Abstract Background Smoking among people with severe mental illness (SMI) is highly prevalent and strongly associated with poor physical health. Currently, evidence-based smoking cessation interventions are scarce and need to be integrated into current mental health care treatment guidelines and clinical practice. Therefore, the present study aims to evaluate the implementation and effectiveness of a smoking cessation intervention in comparison with usual care in people with SMI treated by Flexible Assertive Community Treatment (FACT) teams in the Netherlands. Methods A pragmatic, cluster-randomised controlled trial with embedded process evaluation will be conducted. Randomisation will be performed at the level of FACT teams, which will be assigned to the KISMET intervention or a control group (care as usual). The intervention will include pharmacological treatment combined with behavioural counselling and peer support provided by trained mental health care professionals. The intervention was developed using a Delphi study, through which a consensus was reached on the core elements of the intervention. We aim to include a total of 318 people with SMI (aged 18–65 years) who smoke and desire to quit smoking. The primary outcome is smoking status, as verified by carbon monoxide measurements and self-report. The secondary outcomes are depression and anxiety, psychotic symptoms, physical fitness, cardiovascular risks, substance use, quality of life, and health-related self-efficacy at 12 months. Alongside the trial, a qualitative process evaluation will be conducted to evaluate the barriers to and facilitators of its implementation as well as the satisfaction and experiences of both patients and mental health care professionals. Discussion The results of the KISMET trial will contribute to the evidence gap of effective smoking cessation interventions for people treated by FACT teams. Moreover, insights will be obtained regarding the implementation process of the intervention in current mental health care. The outcomes should advance the understanding of the interdependence of physical and mental health and the gradual integration of both within the mental health care system. Trial registration Netherlands Trial Register, NTR9783. Registered on 18 October 2021.
Abstract Background Smoking among people with severe mental illness (SMI) is highly prevalent and strongly associated with poor physical health. Currently, evidence-based smoking cessation interventions are scarce and need to be integrated into current mental health care treatment guidelines and clinical practice. Therefore, the present study aims to evaluate the implementation and efectiveness of a smoking cessation intervention in comparison with usual care in people with SMI treated by Flexible Assertive Community Treatment (FACT) teams in the Netherlands. Methods A pragmatic, cluster-randomised controlled trial with embedded process evaluation will be conducted. Randomisation will be performed at the level of FACT teams, which will be assigned to the KISMET intervention or a control group (care as usual). The intervention will include pharmacological treatment combined with behavioural counselling and peer support provided by trained mental health care professionals. The intervention was developed using a Delphi study, through which a consensus was reached on the core elements of the intervention. We aim to include a total of 318 people with SMI (aged 18–65 years) who smoke and desire to quit smoking. The primary outcome is smoking status, as verifed by carbon monoxide measurements and self-report. The secondary outcomes are depression and anxiety, psychotic symptoms, physical ftness, cardiovascular risks, substance use, quality of life, and health-related self-efcacy at 12months. Alongside the trial, a qualitative process evaluation will be conducted to evaluate the barriers to and facilitators of its implementation as well as the satisfaction and experiences of both patients and mental health care professionals. Discussion The results of the KISMET trial will contribute to the evidence gap of efective smoking cessation interventions for people treated by FACT teams. Moreover, insights will be obtained regarding the implementation process of the intervention in current mental health care. The outcomes should advance the understanding of the interdependence of physical and mental health and the gradual integration of both within the mental health care system. Trial registration Netherlands Trial Register, NTR9783. Registered on 18 October 2021.
Background: To facilitate adherence to adaptive pain management behaviors after interdisciplinary multimodal pain treatment, we developed a mobile health app (AGRIPPA app) that contains two behavior regulation strategies. Objective: The aims of this project are (1) to test the effectiveness of the AGRIPPA app on pain disability; (2) to determine the cost-effectiveness; and (3) to explore the levels of engagement and usability of app users. Methods: We will perform a multicenter randomized controlled trial with two parallel groups. Within the 12-month inclusion period, we plan to recruit 158 adult patients with chronic pain during the initial stage of their interdisciplinary treatment program in one of the 6 participating centers. Participants will be randomly assigned to the standard treatment condition or to the enhanced treatment condition in which they will receive the AGRIPPA app. Patients will be monitored from the start of the treatment program until 12 months posttreatment. In our primary analysis, we will evaluate the difference over time of pain-related disability between the two conditions. Other outcome measures will include health-related quality of life, illness perceptions, pain self-efficacy, app system usage data, productivity loss, and health care expenses. Results: The study was approved by the local Medical Research Ethics Committee in October 2019. As of March 20, 2020, we have recruited 88 patients. Conclusions: This study will be the first step in systematically evaluating the effectiveness and efficiency of the AGRIPPA app. After 3 years of development and feasibility testing, this formal evaluation will help determine to what extent the app will influence the maintenance of treatment gains over time. The outcomes of this trial will guide future decisions regarding uptake in clinical practice.
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De mondgezondheid van te veel jonge kinderen in Nederland is slecht: tandbederf (cariës) komt vaak voor. Een deel van de kinderen bezoekt de mondzorgprofessional te laat. Om de mondgezondheid van deze kinderen te verbeteren is de interventie Gezonde Peutermonden ontwikkeld. Op consultatiebureaus zorgt een mondzorgcoach (mondzorgprofessional) voor coaching en begeleiding van ouders van jonge kinderen bij het aanleren van gezonde eet-/ en mondzorg gedrag. Het effect hiervan wordt momenteel in een 'clinical trial' getest. De tussentijdse resultaten zijn veelbelovend en de interventie heeft enthousiaste reacties opgeleverd. Terwijl een definitieve trialuitkomst op zich laat wachten, nemen mondzorgpraktijken het initiatief tot samenwerking met Jeugdgezondheidszorg. In de regio Heerlen en Tilburg is vanwege een hoog percentage van kinderen met tandbederf, grote belangstelling en bereidheid van mondzorgprofessionals, gemeente, GGD en zorgverzekeraar om het initiatief te nemen. Zij vragen ons om hulp en ondersteuning bij interventie implementatie in hun regio. Naar aanleiding hiervan willen wij in samenwerking met deze partijen in beide regio’s de implementatie van Gezonde Peutermonden onderzoeken. Het doel daarbij is het krijgen van inzicht in de belemmerende en bevorderende factoren bij de implementatie van Gezonde Peutermonden. Zodoende wordt beoogd de ‘beste’ implementatiestrategieën te kunnen achterhalen. Door het verzamelen van kwantitatieve en kwalitatieve gegevens middels ‘mixed methods’ wordt de context in kaart gebracht, gericht op factoren binnen en buiten de organisatie, kenmerken van de doelgroep en de zorgverleners. Scholing, een ‘toolkit’ en voorlichtingsmateriaal worden ontwikkeld en beschikbaar gesteld aan mondzorgprofessionals. Proces-en effectuitkomsten worden gemeten, waartoe gegevens worden verzameld voor, tijdens en na de implementatie van de interventie. Deze aanvraag beschrijft de extra inspanning om de interventie Gezonde Peutermonden om te zetten naar een blended vorm, combinatie van fysieke en video/telefonische consulten, en de ontwikkeling van een protocol voor de gecombineerde consulten voor kinderen tussen 0-4 jaar ten gevolge van de Covid-19 maatregelen.
