of patients who have drug related death |
| Drug-related Readmissions | 30 days after the inclusion date | number of patients who have drug related readmissions |
| Percentage of Medication Changes Accepted by GPs | 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. |
| Medication Review Changes Accepted by Physicians (in Hospital) | 1 month | Medication 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
| Arm | Count |
|---|---|
| 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 |
| Total | 1,467 |
Baseline characteristics
| Characteristic | Usual Care | Basic Intervention | Extended Intervention | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 377 Participants | 352 Participants | 346 Participants | 1075 Participants |
| Age, Categorical Between 18 and 65 years | 121 Participants | 141 Participants | 130 Participants | 392 Participants |
| Age, Continuous | 73 years | 72 years | 71 years | 72 years |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 278 Participants | 248 Participants | 262 Participants | 788 Participants |
| Sex: Female, Male Male | 220 Participants | 245 Participants | 214 Participants | 679 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 50 / 498 | 42 / 493 | 54 / 476 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Admissions
number of patients who have been admitted
Time frame: 180 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Admissions | 243 Participants |
| Basic Intervention | Admissions | 233 Participants |
| Extended Intervention | Admissions | 189 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Composite Endpoint, Admissions or Emergency Department Visits | 243 Participants |
| Basic Intervention | Composite Endpoint, Admissions or Emergency Department Visits | 233 Participants |
| Extended Intervention | Composite Endpoint, Admissions or Emergency Department Visits | 193 Participants |
Emergency Department Visits
number of patients who have emergency department visits
Time frame: 180 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Emergency Department Visits | 21 Participants |
| Basic Intervention | Emergency Department Visits | 19 Participants |
| Extended Intervention | Emergency Department Visits | 15 Participants |
Readmissions
number of patients who have been readmitted
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Readmissions | 111 Participants |
| Basic Intervention | Readmissions | 98 Participants |
| Extended Intervention | Readmissions | 68 Participants |
Drug-related Admissions
number of patients who have drug related admissions
Time frame: 180 days after the inclusion date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Drug-related Admissions | 96 Participants |
| Basic Intervention | Drug-related Admissions | 95 Participants |
| Extended Intervention | Drug-related Admissions | 75 Participants |
Drug Related Mortality
number of patients who have drug related death
Time frame: 180 days after the inclusion date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Drug Related Mortality | 6 Participants |
| Basic Intervention | Drug Related Mortality | 3 Participants |
| Extended Intervention | Drug Related Mortality | 5 Participants |
Drug-related Readmissions
number of patients who have drug related readmissions
Time frame: 30 days after the inclusion date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Drug-related Readmissions | 38 Participants |
| Basic Intervention | Drug-related Readmissions | 34 Participants |
| Extended Intervention | Drug-related Readmissions | 24 Participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Medication Review Changes Accepted by Physicians (in Hospital) | 61 percentage of medication changes |
| Basic Intervention | Medication Review Changes Accepted by Physicians (in Hospital) | 61 percentage of medication changes |
Mortality
number of patient who died within 6 month after inclusion
Time frame: 180 days after the inclusion date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Mortality | 50 Participants |
| Basic Intervention | Mortality | 42 Participants |
| Extended Intervention | Mortality | 54 Participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Percentage of Medication Changes Accepted by GPs | 66 percentage of medication changes |