OptiMEDs Pilot Study (NCT04142645) | Clinical Trial Compass
CompletedNot Applicable
OptiMEDs Pilot Study
Belgium148 participantsStarted 2019-10-09
Plain-language summary
Pilot study of the OptiMEDs intervention: a complex intervention for multidisciplinary medication review (including nurses, pharmacists, and physicians) in nursing homes (NH), with ICT-support for the evaluation of the appropriateness of prescribing and for side-effect monitoring.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria for nursing homes:
* located in East Flanders
* size: \> 100 beds
* mixed population of high care dependent and low care-dependent residents with and without dementia
* software of Care Solutions or Farmad is used for electronic handling of the medication chart
* the NH management as well as the responsible CRA and the community pharmacist who delivers the medication in the NH give their written agreement to participate
Inclusion criteria for residents:
All residents of all wards of the participating nursing homes will be considered for inclusion if they meet the following inclusion criteria:
* aged 65 years or older
* mentally fit as well as cognitive impaired NH residents will be included after Informed Consent given by the resident (mentally capable residents) or his representative (cognitive impaired residents, defined as a sumscore of 6 or more on the KATZ items of disorientation in time and place).
Exclusion criteria for residents
Residents will not be considered for inclusion if:
* they have a limited life-expectancy (less than 3 months, as judged and documented by the treating GP)
* they are residing in a short-stay / revalidation bed
* GP refused to have his NH residents included in this pilot
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.