search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


PIL: Polypharmacie intervention Limburg, too much or too little?


- candidate number6850
- NTR NumberNTR2154
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jan-2010
- Secondary IDs60-61900-98-214 ZonMW
- Public TitlePIL: Polypharmacie intervention Limburg, too much or too little?
- Scientific TitlePIL: Polypharmacie intervention Limburg, too much or too little?
- ACRONYM
- hypothesisThe ultimate goal of this project is to increase quality of life through optimization of the medication use of people with multimorbidity and polypharmacy. Goal is not to decrease the number of medications, but to optimize use of medication, and to assure appropriate prescription.
- Healt Condition(s) or Problem(s) studiedOlder adults, General practitioner, Pharmacist, Polypharmacy
- Inclusion criteria1. Patients older than 60 years with use of five ore more different prescription drugs;
2. Good knowledge of the Dutch language;
3. Informed consent.
- Exclusion criteria1. Critically ill patients with a life expectancy less than one year;
2. Patients who are incompetent to act for themselves.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2009
- planned closingdate1-okt-2010
- Target number of participants1240
- InterventionsIntervention. The integral medication control and monitoring system exists of an integrated approach:
1. The pharmacist selects patients aged 60 years or older who have polypharmacy;
2. Patients are visited by the nurse practitioner, who makes an inventory of all medication currently used by the patient as well as length and weight of the patient, and blood pressure during a home visit. The patient is also asked about his last visit to a medical specialist and when the next visit will be, because the correspondence of the specialists is not always up to date. Finally the nurse practitioner will measure the relevant patient related outcomes (including the minimal data set (MDS));
3. Information from the electronic patient record (EPR) in general practice is added (medication according to the GP, medical problem list (diagnoses), recent correspondence from other medical specialists and lab results from the last year (kidney, liver enzymes, TSH, glucose, cholesterol, electrolytes and others if relevant for the condition of the patient));
4. If lab results are incomplete or when they are older then 1 year, additional blood tests (kidney, liver enzymes, TSH, glucose, cholesterol, electrolytes and others if relevant for the condition of the patient are performed to complete the file;
5. Based on this comprehensive set of information the pharmacist and general practitioner define an integral medication advice (if appropriate including a reconstruction scheme and fitting in the patientís specific profile (tailor made));
6. This medical advice is reached by following the next six steps:
A. Rubricating medication prescribed in the following seven groups;
a. Cardiovascular;
b. Diabetes mellitus;
c. Tractus digestivus;
d. Pulmonary diseases;
e. Psychofarmaca;
f. Pain medication;
g. Other. B. Current medication use by the patient, including over the counter drugs and herbs;
C. Indication of the prescriptions. Medication prescriptions are compared with the indications (medical problem list) registered by the GP, and correspondence of the different medical specialists. Possibly patients are undertreated or an indication is not relevant anymore. Different guidelines are used as basis;
D. Side effects;
E. Drug-drug interactions;
F. Evaluation of the way medication is given, and adjustment of dose. In this step we will use the patient parameters like kidney-function and BMI. 7. The integral advice is sent to the medical specialist(s) involved, together with an accompanying letter. The two main questions for the specialists are:
A. Which of the medication they had prescribed do they consider absolutely indispensable;
B. Whether they can support the medication advice as formulated;
8. After this analyses, the GP integrates the reaction of the medical specialists with the original advice, based on a protocol that takes into account the indication using the Beers-list (Vingerhoets et al, 2005), replacement of certain drugs, interactions, pseudo-double medication, side-effects, contra-indications and dose;
9. The GP discusses the final advice with the patient, and modifications are carried through after patientís consent;
10. In case of new medication prescribed by another medical specialist the patient is asked to visit his/her GP first, in order to evaluate the new medication from the perspective of or in relation to the former integral medication advice.

GPs will be trained to interpret the medication advice and to communicate this advice to their patients (knowledge, communication skills). Eventually, the GP and the pharmacist working together in practice, are trained to make the analysis of the polypharmacy patients. Every month a new practice will start implementing the intervention. During the first two months there will be an intensive training of the GP how to interpret the comprehensive set of information and how to make the medication advice.
The proposed intervention was developed in a pilot project in an academic primary care center in Kerkrade (MCWK) also built on the experiences of two other academic primary care centers. Important experiences, some also reported by others, were that 1) the GP and pharmacist need to cooperate to get a realistic overview of medication and indications (Hanlon 1996); 2) the analysis reveals not only cases of too many, but also cases of too few medications (Kuijper et al, 2007); 3) grouping medication and relating it to diagnoses and treatment aims is very helpful; 4) data on renal and hepatic function were often lacking; 5) early involvement of the patient is necessary to reach effective change in a later stage: patients need to be convinced that his specialist(s) were involved in the medication preview (Denneboom, 2008); 6) it is necessary to involve other medical specialists in the medication review; 7) a home visit by the practice nurse is necessary, not only to explain the project and ask for informed consent, but also to get insight into the real use of medication prescribed (Barat, 2000) and the use of over-the-counter medication.
- Primary outcome1. Patient physical and mental health ] outcomes (using data from the MDS);
2. Patient psychosocial outcomes, including quality of life outcomes, well-being and measures of disability of functional status (using data from the MDS).
- Secondary outcome1. Measures of patient medication adherence, utilization of health services (including the number of prescriptions, number of hospitalizations);
2. Acceptability and feasibility of the intervention according to patients, GPs, nurse practitioners and pharmacists (barriers and facilitators);
3. Costs of medication prescriptions;
4. Medication compliance bij measering pill- count.
- Timepoints1. Maand 0: 0-meting, Start Interventie groep A (10 deelnemende praktijken);
2. Maand 3: 0-meting, Evaluatie groep A (1 maand), Start interventie groep B (10 deelnemende praktijken;
3. Maand 6: 0-meting, Evaluatie groep B (1maand), Evaluatie groep A(3 maanden), Start interventie groep C (10 deelnemende praktijken);
4. Maand 9: Evaluatie Groep C (1maand), Evaluatie Groep B (3 maanden), Evaluatie en HA consult Groep A (6maanden);
5. Maand 12: Evaluatie Groep C (3 maanden), Evaluatie en HA consult Groep B, (6maanden), Evaluatie Groep A (9 maanden);
6. Maand 15: Evaluatie en HA consult Groep C (6 maanden), Evaluatie Groep B (9 maanden), Evaluatie en HA consult Groep A (12 maanden);
7. Maand 18: Evaluatie Groep C (9 maanden), Evaluatie en HA consult Groep B (12 maanden);
8. Maand 21: Evaluatie en HA consult Groep C (12 maanden).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. B. Bosch-Lenders
- CONTACT for SCIENTIFIC QUERIES M. Akker, van den
- Sponsor/Initiator Maastricht University Medical Center (MUMC+), CAPHRI, The Research Institute of the University Maastricht and University Hospital Maastricht (AZM)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryPolypharmacy (the long-term use of 5 or more drugs) is a relevant and costly health problem among the elderly. The proportion of people with polypharmacy is rising as a result of the increasing number of people suffering from multimorbidity and the ageing of the population. Guidelines for medical practice are mainly disease-specific and pay little attention to disease-disease, drug-disease and drug-drug combinations and interactions with their potential harmful adverse effects.
A significant part of chronic medication is prescribed within a specific medical specialism, often lacking an integrated view of indications, treatment goals and medication. Polypharmacy increases the risk of side-effects and problems with patient compliance. At the same time polypharmacy may induce suboptimal treatment because the probability of underprescription increases with the number of drugs used, thus increasing the chance of inappropriate prescription.
The GP should play a pivotal role in the improvement of this process, with the availability of comprehensive data from his own practice, from the patient, the pharmacists and from other medical specialists. Furthermore, the GP is in a good position to discuss possibilities to change medication with the patient.
The ultimate goal of this project is to increase quality of life through optimization of the medication use of people with multimorbidity and polypharmacy. The goal is not to decrease the number of medications per se, but to optimize use of medication, and to assure appropriate prescription.
This project consists of a randomized controlled trial. Randomization takes place at practice level, to avoid within-practice, inter-patient contamination. Twelve academic practices, related to Maastricht University will take part in the trial. These practices will include a total of 1240 patients with five or more medication prescriptions and aged 60 years or older. The intervention tested is an integral medication control and monitoring system. Information of the pharmacists is completed with the GPsí electronic patient record and with information from the patients, gathered by the nurse practitioner during home visits. GPs then formulate a medication advice, which is sent to other involved medical specialists to ask for their consent. The GPs formulates a final advice and discusses this with the patient. Modifications are carried through after the patientís consent. Main outcome measures are measured at baseline and after 1, 6 and 12 months. Important outcome measures are:
1.Physical and mental health outcomes (using data from the minimal data set (MDS));
2. Patient psychosocial outcomes, including quality of life outcomes, well-being and measures of disability of functional status (using data from the MDS);
3. Laboratory results with deviating results at baseline;
4. Measures of patient medication adherence, utilization of health services(including the number of prescriptions, number of hospitalizations);
5. Acceptability and feasibility of the intervention according to patients, GPs, nurse practitioners and pharmacists (barriers and facilitators).
- Main changes (audit trail)
- RECORD7-jan-2010 - 14-jan-2010


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl