MultimorbidityOPTIMATENCT05387096
OPTImization of Medication by Transdisciplinary Assessment of Drug Treatment in Elderly Hospitalized Patients
A study testing Definitive multi-faceted intervention consisting of several components in people with Multimorbidity and Polypharmacy, run by University College Cork at 3 sites in 2 countries.
Trial summary
This study is being done to find out if a multi-faceted intervention designed to optimize medication in hospitalized older people with multiple chronic medical conditions exposed to multiple medications can reduce unplanned hospital readmission and emergency department attendance compared to current usual medication… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Multimorbidity, Polypharmacy
- What is being tested?
- Definitive multi-faceted intervention consisting of several components
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 642 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 17 Jan 2023to 31 Aug 2024
- 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
- Age ≥ 70years
- 3 or more chronic conditions.
- ≥ 5 daily medications pre-admission, all medications taken for at least 4 weeks continuously.
- Can speak and understand English (in the two Irish medical centres), and Dutch or French in Ghent University Hospital (Ghent is predominantly Dutch-speaking).
- Can give informed consent or give witnessed verbal consent or have a suitable proxy who can give informed assent on the patient's behalf.
- Agrees to follow-up contact post-discharge up to 180 days post-randomization.
- Agrees to primary researcher contacting the GP and community pharmacist post-discharge.
Who cannot join
- Terminal illness.
- Severe dementia and clearly unable to understand the purpose of the trial or give consent to participation.
- Severe communication disorder, making informed consent impossible.
- Likely to be discharged from hospital within 48 hours of arrival.
- Intensive Care Unit (ICU) admission.
- Primary psychiatric presenting illness.
Show all 15Show fewer
- Unavailable for post-discharge follow-up for any reason.
- Non-accidental poisoning.
- Previous participation in medication optimization trials.
- Active participation in another clinical trial
- Infectious illness requiring strict isolation (including COVID-19 infection) blocking access of the primary researcher to the patient for enrolment.
- End-stage renal, liver or lung disease requiring organ replacement therapy.
- Admitted under the care of specialists in Clinical Pharmacology, Palliative Medicine, Clinical Oncology or Haematology.
- Admitted under the care of specialists in Geriatric Medicine in Ghent University Hospital.
- Trial participation refusal.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Ireland2 sites
Cork University Hospital
Cork
University Hospital Waterford
Waterford
About this study
Official title: OPTImization of Medication by Transdisciplinary Assessment of Drug Treatment in Elderly Hospitalized Patients: Application of a Definitive Intervention by Physicians or Clinical Pharmacists
This study is being done to find out if a multi-faceted intervention designed to optimize medication in hospitalized older people with multiple chronic medical conditions exposed to multiple medications can reduce unplanned hospital readmission and emergency department attendance compared to current usual medication management. The study intervention aims to minimize potentially inappropriate medications in a structured way and involves follow up with patients and GPs. Patients will be allocated equally to (i) standard medication management (control arm) or (ii) trained physician-delivered intervention or (iii) clinical pharmacist-delivered intervention.
Read the detailed description
Background:
Recurrent hospitalization and unplanned emergency department (ED) attendance resulting from potentially inappropriate medication is an increasingly common phenomenon in older people with multi-morbidity and associated polypharmacy. With a growing older population with multi-morbidity/polypharmacy, there is a pressing need to address the increasing challenge of potentially inappropriate medications (PIMs) and potential prescribing omissions (PPOs) and associated problems that accentuate adverse drug reactions/events and avoidable excess morbidity. There is also an imperative to curb excess healthcare expenditure related to preventable medication-related problems.
Objective:
To test the clinical and economic impact of a multi-faceted medication optimization definitive intervention on avoidable rehospitalization and unscheduled ED attendance in multi-morbid patients aged ≥ 70 years hospitalized with acute illness.To test the clinical and economic impact of a multi-faceted medication optimization definitive intervention (DI) on avoidable rehospitalization and unscheduled ED attendance in multi-morbid patients aged ≥ 70 years hospitalized with acute illness.
Design:
A randomized controlled clinical trial is proposed in which it is anticipated to randomize 3 x 463 patients to one of 3 groups: (a) standard pharmaceutical care, or (b) trained physician-implemented DI, or (c) clinical pharmacist-implemented DI.
Setting: Acute care environment in 3 large tertiary referral teaching hospitals with similar custom and practice relating to management of older people with acute illness.
Participants: Patients aged ≥ 70 years with multi-morbid illness i.e. ≥ 3 chronic medical conditions and associated polypharmacy i.e. ≥ 5 daily prescription medications admitted with acute unselected illness.
Intervention:
The definitive multi-faceted intervention will consist of the following components:modified structured history of medication (SHiM), Screening Tool of Older Persons' Prescriptions (STOPP) and Screening Tool to Alert to Right Treatment (START) screening for PIMs and PPOs using STOPP/START version 3.0, drug-drug interaction screening using Stockley's Drug Interaction Checker, face-to-face consultation with attending hospital physicians to discuss PIMs, PPOs, interactions and other issues, pre-discharge medication review and adjustment, detailed medication adjustment discharge report to patients' general practitioners (GPs), post-discharge follow-up contact with patients' GPs and community pharmacists at 1 week and 1 and 3-6 months post-discharge.
Study Population:
OPTIMATE will focus on patients admitted with acute medical or surgical illness to Cork University Hospital, University Hospital Waterford and Ghent University Hospital. Patients to be screened for enrolment are those admitted primarily under the care of specialist departments other than geriatric medicine.
Data Collection:
All OPTIMATE trial data will be collected electronically and entered on a bespoke trial proforma. Once verified as fully correct and complete, all individual participant trial data will be stored on a fully secure clinical trial database.
Statistical Analysis:
Treatment effects for each of the two active intervention arms (versus control) in terms of binary outcomes (e.g. readmission) will be estimated using logistic regression, while Health Related QoL (EQ-5D 5L) will be analyzed using ordinal regression with a logit link function (i.e. a proportional odds model). We will report two models for each outcome: one adjusted for centre and admitting service type; and another further adjusted for centre, age (years), sex, number of comorbidities at baseline, and number of prescribed medications at baseline. Effect estimates will be reported as odds-ratios with 95% confidence intervals and exact p-values. There will be no correction for multiplicity, but we will report results for all outcomes regardless of the result and provide enough information for the reader to make whatever corrections they may consider appropriate. Equivalence tests comparing the two active arms (for each outcome) will be done using a "two one-sided tests" procedure based on a 90% confidence interval (which equates to a 5% type 1 error rate). All analyses will be conducted on an intention-to-treat basis and will be conducted under the quality system and SOPs of the HRB CRF-C Statistics and Data Analysis Unit. A complete statistical analysis plan (SAP) will be pre-registered on the Open Science Framework prior to patient recruitment database lock. Any necessary deviations from this SAP will be documented and explained in the trial report. There will be only one single trial data analysis at the end of the project. All reporting will be carried out in accordance with CONSORT guidelines for clinical trials.
- Conditions
- Multimorbidity, Polypharmacy
- Being tested
- Definitive multi-faceted intervention consisting of several components, Sham Intervention
- Keywords
- inappropriate prescribing, multimorbidity, polypharmacy, hospital admission, older people, frail elderly, medication therapy management, STOPP/START
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Definitive multi-faceted intervention consisting of several componentsOther
Also called STOPP/START criteria, Face to face consultation with attending physician, medication adjustment report to patient's general practitioner, post discharge follow up with GP and community pharmacist
The definitive intervention will consist of the following components: structured history of medication (SHiM), Screening Tool of Older Persons' Prescriptions (STOPP) and Screening Tool to Alert to Right Treatment (START) screening for PIMs and PPOs, drug-drug and drug-disease interactions screening, face-to-face consultation with attending hospital physicians to discuss PIMs, PPOs, interactions and other issues, pre-discharge medication review and adjustment, detailed medication adjustment discharge report to patients' general practitioners (GPs), post-discharge follow-up contact with patients' GPs and community pharmacists at 1 week, 1 month and 3-6 months post -discharge. The interventions will be applied by a trained physician or pharmacist.
Sham InterventionOther
Also called Control
Sham intervention in the form of the modified Medication Adherence Rating Scale (MARS) questionnaire in addition to standard care.
| Study group | Role | What they receive |
|---|---|---|
| Control: standard pharmaceutical care | Sham comparator | Patients in the control arm (standard pharmaceutical care) will receive a sham intervention in the form of the modified Medication Adherence Rating Scale (MARS) questionnaire Receives: Other: Sham Intervention |
| trained physician-implemented intervention | Active comparator | The definitive multi-faceted intervention delivered by a trained physician. Receives: Other: Definitive multi-faceted intervention consisting of several components |
| clinical pharmacist-implemented intervention | Active comparator | The definitive multi-faceted intervention delivered by a trained pharmacist. Receives: Other: Definitive multi-faceted intervention consisting of several components |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unscheduled readmission to hospital.
All-cause re-hospitalization in multi-morbid older people exposed to polypharmacy. Computerized hospital admission records will be inspected. If hospital readmission has occurred dates of admission and discharge will be recorded in the electronic case report form.
Measured: At day 30 post-discharge.
Emergency Department attendance.
Unscheduled emergency department attendance at in multi-morbid older people exposed to polypharmacy. Computerized hospital emergency department attendance records will be inspected. The primary researcher will record on the electronic case report form whether there has there been an unscheduled emergency department attendance since the first follow-up post discharge.
Measured: At day 30 post-discharge.
Composite endpoint 1
Composite endpoint of readmission to hospital or emergency department attendance within 30 days of discharge from the index admission.
Measured: At day 30 post-discharge.
Unscheduled readmission to hospital.
Unscheduled readmission at 180 days post-discharge in multi-morbid older people exposed to polypharmacy. This will be ascertained during the follow-up interview within 180 (+/-14) days post-discharge. Computerized hospital emergency department attendance records will be inspected. The primary researcher will record on the electronic case report form whether there has there been an unscheduled readmission at 180 days since discharge from the index hospital admission.
Measured: At between days 90 and 180 post-discharge.
Emergency Department attendance.
Unscheduled emergency department attendance at in multi-morbid older people exposed to polypharmacy. This will be ascertained during the follow-up interview within 180 (+/-14) days post-discharge. Computerized hospital emergency department attendance records will be inspected. The primary researcher will record on the electronic case report form whether there has there been an unscheduled emergency department attendance at 180 days since discharge from the index hospital admission.
Measured: At between days 90 and 180 post-discharge.
Composite endpoint 2
Composite endpoint of readmission to hospital or emergency department attendance within 180 days of discharge from the index admission.
Measured: At between days 90 and 180 post-discharge.
Secondary outcomes (6)
Quality of life measured by EuroQol quality of life 5 dimensional 5 level instrument (incorporating pain control)
The EuroQol quality of life 5 dimensional 5 level instrument (EQ5D-5L) is a self-reported quality of life questionnaire comprised of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each of the five dimensions is divided into five levels: level 1 (no problem), level 2 (slight problems), level 3 (moderate problems), level 4 (severe problems) and level 5 (unable to/extreme problems).The results are used to calculate a five digit score that describes the patient's health state. This value is the converted into an index value, on a range between 0 and 1, where 0 represents "a state as bad as being dead" and 1 represents "full health".In addition, the questionnaire has a Visual Analogue Scale question which asks the patient to indicate their overall health on the day of questionnaire completion. This is a 0 -100 scale where 100 represents "The best health you can imagine' and 0 'The worst health you can imagine'.
Measured: At day 30 post-discharge.
Quality of life measured by EuroQol quality of life 5 dimensional 5 level instrument
The EQ5D-5L is a self-reported quality of life questionnaire comprised of five dimensions. The questionnaire gives a score in the range between 0 and 1, where 0 represents "a state as bad as being dead" and 1 represents "full health".In addition, the questionnaire has a Visual Analogue Scale question which asks the patient to indicate their overall health on the day of questionnaire completion. This is a 0 -100 scale where 100 represents "The best health you can imagine' and 0 'The worst health you can imagine'.
Measured: At between days 90 and 180 post-discharge.
All-cause mortality
secondary outcome
Measured: At day 30 post-discharge.
All-cause mortality
secondary outcome
Measured: At between days 90 and 180 post-discharge.
Occurrence of first admission to residential care facility for long-term nursing care
secondary outcome
Measured: At day 30 post-discharge.
Occurrence of first admission to residential care facility for long-term nursing care
secondary outcome
Measured: At between days 90 and 180 post-discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start17 Jan 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for MultimorbidityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled clinical trial is proposed in which it is anticipated to randomize 3 x 463 patients to one of 3 groups: (a) standard pharmaceutical care, or (b) trained physician-implemented DI, or (c) clinical pharmacist-implemented DI.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 642 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent, University Hospital Waterford
- Responsible party
- Principal investigator, Denis O'Mahony, University College Cork
- Investigators
- Denis O'Mahony, Professor, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387096
- Sponsor's protocol ID
- DIFA-2020-024
- Acronym
- OPTIMATE
- Status last verified
- Feb 2024
- First submitted
- 9 Apr 2022
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Consent from patients participating in OPTIMATE will be obtained for all data to be shared publicly, such as data used in the generation of publications arising from the study. Data sharing repositories will be formerly identified via careful alignment of the expected data object outputs and evaluated using the re3data resource (re3data.org). This is to ensure maximum utility and interoperability of the final data package(s) and assignment of a persistent digital object identifier (DOI). Additional post-study data provenance will be enacted through sharing of analysis scripts and study protocols via Open Science Framework projects with an accompanying DOI(s) and/or through the Health Research Board (HRB) Open Research publishing platform.
Publications
Al Hamid A, Ghaleb M, Aljadhey H, Aslanpour Z. A systematic review of hospitalization resulting from medicine-related problems in adult patients. Br J Clin Pharmacol. 2014 Aug;78(2):202-17. doi: 10.1111/bcp.12293.
PubMed 24283967Blum 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 34257088Cardwell K. Reducing medication errors and transitions of care. Age Ageing. 2020 Jul 1;49(4):537-539. doi: 10.1093/ageing/afaa065. No abstract available.
PubMed 32474582Dalton K, O'Mahony D, O'Sullivan D, O'Connor MN, Byrne S. Prescriber Implementation of STOPP/START Recommendations for Hospitalised Older Adults: A Comparison of a Pharmacist Approach and a Physician Approach. Drugs Aging. 2019 Mar;36(3):279-288. doi: 10.1007/s40266-018-0627-2.
PubMed 30659429Drenth-van Maanen AC, Spee J, van Hensbergen L, Jansen PA, Egberts TC, van Marum RJ. Structured history taking of medication use reveals iatrogenic harm due to discrepancies in medication histories in hospital and pharmacy records. J Am Geriatr Soc. 2011 Oct;59(10):1976-7. doi: 10.1111/j.1532-5415.2011.03610_11.x. No abstract available.
PubMed 22091519El Morabet N, Uitvlugt EB, van den Bemt BJF, van den Bemt PMLA, Janssen MJA, Karapinar-Carkit F. Prevalence and Preventability of Drug-Related Hospital Readmissions: A Systematic Review. J Am Geriatr Soc. 2018 Mar;66(3):602-608. doi: 10.1111/jgs.15244. Epub 2018 Feb 22.
PubMed 29468640Hyttinen V, Jyrkka J, Valtonen H. A Systematic Review of the Impact of Potentially Inappropriate Medication on Health Care Utilization and Costs Among Older Adults. Med Care. 2016 Oct;54(10):950-64. doi: 10.1097/MLR.0000000000000587.
PubMed 27367864Kongkaew C, Noyce PR, Ashcroft DM. Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies. Ann Pharmacother. 2008 Jul;42(7):1017-25. doi: 10.1345/aph.1L037. Epub 2008 Jul 1.
PubMed 18594048Kuhn-Thiel AM, Weiss C, Wehling M; FORTA authors/expert panel members. Consensus validation of the FORTA (Fit fOR The Aged) List: a clinical tool for increasing the appropriateness of pharmacotherapy in the elderly. Drugs Aging. 2014 Feb;31(2):131-40. doi: 10.1007/s40266-013-0146-0.
PubMed 24353033Laugaland K, Aase K, Barach P. Interventions to improve patient safety in transitional care--a review of the evidence. Work. 2012;41 Suppl 1:2915-24. doi: 10.3233/WOR-2012-0544-2915.
PubMed 22317162Lavan A, Eustace J, Dahly D, Flanagan E, Gallagher P, Cullinane S, Petrovic M, Perehudoff K, Gudmondsson A, Samuelsson O, Sverrisdottir A, Cherubin A, Dimitri F, Rimland J, Cruz-Jentoft A, Velez-Diaz-Pallares M, Lozano Montoya I, Soiza RL, Subbarayan S, O'Mahony D. Incident adverse drug reactions in geriatric inpatients: a multicentred observational study. Ther Adv Drug Saf. 2018 Jan;9(1):13-23. doi: 10.1177/2042098617736191. Epub 2017 Oct 24.
PubMed 29318003Leendertse AJ, Van Den Bemt PM, Poolman JB, Stoker LJ, Egberts AC, Postma MJ. Preventable hospital admissions related to medication (HARM): cost analysis of the HARM study. Value Health. 2011 Jan;14(1):34-40. doi: 10.1016/j.jval.2010.10.024.
PubMed 21211484McAuliffe LH, Zullo AR, Dapaah-Afriyie R, Berard-Collins C. Development and validation of a transitions-of-care pharmacist tool to predict potentially avoidable 30-day readmissions. Am J Health Syst Pharm. 2018 Feb 1;75(3):111-119. doi: 10.2146/ajhp170184.
PubMed 29371191Moriarty F, Bennett K, Cahir C, Kenny RA, Fahey T. Potentially inappropriate prescribing according to STOPP and START and adverse outcomes in community-dwelling older people: a prospective cohort study. Br J Clin Pharmacol. 2016 Sep;82(3):849-57. doi: 10.1111/bcp.12995. Epub 2016 Jun 9.
PubMed 27136457O'Brien GL, O'Mahony D, Gillespie P, Mulcahy M, Walshe V, O'Connor MN, O'Sullivan D, Gallagher J, Byrne S. Cost-Effectiveness Analysis of a Physician-Implemented Medication Screening Tool in Older Hospitalised Patients in Ireland. Drugs Aging. 2018 Aug;35(8):751-762. doi: 10.1007/s40266-018-0564-0.
PubMed 30003429
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTImization of Medication by Transdisciplinary Assessment of Drug Treatment in Elderly Hospitalized Patients: Application of a Definitive Intervention by Physicians or Clinical Pharmacists
- ClinicalTrials.gov ID
- NCT05387096
- Acronym / sponsor ID
- OPTIMATE / DIFA-2020-024
- Conditions
- Multimorbidity, Polypharmacy
- Keywords
- inappropriate prescribing, multimorbidity, polypharmacy, hospital admission, older people, frail elderly, medication therapy management, STOPP/START
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 642 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- University Hospital, Ghent, University Hospital Waterford
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 24 May 2022 (actual)
- 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.
This study is being done to find out if a multi-faceted intervention designed to optimize medication in hospitalized older people with multiple chronic medical conditions exposed to multiple medications can reduce unplanned hospital readmission and emergency department attendance compared to current usual medication management. The study intervention aims to minimize potentially inappropriate medications in a structured way and involves follow up with patients and GPs. Patients will be allocated equally to (i) standard medication management (control arm) or (ii) trained physician-delivered intervention or (iii) clinical pharmacist-delivered intervention.
Detailed description
Background:
Recurrent hospitalization and unplanned emergency department (ED) attendance resulting from potentially inappropriate medication is an increasingly common phenomenon in older people with multi-morbidity and associated polypharmacy. With a growing older population with multi-morbidity/polypharmacy, there is a pressing need to address the increasing challenge of potentially inappropriate medications (PIMs) and potential prescribing omissions (PPOs) and associated problems that accentuate adverse drug reactions/events and avoidable excess morbidity. There is also an imperative to curb excess healthcare expenditure related to preventable medication-related problems.
Objective:
To test the clinical and economic impact of a multi-faceted medication optimization definitive intervention on avoidable rehospitalization and unscheduled ED attendance in multi-morbid patients aged ≥ 70 years hospitalized with acute illness.To test the clinical and economic impact of a multi-faceted medication optimization definitive intervention (DI) on avoidable rehospitalization and unscheduled ED attendance in multi-morbid patients aged ≥ 70 years hospitalized with acute illness.
Design:
A randomized controlled clinical trial is proposed in which it is anticipated to randomize 3 x 463 patients to one of 3 groups: (a) standard pharmaceutical care, or (b) trained physician-implemented DI, or (c) clinical pharmacist-implemented DI.
Setting: Acute care environment in 3 large tertiary referral teaching hospitals with similar custom and practice relating to management of older people with acute illness.
Participants: Patients aged ≥ 70 years with multi-morbid illness i.e. ≥ 3 chronic medical conditions and associated polypharmacy i.e. ≥ 5 daily prescription medications admitted with acute unselected illness.
Intervention:
The definitive multi-faceted intervention will consist of the following components:modified structured history of medication (SHiM), Screening Tool of Older Persons' Prescriptions (STOPP) and Screening Tool to Alert to Right Treatment (START) screening for PIMs and PPOs using STOPP/START version 3.0, drug-drug interaction screening using Stockley's Drug Interaction Checker, face-to-face consultation with attending hospital physicians to discuss PIMs, PPOs, interactions and other issues, pre-discharge medication review and adjustment, detailed medication adjustment discharge report to patients' general practitioners (GPs), post-discharge follow-up contact with patients' GPs and community pharmacists at 1 week and 1 and 3-6 months post-discharge.
Study Population:
OPTIMATE will focus on patients admitted with acute medical or surgical illness to Cork University Hospital, University Hospital Waterford and Ghent University Hospital. Patients to be screened for enrolment are those admitted primarily under the care of specialist departments other than geriatric medicine.
Data Collection:
All OPTIMATE trial data will be collected electronically and entered on a bespoke trial proforma. Once verified as fully correct and complete, all individual participant trial data will be stored on a fully secure clinical trial database.
Statistical Analysis:
Treatment effects for each of the two active intervention arms (versus control) in terms of binary outcomes (e.g. readmission) will be estimated using logistic regression, while Health Related QoL (EQ-5D 5L) will be analyzed using ordinal regression with a logit link function (i.e. a proportional odds model). We will report two models for each outcome: one adjusted for centre and admitting service type; and another further adjusted for centre, age (years), sex, number of comorbidities at baseline, and number of prescribed medications at baseline. Effect estimates will be reported as odds-ratios with 95% confidence intervals and exact p-values. There will be no correction for multiplicity, but we will report results for all outcomes regardless of the result and provide enough information for the reader to make whatever corrections they may consider appropriate. Equivalence tests comparing the two active arms (for each outcome) will be done using a "two one-sided tests" procedure based on a 90% confidence interval (which equates to a 5% type 1 error rate). All analyses will be conducted on an intention-to-treat basis and will be conducted under the quality system and SOPs of the HRB CRF-C Statistics and Data Analysis Unit. A complete statistical analysis plan (SAP) will be pre-registered on the Open Science Framework prior to patient recruitment database lock. Any necessary deviations from this SAP will be documented and explained in the trial report. There will be only one single trial data analysis at the end of the project. All reporting will be carried out in accordance with CONSORT guidelines for clinical trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- A randomized controlled clinical trial is proposed in which it is anticipated to randomize 3 x 463 patients to one of 3 groups: (a) standard pharmaceutical care, or (b) trained physician-implemented DI, or (c) clinical pharmacist-implemented DI.
| Arm | Type | Receives |
|---|---|---|
| Control: standard pharmaceutical care | Sham comparator | Other: Sham InterventionPatients in the control arm (standard pharmaceutical care) will receive a sham intervention in the form of the modified Medication Adherence Rating Scale (MARS) questionnaire |
| trained physician-implemented intervention | Active comparator | Other: Definitive multi-faceted intervention consisting of several componentsThe definitive multi-faceted intervention delivered by a trained physician. |
| clinical pharmacist-implemented intervention | Active comparator | Other: Definitive multi-faceted intervention consisting of several componentsThe definitive multi-faceted intervention delivered by a trained pharmacist. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age ≥ 70years
- 3 or more chronic conditions.
- ≥ 5 daily medications pre-admission, all medications taken for at least 4 weeks continuously.
- Can speak and understand English (in the two Irish medical centres), and Dutch or French in Ghent University Hospital (Ghent is predominantly Dutch-speaking).
- Can give informed consent or give witnessed verbal consent or have a suitable proxy who can give informed assent on the patient's behalf.
Key exclusion criteria (15 listed)
- Terminal illness.
- Severe dementia and clearly unable to understand the purpose of the trial or give consent to participation.
- Severe communication disorder, making informed consent impossible.
- Likely to be discharged from hospital within 48 hours of arrival.
- Intensive Care Unit (ICU) admission.
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 |
|---|---|---|
| Definitive multi-faceted intervention consisting of several componentsAlso: STOPP/START criteria, Face to face consultation with attending physician, medication adjustment report to patient's general practitioner, post discharge follow up with GP and community pharmacistThe definitive intervention will consist of the following components: structured history of medication (SHiM), Screening Tool of Older Persons' Prescriptions (STOPP) and Screening Tool to Alert to Right Treatment (START) screening for PIMs and PPOs, drug-drug and drug-disease interactions screening, face-to-face consultation with attending hospital physicians to discuss PIMs, PPOs, interactions and other issues, pre-discharge medication review and adjustment, detailed medication adjustment discharge report to patients' general practitioners (GPs), post-discharge follow-up contact with patients' GPs and community pharmacists at 1 week, 1 month and 3-6 months post -discharge. The interventions will be applied by a trained physician or pharmacist. | Other | clinical pharmacist-implemented intervention, trained physician-implemented intervention |
| Sham InterventionAlso: ControlSham intervention in the form of the modified Medication Adherence Rating Scale (MARS) questionnaire in addition to standard care. | Other | Control: standard pharmaceutical care |
Primary outcome
Unscheduled readmission to hospital.
Time frame: At day 30 post-discharge.
All-cause re-hospitalization in multi-morbid older people exposed to polypharmacy. Computerized hospital admission records will be inspected. If hospital readmission has occurred dates of admission and discharge will be recorded in the electronic case report form.
Emergency Department attendance.
Time frame: At day 30 post-discharge.
Unscheduled emergency department attendance at in multi-morbid older people exposed to polypharmacy. Computerized hospital emergency department attendance records will be inspected. The primary researcher will record on the electronic case report form whether there has there been an unscheduled emergency department attendance since the first follow-up post discharge.
Composite endpoint 1
Time frame: At day 30 post-discharge.
Composite endpoint of readmission to hospital or emergency department attendance within 30 days of discharge from the index admission.
Unscheduled readmission to hospital.
Time frame: At between days 90 and 180 post-discharge.
Unscheduled readmission at 180 days post-discharge in multi-morbid older people exposed to polypharmacy. This will be ascertained during the follow-up interview within 180 (+/-14) days post-discharge. Computerized hospital emergency department attendance records will be inspected. The primary researcher will record on the electronic case report form whether there has there been an unscheduled readmission at 180 days since discharge from the index hospital admission.
Emergency Department attendance.
Time frame: At between days 90 and 180 post-discharge.
Unscheduled emergency department attendance at in multi-morbid older people exposed to polypharmacy. This will be ascertained during the follow-up interview within 180 (+/-14) days post-discharge. Computerized hospital emergency department attendance records will be inspected. The primary researcher will record on the electronic case report form whether there has there been an unscheduled emergency department attendance at 180 days since discharge from the index hospital admission.
Composite endpoint 2
Time frame: At between days 90 and 180 post-discharge.
Composite endpoint of readmission to hospital or emergency department attendance within 180 days of discharge from the index admission.
6 secondary outcomes
Quality of life measured by EuroQol quality of life 5 dimensional 5 level instrument (incorporating pain control)
Time frame: At day 30 post-discharge.
Quality of life measured by EuroQol quality of life 5 dimensional 5 level instrument
Time frame: At between days 90 and 180 post-discharge.
All-cause mortality
Time frame: At day 30 post-discharge.
All-cause mortality
Time frame: At between days 90 and 180 post-discharge.
Occurrence of first admission to residential care facility for long-term nursing care
Time frame: At day 30 post-discharge.
Occurrence of first admission to residential care facility for long-term nursing care
Time frame: At between days 90 and 180 post-discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Background: PubMed 24283967Al Hamid A, Ghaleb M, Aljadhey H, Aslanpour Z. A systematic review of hospitalization resulting from medicine-related problems in adult patients. Br J Clin Pharmacol. 2014 Aug;78(2):202-17. doi: 10.1111/bcp.12293.
- Background: PubMed 34257088Blum 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.
- Background: PubMed 32474582Cardwell K. Reducing medication errors and transitions of care. Age Ageing. 2020 Jul 1;49(4):537-539. doi: 10.1093/ageing/afaa065. No abstract available.
- Background: PubMed 30659429Dalton K, O'Mahony D, O'Sullivan D, O'Connor MN, Byrne S. Prescriber Implementation of STOPP/START Recommendations for Hospitalised Older Adults: A Comparison of a Pharmacist Approach and a Physician Approach. Drugs Aging. 2019 Mar;36(3):279-288. doi: 10.1007/s40266-018-0627-2.
- Background: PubMed 22091519Drenth-van Maanen AC, Spee J, van Hensbergen L, Jansen PA, Egberts TC, van Marum RJ. Structured history taking of medication use reveals iatrogenic harm due to discrepancies in medication histories in hospital and pharmacy records. J Am Geriatr Soc. 2011 Oct;59(10):1976-7. doi: 10.1111/j.1532-5415.2011.03610_11.x. No abstract available.
- Background: PubMed 29468640El Morabet N, Uitvlugt EB, van den Bemt BJF, van den Bemt PMLA, Janssen MJA, Karapinar-Carkit F. Prevalence and Preventability of Drug-Related Hospital Readmissions: A Systematic Review. J Am Geriatr Soc. 2018 Mar;66(3):602-608. doi: 10.1111/jgs.15244. Epub 2018 Feb 22.
- Background: PubMed 27367864Hyttinen V, Jyrkka J, Valtonen H. A Systematic Review of the Impact of Potentially Inappropriate Medication on Health Care Utilization and Costs Among Older Adults. Med Care. 2016 Oct;54(10):950-64. doi: 10.1097/MLR.0000000000000587.
- Background: PubMed 18594048Kongkaew C, Noyce PR, Ashcroft DM. Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies. Ann Pharmacother. 2008 Jul;42(7):1017-25. doi: 10.1345/aph.1L037. Epub 2008 Jul 1.
- Background: PubMed 24353033Kuhn-Thiel AM, Weiss C, Wehling M; FORTA authors/expert panel members. Consensus validation of the FORTA (Fit fOR The Aged) List: a clinical tool for increasing the appropriateness of pharmacotherapy in the elderly. Drugs Aging. 2014 Feb;31(2):131-40. doi: 10.1007/s40266-013-0146-0.
- Background: PubMed 22317162Laugaland K, Aase K, Barach P. Interventions to improve patient safety in transitional care--a review of the evidence. Work. 2012;41 Suppl 1:2915-24. doi: 10.3233/WOR-2012-0544-2915.
- Background: PubMed 29318003Lavan A, Eustace J, Dahly D, Flanagan E, Gallagher P, Cullinane S, Petrovic M, Perehudoff K, Gudmondsson A, Samuelsson O, Sverrisdottir A, Cherubin A, Dimitri F, Rimland J, Cruz-Jentoft A, Velez-Diaz-Pallares M, Lozano Montoya I, Soiza RL, Subbarayan S, O'Mahony D. Incident adverse drug reactions in geriatric inpatients: a multicentred observational study. Ther Adv Drug Saf. 2018 Jan;9(1):13-23. doi: 10.1177/2042098617736191. Epub 2017 Oct 24.
- Background: PubMed 21211484Leendertse AJ, Van Den Bemt PM, Poolman JB, Stoker LJ, Egberts AC, Postma MJ. Preventable hospital admissions related to medication (HARM): cost analysis of the HARM study. Value Health. 2011 Jan;14(1):34-40. doi: 10.1016/j.jval.2010.10.024.
- Drug-drug interaction toolLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Consent from patients participating in OPTIMATE will be obtained for all data to be shared publicly, such as data used in the generation of publications arising from the study. Data sharing repositories will be formerly identified via careful alignment of the expected data object outputs and evaluated using the re3data resource (re3data.org). This is to ensure maximum utility and interoperability of the final data package(s) and assignment of a persistent digital object identifier (DOI). Additional post-study data provenance will be enacted through sharing of analysis scripts and study protocols via Open Science Framework projects with an accompanying DOI(s) and/or through the Health Research Board (HRB) Open Research publishing platform.
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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.
Denis O'Mahony, Professor principal investigator
University College Cork
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Definitive multi-faceted intervention consisting of several components in people with Multimorbidity and Polypharmacy, run by University College Cork at 3 sites in 2 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 7 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ireland, Belgium. 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?
Results are not available in the source record.
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?
Unscheduled readmission to hospital. (time frame: At day 30 post-discharge.). The study lists 6 primary outcomes in all. 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 NCT05387096, which also lists 26 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 10 Jul 2024.