3 or More Chronic Conditions for 6 Months or LongerOPERAMNCT02986425
OPtimising thERapy to Prevent Avoidable Hospital Admissions in the Multimorbid Older People
A study testing STRIP intervention in people with 3 or More Chronic Conditions for 6 Months or Longer and 5 or More Regular Drugs, run by Insel Gruppe AG, University Hospital Bern at 4 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- 3 or More Chronic Conditions for 6 Months or Longer, 5 or More Regular Drugs
- What is being tested?
- STRIP intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,009 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Dec 2016to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Switzerland1 site
University of Bern and University Hospital Bern (Inselspital)
Bern, 3010
About this study
Official title: OPERAM: OPtimising thERapy to Prevent Avoidable Hospital Admissions in the Multimorbid Older People: a Cluster Randomised Controlled Trial
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.
Read the detailed description
Background:
Drug-related morbidity and mortality is an increasing problem in European healthcare systems. Multimorbidity, polypharmacy and old age are important risk factors for drug-related hospital admissions (DRA). The reported incidence of DRAs in the elderly may be as high as 30% of all acute cases, and about half of DRAs are likely to be preventable. They are mainly related to prescribing problems and non-compliance with drug regimens. A significant proportion of healthcare costs are spent on unnecessary interventions and inappropriate medications. The Systematic Tool to Reduce Inappropriate Prescribing (STRIP) is a structured method to perform a medication review to optimise pharmacotherapy.
Design:
European multi-centre, cluster randomised, controlled trial of people aged 70 years or older, with multimorbidity and polypharmacy, being on an ambulatory visit or on a hospital stay in one of the four participating centres in Ireland, Belgium, Switzerland and the Netherlands. A cluster is defined around a treating physician, i.e. the treating physician is randomised and defines the allocation of his patients. Clusters of patients will be randomised to the intervention arm receiving STRIP for optimising therapy or to the control arm undergoing usual clinical care. The patients of physicians who are allocated to the intervention group will undergo a systematic drug review and pharmacotherapy optimisation by a physician and a pharmacist using STRIP, including the STRIPA software. That provides the research team with a recommendation of changes in the patient's medication. Based on STRIPA recommendation and agreement on changes to the patients' pharmacotherapy between the team of the research physician and pharmacist and the prescribing physician, will the patient receive structured counselling about his/her medication; general practitioners will receive a report. Patients will be further followed for 1 year with follow-up phone calls after 2, 6 and 12 months. For the purpose of this trial, all hospitalisations during follow-up of participants will be adjudicated to assess their relationship to adverse drug events.
Objectives:
The primary objective is to assess the effect of a structured medication review and pharmacotherapy optimisation using the STRIP on drug-related hospitalisations (DRA) caused by over-, mis-, and underuse or over-, mis-, and underprescribing of medications.
Secondary objectives will be to assess the impact of pharmacotherapy optimisation on falls, quality of life, polypharmacy, medication changes, activities of daily living, and mortality.
Statistical considerations:
80 clusters with a cluster size ranging from 12 to 38 participants will be included. Therefore, 2000 patients, 1000 patients in each arm, will be recruited over 18 months. The trial will have 80% power with this sample size.
The primary analysis will be an intention-to-treat (ITT) analysis, whereby all randomised patients will be included in the group they were allocated to.
The primary outcome of drug-related admission will be analysed using a random-effects competing risk proportional hazards model that accounts for the competing risk of death and for clustering of data within centre and prescribing physician.
Overall survival will be analysed using a random-effects Cox proportional hazards model that accounts for clustering of data within centre and prescribing physician. The analysis of falls will also take into account the competing risk of death. Continuous outcomes will be analysed by random-effects linear regression. All effect measures will be accompanied by 95% confidence intervals and all p-values will be two-sided.
- Being tested
- STRIP intervention, Control
- Keywords
- Drug Utilization Review, Older people
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRIP interventionOther
Also called Systematic drug review
The STRIP intervention consists of 9 steps:
- structured history taking of medication
- recording medication and diagnoses in STRIPA
- 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
- communication and discussion of the structured drug review with prescribing physician with possible adaptation of the recommendation
- shared decision-making with the patient with possible adaptation of the recommendation
- optional revision based on new accumulating data during hospitalisation (e.g. new diagnoses, adverse drug reactions)
- generation of general practioner (GP) report
- delivery of the report to the patient and to the GP (optional additional direct communication)
- follow-up
ControlOther
Also called Standard care
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (14)
Number of survivors
Including causes of death
Measured: 12 months
Number of cancer deaths
As subgroup of all deaths this is considered a negative control outcome.
Measured: 12 months
Number of patients with hospitalisations
Detected during the follow-up phone calls
Measured: 12 months
Number of patients with falls
Detected during the follow-up phone calls
Measured: 12 months
Patients' degree of poly-pharmacy
Degree of polypharmacy, defined as the number of regular long-term medications
Measured: 12 months
Patients' quality of life
Quality of life as measured by the visual analogue scale of the European Quality of Life-5 Dimensions instrument (EQ-5D)
Measured: 12 months
Patients' level of pain/discomfort
Item form EQ-5D questionnaire
Measured: 12 months
Patients' basic activities of daily living
Measured by questionnaire Barthel Index Basic Activities of Daily Living (ADL)
Measured: 12 months
Patients' drug compliance
Measured by the Morisky Medication Adherence Questionnaire (MMAS-8)
Measured: 12 months
Number of clinically significant drug-drug interactions
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
Measured: 2 months
Number of drug overuse
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
Measured: 2 months
Number of drug underuse
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
Measured: 2 months
Number of potentially inappropriate medications
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
Measured: 2 months
Number of patients with a serious adverse event
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for 3 or More Chronic Conditions for 6 Months or LongerStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,009 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Nicolas Rodondi, Prof., Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986425
- Sponsor's protocol ID
- U1111-1181-9400
- Acronym
- OPERAM
- Status last verified
- Aug 2020
- First submitted
- 21 Oct 2016
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 18809816Gillespie 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.
PubMed 19433702Howard 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.
PubMed 16803468Laws 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.
PubMed 15321917Huschka J, Jungo KT, Aponte Ribero V, Brockhus L, O'Mahony D, Randles M, Marien S, Drenth C, Spinewine A, Knol W, Aujesky D, Rodondi N, Aubert CE. Trends over time and risk factors in inappropriate prescribing in older adults with multimorbidity and polypharmacy: a longitudinal secondary analysis of the OPERAM trial. Swiss Med Wkly. 2026 Feb 12;156:4892. doi: 10.57187/4892.
PubMed 41962085Stuber 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.
PubMed 40879205Moutzouri 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.
PubMed 40684074Gastens 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.
PubMed 40033449Sibille 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.
PubMed 37221407Sallevelt 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.
PubMed 36319944Huibers 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.
PubMed 35291025Sallevelt 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.
PubMed 34877629Blum 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.
PubMed 34257088Kempen 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.
PubMed 33929523Crowley 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.
PubMed 32183810
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPERAM: OPtimising thERapy to Prevent Avoidable Hospital Admissions in the Multimorbid Older People: a Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02986425
- Acronym / sponsor ID
- OPERAM / U1111-1181-9400
- Keywords
- Drug Utilization Review, Older people
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,009 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- 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
- Study start
- Dec 2016 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Drug-related morbidity and mortality is an increasing problem in European healthcare systems. Multimorbidity, polypharmacy and old age are important risk factors for drug-related hospital admissions (DRA). The reported incidence of DRAs in the elderly may be as high as 30% of all acute cases, and about half of DRAs are likely to be preventable. They are mainly related to prescribing problems and non-compliance with drug regimens. A significant proportion of healthcare costs are spent on unnecessary interventions and inappropriate medications. The Systematic Tool to Reduce Inappropriate Prescribing (STRIP) is a structured method to perform a medication review to optimise pharmacotherapy.
Design:
European multi-centre, cluster randomised, controlled trial of people aged 70 years or older, with multimorbidity and polypharmacy, being on an ambulatory visit or on a hospital stay in one of the four participating centres in Ireland, Belgium, Switzerland and the Netherlands. A cluster is defined around a treating physician, i.e. the treating physician is randomised and defines the allocation of his patients. Clusters of patients will be randomised to the intervention arm receiving STRIP for optimising therapy or to the control arm undergoing usual clinical care. The patients of physicians who are allocated to the intervention group will undergo a systematic drug review and pharmacotherapy optimisation by a physician and a pharmacist using STRIP, including the STRIPA software. That provides the research team with a recommendation of changes in the patient's medication. Based on STRIPA recommendation and agreement on changes to the patients' pharmacotherapy between the team of the research physician and pharmacist and the prescribing physician, will the patient receive structured counselling about his/her medication; general practitioners will receive a report. Patients will be further followed for 1 year with follow-up phone calls after 2, 6 and 12 months. For the purpose of this trial, all hospitalisations during follow-up of participants will be adjudicated to assess their relationship to adverse drug events.
Objectives:
The primary objective is to assess the effect of a structured medication review and pharmacotherapy optimisation using the STRIP on drug-related hospitalisations (DRA) caused by over-, mis-, and underuse or over-, mis-, and underprescribing of medications.
Secondary objectives will be to assess the impact of pharmacotherapy optimisation on falls, quality of life, polypharmacy, medication changes, activities of daily living, and mortality.
Statistical considerations:
80 clusters with a cluster size ranging from 12 to 38 participants will be included. Therefore, 2000 patients, 1000 patients in each arm, will be recruited over 18 months. The trial will have 80% power with this sample size.
The primary analysis will be an intention-to-treat (ITT) analysis, whereby all randomised patients will be included in the group they were allocated to.
The primary outcome of drug-related admission will be analysed using a random-effects competing risk proportional hazards model that accounts for the competing risk of death and for clustering of data within centre and prescribing physician.
Overall survival will be analysed using a random-effects Cox proportional hazards model that accounts for clustering of data within centre and prescribing physician. The analysis of falls will also take into account the competing risk of death. Continuous outcomes will be analysed by random-effects linear regression. All effect measures will be accompanied by 95% confidence intervals and all p-values will be two-sided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STRIP intervention | Experimental | Other: STRIP interventionThe 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. |
| Control | Sham comparator | Other: ControlParticipants 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STRIP interventionAlso: Systematic drug reviewThe 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 | STRIP intervention |
| ControlAlso: Standard careStandard 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 | Control |
Primary outcome
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.
14 secondary outcomes
Number of survivors
Time frame: 12 months
Number of cancer deaths
Time frame: 12 months
Number of patients with hospitalisations
Time frame: 12 months
Number of patients with falls
Time frame: 12 months
Patients' degree of poly-pharmacy
Time frame: 12 months
Patients' quality of life
Time frame: 12 months
Patients' level of pain/discomfort
Time frame: 12 months
Patients' basic activities of daily living
Time frame: 12 months
Patients' drug compliance
Time frame: 12 months
Number of clinically significant drug-drug interactions
Time frame: 2 months
Number of drug overuse
Time frame: 2 months
Number of drug underuse
Time frame: 2 months
Number of potentially inappropriate medications
Time frame: 2 months
Number of patients with a serious adverse event
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Background: PubMed 18809816Leendertse 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.
- Background: PubMed 19433702Gillespie 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.
- Background: PubMed 16803468Howard 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.
- Background: PubMed 15321917Laws 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.
- Derived from this study: PubMed 41962085Huschka J, Jungo KT, Aponte Ribero V, Brockhus L, O'Mahony D, Randles M, Marien S, Drenth C, Spinewine A, Knol W, Aujesky D, Rodondi N, Aubert CE. Trends over time and risk factors in inappropriate prescribing in older adults with multimorbidity and polypharmacy: a longitudinal secondary analysis of the OPERAM trial. Swiss Med Wkly. 2026 Feb 12;156:4892. doi: 10.57187/4892.
- Derived from this study: PubMed 40879205Stuber 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.
- Derived from this study: PubMed 40684074Moutzouri 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.
- Derived from this study: PubMed 40033449Gastens 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.
- Derived from this study: PubMed 37221407Sibille 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.
- Derived from this study: PubMed 36319944Sallevelt 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.
- Derived from this study: PubMed 35291025Huibers 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.
- Derived from this study: PubMed 34877629Sallevelt 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.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Rodondi, Prof. principal investigator
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
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STRIP intervention in people with 3 or More Chronic Conditions for 6 Months or Longer and 5 or More Regular Drugs, run by Insel Gruppe AG, University Hospital Bern at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Ireland, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with confirmed DRA after discharge from the index hospitalisation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02986425, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.