|- candidate number||22020|
|- NTR Number||NTR5135|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-apr-2015|
|- Secondary IDs||RTPO 937a |
|- Public Title||Deployment of dedicated nursing staff to stimulate use of clozapine.|
|- Scientific Title||Deployment of dedicated nursing staff to stimulate use of clozapine.|
|- hypothesis||Delegation of clozapine monitoring tasks to a Nurse Practitioner (condition A) is at least as safe as Treatment As Usual: physicians perform monitoring tasks themselves (condition B).|
|- Healt Condition(s) or Problem(s) studied||Non-affective psychotic disorder|
|- Inclusion criteria||Teams:|
- Outpatient teams in which a nurse practitioner participates
- Age 18-55
- Diagnosis: non-affective psychotic disorder
|- Exclusion criteria||If the proportion of NAPD patients, who already use clozapine, exceeds 20%, the team is excluded.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||4-jun-2015|
|- planned closingdate||7-mei-2017|
|- Target number of participants||16|
|- Interventions||1. Education of physicians and NPs about indications for clozapine.|
2. Physicians and NPs screen all patients in their team for a possible indication for clozapine. 3. Randomization of teams into condition A or B (treatment as usual).
4. Training of NPs from teams in condition A in management of patients on clozapine.
5. One-year study period, during which eligible patients will be started on clozapine or not.
|- Primary outcome||1a. Proportion of missed weekly lab exams (white blood cells) in condition A vs. B. |
1b. Number of days the lab exams (white blood cells) are delayed, divided by total number of required lab exams in condition A vs. B.
|- Secondary outcome||1. Duration of clozapine use in condition A vs. B.
2. Clinical Global Impression-Schizophrenia scale (CGI-SCH) score of change in condition A vs. B.
3. Proportion of patients indicated for clozapine (in condition A vs. B) who actually start with this drug.
4. Proportion of patients for whom clozapine is indicated.
5. Qualitative data to explore how potentially hazardous side-effects were handled.
|- Timepoints||04-06-2015: Education of physicians and NPs: during one afternoon psychiatrists of the Dutch Clozapine Collaboration Group (www.clozapinepluswerkgroep.nl) educate physicians and NPs of all participating teams about the diagnosis of treatment-resistance and about other indications for clozapine. |
Between 04-06-2015 and 01-10-2015: Baseline assessment: The independent researcher, the responsible physician and NP of each team discuss every patient with NAPD to determine if the patient: a. already uses clozapine; b. has used clozapine and has discontinued this drug (justified or unjustified); c. has an indication for clozapine, with information on type(s) of indication; d. has no indication for clozapine.
September 2015: Training of nurse practitioners.
Between 01-10-2015 and 04-02-2017: One–year study period during which eligible patients will start using clozapine or not. Of all patients that start using clozapine, data will be collected during 18 weeks. Since a patient started in the last week of this year should be monitored for 18 weeks, the study will last an extra 4 months (until February 2017).
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Yvonne van der Zalm|
|- CONTACT for SCIENTIFIC QUERIES|| Yvonne van der Zalm|
|- Sponsor/Initiator ||Maastricht University, GGZ Leiden, Rivierduinen|
(Source(s) of Monetary or Material Support)
|GGZ Leiden, Rivierduinen, Leiden|
|- Publications||None yet|
|- Brief summary||Background: The antipsychotic drug clozapine is more effective than other antipsychotics. However, it remains underused, most likely because it is more labour-intensive as white blood cells should be monitored weekly during the first 18 weeks. Especially for outpatients, this generates a lot of extra work for the physician (psychiatrist/resident). A recent survey concluded that professionals “perceived the presence of dedicated staff to arrange and monitor the initiation of clozapine in outpatients as the factor that would enable the use of clozapine most”. The exact proportion of patients with Non-Affective Psychotic Disorder (NAPD) in an outpatient setting who should be treated with clozapine is uncertain.
Primairy objective: To demonstrate that delegation of clozapine monitoring tasks to a NP is at least as safe as Treatment As Usual (TAU).
Secundairy objectives: 1. To examine whether collaboration between a physician and a NP is associated with a longer retention of patients on clozapine. 2. To examine whether collaboration between a physician and a NP is associated with a better outcome in patients who start with clozapine. 3. To examine whether a physician will treat more patients (who have an indication for clozapine) with this drug if he can delegate weekly monitoring tasks and discussion of common side-effects to a Nurse Practitioner (NP). 4. To estimate the proportion of outpatients with NAPD for whom clozapine is indicated, by type of indication 5. To examine the difference between condition A and B in promptness and accuracy of treatment of potentially hazardous side-effects.
In this study we will randomize at least 16 teams into 2 conditions: (A) Collaboration in clozapine treatment between physician and NP, versus (B) TAU: physician performs clozapine monitoring himself.
|- Main changes (audit trail)||18-okt-2015: |
Exclusion criterium " If the proportion of NAPD patients, who already use clozapine, exceeds 20%, the team is excluded." is not applicable anymore, due to changes in the studydesign.
5.One-year study period will be study period of 15 months
Sept 2016-jan. 2017: an extra Treatment As Usual group will be created. This group consists of patients from the intervention teams, who have started clozapine before the start of the trial.
|- RECORD||28-apr-2015 - 29-sep-2016|