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OPtimising thERapy to Prevent Avoidable Hospital Admissions in the Multimorbid Older People (OPERAM)

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ClinicalTrials.gov Identifier: NCT02986425
Recruitment Status : Active, not recruiting
First Posted : December 8, 2016
Last Update Posted : October 28, 2019
Sponsor:
Collaborators:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Cork University Hospital
UMC Utrecht
University of Basel
Université Catholique de Louvain
Utrecht University
University of Bern
European Commission
State Secretariat for Education Research and Innovation, Switzerland
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:
The objective of this Randomised Controlled Trial (RCT) is to evaluate whether the Systematic Tool to Reduce Inappropriate Prescribing (STRIP) including STRIP assistant (STRIPA) implemented by an appropriately qualified team will lead to an improvement in clinical and economic outcomes among patients aged 70 years and more with multimorbidity and polypharmacy.

Condition or disease Intervention/treatment Phase
3 or More Chronic Conditions for 6 Months or Longer 5 or More Regular Drugs Other: STRIP intervention Other: Control Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2009 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: OPERAM: OPtimising thERapy to Prevent Avoidable Hospital Admissions in the Multimorbid Older People: a Cluster Randomised Controlled Trial
Actual Study Start Date : December 2016
Actual Primary Completion Date : October 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: STRIP intervention
The intervention will take place during the initial hospital admission (Index Hospitalisation) or an equivalent situation for outpatients. STRIP is a structured method to perform pharmacotherapy optimisation. The STRIP-intervention consists of 9 steps.
Other: STRIP intervention

The STRIP intervention consists of 9 steps:

  1. structured history taking of medication
  2. recording medication and diagnoses in STRIPA
  3. structured drug review based on the STRIPA with the integrated Screening Tool of Older Person's Prescriptions (STOPP)/ Screening Tool to Alert Doctors to the Right Treatment (START) criteria
  4. communication and discussion of the structured drug review with prescribing physician with possible adaptation of the recommendation
  5. shared decision-making with the patient with possible adaptation of the recommendation
  6. optional revision based on new accumulating data during hospitalisation (e.g. new diagnoses, adverse drug reactions)
  7. generation of general practioner (GP) report
  8. delivery of the report to the patient and to the GP (optional additional direct communication)
  9. follow-up
Other Name: Systematic drug review

Sham Comparator: Control
Participants in the control group will receive medication review by the prescribing physicians in accordance with usual care. If an extended drug review is in place in a ward/specialty corresponding characteristics are collected on cluster level.
Other: Control
Standard care in the department where the trial is conducted. To keep the patients and the blinded team members blinded one questionnaire will be conducted by the intervention team in both arms. This is considered a SHAM intervention.
Other Name: Standard care




Primary Outcome Measures :
  1. Patients with confirmed DRA after discharge from the index hospitalisation [ Time Frame: 12 months ]

    The primary outcome is defined as the first confirmed DRA after discharge from the index hospitalisation within a period of 12 months.

    Confirmation of a drug-related hospital admission will be assessed by an independent and blinded adjudication committee (per site). Prolongation of the index hospitalisation and prolongation of any following hospitalisations will not be adjudicated for drug-relatedness. Adjudication is done according to specific guidelines.



Secondary Outcome Measures :
  1. Number of survivors [ Time Frame: 12 months ]
    Including causes of death

  2. Number of cancer deaths [ Time Frame: 12 months ]
    As subgroup of all deaths this is considered a negative control outcome.

  3. Number of patients with hospitalisations [ Time Frame: 12 months ]
    Detected during the follow-up phone calls

  4. Number of patients with falls [ Time Frame: 12 months ]
    Detected during the follow-up phone calls

  5. Patients' degree of poly-pharmacy [ Time Frame: 12 months ]
    Degree of polypharmacy, defined as the number of regular long-term medications

  6. Patients' quality of life [ Time Frame: 12 months ]
    Quality of life as measured by the visual analogue scale of the European Quality of Life-5 Dimensions instrument (EQ-5D)

  7. Patients' level of pain/discomfort [ Time Frame: 12 months ]
    Item form EQ-5D questionnaire

  8. Patients' basic activities of daily living [ Time Frame: 12 months ]
    Measured by questionnaire Barthel Index Basic Activities of Daily Living (ADL)

  9. Patients' drug compliance [ Time Frame: 12 months ]
    Measured by the Morisky Medication Adherence Questionnaire (MMAS-8)

  10. Number of clinically significant drug-drug interactions [ Time Frame: 2 months ]
    Assessed based on using STRIPA including the list of diagnosis form the Index Hospitalisation and the updated medication list at follow-up. Assessment will be done at the end of the trial, when all data was collected

  11. Number of drug overuse [ Time Frame: 2 months ]
    Assessed based on using STRIPA including the list of diagnosis form the Index Hospitalisation and the updated medication list at follow-up. Assessment will be done at the end of the trial, when all data was collected

  12. Number of drug underuse [ Time Frame: 2 months ]
    Assessed based on using STRIPA including the list of diagnosis form the Index Hospitalisation and the updated medication list at follow-up. Assessment will be done at the end of the trial, when all data was collected

  13. Number of potentially inappropriate medications [ Time Frame: 2 months ]
    Assessed based on using STRIPA including the list of diagnosis form the Index Hospitalisation and the updated medication list at follow-up. Assessment will be done at the end of the trial, when all data was collected

  14. Number of patients with a serious adverse event [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • People 70 years of age or older
  • Multimorbidity: 3 or more coexistent chronic conditions defined by 3 distinct International Classification of Diseases (ICD-10) codes with an estimated duration of 6 months or more or based on a clinical decision
  • Polypharmacy i.e. five or more different regular drugs (defined as authorised medications with registration numbers) for more than 30 days.
  • In inpatient: Estimated minimal length of stay within the cluster is sufficient to apply the intervention
  • If outpatient: prescribing physician has GP function and has a planned appointment to conduct intervention

Exclusion Criteria:

  • Inability to provide informed consent or to obtain informed consent from a proxy for patients with cognitive impairment
  • Direct admission to palliative care (< 24h after admission)
  • Has passed or will pass a systematic structured drug review during this hospitalisation or within the last two months

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): NCT02986425


Locations
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Belgium
Cliniques universitaires Saint-Luc
Bruxelles, Belgium, 1200
Ireland
Dept. of Medicine (Geriatrics), University College Cork
Cork, Ireland
Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3508
Switzerland
University of Bern and University Hospital Bern (Inselspital)
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Cork University Hospital
UMC Utrecht
University of Basel
Université Catholique de Louvain
Utrecht University
University of Bern
European Commission
State Secretariat for Education Research and Innovation, Switzerland
Investigators
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Principal Investigator: Nicolas Rodondi, Prof. Head of Ambulatory Care Department of General Internal Medicine Inselspital, Bern University Hospital, University of Bern, Switzerland; and Institute of Primary Health Care (BIHAM), University of Bern

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02986425     History of Changes
Other Study ID Numbers: U1111-1181-9400
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Data will be deposited in the Bern Open Repository and Information System (BORIS) (www.boris.unibe.ch). BORIS allows searching and is indexed by search engines. All items are stored with a unique Digital Object Identifier (DOI) that can be referenced in respective publication.

The whole study database in csv format, and will include README files, metadata, information about the performed processing and analytical steps, variable definitions, and references to vocabularies used to help secondary users to understand and reuse the data.

Data will only be shared upon request. Data use proposals will be evaluated by the OPERAM publication committee.

The data is owned by the sponsor-investigators. In case of data sharing, a data sharing agreement between the external party and the sponsor-investigator will need to be agreed on and signed.

Keywords provided by University Hospital Inselspital, Berne:
Drug Utilization Review
Older people