Mental Disorders, SevereTACTICNCT05647980
Transmural Collaborative Care Model for CVRM and Medication Review for Patients Using Antipsychotics
A study testing TACTIC in people with Mental Disorders, Severe, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Currently, monitoring of usage and effects of antipsychotic treatment and cardiovascular risk screening in patients with severe mental illness or antipsychotic treatment is not sufficient. Read more about this study
- Who is it for?
- Ages 25 to 84 years
- Conditions the study is for
- Mental Disorders, Severe
- What is being tested?
- TACTIC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- using atypical antipsychotic medication for at least 3 months at baseline
- the atypical antipsychotic medication is prescribed by the general practitioner
- a 10-year cardiovascular risk of at least 5% (as measured with QRISK3 score) at baseline
Who cannot join
- diagnosis of dementia or organic psychosis
- diagnosis of cardiovascular disease (acute myocardial infarction, acute coronary syndrome, heart failure, ischemic stroke, transient ischemic attack, peripheral artery disease, aortic aneurysm or a revascularization procedure, i.e. percutaneous coronary intervention or coronary artery bypass grafting)
Trial locations and contacts
1 site in 1 country.
Karlijn KJ van den Brule-Barnhoorn, MD contact
Netherlands1 site, 1 recruiting
- Recruiting
Radboud university medical centre, Dept. Primary and Community Care
Nijmegen, 6525 GA
Radboud U medical centre, Dept. Primary and Community Care, +31622221879, erik.bischoff@radboudumc.nl
About this study
Official title: Transmural Collaborative Care Model for Cardiovascular Risk Management (CVRM) and Medication Review for Patients Using Antipsychotics: a Cluster Randomised Stepped Wedge Trial
Currently, monitoring of usage and effects of antipsychotic treatment and cardiovascular risk screening in patients with severe mental illness or antipsychotic treatment is not sufficient.
A transmural collaborative care model for cardiovascular risk management and medication review for patients using atypical antipsychotics in general practice (TACTIC) was developed. This trial aims to assess the effectiveness of TACTIC regarding predicted cardiovascular risk and mental quality of life.
Read the detailed description
It is well established that patients with severe mental illness and patients treated with atypical antipsychotics have excess metabolic dysfunction and are at an increased risk of cardiovascular disease. Currently, monitoring of usage and effects of antipsychotic treatment and cardiovascular risk screening in patients with severe mental illness or antipsychotic treatment is not sufficient. General practitioners experience barriers regarding knowledge, collaboration with psychiatrists, and patient compliance. To overcome these barriers a transmural collaborative care model for cardiovascular risk management and medication review for patients using atypical antipsychotics in general practice (TACTIC) was developed. TACTIC is a one-time transmural intervention comprising three steps: 1) an online information video to inform patients about the cardiovascular risks of antipsychotic use and the procedures of the multidisciplinary meeting, 2) a multidisciplinary meeting with the patient to review his or her antipsychotic use and cardiovascular risk and to provide tailored treatment advice, and 3) a follow-up contact with the general practitioner to translate the treatment advice into an individualised action plan through shared decision making.
This trial aims to assess the effectiveness of TACTIC regarding predicted cardiovascular risk and mental quality of life.
- Conditions
- Mental Disorders, Severe
- Being tested
- TACTIC
- Keywords
- Primary health care, Antipsychotics, Cardiovascular risk, Collaborative care, Deprescribing, Off label
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACTICOther
Participants execute the three steps of TACTIC Participants fill in questionnaires Participants take laboratory and biometric tests to measure their cardiovascular risk
| Study group | Role | What they receive |
|---|---|---|
| TACTIC | Experimental | Participants in the TACTIC intervention will be provided a 3-step approach, i.e.
1. an online information video to inform patients about the cardiovascular risks of antipsychotic use and the procedures of the multidisciplinary meeting
2. a multidisciplinary meeting with their general practitioner, the primary care nurse, a psychiatrist, and an experience expert to discuss cardiovascular risk and side effect and to provide personalised treatment options
3. a consultation with their general practitioner to translate treatment options into an individualised treatment plan including lifestyle and medication treatment and monitoring frequency, based on shared-decision making Receives: Other: TACTIC |
| Care as usual | No intervention | Care as usual, i.e. renewal of prescriptions for antipsychotics by the general practitioner without multidisciplinary treatment advice and without the use of scheduled and structured monitoring visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in QRISK3 score as measured with the QRISK3 calculator (https://qrisk.org/three/)
The risk score of developing cardiovascular disease over the next 10 years is estimated using the QRISK®3 algorithm (https://qrisk.org/three/), which calculates a person's ten-year risk of cardiovascular disease by taking multiple risk parameters into account. A higher score means a higher risk. Risks may vary between 0% and 100%. The parameter Townsend deprivation score will be set to 0 (as advised by its developers), meaning neither deprived nor affluent, as this score does not apply to the Dutch population.
Measured: Measurements at baseline, at 5, 10, 15 and 20 months (depending on the specific wave in the stepped-wedge trial in which follow-up starts)
The change in Mental Health, as measured with the Mental Health Inventory questionnaire
Mental Health is measured using the five-item version of the Mental Health Inventory (MHI) questionnaire. The MHI-5 is a derivative of the 36-item short form (SF-36) health survey, and assesses symptoms of depression and anxiety, loss of behavioural or emotional control, and psychological well-being in the prior four weeks. Scores range from 0 to 100, lower scores are worse, and patients with a score ≥60 are considered mentally healthy.
Measured: Measurements at baseline, at 5, 10, 15 and 20 months (depending on the specific wave in the stepped-wedge trial in which follow-up starts)
Secondary outcomes (6)
The change in Quality of Life (QoL) as measured with the EuroQuality of Life Five Dimensions (EQ-5D-5L) questionnaire
QoL is measured using the EuroQuality of Life Five Dimensions (EQ-5D-5L) questionnaire, which measures generic quality of life on 5 domains with a 5-point Likert scale. A higher score means a worse healt state in each domain, with a maximum of 5 points.
Measured: Measurements at baseline, at 5, 10, 15 and 20 months (depending on the specific wave in the stepped-wedge trial in which follow-up starts)
The change in Side effects of antipsychotic medication, as measured with the Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) questionnaire
The side effects of antipsychotic medication is measured using the Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) questionnaire, which assesses side effects of neuroleptic drugs. It has been designed to enable the client to make the rating themselves but can also be administered by mental health workers if the client is unable to complete it. The scale consists of 41 known side effects of neuroleptics. Each 'side-effect' listed is scored on a five point rating scale of 0 - 4, i.e. 0 = 'Not at all' and 4 = Very much. A higher total score means more side-effects. Maximum total score is 84
Measured: Measurements at baseline, at 5, 10, 15 and 20 months (depending on the specific wave in the stepped-wedge trial in which follow-up starts)
The change in Client Satisfaction, as measured with the 8-item Client Satisfaction Questionnaire (CSQ-8)
Client Satisfaction with care is measured using the CSQ-8, an 8-item questionnaire using a 4-point Likert scale. The sum of 8 sub-scores about different aspects of received care can vary between 8 and 32. Higher scores mean higher satisfaction.
Measured: At 5 months from baseline
The change in risk score of developing cardiovascular disease over the next 10 years including a Dutch deprivation score
The risk estimation of the QRISK3 score is based on several parameters including the Townsend deprivation score. For the primary outcome the score will be set to 0, as the original score does not apply to the Dutch population. For this secondary outcome the QRISK3 score will be calculated including a Dutch deprivation index. A higher score means a higher risk. Risks may vary between 0% and 100%.
Measured: Measurements at baseline, at 5, 10, 15 and 20 months (depending on the specific wave in the stepped-wedge trial in which follow-up starts)
The change in QRISK3 score as proportion of the maximum achievable change in QRISK3 score
The change in QRISK3 score as a proportion of the maximum achievable change in QRISK3 score is the change in QRISK3 score that has been achieved at the end of follow-up divided by the change in QRISK3 score that could have been achieved when all modifiable risk factors would have been improved. The proportional score may be 1.0 (actual change equals maximum achievable change) or less.
Measured: Measurements at baseline baseline at 5, 10, 15 and 20 months (depending on the specific wave in the stepped-wedge trial in which follow-up starts)
The change in costs related to health care
Costs include health care utilization, such as medication use, visits to the general practice, visits to relevant medical specialists, hospitalisation. Costs will be calculated during follow-up time and will be compared with the same period of time prior to start of follow-up.
Measured: 1-20 months (depending on the duration of follow-up which differs between the waves in the stepped-wedge trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start1 Mar 2023
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mental Disorders, SevereStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Incomplete stepped wedge cluster randomised trial
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Onze Huisartsen BV.
- Responsible party
- Principal investigator, E. Bischoff, Radboud University Medical Center
- Investigators
- Erik E Bischoff, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647980
- Sponsor's protocol ID
- 10140021910502
- Acronym
- TACTIC
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2022
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Research Information Services (RIS) interface, specifically developed for the Radboud University Nijmegen, will also be used to register and archive our data in the certified DANS EASY archive of KNAW and NWO.
Publications
Bischoff EWMA, Jakobs KM, Assendelft WJJ. Cardiovascular risk management in patients using antipsychotics: it is time to take action. BMC Med. 2020 Nov 2;18(1):339. doi: 10.1186/s12916-020-01811-7. No abstract available.
PubMed 33131496Jakobs KM, Posthuma A, de Grauw WJC, Schalk BWM, Akkermans RP, Lucassen P, Schermer T, Assendelft WJJ, Biermans MJC. Cardiovascular risk screening of patients with serious mental illness or use of antipsychotics in family practice. BMC Fam Pract. 2020 Jul 29;21(1):153. doi: 10.1186/s12875-020-01225-7.
PubMed 32727372Jakobs K, Lautan L, Lucassen P, Janzing J, van Lieshout J, Biermans MCJ, Bischoff EWMA. Cardiovascular risk management in patients with severe mental illness or taking antipsychotics: A qualitative study on barriers and facilitators among dutch general practitioners. Eur J Gen Pract. 2022 Dec;28(1):191-199. doi: 10.1080/13814788.2022.2092093.
PubMed 35796600Jakobs KM, van den Brule-Barnhoorn KJ, van Lieshout J, Janzing JGE, Cahn W, Kievit W, Teerenstra S, van den Muijsenbergh M, Biermans MCJ, Bischoff EWMA. Transmural collaborative care model for cardiovascular risk management and medication review in patients using antipsychotics in primary care (TACTIC): A study protocol of an incomplete stepped wedge cluster randomized trial. Contemp Clin Trials Commun. 2025 Jan 9;44:101418. doi: 10.1016/j.conctc.2024.101418. eCollection 2025 Apr.
PubMed 39897941
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transmural Collaborative Care Model for Cardiovascular Risk Management (CVRM) and Medication Review for Patients Using Antipsychotics: a Cluster Randomised Stepped Wedge Trial
- ClinicalTrials.gov ID
- NCT05647980
- Acronym / sponsor ID
- TACTIC / 10140021910502
- Conditions
- Mental Disorders, Severe
- Keywords
- Primary health care, Antipsychotics, Cardiovascular risk, Collaborative care, Deprescribing, Off label
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Onze Huisartsen BV.
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, monitoring of usage and effects of antipsychotic treatment and cardiovascular risk screening in patients with severe mental illness or antipsychotic treatment is not sufficient.
A transmural collaborative care model for cardiovascular risk management and medication review for patients using atypical antipsychotics in general practice (TACTIC) was developed. This trial aims to assess the effectiveness of TACTIC regarding predicted cardiovascular risk and mental quality of life.
Detailed description
It is well established that patients with severe mental illness and patients treated with atypical antipsychotics have excess metabolic dysfunction and are at an increased risk of cardiovascular disease. Currently, monitoring of usage and effects of antipsychotic treatment and cardiovascular risk screening in patients with severe mental illness or antipsychotic treatment is not sufficient. General practitioners experience barriers regarding knowledge, collaboration with psychiatrists, and patient compliance. To overcome these barriers a transmural collaborative care model for cardiovascular risk management and medication review for patients using atypical antipsychotics in general practice (TACTIC) was developed. TACTIC is a one-time transmural intervention comprising three steps: 1) an online information video to inform patients about the cardiovascular risks of antipsychotic use and the procedures of the multidisciplinary meeting, 2) a multidisciplinary meeting with the patient to review his or her antipsychotic use and cardiovascular risk and to provide tailored treatment advice, and 3) a follow-up contact with the general practitioner to translate the treatment advice into an individualised action plan through shared decision making.
This trial aims to assess the effectiveness of TACTIC regarding predicted cardiovascular risk and mental quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Incomplete stepped wedge cluster randomised trial
| Arm | Type | Receives |
|---|---|---|
| TACTIC | Experimental | Other: TACTICParticipants in the TACTIC intervention will be provided a 3-step approach, i.e. 1. an online information video to inform patients about the cardiovascular risks of antipsychotic use and the procedures of the multidisciplinary meeting 2. a multidisciplinary meeting with their general practitioner, the primary care nurse, a psychiatrist, and an experience expert to discuss cardiovascular risk and side effect and to provide personalised treatment options 3. a consultation with their general practitioner to translate treatment options into an individualised treatment plan including lifestyle and medication treatment and monitoring frequency, based on shared-decision making |
| Care as usual | No intervention | –Care as usual, i.e. renewal of prescriptions for antipsychotics by the general practitioner without multidisciplinary treatment advice and without the use of scheduled and structured monitoring visits. |
Who may qualify
- Ages
- 25 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- using atypical antipsychotic medication for at least 3 months at baseline
- the atypical antipsychotic medication is prescribed by the general practitioner
- a 10-year cardiovascular risk of at least 5% (as measured with QRISK3 score) at baseline
Key exclusion criteria (2 listed)
- diagnosis of dementia or organic psychosis
- diagnosis of cardiovascular disease (acute myocardial infarction, acute coronary syndrome, heart failure, ischemic stroke, transient ischemic attack, peripheral artery disease, aortic aneurysm or a revascularization procedure, i.e. percutaneous coronary intervention or coronary artery bypass grafting)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TACTICParticipants execute the three steps of TACTIC Participants fill in questionnaires Participants take laboratory and biometric tests to measure their cardiovascular risk | Other | TACTIC |
Primary outcome
The change in QRISK3 score as measured with the QRISK3 calculator (https://qrisk.org/three/)
Time frame: Measurements at baseline, at 5, 10, 15 and 20 months (depending on the specific wave in the stepped-wedge trial in which follow-up starts)
The risk score of developing cardiovascular disease over the next 10 years is estimated using the QRISK®3 algorithm (https://qrisk.org/three/), which calculates a person's ten-year risk of cardiovascular disease by taking multiple risk parameters into account. A higher score means a higher risk. Risks may vary between 0% and 100%. The parameter Townsend deprivation score will be set to 0 (as advised by its developers), meaning neither deprived nor affluent, as this score does not apply to the Dutch population.
The change in Mental Health, as measured with the Mental Health Inventory questionnaire
Time frame: Measurements at baseline, at 5, 10, 15 and 20 months (depending on the specific wave in the stepped-wedge trial in which follow-up starts)
Mental Health is measured using the five-item version of the Mental Health Inventory (MHI) questionnaire. The MHI-5 is a derivative of the 36-item short form (SF-36) health survey, and assesses symptoms of depression and anxiety, loss of behavioural or emotional control, and psychological well-being in the prior four weeks. Scores range from 0 to 100, lower scores are worse, and patients with a score ≥60 are considered mentally healthy.
6 secondary outcomes
The change in Quality of Life (QoL) as measured with the EuroQuality of Life Five Dimensions (EQ-5D-5L) questionnaire
Time frame: Measurements at baseline, at 5, 10, 15 and 20 months (depending on the specific wave in the stepped-wedge trial in which follow-up starts)
The change in Side effects of antipsychotic medication, as measured with the Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) questionnaire
Time frame: Measurements at baseline, at 5, 10, 15 and 20 months (depending on the specific wave in the stepped-wedge trial in which follow-up starts)
The change in Client Satisfaction, as measured with the 8-item Client Satisfaction Questionnaire (CSQ-8)
Time frame: At 5 months from baseline
The change in risk score of developing cardiovascular disease over the next 10 years including a Dutch deprivation score
Time frame: Measurements at baseline, at 5, 10, 15 and 20 months (depending on the specific wave in the stepped-wedge trial in which follow-up starts)
The change in QRISK3 score as proportion of the maximum achievable change in QRISK3 score
Time frame: Measurements at baseline baseline at 5, 10, 15 and 20 months (depending on the specific wave in the stepped-wedge trial in which follow-up starts)
The change in costs related to health care
Time frame: 1-20 months (depending on the duration of follow-up which differs between the waves in the stepped-wedge trial.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Background: PubMed 33131496Bischoff EWMA, Jakobs KM, Assendelft WJJ. Cardiovascular risk management in patients using antipsychotics: it is time to take action. BMC Med. 2020 Nov 2;18(1):339. doi: 10.1186/s12916-020-01811-7. No abstract available.
- Background: PubMed 32727372Jakobs KM, Posthuma A, de Grauw WJC, Schalk BWM, Akkermans RP, Lucassen P, Schermer T, Assendelft WJJ, Biermans MJC. Cardiovascular risk screening of patients with serious mental illness or use of antipsychotics in family practice. BMC Fam Pract. 2020 Jul 29;21(1):153. doi: 10.1186/s12875-020-01225-7.
- Background: PubMed 35796600Jakobs K, Lautan L, Lucassen P, Janzing J, van Lieshout J, Biermans MCJ, Bischoff EWMA. Cardiovascular risk management in patients with severe mental illness or taking antipsychotics: A qualitative study on barriers and facilitators among dutch general practitioners. Eur J Gen Pract. 2022 Dec;28(1):191-199. doi: 10.1080/13814788.2022.2092093.
- Derived from this study: PubMed 39897941Jakobs KM, van den Brule-Barnhoorn KJ, van Lieshout J, Janzing JGE, Cahn W, Kievit W, Teerenstra S, van den Muijsenbergh M, Biermans MCJ, Bischoff EWMA. Transmural collaborative care model for cardiovascular risk management and medication review in patients using antipsychotics in primary care (TACTIC): A study protocol of an incomplete stepped wedge cluster randomized trial. Contemp Clin Trials Commun. 2025 Jan 9;44:101418. doi: 10.1016/j.conctc.2024.101418. eCollection 2025 Apr.
- Individual participant dataSharing planned: Yes. The Research Information Services (RIS) interface, specifically developed for the Radboud University Nijmegen, will also be used to register and archive our data in the certified DANS EASY archive of KNAW and NWO.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karlijn KJ van den Brule-Barnhoorn, MD contact
Erik E Bischoff, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TACTIC in people with Mental Disorders, Severe, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karlijn KJ van den Brule-Barnhoorn, MD (+31 24 36 13 237, karlijn.vandenbrule-barnhoorn@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in QRISK3 score as measured with the QRISK3 calculator (https://qrisk.org/three/) (time frame: Measurements at baseline, at 5, 10, 15 and 20 months (depending on the specific wave in the stepped-wedge trial in which follow-up starts)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05647980, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.