NCT03108092

Brief Summary

The objective of the health economic evaluation is to perform a state-of-the-art economic analysis of the STRIP intervention, alongside the OPERAM Randomised Controlled Trial (RCT).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,009

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

2.8 years

First QC Date

April 4, 2017

Last Update Submit

August 24, 2020

Conditions

3 or More Chronic Conditions for 6 Months or Longer5 or More Regular Drugs

Keywords

Drug Utilization ReviewOlder peopleHealth economics

Outcome Measures

Primary Outcomes (1)

  • The cost-effectiveness of the STRIP intervention

    The cost-effectiveness analysis (CEA) is performed by combining clinical data, quality of life data and healthcare utilisation data collected within the trial, and unit costs for participating countries that will stem from external sources.

    12 months

Secondary Outcomes (5)

  • Healthcare utilisation

    12 months

  • Informal care received

    12 months

  • Healthcare costs

    12 months

  • Quality of life EQ-5D

    2, 6, and 12 months

  • Direct costs of the STRIP intervention

    during the index hospitalisation at baseline

Other Outcomes (1)

  • Exploratory outcome measures

    12 months

Study Arms (2)

STRIP intervention

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Interventions

STRIP interventionOTHER

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

Also known as: Systematic drug review
STRIP intervention
ControlOTHER

Standard care in the department where the trial is conducted

Also known as: Standard care
Control

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Dept. of Medicine (Geriatrics), University College Cork

Cork, Ireland

Location

Universitair Medisch Centrum Utrecht

Utrecht, 3508, Netherlands

Location

University of Bern and University Hospital Bern (Inselspital)

Bern, 3010, Switzerland

Location

Related Publications (5)

  • Laws MB. Adverse drug reactions as cause of admission to hospital: definition of adverse drug reactions needs to include overdose. BMJ. 2004 Aug 21;329(7463):459-60; author reply 460. doi: 10.1136/bmj.329.7463.459-b. No abstract available.

    PMID: 15321917BACKGROUND

  • Leendertse AJ, Egberts AC, Stoker LJ, van den Bemt PM; HARM Study Group. Frequency of and risk factors for preventable medication-related hospital admissions in the Netherlands. Arch Intern Med. 2008 Sep 22;168(17):1890-6. doi: 10.1001/archinternmed.2008.3.

    PMID: 18809816RESULT

  • Gillespie U, Alassaad A, Henrohn D, Garmo H, Hammarlund-Udenaes M, Toss H, Kettis-Lindblad A, Melhus H, Morlin C. A comprehensive pharmacist intervention to reduce morbidity in patients 80 years or older: a randomized controlled trial. Arch Intern Med. 2009 May 11;169(9):894-900. doi: 10.1001/archinternmed.2009.71.

    PMID: 19433702RESULT

  • Howard RL, Avery AJ, Slavenburg S, Royal S, Pipe G, Lucassen P, Pirmohamed M. Which drugs cause preventable admissions to hospital? A systematic review. Br J Clin Pharmacol. 2007 Feb;63(2):136-47. doi: 10.1111/j.1365-2125.2006.02698.x. Epub 2006 Jun 26.

    PMID: 16803468RESULT

  • Alldred DP, Raynor DK, Hughes C, Barber N, Chen TF, Spoor P. Interventions to optimise prescribing for older people in care homes. Cochrane Database Syst Rev. 2013 Feb 28;(2):CD009095. doi: 10.1002/14651858.CD009095.pub2.

    PMID: 23450597RESULT

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Nicolas Rodondi, Prof.

    Head of Ambulatory Care Department of General Internal Medicine Inselspital, Bern University Hospital, University of Bern, Switzerland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 11, 2017

Study Start

December 1, 2016

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

August 27, 2020

Record last verified: 2020-08

Locations

BE(1)CH(1)NL(1)IE(1)