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van CCT (UK)

van CCT (UK)

OPtimising thERapy to prevent Avoidable hospital admissions in the Multimorbid elderly

- candidate number24706
- NTR NumberNTR6012
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-jul-2016
- Secondary IDsNL 58279.041.16 METC UMC Utrecht
- Public TitleOPtimising thERapy to prevent Avoidable hospital admissions in the Multimorbid elderly
- Scientific TitleOPtimising thERapy to prevent Avoidable hospital admissions in the Multimorbid elderly: a cluster randomised controlled trial
- hypothesisReducing avoidable hospital admissions in multimorbid elderly by optimising pharmacotherapy using the STRIP method including a webbased decision support software tool with integrated STOPP/START criteria, carried out by a physician and a pharmacist.
- Healt Condition(s) or Problem(s) studiedPolypharmacy, Hospitalization, Multimorbidity
- Inclusion criteriaMen and women 70 years of age or older Multimorbidity: 3 or more coexistent chronic conditions defined by 3 distinct ICD-10 codes with an estimated duration of 6 months or more. Polypharmacy i.e. five or more different regular drugs (defined as authorised medications with registration numbers) for more than 30 days. Estimated minimal length of stay within the cluster is sufficient to apply the intervention
- Exclusion criteriaInability 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
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2016
- planned closingdate1-jun-2018
- Target number of participants2000
- InterventionsSTRIP is a structured method to perform pharmacotherapy optimisation. This STRIP-intervention consists of 9 steps:
1. structured history taking of medication (SHIM)
2. recording medication and diagnoses in STRIPA
3. structured drug review based on the STRIPA with the integrated STOPP/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 GP report
8. delivery of the report to the patient and to the GP (optional additional direct communication)
9. follow-up
A structured questionnaire is used for taking the medication history: Structured History taking of Medication use (SHIM) questionnaire. SHIM will be administered on the bases of the medication which was taken at home and will not consider drugs being administered or stopped during the hospitalization.
The STRIPA is a Dutch software-based tool for the support of the pharmaceutical analysis (step 2 of STRIP) by 1) taking into account the predictable adverse medication effects, 2) advising safe and appropriate therapy using established STOPP/START criteria, 3) interaction monitoring and 4) appropriate dosing in accordance with renal function. It represents a highly efficient and user-friendly software engine capable of individually screening the clinical status and pharmacological therapy of older patients with multimorbidity to define optimal drug therapy and highlight ADR risk.
The STRIPA supported advice provides clinicians with the necessary information for optimising the individual patient’s drug therapy based on a list of clinical data inputs: gender, current medical problems and diagnoses, all medicines that are actually used by the patient according to the SHIM (ATC codes) and dosage, clinical measurements such as heart rate and rhythm, blood pressure, estimated GFR (CKD-epi formula) and other relevant laboratory data. These measurements take about 10 minutes34, and SHIM takes also about 10 minutes28. The STRIPA generates 5 output datasets:
1. potential prescribing omissions of beneficial drugs
2. instances of potentially inappropriate medication
3. presence of ADRs (with use of MedDRA terminology)
4. potential adverse drug interactions
5. dosing advice
- Primary outcomePrimary Outcome Patient-level The primary outcome is defined as the first confirmed DRA after discharge from the index hospitalisation within a period of 12 months. Hospitalisation is defined as a stay in an inpatient hospitalisation for longer than 24 hours. The following will not meet the criteria for a hospitalisation.
- Visits to emergency room without inpatient hospitalisation (even if overnight)
- Hospitalisation or prolonged hospitalisation for diagnostic or elective (surgical) procedures for pre-existing conditions
- Admissions due to deliberate suicide attempts
Confirmation of a drug-related hospital admission will be assessed by an independent and blinded adjudication committee (per site) composed of physicians and pharmacists. 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 (see attachment). Study-level The primary outcome of the trial will be the comparison of the two trial groups with respect to DRA and expressed by the hazard ratio as the primary effect measure.
- Secondary outcomeSecondary Outcomes Secondary objectives are to assess the impact of pharmacotherapy optimisation on economic parameters, health care utilisation, falls, mortality, quality of life, polypharmacy, medication changes, activities of daily living, and patient understandings of their medication. A qualitative assessment of patient preference will also be performed. The following secondary endpoints will be analysed: Up to 12 months after inclusion: - Survival (including causes of death) - Hospitalisation - Clinically significant drug-drug reaction (in case of a hospital admission) - Unnecessary drugs (in case of a hospital admission) - Drug underuse (in case of a hospital admission) - Potentially inappropriate medications (in case of a hospital admission) - Healthcare utilisation as measured by all unplanned hospitalisations, scheduled and unscheduled physician consultations (differentiated by profession), and visits to the emergency room without hospital admission - Falls reported by participants, as defined in the corresponding SOP. - Informal care received - Unit costs for participating countries that will stem from external sources -
The cost-effectiveness of the trial intervention by combining clinical data, quality of life data and healthcare utilisation data collected within the trial, and unit costs for participating countries that will stem from external sources. Extrapolation beyond 12 months may be performed to cover longer term effects of the intervention. 2, 6, and 12 months after inclusion:
- Degree of polypharmacy, defined as the number of daily long-term medications - Quality of life as measured by the 5-level version of the European Quality of Life-5 Dimensions questionnaire (EQ-5D) -
Pain/discomfort (EQ-5D) - Basic Activities of Daily Living (ADL) 2 and 12 months after inclusion: - Drug compliance as measured by Medication Adherence Questionnaire (MAQ) developed by Morisky with the addition of one question based on Gehi et al. (“In the past month, how often did you take your medications as the doctor prescribed?”). 2 months after inclusion: - Patients’ understanding of their medication using the Beliefs about Medicines Questionnaire (BMQ) - Satisfaction with Information about Medicines Scale (SIMS) During index hospitalisation - Direct costs of the intervention
- TimepointsInclusion will take place during the index hospitalisation
SHiM within 72 hours after admission Follow-up telephone calls at 2 (±14 days), 6 (±28 days), and 12 (±28 days) months
- Trial web site
- statusplanned
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Europese Unie (EU), Swiss government
- PublicationsN.A.
- Brief summaryThe objective of this 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.
The primary objective is to assess the effect of pharmacotherapy optimisation on drug-related hospitalisations caused by non-preventable adverse drug reactions of preventable medication error related to over-, miss-, and underuse or over-, miss-, and underprescribing of prescription and non-prescription medications. Secondary objectives will be to assess the impact of pharmacotherapy optimisation by STRIP on economic parameters, health care utilisation, falls, mortality, quality of life, polypharmacy, medication changes, activities of daily living, and patient understanding of their medication and to assess the patient’s perspective on the STRIP.
- Main changes (audit trail)
- RECORD28-jul-2016 - 7-okt-2016

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