|- candidate number||15688|
|- NTR Number||NTR4264|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-nov-2013|
|- Secondary IDs||40-41600-98-11018 ZonMW|
|- Public Title||Opti-Med: Optimisation of a medication review programme for elderly in general practice. |
|- Scientific Title||The effectiveness of an optimized medication review programme in patients with ‘geriatric giants’ in general practice.|
|- hypothesis||Several questions with respect to the routine use of medication reviews are not yet answered which hamper their large scale implementation. The Opti-Med study addresses these three problems.
1. A lack of evidence about the effectiveness of medication reviews in primary care in terms of improving health status;
2. Which patients benefit most of medication reviews and
3. Which method is most feasible in daily care in terms of workload.
In this study we will test the hypothesis that a structured review by a general practitioner and pharmacist, of all medication taken by elderly patients who present with a new geriatric problem in general practice will have a beneficial effect on patients’ quality of life and will be cost-effective.|
|- Healt Condition(s) or Problem(s) studied||Medication review, Older adults, Family practice/general practice, Geriatric giants|
|- Inclusion criteria||One or more of the following new geriatric giants: |
1. Actual mobility problem;
2. Two falls or more in the last 6 months;
3. One fall in the last 6 months and a score on the visual analogue scale for Fear of Falling (VAS-FOF) of 5 or more;
5. Urinary incontinence;
6. Problems with cognition.
The geriatric giants identification is a two-step approach:
1. Identification by ICPC codes in GP registration system. Every 8 weeks patients who consulted the GP with a relevant diagnosis in this time period and did not present the problem to the GP during the previous 12 months will be invited to participate.
2. Self-report by patients of the presence of at least one geriatric giant (5 or more on a scale of 1-10)
Additionally they have to indicate that they are willing to participate in the trial by signing an informed consent form.
|- Exclusion criteria||- All patients with a diagnosis of dementia in the medical record.|
- Patients with an MMSE score of 18 or less. An MMSE interview is only carried out when patients indicated they needed help to fill in the inclusion questionnaire.
- A terminal illness leading to an expected death within six months.
- Not willing or unable to participate in studies trials according to GPs.
- Received a systematic medication review according to polypharmacy Dutch guidelines in the last 6 months
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||13-nov-2013|
|- planned closingdate||1-jul-2015|
|- Target number of participants||500|
|- Interventions||Intervention group|
An external expert team consisting of an assistant, a general practitioner and a pharmacist will carry out the medication review of every participating patient in the intervention practices in cooperation with the practice nurse of each individual GP practice.
related problems (DRPs) experienced by the The patients' medication will be structurally reviewed with the Dutch STRIP method and come to an medication advice.
The GP will have a consultation with the patient in which both the medication advice and the patient’s perspective that has previously been assessed by a questionnaire is discussed and definitive changes in the medication will be implemented.
Usual GP care
|- Primary outcome||1. Quality of Life as assessed with EQ5D and SF12 by the patient and with the EQ5D by proxies.|
2. The presence of geriatric giants on a scale from 1-10.
|- Secondary outcome||- Number of drug related problems|
- Medication satisfaction
- Medication adherence
- Cost effectiveness
- Surplus value of the patient participation on the outcome of the medication advice
- Follow-up of the medication advice by GP and patient
- Process analysis on succes and failure factors
Intervention (for intervention group)
3 months T=1
6 months T=2 = endline
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Floor Willeboordse|
|- CONTACT for SCIENTIFIC QUERIES|| Floor Willeboordse|
|- Sponsor/Initiator ||VU University Medical Center, NIVEL|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||The objective of the Opti-Med study is to establish the cost-effectiveness of a structured medication review and monitoring of the medication used by patients aged 65 and over who present with a new ‘geriatric giant’ problem in general practice.
‘Geriatric giants’ are mobility and stability problems, incontinence and cognitive problems. About 25% of the patients of 65 years or older consult their GP in a year with a new problem that is related to a geriatric giant. In elderly patients these geriatric problems often co-occur with existing chronic diseases and changes in pharmacokinetics and -dynamics. These are all risk factors for suboptimal pharmacotherapy and medication-related problems.
In 2013, a study on an innovative medication review method will start in 20 general practices of the Academic Network of General Practitioner (ANH-Vumc) of the VU medical Centre in Amsterdam, The Netherlands.
In this cluster-randomized controlled study a centrally organised approach of a structured medication review program in 500 patients with geriatric complaints will be investigated.
Primary outcome measures are changes in the presented geriatric giant (on a scale 1-10), health related quality of life by self-assessment with Euroqol (EQ-5D) and SF-12, and Euroqol from a proxy perspective by an informal care giver as well as a health care professional. Secondary outcome measures include medication satisfaction, number of drug related problems (DRPs), medication adherence and health care costs.
In addition, the success and failure factors for this new form of medication review will be investigated in a process analysis study.
Eligible patients will be identified retrospectively every eight weeks on the basis of a newly recorded ICPC coded diagnosis in their electronic medical record that could indicate a geriatric giant and will fill in a questionnaire to confirm their eligibility. Exclusion criteria include an ICPC diagnosis of dementia in the electronic medical file or the inability to fill in the questionnaires in combination with an MMSE examination score of 18 or less indicating serious cognitive impairment.
The medication review will follow Dutch guidelines for review of medicines for polypharmacy patients as much as possible. The unique element of this intervention is that the medication review is carried out by a centrally coordinated expert team, consisting of an independent GP and pharmacist, assisted by a ICT application.
This study is a collaboration between the EMGO+ Institute for Health and Care Research at VU University Medical Center Department of general practice & elderly care medicine and NIVEL (Netherlands Institute for Health Services Research)
|- Main changes (audit trail)|
|- RECORD||12-nov-2013 - 13-dec-2013|