Integrated Smoking Cessation Treatment for Smokers with Serious Mental Illnesses, Massachusetts, 2017-2020 (ICPSR 39152)

Time Period(s) View help for Time Period(s)

Date of Collection View help for Date of Collection

Hide

Study Purpose View help for Study Purpose

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.

Study Design View help for Study Design

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.

Sample View help for Sample

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.

Time Method View help for Time Method

Universe View help for Universe

Individuals receiving outpatient services for serious mental illness who also reported smoking.

Unit(s) of Observation View help for Unit(s) of Observation

Data Type(s) View help for Data Type(s)

Mode of Data Collection View help for Mode of Data Collection

Description of Variables View help for Description of Variables

Datasets in this collection can be linked using the variable IDS_INT_PATIENT (named IDS_INT_AT_PATIENT 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.

Response Rates View help for 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).

Presence of Common Scales View help for Presence of Common Scales

Heaviness of Smoking Index

Hide

Original Release Date View help for Original Release Date

2024-10-03

Version History View help for Version History

Hide