Integrated Smoking Cessation Treatment for Smokers With Serious Mental Illness
2022年2月16日 更新者：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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
介入
入学 (実際)
1165
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Center for Addiction Medicine, Massachusetts General Hospital, Dept. of Psychiatry
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
|
|
実験的：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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実験的：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.
|
|
実験的：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.
|
|
アクティブコンパレータ：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohort 1
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants Who Use of Any First Line, Evidence-based TUD Medication at the Intervention Year 1 or 2 Assessment in Cohort 1
時間枠：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
|
|
Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessment in Cohort 1
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者：A Eden Evins, MD, MPH、Massachusetts General Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年7月14日
一次修了 (実際)
2020年2月2日
研究の完了 (実際)
2021年1月12日
試験登録日
最初に提出
2016年7月20日
QC基準を満たした最初の提出物
2016年7月26日
最初の投稿 (見積もり)
2016年7月27日
学習記録の更新
投稿された最後の更新 (実際)
2022年4月19日
QC基準を満たした最後の更新が送信されました
2022年2月16日
最終確認日
2022年2月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2016P001036
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Treatment as Usual (TAU)の臨床試験
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Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Bostonまだ募集していません自殺念慮 | 自殺未遂 | 自殺
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Institute of Tropical Medicine, BelgiumUniversity Hospital Tuebingen; Mbarara University of Science and Technology; Liverpool School... と他の協力者完了熱 | マラリアブルキナファソ, ガボン, モザンビーク, ナイジェリア, ルワンダ, ウガンダ, ザンビア