Health Economic Evaluation Alongside the OPERAM Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03108092
• Date of registration: 04/04/2017
• Prospective Registration: No
• Primary sponsor: University Hospital Inselspital, Berne
• Public title: Health Economic Evaluation Alongside the OPERAM Trial
• Scientific title: Health Economic Evaluation Alongside the OPERAM Trial (OPtimising thERapy to Prevent Avoidable Hospital Admissions in the Multimorbid Older People: a Cluster Randomised Controlled Trial).
• Date of first enrolment: December 2016
• Target sample size: 2009
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03108092
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Belgium, Ireland, Netherlands, Switzerland

Contacts

• Name: Nicolas Rodondi, Prof.
• Affiliation: Head of Ambulatory Care Department of General Internal Medicine Inselspital, Bern University Hospital, University of Bern, Switzerland

Key inclusion & exclusion 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.

- 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



Age minimum: 70 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

5 or More Regular Drugs

3 or More Chronic Conditions for 6 Months or Longer

Intervention(s)

Other: STRIP intervention

Other: Control

Primary Outcome(s)

The cost-effectiveness of the STRIP intervention [Time Frame: 12 months]

Secondary Outcome(s)

Healthcare utilisation [Time Frame: 12 months]

Direct costs of the STRIP intervention [Time Frame: during the index hospitalisation at baseline]

Healthcare costs [Time Frame: 12 months]

Informal care received [Time Frame: 12 months]

Quality of life EQ-5D [Time Frame: 2, 6, and 12 months]

Secondary ID(s)

2016-01200_1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

UMC Utrecht

Université Catholique de Louvain

University of Basel

Utrecht University

State Secretariat for Education Research and Innovation, Switzerland

University of Bern

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Cork University Hospital

European Commission