Integrated Smoking Cessation Treatment for Smokers With Serious Mental Illness
16 февраля 2022 г. обновлено: A. Eden Evins, Massachusetts General Hospital
The overall aim of this study is to test the effect of academic detailing (i.e.
provider-level educational intervention focused on evidence-based smoking cessation treatment for those with psychiatric illness) and community health worker (CHW) support on the provision and utilization of standard of care smoking cessation treatment to those with serious mental illness (SMI) and smoking cessation rates for adults with SMI who smoke.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Подробное описание
In this study, the investigators aim to test whether a provider-level educational intervention in the form of targeted, practical, action-oriented education to primary care physicians and nurses on safety and effectiveness of and how to use evidence-based smoking cessation treatment for those with psychiatric illness, termed academic detailing (AD), and practical support offered to the primary care physician / primary care team and the smoker with SMI in the form of a community health worker (CHW) will improve recommendation and utilization of standard of care smoking cessation treatments to and by those with SMI and, if so, whether the intervention improves smoking cessation rates for adults with SMI who smoke.
To do so, the investigators will enroll approximately 1300 adult smokers with SMI who receive psychiatric rehabilitation services, Community Based Flexible Support (CBFS) or Assertive Community Treatment (ACT)), from the two largest providers of these services in the Boston area. Primary care clinics that serve 3 or more enrolled participants will be cluster randomized in a 2:1 ratio to either receive AD for their clinical staff or treatment as usual (TAU) in a cluster randomized design. Smokers with SMI in the study who receive primary care at the clinics assigned to the AD intervention to providers will be randomly assigned at the individual level in a 1:1 ratio to be offered CHW support in addition to their ongoing psychiatric rehabilitation (CBFS or ACT) services. This was the original design for the study and these participants comprise Cohort 1. The protocol was modified and approved by the sponsor in February 2018 to include a second cohort. Because 155 enrolled participants received primary care in 155 clinics that served only 1-2 participants, and it was beyond the scope of the trial to deliver AD to so many clinics, a second cohort was formed in which these 155 participants were randomly assigned at the individual level in a 1:1 ratio to CHW or TAU.
This study was also modified by receipt of a qualitative supplement award from the sponsor to conduct mixed methods research to identify and define barriers and facilitators to implementation of components of the integrated care intervention in primary care clinical settings using an interactive convergent mixed-methods design. The aim of this portion of the study is to better understand the factors that impact the integration of Integrated Care and evidence-based treatments for smoking cessation for those with SMI in primary care settings. Qualitative interviews will be conducted for enrolled participants, CHWs, primary care physician, and stakeholders.
Тип исследования
Интервенционный
Регистрация (Действительный)
1165
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02114
- Center for Addiction Medicine, Massachusetts General Hospital, Dept. of Psychiatry
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion:
- adult (18+ years)
- current smoker
- current diagnosis of SMI (e.g. schizophrenia, bipolar disorder, major depressive disorder, etc...)
- currently receiving psychiatric rehabilitation services through CBFS and ACT programs at Bay Cove Human Services and Vinfen Corporation
Exclusion:
- intellectual disability (IQ<70)
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: Treatment as Usual (TAU) - Cohort 1
Usual care (TAU) for adults with SMI in Massachusetts consists of rehabilitation services publicly funded by the state and traditional fee for service outpatient medical and psychiatric care.
Importantly, medical care is not programmatically integrated with the psychiatric rehabilitation services.
Participants in this arm will receive no other study-related intervention.Cohort 1 (AD-eligible) comprised participants seen in primary care clinics serving ≥3 enrolled participants.
|
Usual care (TAU) for adults with SMI in Massachusetts consists of rehabilitation services publicly funded by the state and traditional fee for service outpatient medical and psychiatric care.
Importantly, medical care is not programmatically integrated with the psychiatric rehabilitation services.
|
|
Экспериментальный: AD + CHW - Cohort 1
Academic detailing (AD) is a targeted continuing medical education (CME) strategy that adapts social marketing techniques, using mixed interactive and didactic formats in individual and group settings integrated into the practice setting to promote beneficial changes in medical care. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices. Community Health Worker (CHW) will offer to support patients and prescribers to implement smoking cessation treatments that may be requested by patients and/or recommended by prescribers. |
Academic detailing (AD) is a targeted continuing medical education (CME) strategy that adapts social marketing techniques, using mixed interactive and didactic formats in individual and group settings integrated into the practice setting to promote beneficial changes in medical care.
AD helps clinicians understand and adopt targeted evidence-based practices and is one of the few Continuing Medical Education (CME) interventions that has consistently demonstrated improved alignment of physician prescribing behavior with evidence-based practice.
Community Health Worker (CHW) The CHW will offer to support patients and prescribers in health promotion and preventive care in general and specifically to support communication between the primary care provider and patient regarding smoking status, smoking cessation, and to aid implementation of any smoking cessation treatments recommended by prescribers.
CHWs will complete the standard CHW certificate training program in general preventive medicine, available through the Boston Public Health Commission.
CHWs will then receive the additional specialized training.
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|
Экспериментальный: AD - Cohort 1
Participant in this arm will have Academic Detailing offered to their primary care clinical staff as described above.
Participants who are randomized to this condition will not be offered Community Health Worker support.
|
Academic detailing (AD) is a targeted continuing medical education (CME) strategy that adapts social marketing techniques, using mixed interactive and didactic formats in individual and group settings integrated into the practice setting to promote beneficial changes in medical care.
AD helps clinicians understand and adopt targeted evidence-based practices and is one of the few Continuing Medical Education (CME) interventions that has consistently demonstrated improved alignment of physician prescribing behavior with evidence-based practice.
|
|
Экспериментальный: CHW - Cohort 2
Community Health Worker (CHW) will offer to support patients and prescribers to implement smoking cessation treatments that may be requested by patients and/or recommended by prescribers.
|
Community Health Worker (CHW) The CHW will offer to support patients and prescribers in health promotion and preventive care in general and specifically to support communication between the primary care provider and patient regarding smoking status, smoking cessation, and to aid implementation of any smoking cessation treatments recommended by prescribers.
CHWs will complete the standard CHW certificate training program in general preventive medicine, available through the Boston Public Health Commission.
CHWs will then receive the additional specialized training.
|
|
Активный компаратор: Treatment as Usual (TAU) - Cohort 2
Usual care (TAU) for adults with SMI in Massachusetts consists of rehabilitation services publicly funded by the state and traditional fee for service outpatient medical and psychiatric care.
Importantly, medical care is not programmatically integrated with the psychiatric rehabilitation services.
Participants in this arm will receive no other study-related intervention.
Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants
|
Usual care (TAU) for adults with SMI in Massachusetts consists of rehabilitation services publicly funded by the state and traditional fee for service outpatient medical and psychiatric care.
Importantly, medical care is not programmatically integrated with the psychiatric rehabilitation services.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohort 1
Временное ограничение: Assessment at end of year 2 of intervention
|
Three pairwise comparisons between usual care (TAU), AD+CHW, and AD for number of participants who are abstinent (defined as 7-day point prevalence tobacco abstinence confirmed with an expired CO of 5 ppm or less) at the intervention year 2 assessment.
The investigators hypothesize that (1) those who receive AD+CHW will demonstrate higher rates of tobacco abstinence than those who receive TAU, (2) those who receive AD will demonstrate higher rates of tobacco abstinence than those who received TAU, and (3) those who receive AD+CHW will demonstrate higher rates of tobacco abstinence than those who received AD.
|
Assessment at end of year 2 of intervention
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of Participants Who Use of Any First Line, Evidence-based TUD Medication at the Intervention Year 1 or 2 Assessment in Cohort 1
Временное ограничение: Any use over assessments for years 1 or 2 of intervention
|
Two comparisons, usual care (TAU) versus AD+CHW and TAU versus AD, for use of any first line, evidence-based TUD medication during assessments for years 1 and 2 of the intervention.
The investigators hypothesize that (1) those who receive AD+CHW will demonstrate higher rates of medication use than those who received TAU, and (2) those who receive AD will demonstrate higher rates of medication use than those who received TAU.
|
Any use over assessments for years 1 or 2 of intervention
|
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Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessment in Cohort 1
Временное ограничение: Any use over assessments for years 1 or 2 of intervention
|
Two comparisons, usual care (TAU) versus AD+CHW and TAU versus AD, for use of varenicline during assessments for years 1 and 2 of the intervention.
The investigators hypothesize that (1) those who receive AD+CHW will demonstrate higher rates of varenicline use than those who received TAU, and (2) those who receive AD will demonstrate higher rates of varenicline use than those who received TAU.
|
Any use over assessments for years 1 or 2 of intervention
|
|
Effect of Use of Any TUD Medication on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1
Временное ограничение: Assessment at end of year 2 of intervention
|
Effect of use of any first line, evidence-based TUD medication during assessments for years 1 and 2 of the intervention on number of participants who are abstinent (defined as 7-day point prevalence tobacco abstinence confirmed with an expired CO of 5 ppm or less) at the intervention year 2 assessment.
The investigators hypothesize that those who used any medication will exhibit higher rates of tobacco abstinence than those who did not use any medications.
The indirect effect of AD+CHW and AD interventions on abstinence rates with any TUD medication use as a mediator will be also be assessed.
|
Assessment at end of year 2 of intervention
|
|
Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1
Временное ограничение: Assessment at end of year 2 of intervention
|
Effect of use of varenicline during assessments for years 1 and 2 of the intervention on number of participants who are abstinent (defined as 7-day point prevalence tobacco abstinence confirmed with an expired CO of 5 ppm or less) at the intervention year 2 assessment.
The investigators hypothesize that those who used varenicline will exhibit higher rates of tobacco abstinence than those who did not use any varenicline.
The indirect effect of AD+CHW and AD interventions on abstinence rates with any TUD medication use as a mediator will be also be assessed.
|
Assessment at end of year 2 of intervention
|
|
Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohorts 1 and 2
Временное ограничение: Assessment at end of year 2 of intervention
|
Comparisons between (1) CHW (pooled over AD+CHW and CHW) and (2) AD (pooled over AD+CHW and AD) compared to usual care (TAU) on number of participants who are abstinent (defined as 7-day point prevalence tobacco abstinence confirmed with an expired CO of 5 ppm or less) at the intervention year 2 assessment.
The investigators hypothesize that (1) those who receive CHW support will demonstrate higher rates of tobacco abstinence than those who receive TAU, and (2) those with AD exposure will demonstrate higher rates of tobacco abstinence than those who received TAU.
To make use of all the data, hypotheses will be assessed in Cohorts 1 and 2 via analysis of a factorial design.
|
Assessment at end of year 2 of intervention
|
|
Number of Participants Who Use of Any First Line, Evidence-based TUD Medication at the Intervention Year 1 or 2 Assessment in Cohorts 1 and 2
Временное ограничение: Any use over assessments for years 1 or 2 of intervention
|
Effects of CHW (pooled over AD+CHW and CHW) and AD (pooled over AD+CHW and AD) compared to usual care (TAU) on number of participants who use of any first line, evidence-based TUD medication during assessments for years 1 and 2 of the intervention.
The investigators hypothesize that (1) those who receive CHW support will demonstrate higher rates of medication use than those who receive TAU, and (2) those with AD exposure will demonstrate higher rates of medication use than those who received TAU.
To make use of all the data, hypotheses will be assessed in Cohorts 1 and 2 via analysis of a factorial design.
|
Any use over assessments for years 1 or 2 of intervention
|
|
Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessments in Cohorts 1 and 2
Временное ограничение: Any use over assessments for years 1 or 2 of intervention
|
Effects of CHW (pooled over AD+CHW and CHW) and AD (pooled over AD+CHW and AD) compared to usual care (TAU) on number of participants who use varenicline during assessments for years 1 and 2 of the intervention.
The investigators hypothesize that (1) those who receive CHW support will demonstrate higher rates of varenicline use than those who receive TAU, and (2) those with AD exposure will demonstrate higher rates of varenicline use than those who received TAU.
To make use of all the data, hypotheses will be assessed in Cohorts 1 and 2 via analysis of a factorial design.
|
Any use over assessments for years 1 or 2 of intervention
|
|
Effect of Use of Any TUD Medication on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohorts 1 and 2
Временное ограничение: Assessment at end of year 2 of intervention
|
Effect of use of any first line, evidence-based TUD medication during assessments for years 1 and 2 of the intervention on number of participants who are abstinent (defined as 7-day point prevalence tobacco abstinence confirmed with an expired CO of 5 ppm or less) at the intervention year 2 assessment.
The investigators hypothesize that those who used any medication will exhibit higher rates of tobacco abstinence than those who did not use any medications.
To make use of all the data, the hypothesis will be assessed in Cohorts 1 and 2 via analysis of a factorial design.
The indirect effect of CHW and AD interventions on abstinence rates with any TUD medication use as a mediator will be also be assessed.
|
Assessment at end of year 2 of intervention
|
|
Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohorts 1 and 2
Временное ограничение: Assessment at end of year 2 of intervention
|
Effect of use of varenicline during assessments for years 1 and 2 of the intervention on number of participants who are abstinent (defined as 7-day point prevalence tobacco abstinence confirmed with an expired CO of 5 ppm or less) at the intervention year 2 assessment.
The investigators hypothesize that those who used varenicline will exhibit higher rates of tobacco abstinence than those who did not use any varenicline.
To make use of all the data, the hypothesis will be assessed in Cohorts 1 and 2 via analysis of a factorial design.
The indirect effect of CHW and AD interventions on abstinence rates with varenicline use as a mediator will be also be assessed.
|
Assessment at end of year 2 of intervention
|
|
Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohort 1
Временное ограничение: Assessment at end of year 2 of intervention
|
Three pairwise comparisons between usual care (TAU), AD+CHW, and AD for health-related quality of life at the intervention year 2 assessment as assessed with the single-item self-reported Overall Health (SF-1) scale (measured on a 5-point scale from 1 = 'poor' to 5 = 'excellent').
The investigators hypothesize that (1) those who receive AD+CHW will demonstrate improved quality of life compared than those who receive TAU, (2) those who receive AD will demonstrate improved quality of life compared those who received TAU, and (3) those who receive AD+CHW will demonstrate improved quality of life compared than those who received AD.
|
Assessment at end of year 2 of intervention
|
|
Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohorts 1 and 2
Временное ограничение: Assessment at end of year 2 of intervention
|
Comparisons between (1) CHW (pooled over AD+CHW and CHW) and (2) AD (pooled over AD+CHW and AD) compared to usual care (TAU) on health-related quality of life at the intervention year 2 assessment as assessed with the single-item self-reported Overall Health (SF-1) scale (measured on a 5-point scale from 1 = 'poor' to 5 = 'excellent').
The investigators hypothesize that (1) those who receive CHW support will demonstrate improved quality of life compared to those who receive TAU, and (2) those with AD exposure will demonstrate improved quality of life compared to those who received TAU.
To make use of all the data, hypotheses will be assessed in Cohorts 1 and 2 via analysis of a factorial design.
|
Assessment at end of year 2 of intervention
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Следователи
- Главный следователь: A Eden Evins, MD, MPH, Massachusetts General Hospital
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
14 июля 2016 г.
Первичное завершение (Действительный)
2 февраля 2020 г.
Завершение исследования (Действительный)
12 января 2021 г.
Даты регистрации исследования
Первый отправленный
20 июля 2016 г.
Впервые представлено, что соответствует критериям контроля качества
26 июля 2016 г.
Первый опубликованный (Оценивать)
27 июля 2016 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
19 апреля 2022 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
16 февраля 2022 г.
Последняя проверка
1 февраля 2022 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2016P001036
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .