Cross-Sectional StudyNCT03079375
The Pharmacist Follows You and Your Medication From Hospital to Your Daily Life and Investigate What This Means to You
A study testing basic intervention and extended intervention in people with Cross-Sectional Study, run by Lene V. Ravn-Nielsen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cross-Sectional Study
- What is being tested?
- basic intervention and extended intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,499 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2013to 24 Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Usual medicine of five drugs or above
- Speak and understand Danish
- Admitted via the Acute Medicine Admission Ward
- Are able to give informed consent
Who cannot join
- Patients included in a similar study
- Declared terminal
- Suicidal
- In custody
- Isolated at the hospital
- Im- and/or expressive aphasia
- Severe dementia
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cross-Sectional Study
- Being tested
- basic intervention, extended intervention
- Keywords
- cross sectional, medication review, readmissions, follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
basic interventionOther
medication review
extended interventionOther
medication review, medication interview before discharge and follow-up
| Study group | Role | What they receive |
|---|---|---|
| usual care | No intervention | no pharmaceutical intervention. |
| basic intervention | Sham comparator | Medication review Receives: Other: basic intervention |
| extended intervention | Sham comparator | medication review, medication interview before discharge and follow-up with patient, GP and if relevant pharmacy and nursing home. Receives: Other: extended intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmissions
number of patients who have been readmitted
Measured: 30 days
Admissions
number of patients who have been admitted
Measured: 180 days
Emergency Department Visits
number of patients who have emergency department visits
Measured: 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
Measured: 180 days
Secondary outcomes (6)
Drug-related Admissions
number of patients who have drug related admissions
Measured: 180 days after the inclusion date
Drug-related Readmissions
number of patients who have drug related readmissions
Measured: 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.
Measured: 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.
Measured: 1 month
Mortality
number of patient who died within 6 month after inclusion
Measured: 180 days after the inclusion date
Drug Related Mortality
number of patients who have drug related death
Measured: 180 days after the inclusion date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start1 Sep 2013
- Primary completion24 Apr 2015
- Study completion24 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cross-Sectional StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The combination of pharmacist interventions are compared with medication review alone in comparison to non-intervention (a control group).
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 1,499 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lene V. Ravn-Nielsen
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospitals Pharmacies' and Amgros' Research Development Foundation, University of Southern Denmark, Two public Regional foundations, The Actavis Foundation
- Responsible party
- Sponsor-investigator, Lene V. Ravn-Nielsen, Odense University Hospital
- Investigators
- Lene V. Ravn-Nielsen, M.Sc.Pharm, Study director, Hospital Pharmacy of Funen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079375
- Sponsor's protocol ID
- Cross-sectorial medicine
- Status last verified
- Nov 2019
- First submitted
- 1 Mar 2017
- Last updated
- 2 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only during data analysis between clinical pharmacists. Personal identification number is converted to an anonymous identification number.
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.
PubMed 29379953
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pharmaceutical Medication Review, Medication Interview Before Discharge and Follow-up: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03079375
- Acronym / sponsor ID
- Cross-sectorial medicine
- Conditions
- Cross-Sectional Study
- Keywords
- cross sectional, medication review, readmissions, follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,499 participants (actual)
- Lead sponsor
- Lene V. Ravn-NielsenUniversity, hospital or other
- Collaborators
- The Hospitals Pharmacies' and Amgros' Research Development Foundation, University of Southern Denmark, Two public Regional foundations, The Actavis Foundation
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 24 Apr 2015 (actual)
- Study completion
- 24 Oct 2015 (actual)
- First posted
- 14 Mar 2017 (actual)
- Results
- Posted 2 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- The combination of pharmacist interventions are compared with medication review alone in comparison to non-intervention (a control group).
| Arm | Type | Receives |
|---|---|---|
| usual care | No intervention | –no pharmaceutical intervention. |
| basic intervention | Sham comparator | Other: basic interventionMedication review |
| extended intervention | Sham comparator | Other: extended interventionmedication review, medication interview before discharge and follow-up with patient, GP and if relevant pharmacy and nursing home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Usual medicine of five drugs or above
- Speak and understand Danish
- Admitted via the Acute Medicine Admission Ward
- Are able to give informed consent
Key exclusion criteria (7 listed)
- Patients included in a similar study
- Declared terminal
- Suicidal
- In custody
- Isolated at the hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| basic interventionmedication review | Other | basic intervention |
| extended interventionmedication review, medication interview before discharge and follow-up | Other | extended intervention |
Primary outcome
Readmissions
Time frame: 30 days
number of patients who have been readmitted
Admissions
Time frame: 180 days
number of patients who have been admitted
Emergency Department Visits
Time frame: 180 days
number of patients who have emergency department visits
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
6 secondary outcomes
Drug-related Admissions
Time frame: 180 days after the inclusion date
Drug-related Readmissions
Time frame: 30 days after the inclusion date
Percentage of Medication Changes Accepted by GPs
Time frame: up to 180 days
Medication Review Changes Accepted by Physicians (in Hospital)
Time frame: 1 month
Mortality
Time frame: 180 days after the inclusion date
Drug Related Mortality
Time frame: 180 days after the inclusion date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29379953Ravn-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.
- Individual participant dataSharing planned: Yes. Only during data analysis between clinical pharmacists. Personal identification number is converted to an anonymous identification number.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lene V. Ravn-Nielsen, M.Sc.Pharm study director
Hospital Pharmacy of Funen
Questions about this trial
What is this clinical trial studying?
A study testing basic intervention and extended intervention in people with Cross-Sectional Study, run by Lene V. Ravn-Nielsen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmissions (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03079375, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.