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Medication Reviews Bridging Healthcare: a Cluster-randomised Crossover Trial (MedBridge)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02999412
Recruitment Status : Active, not recruiting
First Posted : December 21, 2016
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
Region Gävleborg
Västmanland County Council, Sweden
Uppsala University
Uppsala Clinical Research Center, Sweden
Information provided by (Responsible Party):
Thomas Kempen, Uppsala County Council, Sweden

Brief 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 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.


Condition or disease Intervention/treatment Phase
Medication Review Procedure: Comprehensive medication review Procedure: Comprehensive medication review with active follow-up Procedure: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2310 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
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
Actual Study Start Date : February 6, 2017
Actual Primary Completion Date : December 11, 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Comprehensive medication review (I1) Procedure: Comprehensive medication review
  • 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.
Other Name: Intervention 1 (I1)

Active Comparator: Comprehensive medication review with active follow-up (I2) Procedure: Comprehensive medication review with active follow-up

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".
Other Name: Intervention 2 (I2)

Usual care (Control) Procedure: Usual Care
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.
Other Name: Control




Primary Outcome Measures :
  1. Incidence of unplanned hospital visits, extracted from the patients' electronic medical record [ Time Frame: 12 months ]
    Admissions plus visits to the emergency department


Secondary Outcome Measures :
  1. Unplanned hospital admissions, extracted from the patients' electronic medical record [ Time Frame: 30 days ]
  2. Unplanned hospital admissions, extracted from the patients' electronic medical record [ Time Frame: 3 months ]
  3. Unplanned hospital admissions, extracted from the patients' electronic medical record [ Time Frame: 6 months ]
  4. Unplanned hospital admissions, extracted from the patients' electronic medical record [ Time Frame: 12 months ]
  5. Emergency department visits, extracted from the patients' electronic medical record [ Time Frame: 30 days ]
  6. Emergency department visits, extracted from the patients' electronic medical record [ Time Frame: 3 months ]
  7. Emergency department visits, extracted from the patients' electronic medical record [ Time Frame: 6 months ]
  8. Emergency department visits, extracted from the patients' electronic medical record [ Time Frame: 12 months ]
  9. Unplanned hospital visits, extracted from the patients' electronic medical record [ Time Frame: 30 days ]
    Admissions plus visits to the emergency department

  10. Unplanned hospital visits, extracted from the patients' electronic medical record [ Time Frame: 3 months ]
    Admissions plus visits to the emergency department

  11. Unplanned hospital visits, extracted from the patients' electronic medical record [ Time Frame: 6 months ]
    Admissions plus visits to the emergency department

  12. Unplanned medication-related hospital admissions, extracted from the patients' electronic medical record [ Time Frame: 30 days ]
    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.

  13. Unplanned medication-related hospital admissions, extracted from the patients' electronic medical record [ Time Frame: 3 months ]
    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.

  14. Unplanned medication-related hospital admissions, extracted from the patients' electronic medical record [ Time Frame: 6 months ]
    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.

  15. Unplanned medication-related hospital admissions, extracted from the patients' electronic medical record [ Time Frame: 12 months ]
    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.

  16. Unplanned primary care visits, extracted from the patients' electronic medical record [ Time Frame: 30 days ]
  17. Unplanned primary care visits, extracted from the patients' electronic medical record [ Time Frame: 3 months ]
  18. Unplanned primary care visits, extracted from the patients' electronic medical record [ Time Frame: 6 months ]
  19. Unplanned primary care visits, extracted from the patients' electronic medical record [ Time Frame: 12 months ]
  20. Time from hospital discharge to first unplanned hospital visit, extracted from the patients' electronic medical record [ Time Frame: up to 12 months ]
    time-to-event

  21. Costs of hospital based care, extracted from the counties' costs per patient (CPP) system [ Time Frame: 6 months ]
    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.

  22. Costs of hospital based care, extracted from the counties' costs per patient (CPP) system [ Time Frame: 12 months ]
    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.

  23. All-cause mortality rates, extracted from the national death registry [ Time Frame: 30 days ]
  24. All-cause mortality rates, extracted from the national death registry [ Time Frame: 3 months ]
  25. All-cause mortality rates, extracted from the national death registry [ Time Frame: 6 months ]
  26. All-cause mortality rates, extracted from the national death registry [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admitted to one of the study wards

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999412


Locations
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Sweden
Gävle Hospital
Gävle, Gävleborg, Sweden, 80324
Enköping Hospital
Enköping, Uppsala Lan, Sweden, 74538
Uppsala University Hospital
Uppsala, Uppsala Lan, Sweden, 75185
Västmanland Hospital
Västerås, Västmanlands Lan, Sweden, 72334
Sponsors and Collaborators
Uppsala County Council, Sweden
Region Gävleborg
Västmanland County Council, Sweden
Uppsala University
Uppsala Clinical Research Center, Sweden
Investigators
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Study Chair: Ulrika Gillespie Uppsala County Council, Sweden
  Study Documents (Full-Text)

Documents provided by Thomas Kempen, Uppsala County Council, Sweden:

Additional Information:
Publications:
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Responsible Party: Thomas Kempen, Principal Investigator, Uppsala County Council, Sweden
ClinicalTrials.gov Identifier: NCT02999412    
Other Study ID Numbers: MEDBRIDGE
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Kempen, Uppsala County Council, Sweden:
Integrated Healthcare System
Inappropriate Prescribing
Pragmatic Clinical Trial
Crossover Design
Randomised Controlled Trial