DOI: 10.3886/icpsr39152.v1
title: Integrated Smoking Cessation Treatment for Smokers with Serious Mental Illnesses, Massachusetts, 2017-2020
title: Version 1

description: In the United States, tobacco smoking is associated with significant morbidity and premature mortality for individuals with serious mental illness (SMI) (e.g., schizophrenia, post-traumatic stress disorder, bipolar disorder, major depressive disorder). While many smokers with SMI wish to quit smoking, few are offered advice or treatments with demonstrated effectiveness in reducing tobacco dependence, primarily medication-assisted treatments. The overall aim of this randomized controlled trial was to test the effects of provider education (PE) (i.e. provider-level educational intervention focused on evidence-based smoking cessation treatment for those with SMI) and community health worker (CHW) support on the provision and utilization of smoking cessation treatment to those with SMI, and cessation rates for adults with SMI who smoke or use tobacco over a 2-year period. The objectives of this trial were to:

Examine whether an intervention combining PE and CHW support would increase prescriber provision of advice and assistance to quit smoking, and improve tobacco cessation rates in smokers with SMI compared to usual care/treatment as usual (TAU) and compared to PE-only treatment
Determine the effect of the combined PE+CHW intervention on patient-reported overall health compared to TAU and PE-only treatment


Eligible individuals were recruited from two outpatient psychiatric service providers in the Boston, Massachusetts metropolitan area. Clinics where individuals received services were randomized into either the TAU condition or into the PE condition, where health care providers would receive additional education on first-line medications used to treat tobacco use disorder. Within clinics in the PE arm, individuals were further randomized into the community health worker (CHW) support condition (PE+CHW), where CHWs would assist participants with smoking cessation care access and provide community outreach and education, or no CHW support (PE-only). Enrolled participants (n=1,010) completed surveys on smoking/tobacco use at 3 timepoints: study baseline, 1 year post-randomization, and 2 years post-randomization.
A mixed-methods evaluation of the trial was also conducted post-intervention, using an interactive convergent design. The aims of the evaluation were to identify barriers and facilitators to effective implementation; examine how primary care providers differed by performance and engagement level, and how experiences with the intervention compared across these groups; and identify anticipated barriers to implementing the intervention as discussed by stakeholders. Quantitative outcome and visit data from the trial were used in the evaluation. For the evaluation's qualitative component, interviews were conducted with purposively sampled community health workers, smoker participants, primary care providers, and other stakeholders in policy, payor, and clinical administration. <b>Please note that the qualitative evaluation data are not available for this collection.</b>
description: The purpose of this study was to examine whether provider education alone or with support from community health workers would increase smoking/tobacco cessation among adults with serious mental illness, compared to usual care.
description: This study used a pragmatic, cluster-randomized clinical trial design. All adults who met the eligibility criteria (receiving psychiatric outpatient services, reported smoking in past 30 days) were contacted by outpatient program staff to assess their willingness to participate in the study. Eligible clients who agreed to participate answered the baseline survey. Following baseline survey completion, participants were randomized into treatment arms at the clinic level. Primary care clinics serving 3 or more enrolled participants were randomized to either provider education (PE) or usual care/treatment as usual (TAU). Within clinics assigned to PE, individuals were further randomized to also receive visits from a community health worker (CHW) or receive no CHW visits. Randomization was conducted by staff not involved in the study via computer-generated random sequence.
For the PE intervention, doctoral-level clinical study staff delivered educational outreach to primary care physicians, psychiatrists, physician assistants, and prescribing nurses at clinics assigned to the PE condition from December 2017 to February 2020. The aim of PE was to increase the use of first-line smoking cessation medications and encourage providers to recommend medications for all who smoked regardless of readiness to quit.
For the CHW intervention, CHW support was provided by staff who received training on working with individuals with serious mental illness and tobacco use disorder. Participants who were assigned and consented to CHW support met with CHWs on a mutually determined schedule from November 2017 to January 2020 in their homes or neighborhoods, and had access to community-based smoking cessation group counseling sessions co-led by CHWs.
Of the 1,010 enrolled in the study, 336 were assigned to the PE combined with CHW support group, 341 to the PE-only group, and 333 received usual care. Enrolled participants were interviewed at baseline, after 1 year, and after 2 years of the intervention during meetings with rehabilitation team members. Surveys took approximately 5 minutes to complete. Study staff conducting the annual follow-ups were blind to intervention assignment.
description: Datasets in this collection can be linked using the variable <strong>IDS_INT_PATIENT</strong> (named <strong>IDS_INT_AT_PATIENT</strong> in the survey data).
The primary outcome was 7-day smoking/tobacco abstinence at 2 years, defined as participant self-report of no smoking in the past week and expired air carbon monoxide of less than 5 parts per million.
Cognitive behavioral therapy (CBT) visit data (DS1) includes number of visits and visit duration (minutes) per participant.
Community health worker (CHW) visit data (DS2) includes the following items:

Number of CBT visits
Quality of health
Willingness to quit smoking
Purpose of CHW visit
Content covered in session, including motivational tools used and educational topics discussed
Self-reported use of smoke products/tobacco use (including attempts to quit or relapses)
Survey data (DS3) includes the following items for each of the three timepoints:

Quality of health
Recommendations and prescriptions made to patient (e.g., quit smoking, prescribing medications), and who made the recommendations (e.g., psychiatrist, doctor, CHW)
Heaviness of smoking
Types of smoking/tobacco products used and number of products per day used
Chronic health conditions experienced by the patient (e.g., heart disease, cancer, emphysema, asthma, chronic bronchitis, diabetes, etc.) Expired carbon monoxide measures from Smokerlyzer
Use of cessation medications/nicotine replacement therapies
Number of 7-day quit attempts
Demographic variables in CHW and survey data include age, sex, race, and Hispanic ethnicity.
description: Response Rates: Of 1,496 potentially eligible participants, 276 (18%) declined to participate and 55 (4%) were not outpatient. Of the 1,165 who agreed to participate, 155 (13%) received primary care at a clinic serving fewer than 3 participants and were ineligible.
1,010 participants were enrolled. 608 had observed data and 179 had imputed data for year 2 outcomes. 223 (22%) were lost to follow-up before year 1 (due to death, severe illness, refusal, unable to contact, ineligible for ongoing psychiatric services).
description: Presence of Common Scales: Heaviness of Smoking Index
description: Individuals recruited for the study were, at the time of study, receiving outpatient psychiatric rehabilitation services for serious mental illness through Community Based Flexible Support (CBFS) or Program of Assertive Community Treatment (PACT) programs administered through one of two service providers in the Greater Boston area (Bay Cover Human Services, Vinfen Inc.). Eligible individuals also reported smoking within the past 30 days at their annual service evaluation. Participant interest in changing smoking behavior was not required. Individuals with co-occurring dementia or intellectual disability were excluded.
description: Datasets: 
DS0: Study-Level Files
DS1: Cognitive Behavioral Therapy (CBT) Sessions Data
DS2: Community Health Worker (CHW) Sessions Data
DS3: Yearly Survey Data
description: Individuals receiving outpatient services for serious mental illness who also reported smoking.
description: face-to-face interview; telephone interview