A single-center, investigator-initiated, prospective, open, randomized controlled trial to study the efficacy of an add-on collaborative clinical counselling service to reduce opioid analgesics in hospitalized patients

A single-center, investigator-initiated, prospective, open, randomized controlled trial to study the efficacy of an add-on collaborative clinical counselling service to reduce opioid analgesics in hospitalized patients - iPROACTIVE

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00036364

Enrollment

Registered

2025-05-21

Start date

2025-06-23

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia with opioids

Interventions

Group 1: Interventional arm: Ccounselling service plus patient education. The intervention will be conducted as an add-on element to the existing healthcare delivery. Group 2: Control arm: Usual care

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Hospitalized patients with consecutive use of opioid analgesics of three days or more; Planned reduction or discontinuation of opioid analgesics, as confirmed by the treating physician; Signed informed consent form (ICF)

Exclusion criteria

Exclusion criteria: Inability to understand spoken and/or written German; Inability to make informed decisions or follow opioid reduction education (e.g., cognitive impairment); Diagnosis of dementia or active treatment with antidementia drugs (N06D, excluding N06DX02 ginkgo biloba containing drugs) Opioid analgesic therapy for cancer End-of-life care (involved in best care for the dying patient program), less than one year life expectancy Treatment in critical care, intermediate care, postoperative recovery rooms Pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the time of return to prehospitalization morphine milligram equivalent (MMEs) observed between study entry and the last day of follow-up.	—

Secondary

Measure	Time frame
(a) Morphine milligram equivalents dispensed between study entry and last day of follow-up; (b) PROMIS pain interference; (c) SOWS subjective opioid withdrawal score; (d) SATMED-Q treatment satisfaction with medicines questionnaire.	—

Countries

Switzerland

Contacts

Public ContactDominik Stämpfli

ETH Zürich

dominik.staempfli@pharma.ethz.ch+41564861852

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026