Evaluation of Community Health Worker Support to Help People With Serious Mental Illness to Quit Smoking
Evaluation of Community Health Worker Support to Improve Tobacco Use Disorder Outcomes in Medicaid Beneficiaries With Serious Mental Illness
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Our aim is to determine whether CHW support integrated into behavioral health care improves tobacco abstinence and cardiovascular risk in those with SMI and TUD when delivered by Intensive Case Manager (ICM) staff within existing ACOs, with the hypothesis that those assigned to Integrated CHW support will have higher rates of biochemically verified 7-day point prevalence combusted tobacco abstinence at 18 months than those assigned to EUC, greater reduction in cardiovascular risk estimates at 18 months, greater improvement in psychiatric symptom severity, stress, and loneliness over 18 months, greater engagement with care, greater healthcare satisfaction ratings, and reduction in emergency department visits and inpatient hospitalization days in month 18 of the intervention than those assigned to EUC.
To do so, 937 adults with SMI and TUD, receiving behavioral healthcare through a large human services agency, will be enrolled and randomly assigned to 1) receive behavioral health team support from their Intensive Case Manager who has received brief CHW and TTS training (ICM-T) or 2) continue to receive usual ICM support (Enhanced usual care, EUC). All care team clinicians will be offered education on first-line, evidence-based TUD treatment in SMI.
Aim 1: Determine whether Integrated CHW support improves tobacco abstinence and reduces cardiovascular risk in those with SMI and TUD when delivered by ICMs within Medicaid ACOs.
Aim 2. Determine whether Integrated CHW support improves mental health, social, and healthcare utilization outcomes in those with Medicaid-eligible SMI and TUD.
Aim 3: Examine implementation of the Integrated CHW support intervention, using quantitative data and qualitative interviews with human service organization, health system, CHW and patient stakeholders.
General Description of Study Design 937 adults, ages 18-75, with SMI who receive behavioral healthcare through a Medicaid ACO at community human services agencies and report daily tobacco smoking will be enrolled in a single blind (outcome assessor), active-controlled, randomized study of the effect of an Integrated CHW support intervention delivered by their Medicaid ACO. Half of the participants will receive support from their ICM who has received CHW and TTS (ICM-T) training and half will receive enhanced usual care (EUC) e.g. continue to receive ICM care. ICM who don't receive CHW and TTS training during the intervention will be offered the training at the conclusion of the intervention. The investigators hypothesize that those assigned to Integrated CHW support (ICM-T) will have higher rates of biochemically verified 7-day point prevalence tobacco abstinence at 18 months than those assigned to EUC.
Recruitment All patients with SMI and TUD, receiving care through a Medicaid ACO at one of the community human services agencies in Greater Boston who are willing to meet with a CHW at least once and to meet with study assessors for a brief interview every 6 months for 18 months will be eligible to enroll. Recruitment will be conducted in waves by clinic site. There will be six waves, corresponding to 6 clinical sites.
Subject Enrollment Adults, aged 18-75, with SMI, daily cigarette smoking, enrolled in a Medicaid ACOs teams at a community human services agency will be eligible to enroll. There will be six waves, corresponding to the 6 clinical sites. The investigators will enroll at each clinic sequentially, enrolling 156-157 participants per site, or 937 total participants, with half at each site randomly assigned to the Integrated CHW support intervention and half to the control (EUC) arm, approximately 468 per arm. Participant consent procedures at the enrollment visit will include description of study procedures, potential adverse events, confidentiality, and voluntariness of participation. Potential participants will be encouraged to ask questions about their participation. Participants must demonstrate understanding of the nature of this study, its potential risks, discomforts, and benefits before they will be allowed to sign consent forms. Electronic informed consent will be offered. No other study procedures will occur until the informed consent/assent documents are signed. Participants will be given a copy of their signed consent/assent documents.
Randomization The randomization will be at the level of the ICM. There are 89 ICMs serving on 13 teams across 6 sites. Randomization will be stratified by care team, such that half of ICMs on each team will be assigned to CHW and TTS certificate training. ICMs not assigned to CHW training at the beginning of the intervention will be offered the training at the end of the intervention when data collection is complete Participants who were randomized to receive CHW intervention, will be asked to provide informed consent to the CHW services. CHWs will discuss the study in detail with the participant. Information about the study and its purpose, including potential risks and benefits will be provided in written form in language understandable to the participant. Participants will be given the opportunity to ask questions, and it will be explained that even after they have made a voluntary agreement to participate in the study, they may withdraw from the study at any time without penalty. The CHW will evaluate the participant and assess his or her competence to provide informed consent and this or her factual understanding of the study and its risks using a Consent Form Test. This questionnaire consists of 8 true-false questions about important aspects of the study procedures, potential risks, and the patient's right to end participation at any time. A participant must score 80% to participate. If the participant is deemed not competent to consent to study procedures due to illness or any other reason, they will not be enrolled into the CHW intervention phase and all study-related procedures will cease for that patient. Subjects who provide informed consent will be given a copy of the signed consent form to keep.
STUDY VISITS Bi-annual surveys Study participants will be asked to participate in 4 data collection visits. Trained clinical research coordinators (CRCs), who are blind to treatment assignment, will collect participant reported outcomes from all individuals enrolled in the study. CRCs will attend the ICM meetings for those who agree. CRCs will follow a brief script to explain the study to participants, to inform them that participation in the 5 brief bi-annual surveys is entirely voluntary, that their decision of whether or not to participate will in no way impact their ongoing services or primary care, and to obtain verbal consent from those who agree to answer the smoking and smoking-treatment-related questions. CRCs will conduct five interviews over two years with each participant, at baseline, 6, 12, and 18 months, in-person or by zoom as needed.
Visit 1 Baseline:
- Demographic characteristics, and social determinants of health: age, sex, race, housing status/living situation, internet access (to communicate with health care providers), social support
- Readiness to quit smoking
- Lifetime history of tobacco use, dependence and treatment
- Substance use history
- Tobacco Timeline Follow back (TLFB): to report tobacco product use in the past 90 days
- Patient satisfaction with mental health services.
Visits at 6, 12, and 18 Months
- TLFB to report tobacco product use in the past 90 days
- Readiness to quit smoking
- Nicotine withdrawal symptoms.
- Life stress
- Use of tobacco, alcohol, prescription medication, and other substances
- Patient satisfaction with mental health services.
- Smoking Status: If smoking: number of cigarettes smoked per day; if prior smoker: time since last cigarette and quitting method.
Bio-verification of self-reported 7-day point prevalence abstinence will be operationalized as semi-quantitative salivary cotinine <30 ng/ml. For those using NRT or e-cigarettes at the time of testing expired carbon monoxide (CO) <5 ppm by trained assessors will be used to verify combusted tobacco abstinence. Participants reporting tobacco abstinence by zoom will have an in-person meeting with the CRC in the community or clinic for cotinine or CO measurement to bio-verify self-report of tobacco abstinence.
b. Electronic Health Records (EHR)
The agency Quality Manager will provide de-identified EHR data, identified only by study ID, to study staff, at 3-month intervals, including:
- TUD pharmacotherapy prescriptions,
- Cardiovascular risk factors (age, sex, race, blood pressure, HDL, LDL and total cholesterol, statin, aspirin antihypertensive use, diabetes diagnosis, and smoking status),
- Completed MIRAH clinical assessments routinely administered as part of clinical care,
- Emergency department visits and hospitalization days since last assessment
- Psychiatric and medical diagnoses and current medications since last assessment
Functional impairment due to psychiatric illness assessed with Clinical Global Severity Scale (CGI-S) will be extracted from the EHR
c. Qualitative interviews They will be conducted at the end of the intervention (month 18) at each clinical site with stakeholders, including all CHWs, clinical and administrative leadership at the human service organization, and patients involved in the Integrated CHW support intervention, to evaluate implementation outcomes, process, and determinants. At least N=30 patients will be purposively selected based on stratified groups of low and high levels of health improvements to maximize representativeness across outcomes associated with CHW engagement (i.e., tobacco abstinence, TUD pharmacotherapy use, reduced cardiovascular risk, reduced mental health symptoms and stress).
INTERVENTIONS Enhanced Usual Care (EUC): All enrolled participants will receive EUC which includes routine outpatient behavioral healthcare by their care team, including their intensive case manager (ICM) and provider education (PE) that will be offered to all clinicians across the agency on safety and efficacy of first-line, guideline-concordant, evidence-based TUD treatments for people with SMI.
Integrated CHW support: CHW support will be fully integrated into the ICM work ICMs will complete 40 hours of training in core competencies for CHW certification and tobacco treatment specialist (TTS) training. One agency, Eliot Community Human Services employs 89 bachelor's level ICMs serving 13 teams, across 6 sites, with an average caseload of 25 patients who they see on average 4 times per month, in person, in the community. Random assignment to Integrated CHW support (ICM-T) will be through randomly assigning half of the ICM staff, 3-4 ICMs per team (45 of the 89 ICMs) to be provided with CHW and TTS certificate training to be able to then deliver the CHW intervention integrated with their ICM duties (ICM-T). ICMs assigned to CHW and TTS (ICM-T) training at will deliver the Integrated CHW intervention to their patients who enroll in the trial, and ICMs assigned to EUC will deliver EUC to their patients who enroll in the trial.
ICM-T intervention will be fully integrated into the ICM duties. ICM-T will conduct visits in the community with the same frequency as in usual ICM practice, community visits per month, augmented with phone or videoconference support as needed. Thus, while conducting usual ICM duties of assessing functioning in the home and community, medication adherence, assisting obtaining medications and adherence to primary care visits, ICM-T will help patients assess their tobacco use, educate on smoking cessation treatments, encourage cessation trials, provide behavioral support for cessation, accompany patients to primary care / psychiatric prescriber visits where they offer to help patients communicate their health goals, often their wish to initiate TUD pharmacotherapy, and where they also offer to support the prescriber by supporting medication acquisition and adherence and by facilitating communication of any adverse effect or difficulty with the medication, and help clients obtain medication treatment for smoking cessation per clinical practice guidelines.
CHW Training and Support:
ICMs receive extensive training, which includes foundational learning about ethics, crisis management, and human rights as well as specialized coursework relevant to understanding and working with individuals with SMI, including, psychiatric diagnosis, engaging patients in recovery-oriented, and trauma-informed care, motivational interviewing, CBT Basics, Problem-Solving, in addition to Medication Administration Program (MAP) training.
The Integrated CHW support intervention comprises components of effective CHW interventions in general low SES Medicaid and uninsured populations, including training in core competencies, motivational interviewing, professional boundaries, and work practices centered around goal setting, goal support, and connection with primary care. CHW training will include the ten core competencies required for Massachusetts CHW certification, emphasizing understanding the CHW role and how it relates to other care team members, working to improve clinical workflow, introduction to the electronic health record, and methods for integration within care teams. This robust training will be followed by ongoing supervision and support for CHWs, including communication with all care staff regarding the benefit of CHWs and how the CHW role fits within the team, all factors stakeholders identified as key for successful CHW integration.
ASSESSMENTS
Assessments conducted at Baseline only:
PhenX Toolkit instruments will be used to collect research domain demographics items on age, ethnicity, race, current address, biologic sex, gender, and educational attainment.
Health Information National Trends Survey (HINTS) 4-items from this scale will be used to assess internet access, quality, and ability to use the internet to communicate with CHWs and study assessors.
Housing status Lifetime tobacco use and treatment and other substance use history: The investigators will administer PhenX measures for: Age of Initiation of Tobacco Use (adapted to include onset of daily use), past year Methods of Quitting Smoking (adapted to include number, timing, and duration of prior trials of TUD pharmacotherapy and use of concurrent TUD pharmacotherapies), Use of Tobacco Products, including poly-tobacco product use (lifetime and past month).
Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) will be used to describe the sample in terms of lifetime problematic use of cannabis, sedatives, opioids, and prescription medications.
The QuickSCID* administered by the clinical team, will be used to identify psychiatric diagnosis to characterize the sample.
Health Leads Social Needs Screening Tool* is a 10-item questionnaire that will be used to assess SDoH.
Psychiatric and medical diagnoses and current medications* will be ascertained from the electronic health record (EHR) by the Quality Management staff at the community human services agencies.
Clinical Global Severity Scale (CGI-S)* extracted from the EHR will be used to characterize the sample with regards to functional impairment due to psychiatric illness.
The Fagerstrom Test for Nicotine Dependence (FTND)* will be used to assess severity of tobacco dependence at baseline.
-Tobacco product use, tobacco treatment, tobacco product abstinence and cardiovascular risk: TLFB: Participants will be asked to report tobacco product use in the past 90 days using TLFB methods, including any periods of tobacco product abstinence lasting ≥ 24 hrs, duration of abstinence in that period, whether they used any TUD pharmacotherapy in that period, and duration of use. The primary outcome will be operationalized as self-report of abstinence from combusted tobacco product use for the past 7 days at the Year 2 assessment, Bio-verification of self-reported 7-day point prevalence abstinence: Participants reporting combusted tobacco product abstinence for ≥7 days prior to any assessment will be assessed for biomarkers of nicotine and tobacco use. Bio-verification of self-reported 7-day point prevalence abstinence will be operationalized as semi-quantitative salivary cotinine <30 ng/ml. To do this, participants will provide a saliva sample via passive drool that will be tested with a semi-quantitative cotinine test. For those using NRT or e-cigarettes at the time of testing expired carbon monoxide (CO) <5 ppm by trained assessors will be used to verify combusted tobacco abstinence. Expired CO will be measured with a small, hand-held CO monitor. To do so, participants will blow into a straw attached to the device, a Bedfont Smokerlyzer II (Kent, England), following a 15-second breath hold to verify self-report of non-smoking status. Expired CO <5 parts per million (ppm) is consistent with smoking abstinence.
Readiness to quit smoking : it will be assessed with a single item "How motivated are you to quit smoking?" on a 10-point visual analogue scale.
Minnesota Withdrawal Scale (MNWS), is a 9-item self-rated scale that will be used to assess nicotine withdrawal symptoms. It includes craving; depressed mood; irritability; frustration; anxiety; difficulty concentrating; restlessness; increased appetite; insomnia on an ordinal scale from 0 (not at all) to 4 (extreme).
Cardiovascular risk:* The American College of Cardiology (ACC)/American Heart Association (AHA) ASCVD calculator for cardiovascular risk will be used to estimate the 10-year and lifetime atherosclerotic risk based on: age, sex, race, blood pressure, smoking status, lipids (HDL and total cholesterol), diabetes diagnosis, HbA1c, antihypertension therapy. Change in individual risk factors and the AHA risk score incorporating CVD-kidney-metabolic health will also be reported. Community human services agencies staff will extract these data from the EHR every 6 months.
-Psychiatric symptoms, SDoH, and substance use other than nicotine: Generalized Anxiety Disorder-7* will be used to assess anxiety symptom severity, with scores ranging from 0 to 21.
Patient Health Questionnaire 9-item (PHQ-9)* will be used to assess depression symptom severity.
Colorado Symptom Index* and Clinical Global Improvement Scale (CGI-I)*30 will be used to assess general psychiatric symptoms.
Perceived Stress Scale will be used to assess life stress. Illness Management and Recovery Scale (IMR)* will be used to assess illness self-management.
The Social Connectedness Scale - Revised (SCS-R)* will assess social support The UCLA Loneliness Scale* will assess loneliness Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) will be used to screen for past 90-day use and problematic use of alcohol, cannabis, sedatives, opioids, and prescription medications.
The Alcohol Use Disorders Identification Test (AUDIT-C)* will be conducted to assess symptoms of alcohol use disorder.
Service use and medication adherence*: EHR data extraction will be used as a primary data source to validate TUD pharmacotherapy prescriptions (Hypothesis 1.2), emergency service use (i.e., emergency room, emergency service team) and medical or psychiatric hospitalization using the Service Use and Resource Form (SURF) which captures inpatient, emergency service, and outpatient care. The investigators will adapt the SURF to assess service use in the 6 months prior to each assessment time point. The SURF will also be used to document CHW contacts as an outpatient service and will record any missed or cancelled patient visits documented in the EMR.
The Client Satisfaction Questionnaire (CSQ-8), an 8-item questionnaire that will be used to assess patient satisfaction with health services every 6 months.
Qualitative interviews They will be conducted at the end of the intervention at each clinical site with stakeholders, including all CHWs, clinical and administrative leadership at the human service organization, and patients involved in the Integrated CHW support intervention, to evaluate implementation outcomes, process, and determinants. At least N=30 patients will be purposively selected based on stratified groups of low and high levels of health improvements to maximize representativeness across outcomes associated with CHW engagement (i.e., tobacco abstinence, TUD pharmacotherapy use, reduced cardiovascular risk, reduced mental health symptoms and stress).
Semi-structured interview guides will be informed by the Expanded Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM)/ Practical Robust Implementation and Sustainability Model (PRISM) to provide a framework for evaluating implementation success and planning future integration of health service programs. It will include questions to assess perceived acceptability, effectiveness, reasons for adoption, successful and less successful implementation strategies and intervention adaptations, and factors impeding and supporting sustainment of the Integrated PEaCH intervention in the organization. Questions will highlight contextual factors (i.e., recipients, implementation and sustainability infrastructure, and external environment) that enhance RE-AIM implementation outcomes. Interviews with patients and CHWs will also assess factors impacting ability to articulate, communicate, and address their health goals and overcome barriers to addressing/achieving their health goals, including housing and food insecurity, economic barriers to basic life needs, transportation, and prescription medication, and overcoming other adverse SDoH such as stress and stigma in the community that are pervasive in this population.
Risks and Discomforts Justification of risk of treatments to be studied: The risks of the intervention to be tested will be minimal. The benefit of tobacco smoking cessation vastly outweighs any risk of smoking cessation in this population. People with SMI in the US die approximately 25 years earlier than those without mental illness, primarily directly from smoking related diseases. Due to attitudinal, knowledge, and resource barriers including adverse social determinants of health (SDoH), lifesaving TUD treatment is not routinely delivered to smokers with SMI in the community, despite converging evidence that a majority of smokers with psychiatric illness want to quit smoking, and that cessation aids combined with behavioral support are very effective and well tolerated by smokers with SMI.
Adequacy of Protection Against Risks
- Informed Consent: Adults ages 18-75 with SMI and TUD will be recruited for this study. This study will be performed with the approval of the Massachusetts General Brigham Institutional Review Board. At the initial meeting, during the verbal consent process, a qualified member of the study team will explain the purpose, procedures, and potential discomforts and risks of the study, participants will be told that the co-investigators are available to answer any questions or concerns they may have about the study, and that their decision to participate will not change the medical care they get through MGH or any community human services agency. Participants will be provided with a factsheet that details important information about the study, including who can be contacted for more information. Participants will also be offered a copy of the Privacy Notice.
- Protection against Risk: Participant safety will be overseen in the provision of usual care. Risks and benefits of tobacco smoking cessation and safety data on tobacco smoking cessation treatment options will be included in the PE content to prescribers and TTS content to ICM-T. Since the investigators are studying a system of usual care delivery, there may be inclusion of pregnant women. All of the conditions for the protection of pregnant women as defined by 45 CFR 46. (Research involving pregnant women or fetuses) are met by this study. It will be up to the pregnant woman and her medical provider to decide if the risks of tobacco smoking during pregnancy are outweighed by risks of smoking cessation, including pharmacotherapeutic treatment for tobacco smoking cessation to the woman and her fetus.
All study personnel and care providers involved in the study will be trained in emergency procedures in the event that a study participant is determined to be at risk of harm to self or others during any of the assessments. ICMs are trained and have the necessary information to handle a psychiatric emergency. In accordance with best practices, the investigators have developed a detailed plan for training clinical research coordinators (CRCs) who will conduct assessments and collect data. CRC staff will complete comprehensive training before data collection begins. Once study procedures have begun, study staff members will meet with the PI and other senior investigators on a weekly basis to discuss study progress, review procedures, and conduct ongoing training and fidelity assessments. The investigators will review all new adverse events weekly and as needed.
Risk of nicotine withdrawal: Participants may experience nicotine withdrawal symptoms. They will receive written materials that list withdrawal symptoms that can be expected. CHWs will support participants in managing nicotine withdrawal. Withdrawal symptoms are usually short-lived and are not medically dangerous, and most abate after 1-2 weeks.
Risk of neuropsychiatric adverse events: Those who report worsening of depressed mood, agitation, or aggression or thoughts of harming self or others at any point during the study will receive a clinical evaluation by a clinically trained, doctoral level study staff member. MGH study staff is comprised of several investigators with significant expertise in mental health assessment and treatment who will have direct participant contact. The study team, including ICM-T, is well prepared to identify and address urgent issues that may arise in the setting of new neuropsychiatric adverse events. All study staff and ICM-T will be trained by a licensed psychiatrist and licensed clinical psychologists on identifying and responding to emotional distress in research participants. Participants will be referred for clinical care if the research team determines that the participant's mental or physical health has deteriorated.
Psychosocial, Social, and Legal Protections: The investigators will maintain a Certificate of Confidentiality (CoC) from the National Institutes of Health for this study. The CoC protects the privacy of individuals who are subjects of research by establishing prohibitions on disclosure, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, of the names of research participants or any information, documents, or biospecimens that contain identifiable, sensitive information collected or used in research by an investigator or institution. The investigators will use the Certificate to resist demands for information that would identify participants, to the extent allowed by law. To minimize potential risks, all data will be coded with unique subject identifiers to minimize breaches of confidentiality which may decrease comfort to respond to questions and interviews truthfully. Participants will be reminded by study staff that they may omit any questions they do not wish to answer or discontinue their participation at any time with no penalty or repercussions. For any participant for whom investigators have concerns about emotional wellbeing that do not rise to the severity of an imminent safety risk, investigators will ask him/her if the investigators can discuss this with his/her treater to help coordinate a plan for monitoring and treatment.
Confidentiality Protections: Protecting the confidentiality and integrity of research participants is a top priority. MGH's careful consent and data confidentiality procedures greatly minimize risk to privacy. Only MGH project investigators and authorized study staff will have access to data. Study staff will break confidentiality only if in the study team's assessment there is an imminent and significant risk to that participant's safety. Once collected, an individual's data will not be released to anyone outside of MGH study staff. Confidentiality is further assured by assigning a unique identifier to each participant. There will be a restricted access master list of identifying information linked to the study identification number. The master list will be kept in a locked cabinet in a locked office in a badge-access only office suite and a password-protected computer file, separate from other data, along with other materials that have the participants' names (e.g., consent forms). No identifying information is listed on questionnaires or any other materials with data on them. Self-report questionnaires will be administered via REDCap, minimizing the risk of confidentiality breaches. Only authorized MGH study staff will be allowed access to this data. Any data files in electronic format will be housed in our network server at the Center for Addiction Medicine at MGH, password protected with dual authentication so that only authorized study staff can access them. These files will not have participant names or identifying information attached to them.
Limits of Confidentiality on Clinical Information: While the investigators are committed to maintaining confidentiality to the extent allowed by law, confidentiality is limited when there is a deemed imminent risk to oneself or others or reports of child or elder abuse. Study staff will inform participants during the consent process that in emergency situations (in which an individual is at immediate risk for harm) the investigators will release information about the participant. Specifically, if a participant tells any member of study staff that he/she has intent and/or a plan to cause physical harm to self or others, study staff will start the Center Emergency Protocol that includes a psychiatric evaluation by a licensed mental health professional and could even involve calling 911. If the participant says that he/she has recurrent thoughts about harming him/herself or someone else but does not have intent or plan to do so, study staff will ask participant permission to notify appropriate medical personnel. If study staff learns about mood concerns or problematic substance use, study staff will provide the participant with referral resources for follow-up consultation and care
Benefits For research participants: Risks to study participants are minimal, and the potential gains in improved health, function, and longevity are high to participants in the study and to smokers with SMI who may benefit from a widely disseminated, effective intervention.
For others: This study will test a scalable CHW intervention, delivered by ICMs serving as Medicaid-ACO behavioral healthcare members, in adults with SMI served by these teams to increase cessation
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gladys Pachas, MD, MPH
- Phone Number: 617-643-1991
- Email: gpachas1@mgh.harvard.edu
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Center for Addiction Medicine - Massachusetts General Hospital
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Contact:
- Gladys Pachas, MD, MPH
- Phone Number: 617-643-1991
- Email: gpachas1@mgh.harvard.edu
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Principal Investigator:
- Anne Eden Evins, MD, MPH
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Sub-Investigator:
- Corinne Cather, PhD
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Sub-Investigator:
- Gladys N Pachas, MD, MPH
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Sub-Investigator:
- Harrison Reeder, PhD
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Sub-Investigator:
- Cheryl Shee, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-75, inclusive
- Have been diagnosed with SMI that has qualified them for Medicaid behavioral health services (i.e., mood, anxiety, traumatic, and psychotic disorders with or without functional impairment) and receive care through the community human services organizations in Massachusetts.
- Self-report of past year daily tobacco smoking
- Able to understand study procedures and communicate in English or Spanish
- Willingness to participate in a biannual interview with a research coordinator and to meet with a CHW if assigned to one
- Competent and willing to provide informed consent
Exclusion Criteria:
- Have dementia or intellectual disability (estimated IQ< 70)
- Not able to communicate in English or Spanish
- Unstable medical condition that compromises ability to safely participate, in the investigator's opinion
- Evidence of active problem substance use severe enough to compromise ability to safely participate, in the investigator's opinion
- Unwilling to participate in study procedures
- Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Integrated CHW support intervention
The randomization will be at the level of intensive care managers (ICM).
Randomization will be stratified by care team.
ICMs in this arm will be assigned to receive CHW and Tobacco Treatment Specialist certificate training (ICM-T) .
Participants receive support from their ICM who has received CHW and TTS (ICM-T) training
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Participants assigned to the Integrated CHW Support intervention will receive smoking cessation support from their Intensive Case Manager (ICM), who has completed Community Health Worker (CHW) core competency training and Tobacco Treatment Specialist (TTS) certification.
The intervention is integrated into routine case management and includes individualized smoking cessation counseling, education, motivational support, assistance with setting quit goals, facilitation of evidence-based tobacco treatment medications through participants' healthcare providers, coordination of healthcare services, accompaniment to medical appointments when appropriate, and support addressing social determinants of health that may affect tobacco cessation (e.g., housing, transportation, food insecurity, medication access).
Participants will receive approximately four in-person or community-based contacts per month, supplemented by telephone or video contacts as needed, over a 18-month intervention period.
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Other: Enhanced usual care (EUC)
The randomization will be at the level of intensive care managers (ICM).
Randomization will be stratified by care team.
ICMs in this arm (active-controlled) will not receive CHW and TTS training, participants will receive enhanced usual care (EUC) e.g.
continue to receive ICM care.
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Participants assigned to Enhanced Usual Care (EUC) will continue to receive standard behavioral health and case management services provided by their Intensive Case Manager (ICM).
ICMs assigned to the EUC arm will not receive Community Health Worker (CHW) core competency training or Tobacco Treatment Specialist (TTS) certification and will not deliver the structured Integrated CHW Support intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Biochemically Verified 7-Day Point Prevalence Abstinence From Combusted Tobacco
Time Frame: 18 months
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Number of participants with self-reported abstinence from combusted tobacco products for at least 7 days at the 18-month assessment, biochemically verified using salivary cotinine or expired carbon monoxide (CO).
Abstinence will be verified by salivary cotinine <30 ng/mL.
For participants using nicotine replacement therapy (NRT) or e-cigarettes at the time of assessment, expired CO <5 parts per million (ppm) will be used to verify abstinence from combusted tobacco.
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18 months
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Change in Estimated Cardiovascular Risk (ACC/AHA ASCVD Risk Estimator)
Time Frame: Baseline - 18 months
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Change in estimated 10-year risk of atherosclerotic cardiovascular disease (ASCVD) from baseline to 18 months, as calculated using the American College of Cardiology (ACC)/American Heart Association (AHA) ASCVD Risk Estimator based on: age, sex, race, blood pressure, smoking status, lipids (HDL and total cholesterol), diabetes diagnosis, HbA1c, antihypertension therapy.
Lower estimated risk indicates improvement in cardiovascular risk.
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Baseline - 18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Depressive Symptoms (PHQ-9)
Time Frame: Baseline - 18 months
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Change in depressive symptom severity from baseline to 18 months, as measured by the Patient Health Questionnaire-9 (PHQ-9).
Scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
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Baseline - 18 months
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Change in Anxiety Symptoms (GAD-7)
Time Frame: Baseline - 18 months
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Change in anxiety symptom severity from baseline to 18 months, as measured by the Generalized Anxiety Disorder-7 (GAD-7) questionnaire.
Scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
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Baseline - 18 months
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Change in Psychiatric Symptoms (Colorado Symptom Index)
Time Frame: Baseline - 18 months
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Change in psychiatric symptom severity from baseline to 18 months, as measured by the Colorado Symptom Index (CSI).
Higher scores indicate greater psychiatric symptom burden.
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Baseline - 18 months
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Clinical Global Improvement
Time Frame: Baseline - 18 months
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Clinical improvement at 18 months, as assessed by the Clinical Global Impression-Improvement (CGI-I) scale.
Scores range from 1 ("very much improved") to 7 ("very much worse"), with lower scores indicating greater clinical improvement.
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Baseline - 18 months
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Change in Loneliness
Time Frame: Baseline - 18 months
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Change in perceived loneliness from baseline to 18 months, as measured by the UCLA Loneliness Scale.
Scores range from 20 to 80, with higher scores indicating greater perceived loneliness.
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Baseline - 18 months
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satisfaction with healthcare
Time Frame: 18 months
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Satisfaction with healthcare at 18 months, as measured by the Client Satisfaction Questionnaire-8 (CSQ-8).
The CSQ-8 consists of 8 items with total scores ranging from 8 to 32, with higher scores indicating greater satisfaction with healthcare services.
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18 months
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Emergency department visits
Time Frame: baseline through 18 months
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Number of emergency department visits from baseline through the 18-month visit, as documented in the electronic health record (EHR).
Emergency department visits occurring since the previous study assessment will be recorded.
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baseline through 18 months
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Number of Inpatient Hospitalization Days
Time Frame: baseline through 18 months
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Number of inpatient hospitalization days from baseline through the 18-month visit, as documented in the electronic health record (EHR).
Inpatient hospitalization days occurring since the previous study assessment will be recorded.
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baseline through 18 months
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Healthcare Service Utilization
Time Frame: baseline through 18 months
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Healthcare service utilization assessed using electronic health record (EHR) data extraction and the Service Use and Resource Form (SURF).
Measures include emergency department visits, emergency service team encounters, inpatient medical and psychiatric hospitalizations, and outpatient healthcare utilization.
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baseline through 18 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne Eden Evins, MD, MPH, Massachusetts General Hospital
Publications and helpful links
General Publications
- Evins AE, Cather C, Deckersbach T, Freudenreich O, Culhane MA, Olm-Shipman CM, Henderson DC, Schoenfeld DA, Goff DC, Rigotti NA. A double-blind placebo-controlled trial of bupropion sustained-release for smoking cessation in schizophrenia. J Clin Psychopharmacol. 2005 Jun;25(3):218-25. doi: 10.1097/01.jcp.0000162802.54076.18.
- Evins AE, Cather C, Pratt SA, Pachas GN, Hoeppner SS, Goff DC, Achtyes ED, Ayer D, Schoenfeld DA. Maintenance treatment with varenicline for smoking cessation in patients with schizophrenia and bipolar disorder: a randomized clinical trial. JAMA. 2014 Jan 8;311(2):145-54. doi: 10.1001/jama.2013.285113.
- Khan SS, Coresh J, Pencina MJ, Ndumele CE, Rangaswami J, Chow SL, Palaniappan LP, Sperling LS, Virani SS, Ho JE, Neeland IJ, Tuttle KR, Rajgopal Singh R, Elkind MSV, Lloyd-Jones DM; American Heart Association. Novel Prediction Equations for Absolute Risk Assessment of Total Cardiovascular Disease Incorporating Cardiovascular-Kidney-Metabolic Health: A Scientific Statement From the American Heart Association. Circulation. 2023 Dec 12;148(24):1982-2004. doi: 10.1161/CIR.0000000000001191. Epub 2023 Nov 10.
- Payne J, Razi S, Emery K, Quattrone W, Tardif-Douglin M. Integrating Community Health Workers (CHWs) into Health Care Organizations. J Community Health. 2017 Oct;42(5):983-990. doi: 10.1007/s10900-017-0345-4.
- Findley S, Matos S, Hicks A, Chang J, Reich D. Community health worker integration into the health care team accomplishes the triple aim in a patient-centered medical home: a Bronx tale. J Ambul Care Manage. 2014 Jan-Mar;37(1):82-91. doi: 10.1097/JAC.0000000000000011.
- Evins AE, Cather C, Maravic MC, Reyering S, Pachas GN, Thorndike AN, Levy DE, Fung V, Fischer MA, Schnitzer K, Pratt S, Fetters MD, Deeb B, Potter K, Schoenfeld DA. A Pragmatic Cluster-Randomized Trial of Provider Education and Community Health Worker Support for Tobacco Cessation. Psychiatr Serv. 2023 Apr 1;74(4):365-373. doi: 10.1176/appi.ps.20220187. Epub 2022 Nov 9.
- Evins AE, Cather C. Addressing Barriers to Provision of First-Line Pharmacotherapy for Tobacco Use Disorder. Psychiatr Serv. 2023 Apr 1;74(4):429-430. doi: 10.1176/appi.ps.20220467. Epub 2022 Nov 9. No abstract available.
- Han B, Aung TW, Volkow ND, Silveira ML, Kimmel HL, Blanco C, Compton WM. Tobacco Use, Nicotine Dependence, and Cessation Methods in US Adults With Psychosis. JAMA Netw Open. 2023 Mar 1;6(3):e234995. doi: 10.1001/jamanetworkopen.2023.4995.
- Olfson M, Gerhard T, Huang C, Crystal S, Stroup TS. Premature Mortality Among Adults With Schizophrenia in the United States. JAMA Psychiatry. 2015 Dec;72(12):1172-81. doi: 10.1001/jamapsychiatry.2015.1737.
- Cook BL, Wayne GF, Kafali EN, Liu Z, Shu C, Flores M. Trends in smoking among adults with mental illness and association between mental health treatment and smoking cessation. JAMA. 2014 Jan 8;311(2):172-82. doi: 10.1001/jama.2013.284985.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026P001847
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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