Medication ReviewMedBridgeNCT02999412
Medication Reviews Bridging Healthcare: a Cluster-randomised Crossover Trial
A study testing Comprehensive medication review and Comprehensive medication review with active follow-up in people with Medication Review, run by Uppsala County Council, Sweden at 4 sites in Sweden.
Trial summary
Background: Mismanaged prescribing and use of medication among elderly puts major pressure on current healthcare systems. Performing a medication review, a structured critical examination of a patient's medications, during hospital stay with active follow-up into primary care could optimise treatment benefit and… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Medication Review
- What is being tested?
- Comprehensive medication review and Comprehensive medication review with active follow-up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,637 participants
- Where
- 4 sitesSweden
- Study dates
- 6 Feb 2017to 3 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Admitted to one of the study wards
Who cannot join
- Has been subject to a medication review within the last 30 days as stated within their medical record;
- Residing in another than the hospital's county
- Being in a palliative stage as stated in their medical record
- Admitted for only one day
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Enköping Hospital
Enköping, Uppsala County, 74538
Gävle Hospital
Gävle, Gävleborg County, 80324
Uppsala University Hospital
Uppsala, Uppsala County, 75185
Västmanland Hospital
Västerås, Västmanlands Lan, 72334
About this study
Official title: Medication Reviews Bridging Healthcare: a Cluster-randomised Crossover Trial to Study the Effects of Hospital-initiated Comprehensive Medication Reviews, Including Active Follow-up, on Elderly Patients' Healthcare Utilisation
Background: Mismanaged prescribing and use of medication among elderly puts major pressure on current healthcare systems. Performing a medication review, a structured critical examination of a patient's medications, during hospital stay with active follow-up into primary care could optimise treatment benefit and minimise harm. However, a lack of high quality evidence inhibits widespread implementation. This manuscript describes the rationale and design of a pragmatic cluster-randomised, crossover trial to fulfil this need for evidence.
Aim: To study the effects of hospital-initiated comprehensive medication reviews, including active follow-up, on elderly patients' healthcare utilisation compared to 1) usual care and 2) solely hospital based reviews.
Read more
Design: Multicentre, three-treatment, replicated, cluster-randomised, crossover trial.
Setting: 8 wards with a multidisciplinary team within 4 hospitals in 3 Swedish counties.
Participants: Patients aged 65 years or older, admitted to one of the study wards. Exclusion criteria: Palliative stage; residing in other than the hospital's county; medication review within the last 30 days; one-day admission.
Interventions: 1, comprehensive medication review during hospital stay; 2, same as 1 with the addition of active follow-up into primary care; 3, usual care.
Primary outcome measure: Incidence of unplanned hospital visits during a 12-month follow-up period.
Data collection and analyses: Extraction and collection from the counties' medical record system into a GCP compliant electronic data capture system. Intention-to-treat-analyses using log-linear Poisson generalized linear mixed models and frailty models.
Relevance: This study has a high potential to show a reduction in elderly patients' morbidity, contributing to more sustainable healthcare in the long run.
Read the detailed description
Background:
Mismanaged use of multiple medications is one of the greatest risks for healthcare-related harm in the elderly and puts major pressure on current healthcare systems [1,2]. Identifying effective interventions to optimise treatment benefit and minimise harm is an international public health priority [3]. Comprehensive medication review, a structured and critical examination of an individual patient's medications in relation to the patient's conditions, aims to accomplish these goals [4]. A recently published Cochrane meta-analysis examined whether medication reviews lead to improvement in health outcomes of hospitalised adult patients compared with standard care [5]. Ten randomised controlled trials (RCTs) were eventually used for analysis. The authors stated that they "found no evidence that medication review reduces mortality or hospital readmissions, although we did find evidence that medication review may reduce emergency department contacts."[5] A beneficial or detrimental effect on mortality or hospital admissions could be ruled out because estimates were uncertain and follow-up was short. The authors stated that there is a strong need for RCTs of high quality with at least one year follow-up and which are randomised at a cluster level to minimise contamination bias [5]. In addition, a cluster randomised crossover design in which each cluster serves as its own control would increase statistical power [6].
One of the included RCTs in this meta-analysis was conducted by our research group at Uppsala University Hospital in 2005-2006 [7]. We demonstrated in this study that patients, aged 80 years or older, who received a comprehensive medication review including follow-up after hospital discharge, performed by ward based clinical pharmacist, had 16% fewer hospital revisits in the following year. The costs of hospital based care were approximately €200 lower per patient in the intervention group compared to the control group after the intervention costs had been included. The study was conducted on two internal medicine wards with 400 enrolled patients, all 80 years or older, which limits the generalisability of its results.
Today, ten years after our previous RCT, several counties in Sweden have employed clinical pharmacists who perform medication reviews in hospital settings. However, their way of working has changed over time. For this reason it is important to identify the activities that generate the greatest benefits to the patients, which can be done by performing a pragmatic clinical trial, specifically designed to show the real-world effects of such interventions [8]. Therefore we propose this pragmatic cluster-randomised, three-treatment, crossover trial to study the effects of multidisciplinary medication reviews with active follow-up after hospital discharge on elderly patients' healthcare utilisation, compared with solely hospital based reviews and usual care. This large study will generate more robust results and high external validity, with the potential to show effects on hard outcomes such as healthcare utilisation. A similar study has, to our knowledge, not been undertaken anywhere else in the world.
Aim:
To study the effects of hospital-initiated comprehensive medication reviews, including active follow-up, on elderly patients' healthcare utilisation compared to 1) usual care and 2) solely hospital based reviews.
Primary objectives:
- The first primary objective is to test the hypothesis that the incidence of unplanned hospital visits (admissions plus visits to the emergency department) among elderly patients during a one year follow-up is lower, if they receive a comprehensive medication review with active follow-up after discharge, than if they receive usual care.
- The second primary objective is to test the hypothesis that a comprehensive medication review with active follow-up after discharge reduces the incidence of unplanned hospital visits more than only a medication review during hospital stay compared to usual care.
Methods:
This study protocol has been developed by using the applicable recommendations of the SPIRIT 2013 Guidance for protocols of clinical trials, the Consort 2010 extension to cluster randomised trials and the Consort 2010 extension to randomized trials of non-pharmacologic treatment [9-11]. The full study protocol is attached to this trial registration.
Setting and clusters:
The study will be conducted in three counties in Sweden: Västmanland, Uppsala and Gävleborg. Within these counties there will be four hospitals taking part in the study: Uppsala University Hospital and the hospitals of Västerås, Enköping and Gävle. At these hospitals clinical pharmacy, including the performance of medication reviews, is an established practice or is planned to be implemented prior to the study. The intervention components of the study will be performed by the existing workforce at two wards within each hospital. The wards differ in terms of medical specialty: geriatric, internal medicine and stroke. All wards are staffed with a multidisciplinary team consisting of physicians, nurses and clinical pharmacists. The pharmacists have either followed a full-time one year post-graduate programme in clinical pharmacy, in which the performance of medication reviews plays a central role, or have followed undergraduate courses in clinical pharmacy and advanced pharmacotherapy. Next to that, all pharmacists have at least six months working experience with performing medication reviews in a multidisciplinary team. To assess clinical skill performance related to medication reviews, all pharmacists participated in an objective structured clinical examination (OSCE), prior to the start of the study. All pharmacists have also participated in a training day with patient case discussions, to assure common practice across all study sites. Other members of the ward team did not receive additional training.
In total eight wards will be included, with each ward acting as a cluster. The study will be carried out as far as possible identically at the eight wards.
- Conditions
- Medication Review
- Being tested
- Comprehensive medication review, Comprehensive medication review with active follow-up, Usual Care
- Keywords
- Integrated Healthcare System, Inappropriate Prescribing, Pragmatic Clinical Trial, Crossover Design, Randomised Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive medication reviewProcedure or surgery
Also called Intervention 1 (I1)
- A thorough medication reconciliation, including a patient/carer interview, by a clinical pharmacist.
- The clinical pharmacist performs a comprehensive medication review in collaboration with the ward physician and patient, similar to a level three clinical medication review as earlier described in the literature [4]. This includes a structured, critical examination of all of the patient's medications in relation to the patient's conditions, based on information from the patient and the medical record. The objective is to optimise the impact of medications and minimizing the number of medication-related problems. The effects of medication changes will be monitored during the hospital stay by the physician or pharmacist, depending on the specific situation.
- Before discharge, the clinical pharmacist performs another medication reconciliation to check if the patient's prescriptions for medications to be used after hospital stay are consistent with the patient's medical record.
Comprehensive medication review with active follow-upProcedure or surgery
Also called Intervention 2 (I2)
The same as I1 but with the following additions:
- In case of any monitoring needs or necessary subsequent actions to be taken after hospital discharge, the clinical pharmacist and the ward physician send an electronic medication review referral to the patient's primary care physician upon discharge.
- A first phone call to the patient or carer is made by the clinical pharmacist 2-7 days after the patient is discharged depending on health condition and the pharmacist's availability. This phone call aims to ensure that all information has been understood correctly and to find out if any problems, concerns or questions have arisen after discharge.
- A second phone call will be made by the clinical pharmacist approximately 30 days after hospital discharge. This phone call aims to find out how the patient is managing the medication and if any problems, concerns or questions have arisen, and to provide the patient with a motivational "boost".
Usual CareProcedure or surgery
Also called Control
The control group will receive usual hospital care. According to Swedish legislation, usual care includes medication reconciliation upon admission. Next to that, the law requires a medication report addressing the patient's medication treatment to be given to the patient or carer upon hospital discharge and to be attached to the electronic discharge letter. This report contains a motivation and explanation to the changes in medication treatment that have been made during hospital stay, as well as the patient's updated medication list. These mandatory activities are currently carried out to various degree within the different hospitals and wards. Other activities as described in the interventions above may be carried out to a certain degree as well, but no clinical pharmacist will be involved.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive medication review (I1) | Active comparator | Not described Receives: Procedure: Comprehensive medication review |
| Comprehensive medication review with active follow-up (I2) | Active comparator | Not described Receives: Procedure: Comprehensive medication review with active follow-up |
| Usual care (Control) | Other | Not described Receives: Procedure: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of unplanned hospital visits, extracted from the patients' electronic medical record
Admissions plus visits to the emergency department
Measured: 12 months
Secondary outcomes (26)
Unplanned hospital admissions, extracted from the patients' electronic medical record
Measured: 30 days
Unplanned hospital admissions, extracted from the patients' electronic medical record
Measured: 3 months
Unplanned hospital admissions, extracted from the patients' electronic medical record
Measured: 6 months
Unplanned hospital admissions, extracted from the patients' electronic medical record
Measured: 12 months
Emergency department visits, extracted from the patients' electronic medical record
Measured: 30 days
Emergency department visits, extracted from the patients' electronic medical record
Measured: 3 months
Emergency department visits, extracted from the patients' electronic medical record
Measured: 6 months
Emergency department visits, extracted from the patients' electronic medical record
Measured: 12 months
Unplanned hospital visits, extracted from the patients' electronic medical record
Admissions plus visits to the emergency department
Measured: 30 days
Unplanned hospital visits, extracted from the patients' electronic medical record
Admissions plus visits to the emergency department
Measured: 3 months
Unplanned hospital visits, extracted from the patients' electronic medical record
Admissions plus visits to the emergency department
Measured: 6 months
Unplanned medication-related hospital admissions, extracted from the patients' electronic medical record
Two experienced clinicians will independently assess to what extent the hospital visits were medication-related using the WHO criteria for causality (certain, probable, possible and unlikely). This causality assessment will be based on Case Report Form (CRF) data in which treatment allocation has been blinded, and make use of validated algorithms such as the Naranjo algorithm and the Liverpool ADR Causality Assessment Tool. For a visit to be classified as medication-related consensus needs to be reached between the two clinicians, and where this is not possible, a third expert will have the deciding vote.
Measured: 30 days
Unplanned medication-related hospital admissions, extracted from the patients' electronic medical record
Two experienced clinicians will independently assess to what extent the hospital visits were medication-related using the WHO criteria for causality (certain, probable, possible and unlikely). This causality assessment will be based on Case Report Form (CRF) data in which treatment allocation has been blinded, and make use of validated algorithms such as the Naranjo algorithm and the Liverpool ADR Causality Assessment Tool. For a visit to be classified as medication-related consensus needs to be reached between the two clinicians, and where this is not possible, a third expert will have the deciding vote.
Measured: 3 months
Unplanned medication-related hospital admissions, extracted from the patients' electronic medical record
Two experienced clinicians will independently assess to what extent the hospital visits were medication-related using the WHO criteria for causality (certain, probable, possible and unlikely). This causality assessment will be based on Case Report Form (CRF) data in which treatment allocation has been blinded, and make use of validated algorithms such as the Naranjo algorithm and the Liverpool ADR Causality Assessment Tool. For a visit to be classified as medication-related consensus needs to be reached between the two clinicians, and where this is not possible, a third expert will have the deciding vote.
Measured: 6 months
Unplanned medication-related hospital admissions, extracted from the patients' electronic medical record
Two experienced clinicians will independently assess to what extent the hospital visits were medication-related using the WHO criteria for causality (certain, probable, possible and unlikely). This causality assessment will be based on Case Report Form (CRF) data in which treatment allocation has been blinded, and make use of validated algorithms such as the Naranjo algorithm and the Liverpool ADR Causality Assessment Tool. For a visit to be classified as medication-related consensus needs to be reached between the two clinicians, and where this is not possible, a third expert will have the deciding vote.
Measured: 12 months
Unplanned primary care visits, extracted from the patients' electronic medical record
Measured: 30 days
Unplanned primary care visits, extracted from the patients' electronic medical record
Measured: 3 months
Unplanned primary care visits, extracted from the patients' electronic medical record
Measured: 6 months
Unplanned primary care visits, extracted from the patients' electronic medical record
Measured: 12 months
Time from hospital discharge to first unplanned hospital visit, extracted from the patients' electronic medical record
time-to-event
Measured: up to 12 months
Costs of hospital based care, extracted from the counties' costs per patient (CPP) system
Costs for healthcare utilisation including the costs for the intervention. Costs for hospital based healthcare will be retrieved from the counties' CPP system, and average costs for clinical pharmacist employment will be calculated to account for the intervention costs.
Measured: 6 months
Costs of hospital based care, extracted from the counties' costs per patient (CPP) system
Costs for healthcare utilisation including the costs for the intervention. Costs for hospital based healthcare will be retrieved from the counties' CPP system, and average costs for clinical pharmacist employment will be calculated to account for the intervention costs.
Measured: 12 months
All-cause mortality rates, extracted from the national death registry
Measured: 30 days
All-cause mortality rates, extracted from the national death registry
Measured: 3 months
All-cause mortality rates, extracted from the national death registry
Measured: 6 months
All-cause mortality rates, extracted from the national death registry
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start6 Feb 2017
- Primary completion11 Dec 2019
- Study completion3 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Medication ReviewStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,637 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala County Council, Sweden
- Sponsor type
- Other government
- Collaborators
- Region Gävleborg, Västmanland County Council, Sweden, Uppsala University
- Responsible party
- Principal investigator, Thomas Kempen, Uppsala County Council, Sweden
- Investigators
- Ulrika Gillespie, Study chair, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999412
- Sponsor's protocol ID
- MEDBRIDGE
- Acronym
- MedBridge
- Status last verified
- Jun 2021
- First submitted
- 14 Dec 2016
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kempen TGH, Bertilsson M, Lindner KJ, Sulku J, Nielsen EI, Hogberg A, Vikerfors T, Melhus H, Gillespie U. Medication Reviews Bridging Healthcare (MedBridge): Study protocol for a pragmatic cluster-randomised crossover trial. Contemp Clin Trials. 2017 Oct;61:126-132. doi: 10.1016/j.cct.2017.07.019. Epub 2017 Jul 21.
PubMed 28739539Kempen TGH, Hedstrom M, Olsson H, Johansson A, Ottosson S, Al-Sammak Y, Gillespie U. Assessment tool for hospital admissions related to medications: development and validation in older patients. Int J Clin Pharm. 2019 Feb;41(1):198-206. doi: 10.1007/s11096-018-0768-8. Epub 2018 Dec 26.
PubMed 30585296Kempen TGH, Kalvemark A, Gillespie U, Stewart D. Comprehensive medication reviews by ward-based pharmacists in Swedish hospitals: What does the patient have to say? J Eval Clin Pract. 2020 Feb;26(1):149-157. doi: 10.1111/jep.13121. Epub 2019 Mar 4.
PubMed 30834647Kempen TGH, Cam H, Kalvemark A, Lindner KJ, Melhus H, Nielsen EI, Sulku J, Gillespie U. Intervention fidelity and process outcomes of medication reviews including post-discharge follow-up in older hospitalized patients: Process evaluation of the MedBridge trial. J Clin Pharm Ther. 2020 Oct;45(5):1021-1029. doi: 10.1111/jcpt.13128. Epub 2020 Mar 14.
PubMed 32171028Kempen TGH, Kalvemark A, Sawires M, Stewart D, Gillespie U. Facilitators and barriers for performing comprehensive medication reviews and follow-up by multiprofessional teams in older hospitalised patients. Eur J Clin Pharmacol. 2020 Jun;76(6):775-784. doi: 10.1007/s00228-020-02846-8. Epub 2020 Feb 19.
PubMed 32076745Kempen TGH, Bertilsson M, Hadziosmanovic N, Lindner KJ, Melhus H, Nielsen EI, Sulku J, Gillespie U. Effects of Hospital-Based Comprehensive Medication Reviews Including Postdischarge Follow-up on Older Patients' Use of Health Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2021 Apr 1;4(4):e216303. doi: 10.1001/jamanetworkopen.2021.6303.
PubMed 33929523
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Reviews Bridging Healthcare: a Cluster-randomised Crossover Trial to Study the Effects of Hospital-initiated Comprehensive Medication Reviews, Including Active Follow-up, on Elderly Patients' Healthcare Utilisation
- ClinicalTrials.gov ID
- NCT02999412
- Acronym / sponsor ID
- MedBridge / MEDBRIDGE
- Conditions
- Medication Review
- Keywords
- Integrated Healthcare System, Inappropriate Prescribing, Pragmatic Clinical Trial, Crossover Design, Randomised Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,637 participants (actual)
- Lead sponsor
- Uppsala County Council, SwedenOther government
- Collaborators
- Region Gävleborg, Västmanland County Council, Sweden, Uppsala University
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 3 Jun 2020 (actual)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Mismanaged prescribing and use of medication among elderly puts major pressure on current healthcare systems. Performing a medication review, a structured critical examination of a patient's medications, during hospital stay with active follow-up into primary care could optimise treatment benefit and minimise harm. However, a lack of high quality evidence inhibits widespread implementation. This manuscript describes the rationale and design of a pragmatic cluster-randomised, crossover trial to fulfil this need for evidence.
Aim: To study the effects of hospital-initiated comprehensive medication reviews, including active follow-up, on elderly patients' healthcare utilisation compared to 1) usual care and 2) solely hospital based reviews.
Design: Multicentre, three-treatment, replicated, cluster-randomised, crossover trial.
Setting: 8 wards with a multidisciplinary team within 4 hospitals in 3 Swedish counties.
Participants: Patients aged 65 years or older, admitted to one of the study wards. Exclusion criteria: Palliative stage; residing in other than the hospital's county; medication review within the last 30 days; one-day admission.
Interventions: 1, comprehensive medication review during hospital stay; 2, same as 1 with the addition of active follow-up into primary care; 3, usual care.
Primary outcome measure: Incidence of unplanned hospital visits during a 12-month follow-up period.
Data collection and analyses: Extraction and collection from the counties' medical record system into a GCP compliant electronic data capture system. Intention-to-treat-analyses using log-linear Poisson generalized linear mixed models and frailty models.
Relevance: This study has a high potential to show a reduction in elderly patients' morbidity, contributing to more sustainable healthcare in the long run.
Detailed description
Background:
Mismanaged use of multiple medications is one of the greatest risks for healthcare-related harm in the elderly and puts major pressure on current healthcare systems [1,2]. Identifying effective interventions to optimise treatment benefit and minimise harm is an international public health priority [3]. Comprehensive medication review, a structured and critical examination of an individual patient's medications in relation to the patient's conditions, aims to accomplish these goals [4]. A recently published Cochrane meta-analysis examined whether medication reviews lead to improvement in health outcomes of hospitalised adult patients compared with standard care [5]. Ten randomised controlled trials (RCTs) were eventually used for analysis. The authors stated that they "found no evidence that medication review reduces mortality or hospital readmissions, although we did find evidence that medication review may reduce emergency department contacts."[5] A beneficial or detrimental effect on mortality or hospital admissions could be ruled out because estimates were uncertain and follow-up was short. The authors stated that there is a strong need for RCTs of high quality with at least one year follow-up and which are randomised at a cluster level to minimise contamination bias [5]. In addition, a cluster randomised crossover design in which each cluster serves as its own control would increase statistical power [6].
One of the included RCTs in this meta-analysis was conducted by our research group at Uppsala University Hospital in 2005-2006 [7]. We demonstrated in this study that patients, aged 80 years or older, who received a comprehensive medication review including follow-up after hospital discharge, performed by ward based clinical pharmacist, had 16% fewer hospital revisits in the following year. The costs of hospital based care were approximately €200 lower per patient in the intervention group compared to the control group after the intervention costs had been included. The study was conducted on two internal medicine wards with 400 enrolled patients, all 80 years or older, which limits the generalisability of its results.
Today, ten years after our previous RCT, several counties in Sweden have employed clinical pharmacists who perform medication reviews in hospital settings. However, their way of working has changed over time. For this reason it is important to identify the activities that generate the greatest benefits to the patients, which can be done by performing a pragmatic clinical trial, specifically designed to show the real-world effects of such interventions [8]. Therefore we propose this pragmatic cluster-randomised, three-treatment, crossover trial to study the effects of multidisciplinary medication reviews with active follow-up after hospital discharge on elderly patients' healthcare utilisation, compared with solely hospital based reviews and usual care. This large study will generate more robust results and high external validity, with the potential to show effects on hard outcomes such as healthcare utilisation. A similar study has, to our knowledge, not been undertaken anywhere else in the world.
Aim:
To study the effects of hospital-initiated comprehensive medication reviews, including active follow-up, on elderly patients' healthcare utilisation compared to 1) usual care and 2) solely hospital based reviews.
Primary objectives:
- The first primary objective is to test the hypothesis that the incidence of unplanned hospital visits (admissions plus visits to the emergency department) among elderly patients during a one year follow-up is lower, if they receive a comprehensive medication review with active follow-up after discharge, than if they receive usual care.
- The second primary objective is to test the hypothesis that a comprehensive medication review with active follow-up after discharge reduces the incidence of unplanned hospital visits more than only a medication review during hospital stay compared to usual care.
Methods:
This study protocol has been developed by using the applicable recommendations of the SPIRIT 2013 Guidance for protocols of clinical trials, the Consort 2010 extension to cluster randomised trials and the Consort 2010 extension to randomized trials of non-pharmacologic treatment [9-11]. The full study protocol is attached to this trial registration.
Setting and clusters:
The study will be conducted in three counties in Sweden: Västmanland, Uppsala and Gävleborg. Within these counties there will be four hospitals taking part in the study: Uppsala University Hospital and the hospitals of Västerås, Enköping and Gävle. At these hospitals clinical pharmacy, including the performance of medication reviews, is an established practice or is planned to be implemented prior to the study. The intervention components of the study will be performed by the existing workforce at two wards within each hospital. The wards differ in terms of medical specialty: geriatric, internal medicine and stroke. All wards are staffed with a multidisciplinary team consisting of physicians, nurses and clinical pharmacists. The pharmacists have either followed a full-time one year post-graduate programme in clinical pharmacy, in which the performance of medication reviews plays a central role, or have followed undergraduate courses in clinical pharmacy and advanced pharmacotherapy. Next to that, all pharmacists have at least six months working experience with performing medication reviews in a multidisciplinary team. To assess clinical skill performance related to medication reviews, all pharmacists participated in an objective structured clinical examination (OSCE), prior to the start of the study. All pharmacists have also participated in a training day with patient case discussions, to assure common practice across all study sites. Other members of the ward team did not receive additional training.
In total eight wards will be included, with each ward acting as a cluster. The study will be carried out as far as possible identically at the eight wards.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Comprehensive medication review (I1) | Active comparator | Procedure: Comprehensive medication review |
| Comprehensive medication review with active follow-up (I2) | Active comparator | Procedure: Comprehensive medication review with active follow-up |
| Usual care (Control) | Other | Procedure: Usual Care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Admitted to one of the study wards
Key exclusion criteria (4 listed)
- Has been subject to a medication review within the last 30 days as stated within their medical record;
- Residing in another than the hospital's county
- Being in a palliative stage as stated in their medical record
- Admitted for only one day
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 |
|---|---|---|
| Comprehensive medication reviewAlso: Intervention 1 (I1)* A thorough medication reconciliation, including a patient/carer interview, by a clinical pharmacist. * The clinical pharmacist performs a comprehensive medication review in collaboration with the ward physician and patient, similar to a level three clinical medication review as earlier described in the literature [4]. This includes a structured, critical examination of all of the patient's medications in relation to the patient's conditions, based on information from the patient and the medical record. The objective is to optimise the impact of medications and minimizing the number of medication-related problems. The effects of medication changes will be monitored during the hospital stay by the physician or pharmacist, depending on the specific situation. * Before discharge, the clinical pharmacist performs another medication reconciliation to check if the patient's prescriptions for medications to be used after hospital stay are consistent with the patient's medical record. | Procedure or surgery | Comprehensive medication review (I1) |
| Comprehensive medication review with active follow-upAlso: Intervention 2 (I2)The same as I1 but with the following additions: * In case of any monitoring needs or necessary subsequent actions to be taken after hospital discharge, the clinical pharmacist and the ward physician send an electronic medication review referral to the patient's primary care physician upon discharge. * A first phone call to the patient or carer is made by the clinical pharmacist 2-7 days after the patient is discharged depending on health condition and the pharmacist's availability. This phone call aims to ensure that all information has been understood correctly and to find out if any problems, concerns or questions have arisen after discharge. * A second phone call will be made by the clinical pharmacist approximately 30 days after hospital discharge. This phone call aims to find out how the patient is managing the medication and if any problems, concerns or questions have arisen, and to provide the patient with a motivational "boost". | Procedure or surgery | Comprehensive medication review with active follow-up (I2) |
| Usual CareAlso: ControlThe control group will receive usual hospital care. According to Swedish legislation, usual care includes medication reconciliation upon admission. Next to that, the law requires a medication report addressing the patient's medication treatment to be given to the patient or carer upon hospital discharge and to be attached to the electronic discharge letter. This report contains a motivation and explanation to the changes in medication treatment that have been made during hospital stay, as well as the patient's updated medication list. These mandatory activities are currently carried out to various degree within the different hospitals and wards. Other activities as described in the interventions above may be carried out to a certain degree as well, but no clinical pharmacist will be involved. | Procedure or surgery | Usual care (Control) |
Primary outcome
Incidence of unplanned hospital visits, extracted from the patients' electronic medical record
Time frame: 12 months
Admissions plus visits to the emergency department
26 secondary outcomes
Unplanned hospital admissions, extracted from the patients' electronic medical record
Time frame: 30 days
Unplanned hospital admissions, extracted from the patients' electronic medical record
Time frame: 3 months
Unplanned hospital admissions, extracted from the patients' electronic medical record
Time frame: 6 months
Unplanned hospital admissions, extracted from the patients' electronic medical record
Time frame: 12 months
Emergency department visits, extracted from the patients' electronic medical record
Time frame: 30 days
Emergency department visits, extracted from the patients' electronic medical record
Time frame: 3 months
Emergency department visits, extracted from the patients' electronic medical record
Time frame: 6 months
Emergency department visits, extracted from the patients' electronic medical record
Time frame: 12 months
Unplanned hospital visits, extracted from the patients' electronic medical record
Time frame: 30 days
Unplanned hospital visits, extracted from the patients' electronic medical record
Time frame: 3 months
Unplanned hospital visits, extracted from the patients' electronic medical record
Time frame: 6 months
Unplanned medication-related hospital admissions, extracted from the patients' electronic medical record
Time frame: 30 days
Unplanned medication-related hospital admissions, extracted from the patients' electronic medical record
Time frame: 3 months
Unplanned medication-related hospital admissions, extracted from the patients' electronic medical record
Time frame: 6 months
Unplanned medication-related hospital admissions, extracted from the patients' electronic medical record
Time frame: 12 months
Unplanned primary care visits, extracted from the patients' electronic medical record
Time frame: 30 days
Unplanned primary care visits, extracted from the patients' electronic medical record
Time frame: 3 months
Unplanned primary care visits, extracted from the patients' electronic medical record
Time frame: 6 months
Unplanned primary care visits, extracted from the patients' electronic medical record
Time frame: 12 months
Time from hospital discharge to first unplanned hospital visit, extracted from the patients' electronic medical record
Time frame: up to 12 months
Costs of hospital based care, extracted from the counties' costs per patient (CPP) system
Time frame: 6 months
Costs of hospital based care, extracted from the counties' costs per patient (CPP) system
Time frame: 12 months
All-cause mortality rates, extracted from the national death registry
Time frame: 30 days
All-cause mortality rates, extracted from the national death registry
Time frame: 3 months
All-cause mortality rates, extracted from the national death registry
Time frame: 6 months
All-cause mortality rates, extracted from the national death registry
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Background: PubMed 28739539Kempen TGH, Bertilsson M, Lindner KJ, Sulku J, Nielsen EI, Hogberg A, Vikerfors T, Melhus H, Gillespie U. Medication Reviews Bridging Healthcare (MedBridge): Study protocol for a pragmatic cluster-randomised crossover trial. Contemp Clin Trials. 2017 Oct;61:126-132. doi: 10.1016/j.cct.2017.07.019. Epub 2017 Jul 21.
- Background: PubMed 30585296Kempen TGH, Hedstrom M, Olsson H, Johansson A, Ottosson S, Al-Sammak Y, Gillespie U. Assessment tool for hospital admissions related to medications: development and validation in older patients. Int J Clin Pharm. 2019 Feb;41(1):198-206. doi: 10.1007/s11096-018-0768-8. Epub 2018 Dec 26.
- Results publication: PubMed 30834647Kempen TGH, Kalvemark A, Gillespie U, Stewart D. Comprehensive medication reviews by ward-based pharmacists in Swedish hospitals: What does the patient have to say? J Eval Clin Pract. 2020 Feb;26(1):149-157. doi: 10.1111/jep.13121. Epub 2019 Mar 4.
- Results publication: PubMed 32171028Kempen TGH, Cam H, Kalvemark A, Lindner KJ, Melhus H, Nielsen EI, Sulku J, Gillespie U. Intervention fidelity and process outcomes of medication reviews including post-discharge follow-up in older hospitalized patients: Process evaluation of the MedBridge trial. J Clin Pharm Ther. 2020 Oct;45(5):1021-1029. doi: 10.1111/jcpt.13128. Epub 2020 Mar 14.
- Results publication: PubMed 32076745Kempen TGH, Kalvemark A, Sawires M, Stewart D, Gillespie U. Facilitators and barriers for performing comprehensive medication reviews and follow-up by multiprofessional teams in older hospitalised patients. Eur J Clin Pharmacol. 2020 Jun;76(6):775-784. doi: 10.1007/s00228-020-02846-8. Epub 2020 Feb 19.
- Results publication: PubMed 33929523Kempen TGH, Bertilsson M, Hadziosmanovic N, Lindner KJ, Melhus H, Nielsen EI, Sulku J, Gillespie U. Effects of Hospital-Based Comprehensive Medication Reviews Including Postdischarge Follow-up on Older Patients' Use of Health Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2021 Apr 1;4(4):e216303. doi: 10.1001/jamanetworkopen.2021.6303.
- Individual participant dataSharing planned: No
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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.
Ulrika Gillespie study chair
Uppsala University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive medication review and Comprehensive medication review with active follow-up in people with Medication Review, run by Uppsala County Council, Sweden at 4 sites in Sweden.
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 1 inclusion and 4 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 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of unplanned hospital visits, extracted from the patients' electronic medical record (time frame: 12 months). 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 NCT02999412, which also lists 6 linked publications.
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 25 Jun 2021.