|- candidate number||9198|
|- NTR Number||NTR2800|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-mrt-2011|
|- Secondary IDs||171103007 ZonMw|
|- Public Title||Gestructureerd farmacotherapie overleg: Een kosteneffectief middel om naleven van medicamenteuze richtlijnadviezen te bevorderen?|
|- Scientific Title||Pharmacotherapy audit meetings (PTAMs) using quality circles: A cost-effective strategy to improve guideline adherence in nursing homes?|
|- hypothesis||Implementation of pharmacotherapy audit meetings (PTAMs) using quality circles will increase guideline adherence in nursing homes and result in improved quality of psychotropics-prescription in nursing homes.|
|- Healt Condition(s) or Problem(s) studied||Dementia, Sleep disorders, Behavioral problems|
|- Inclusion criteria||Pharmacotherapy audit meetings (PTAMs) in Dutch nursing homes not using quality circles or working with quality circles functioning at level 1 or 2.|
|- Exclusion criteria||Pharmacotherapy audit meetings (PTAMs) already working with quality circles and functioning on level 3 or 4.|
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2011|
|- planned closingdate||30-jun-2014|
|- Target number of participants||26|
|- Interventions||Implementation of working with quality circles at level 3 or 4 in already existing pharmacotherapy audit meetings (PTAMs).
PTAMs of the intervention group will be trained and intensively supported in working with quality circles during their meetings for one year. Quality circles are defined as a cyclic method in which evidence-based information about prescription is provided to the participants and feedback on individual prescription is given. Participants discuss this information, reflect on the prescription data and make general treatment agreements. In consecutive meetings the results are evaluated by using prescription data. This can result in adjusted treatment agreements if target goals are not achieved. PTAMs using quality circles can be seen as a multifaceted implementation strategy. In this study the national guideline for problem behaviour of the Dutch Society of Elderly Care Physicians (Verenso) will be the source for evidence-based information about prescription of hypnotics and antipsychotics.
In PTAMs participate the pharmacist, all physicians and two representatives of the nursing staff of a nursing home organisation.
The control intervention is the 'usual way' of PTAMs: Not using working with quality circles or working with quality circles at a very low level (level 1 or 2).
|- Primary outcome||Percentage of residents of the physicians/nursing homes of pharmacotherapy counselling groups that using:|
|- Secondary outcome||1. Scores on other prescriptionindicators (chosen drug, dosage, treatment time) of residents of participating pharmacotherapy counselling groups;|
2. Experienced workload/worksatisfaction of participating pharmacotherapy counselling group members;
3. Falls, hospital admissions and mortality of residents of participating pharmacotherapy counselling groups;
4. Costs (hospital admissions, falls, medication, intervention);
5. Use of other psychotropics drugs by residents of participating pharmacotherapy counselling groups;
6. Use of physical restriants by residents of participating pharmacotherapy counselling groups.
|- Timepoints||Baseline, 3 monts, 6 months and 1 year.|
The time points we are eventually interested in are baseline and 1 year.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. Martin Smalbrugge|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Martin Smalbrugge|
|- Sponsor/Initiator ||IVM, Dutch Institute for Rational Use of Medicine, VU University Medical Center|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||IMPLEMENTATION OBJECTIVE(S)/RESEARCH QUESTION(S):|
The aim is to study if working with quality circles by pharmacotherapy counselling groups (PCGs) improves guideline adherence to the prescription of hypnotics and antipsychotics in nursing homes. In general, these classes of drugs are used too often and too long. The main research questions are: What is the effect of the implementation of quality circles as a working method in nursing home PCGs on guideline adherence to the prescription of hypnotics and antipsychotics? Is it cost-effective compared to pharmacotherapy counselling groups 'as usual'?
DESIGN, STUDY POPULATION:
The study will be a cluster randomized trial with 26 PCGs consisting of physicians and pharmacists. Both the intervention and the control group will consist of 13 PCGs.
INTERVENTION TO BE IMPLEMENTED:
The pharmacotherapy paragraph about hypnotics and antipsychotics of the guideline for problem behaviour.
For a year PCGs will be trained and intensively supported to use quality circles during their meetings. Nursing staff will
participate in the intervention PCGs.
OUTCOME MEASURES & PROCESS INDICATORS:
Guideline adherence will be measured by prescription indicators. Primary outcome: percentage of residents using hypnotics and antipsychotics. An extensive process evaluation will be carried out to determine facilitators and barriers for the implementation of quality circles.
SAMPLE-SIZE CALCULATION/DATA ANALYSIS:
Based on a mean PCG-size of 10 physicians, two times 13 PCGs are necessary. Multilevel logistic regression and generalize estimated equations will be used for statistical analyses of the outcomes.
An economic evaluation will be carried to study if the implementation of quality circles in PCGs is a cost-effective strategy to implement the pharmacotherapy paragraphs of the guideline for problem behaviour.
The study will take 3.5 years:
1. 0-12 months: Recruitment, development of educational material and indicators;
2. 13-30 months: Implementation of quality circles in PCGs, measurements;
3. 31-42 months: Analysis, writing papers, knowledge transfer.
|- Main changes (audit trail)|
|- RECORD||10-mrt-2011 - 16-mrt-2011|