NCT02986425

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.

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

First Submitted

Initial submission to the registry

October 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2016

Completed
2.8 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 25, 2020

Status Verified

August 1, 2020

Enrollment Period

2.8 years

First QC Date

October 21, 2016

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 people

Outcome Measures

Primary Outcomes (1)

  • Patients with confirmed DRA after discharge from the index hospitalisation

    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.

    12 months

Secondary Outcomes (14)

  • Number of survivors

    12 months

  • Number of cancer deaths

    12 months

  • Number of patients with hospitalisations

    12 months

  • Number of patients with falls

    12 months

  • Patients' degree of poly-pharmacy

    12 months

  • +9 more secondary outcomes

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. 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.

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.
  • 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

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 (15)

  • 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: 18809816BACKGROUND

  • 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: 19433702BACKGROUND

  • 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: 16803468BACKGROUND

  • 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

  • Stuber MJ, Brockhus LA, Spinewine A, O'Mahony D, Jennings E, Dalleur O, Knol W, Koek HL, Baggio S, Rodondi N, Aubert CE. Central Nervous System-Active Medications and Risk of Hospital Readmission in Older Multimorbid Adults. J Am Geriatr Soc. 2025 Oct;73(10):3113-3122. doi: 10.1111/jgs.70049. Epub 2025 Aug 29.

    PMID: 40879205DERIVED

  • Moutzouri E, Beglinger S, Feller M, Eichenberger A, Dalleur O, Knol W, Emmelot-Vonk M, O'Mahony D, Boland B, Aubert CE, Chocano-Bedoya PO, Aujesky D, Spinewine A, Rodondi N. Inappropriate vitamin D supplementation among multimorbid older patients: a multicountry analysis. BMC Geriatr. 2025 Jul 19;25(1):541. doi: 10.1186/s12877-025-06189-w.

    PMID: 40684074DERIVED

  • Gastens V, Chiolero A, Feller M, Bauer DC, Rodondi N, Del Giovane C. Development and internal validation of a new life expectancy estimator for multimorbid older adults. Diagn Progn Res. 2025 Mar 4;9(1):5. doi: 10.1186/s41512-025-00185-9.

    PMID: 40033449DERIVED

  • Sibille FX, de Saint-Hubert M, Henrard S, Aubert CE, Goto NA, Jennings E, Dalleur O, Rodondi N, Knol W, O'Mahony D, Schwenkglenks M, Spinewine A. Benzodiazepine Receptor Agonists Use and Cessation Among Multimorbid Older Adults with Polypharmacy: Secondary Analysis from the OPERAM Trial. Drugs Aging. 2023 Jun;40(6):551-561. doi: 10.1007/s40266-023-01029-1. Epub 2023 May 23.

    PMID: 37221407DERIVED

  • Sallevelt BTGM, Egberts TCG, Huibers CJA, Ietswaart J, Drenth-van Maanen AC, Jennings E, O'Mahony C, Jungo KT, Feller M, Rodondi N, Sibille FX, Spinewine A, van Puijenbroek EP, Wilting I, Knol W. Detectability of Medication Errors With a STOPP/START-Based Medication Review in Older People Prior to a Potentially Preventable Drug-Related Hospital Admission. Drug Saf. 2022 Dec;45(12):1501-1516. doi: 10.1007/s40264-022-01237-5. Epub 2022 Nov 1.

    PMID: 36319944DERIVED

  • Huibers CJA, Sallevelt BTGM, Heij JMJO, O'Mahony D, Rodondi N, Dalleur O, van Marum RJ, Egberts ACG, Wilting I, Knol W. Hospital physicians' and older patients' agreement with individualised STOPP/START-based medication optimisation recommendations in a clinical trial setting. Eur Geriatr Med. 2022 Jun;13(3):541-552. doi: 10.1007/s41999-022-00633-5. Epub 2022 Mar 15.

    PMID: 35291025DERIVED

  • Sallevelt BTGM, Huibers CJA, Heij JMJO, Egberts TCG, van Puijenbroek EP, Shen Z, Spruit MR, Jungo KT, Rodondi N, Dalleur O, Spinewine A, Jennings E, O'Mahony D, Wilting I, Knol W. Frequency and Acceptance of Clinical Decision Support System-Generated STOPP/START Signals for Hospitalised Older Patients with Polypharmacy and Multimorbidity. Drugs Aging. 2022 Jan;39(1):59-73. doi: 10.1007/s40266-021-00904-z. Epub 2021 Dec 8.

    PMID: 34877629DERIVED

  • Blum MR, Sallevelt BTGM, Spinewine A, O'Mahony D, Moutzouri E, Feller M, Baumgartner C, Roumet M, Jungo KT, Schwab N, Bretagne L, Beglinger S, Aubert CE, Wilting I, Thevelin S, Murphy K, Huibers CJA, Drenth-van Maanen AC, Boland B, Crowley E, Eichenberger A, Meulendijk M, Jennings E, Adam L, Roos MJ, Gleeson L, Shen Z, Marien S, Meinders AJ, Baretella O, Netzer S, de Montmollin M, Fournier A, Mouzon A, O'Mahony C, Aujesky D, Mavridis D, Byrne S, Jansen PAF, Schwenkglenks M, Spruit M, Dalleur O, Knol W, Trelle S, Rodondi N. Optimizing Therapy to Prevent Avoidable Hospital Admissions in Multimorbid Older Adults (OPERAM): cluster randomised controlled trial. BMJ. 2021 Jul 13;374:n1585. doi: 10.1136/bmj.n1585.

    PMID: 34257088DERIVED

  • Kempen TGH, Bertilsson M, Hadziosmanovic N, Lindner KJ, Melhus H, Nielsen EI, Sulku J, Gillespie U. Effects of Hospital-Based Comprehensive Medication Reviews Including Postdischarge Follow-up on Older Patients' Use of Health Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2021 Apr 1;4(4):e216303. doi: 10.1001/jamanetworkopen.2021.6303.

    PMID: 33929523DERIVED

  • Crowley EK, Sallevelt BTGM, Huibers CJA, Murphy KD, Spruit M, Shen Z, Boland B, Spinewine A, Dalleur O, Moutzouri E, Lowe A, Feller M, Schwab N, Adam L, Wilting I, Knol W, Rodondi N, Byrne S, O'Mahony D. Intervention protocol: OPtimising thERapy to prevent avoidable hospital Admission in the Multi-morbid elderly (OPERAM): a structured medication review with support of a computerised decision support system. BMC Health Serv Res. 2020 Mar 17;20(1):220. doi: 10.1186/s12913-020-5056-3.

    PMID: 32183810DERIVED

  • Adam L, Moutzouri E, Baumgartner C, Loewe AL, Feller M, M'Rabet-Bensalah K, Schwab N, Hossmann S, Schneider C, Jegerlehner S, Floriani C, Limacher A, Jungo KT, Huibers CJA, Streit S, Schwenkglenks M, Spruit M, Van Dorland A, Donze J, Kearney PM, Juni P, Aujesky D, Jansen P, Boland B, Dalleur O, Byrne S, Knol W, Spinewine A, O'Mahony D, Trelle S, Rodondi N. Rationale and design of OPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people (OPERAM): a cluster randomised controlled trial. BMJ Open. 2019 Jun 3;9(6):e026769. doi: 10.1136/bmjopen-2018-026769.

    PMID: 31164366DERIVED

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; and Institute of Primary Health Care (BIHAM), University of Bern

    PRINCIPAL INVESTIGATOR

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

October 21, 2016

First Posted

December 8, 2016

Study Start

December 1, 2016

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

August 25, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

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.

Locations

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