Evaluation of a student-run smoking cessation clinic for a medically underserved population

Study Setting

The Smoking Cessation Clinic (SCC) is in Rochester, Minnesota, with a catchment area of approximately 140,000 people of whom 89% are white, 3.7% are African American, 5% are Asian, and 0.3% are Hispanic [18]. The current unemployment rate for the community is 5.4% [19]. Approximately 8.7% of residents have no health insurance [20].

The SCC is located in the Rochester Salvation Army's Good Samaritan Health Clinic (GSHC). The GSHC was established in 1995 by the Salvation Army in partnership with Mayo Clinic physicians to voluntarily provide selected free healthcare services to medically underserved individuals in the community. Clinic services include acute care, selected chronic disease management (e.g., diabetes), dental services, ophthalmologic screening, and psychiatry/psychology assessment and support.

The study took place between January 2005 and March 2009. SCC sessions are conducted after hours one night a week coinciding with acute care clinical activities of the GSHC. Licensed medical providers and on-site pharmacy services of the GSHC are available to SCC student counselors as necessary.

Patient Enrollment

The SCC is advertised to the community with print and radio advertising. Patients seen by providers in other GSHC areas (e.g., GSHC Dental Clinic) are referred to the SCC as appropriate. Although both the SCC and GSHC are oriented toward providing services to uninsured individuals of lower socioeconomic status, all patients requesting smoking intervention services can receive services regardless of their financial status, current health conditions, or stated motivation to complete the program.

Individualized Therapy

Medical student volunteers are trained using an apprenticeship model with minimal physician intervention. Experienced second year medical student counselors train first year volunteer medical student counselors by modeling SCC interviews. The second year counselors then observe first year counselors interviewing patients and provide feedback on provider-patient interactions. Activities at the SCC are regularly reviewed by a physician staff specialist of the Mayo Clinic Nicotine Dependence Center.

At the first visit, each patient completes an 8-page intake questionnaire addressing tobacco use history, demographic information, and smoking-related or psychiatric health conditions. Patients then meet individually with a student counselor for approximately 45 minutes so that the patient and counselor may discuss program structure, cigarette use history, and other elements of the intake assessment.

Depression screening is completed using the Center for Epidemiological Studies - Depressed Mood Scale (CES-D). This instrument has been found to have good internal consistency and concurrent validity. It has been shown to be appropriate for use in populations with a broad range of demographic characteristics [21]. The intake assessment also includes a detailed checklist to screen for contraindications to pharmacotherapy. The checklist of contraindications is verbally read to each patient to ensure patient understanding of each question.

Patients are given the option of individual counseling only or counseling in conjunction with varenicline, bupropion, and/or nicotine replacement therapy (NRT). Patients who request and qualify for NRT receive their choice of a 7-day supply of patches, gum, lozenges, inhalers, or nasal spray according to their preferences on the first intake visit. Medical prescriptions are signed by an on-site licensed volunteer GSHC provider. Intake assessment and management plans for all enrolled subjects are reviewed and approved by a physician specialist of the Mayo Clinic Nicotine Dependence Center. Financial support is provided by Mayo Clinic and medications are supplied by pharmaceutical companies.

Patients are invited to return to the SCC for weekly follow-up counseling sessions for the next 12 weeks of the program. During these 15-30 minute sessions, counselors discuss management of cravings and withdrawal symptoms as well as encourage patients to make lifestyle modifications in order to address the behavioral aspects of smoking addiction. Appropriate medication use and potential adverse effects are reviewed with the patient and pharmacotherapy is modified as necessary. Finally, counselors partner with patients to establish weekly goals for continued progress towards complete smoking cessation. At the end of each session, the counselors complete a weekly follow-up form documenting the patient's smoking cessation progress, motivation, and medication side effects. An additional 7-day supply of the appropriate medication is dispensed if requested by the patient, and the patient is encouraged to return the following week. Patients were requested to return for weekly sessions for 12 weeks. At the end of 12 weeks, patients who complete the program are tapered off their medications as appropriate.

Data Collection

Each subject completes general research authorization during their first visit with the understanding that refusal to authorize research participation does not affect their current or future care at either the SCC or the GSHC. Minors (i.e., age < 18 years) and those who refused participation are excluded from the current analysis. Participant charts were abstracted for sociodemographic data, smoking history, and program progress. Self-reported abstinence was biochemically confirmed by counselors with exhaled carbon monoxide (CO).

Statistical Methods

Baseline patient demographic information, health history, and tobacco use patterns were recorded at initial intake. Clinic utilization data, patient tobacco use, and dispensed medication were recorded from weekly follow-up forms. Descriptive statistics were used to compile means, standard deviations (SDs), frequencies, and percentages for all enrolled subjects. The number and percentage of patients given each medication were calculated as the number/percentage of patients who received that medication during the course of their therapy even if they later switched to a different medication.

Smoking abstinence was defined as 7-day point prevalence abstinence (i.e., no smoking, not even a puff in the last 7 days) and continuous abstinence (i.e., no smoking for ≥ 4 weeks) prior to their last contact with SCC. Abstinence rates were compiled for the entire study population and time period. Subgroup analyses were conducted in order to test for the effect of the release of varenicline on smoking abstinence rates, to examine temporal trends in patient abstinence rates on a yearly basis, and to examine the effects of each treatment type on abstinence rates. Specifically, subgroup analyses included abstinence rates for: 1) the study population before and after February 2006, the date on which varenicline became available for use at the SCC; 2) each individual year from 2005-2008; and 3) each treatment type (varenicline, bupropion alone, NRT alone, or a combination of bupropion and NRT). Abstinence rates for each treatment type were calculated as the percentage of patients abstinent at the time of last contact out of the total number of patients who took that treatment type. Abstinence rates were calculated for treatment type such that an individual subject could be counted in two different treatment groups if they received more than one type of therapy over the study timeframe. Abstinence rates were also calculated for the total patient population using an intention-to-treat analysis for 1-month, 2-month and 3-month time points since program enrollment in which all patients who did not return for their appointments were counted as smoking.

To test for demographic characteristic differences among smokers who chose different treatment plans, we conducted ANOVA analysis for continuous baseline variables (age and cigarettes smoked per day at the beginning of treatment) as well as a chi-square test for categorical variables (sex and motivation level). Although there were 5 treatment groups, there were very few people who received bupropion alone (n = 1). We restricted this analysis to patients who were only on bupropion+NRT and never switched to any other therapy (n = 5). Therefore, when comparing the other baseline variables across treatment groups, we eliminated these groups and compared the variables across the other 3 treatment groups (varenicline, NRT, and combination therapy). Combination therapy was defined as a patient who began treatment with one medication but later changed to a different medication during the course of treatment.

Yearly budgets for 2005, 2006, 2007, and 2008 were calculated based on the average cost of medication distributed to patients for that year. The average cost-per-quit was calculated by averaging the yearly cost of running the clinic by the number of patients with 7-day point prevalence smoking abstinence at their 3-month time point since program enrollment adjudicating all patients not present as smoking.

Demographic Data

A majority of patients (74.6%; n = 192) reported at least one smoking related medical condition and were coping with at least one major stressor in their lives (72.4%; n = 186). Nearly one-half of patients received formal treatment for major depression and a third of patients reported "feeling sad" for most of that year. Almost all patients reported consuming alcohol at one point in their life (96.1%; n = 247) and over one-quarter of patients felt that they needed to decrease their alcohol intake (26.1%; n = 67). Over one-quarter of patients had also entered into a formal treatment program for drug abuse (28.4%; n = 73), although the majority of patients stated that they had been drug free for greater than one year at the time of initial treatment (93.4%; n = 240).

In general, the patient population self-reported that they were highly motivated to quit smoking (79.8%; n = 205). Most patients had a desire to quit for >1 year (56%; n = 144) and most patients (69.3%; n = 164) had made at least 2 to 5 quit attempts in the past.

Treatment and Follow-Up

Patients could receive more than one type of medication therapy. Among the patients receiving pharmacotherapy (N = 282), 60.0% (n = 169) of patients received varenicline, 40.0% (n = 112) received NRT alone, 12.1% (n = 34) received combination therapy with bupropion and NRT, and 6.0% (n = 17) received bupropion alone. No significant differences were observed between treatment groups for any of the characteristics evaluated (sex p = 0.30, motivation p = 0.95, age p = 0.13, cigarettes per day p = 0.22).

Smoking Abstinence

Of 282 patients, 94 (33.3%) successfully quit smoking for ≥ 7 days prior to last contact and 39 (13.8%) were continuously abstinent for ≥ 4 weeks at time of last contact. Although only 54.3% (n = 153) of patients attended the fourth treatment session, 29.8% (n = 84) of the patients successfully abstaining from smoking had quit by one month after initial consultation. Almost one-third (28.7%; n = 81) of patients did not return after their second visit.

Before the clinic began offering varenicline in February 2006, 83 patients received treatment at SCC of whom 18.0% (n = 15) successfully abstained from smoking ≥ 7 days at last contact. After the clinic began dispensing varenicline, 199 patients were treated at SCC before March 2009 of whom 39.7% (n = 79) achieved 7-day point prevalence smoking abstinence at last contact.

The overall clinic 7-day point prevalence smoking abstinence rates at last contact were as follows: 19.2% in 2005 (14/73 patients); 22.2% in 2006 (16/72 patients); 42.9% in 2007 (36/84 patients); and 46.9% in 2008 (23/49 patients).). The 7-day point prevalence abstinence rates for the different medications were as follows: 58.6% (99/169 patients) for varenicline; 41.1% (7/17 patients) for bupropion alone; 33.9% (38/112 patients) for NRT alone; and 23.5% (8/34 patients) for bupropion and NRT.

Abstinence rates were also determined at monthly time points for program participation. Of 113 patients seen at their 1-month follow-up visit, 20% (n = 23) achieved 7-day point prevalence smoking abstinence. Of 56 patients presenting for their 2-month follow-up visit, 25% (n = 14) were abstinent. Of the 40 patients presenting for their 3-month follow-up, 23% (n = 9) were abstinent. Of the entire patient population with subjects not returning adjudicated as smoking, the 7-day point prevalence abstinence rates for 1-, 2-, and 3-month follow up visits were 7.1% (n = 20), 8.9% (n = 25), and 8.2% (n = 23), respectively.

We also analyzed correlations between patient demographics and attendance at counseling sessions. While 25.7% (n = 44) of the 169 patients who returned for their third visit had received treatment for illicit drug use, 35.7% (n = 30) of the 84 patients not returning for their third visit had received treatment. Similarly, while 100% of those patients who returned for their third visit had been abstinent from illegal drugs for >1 year, only 80% (n = 67) of those not returning had been abstinent.

Budget

The total budget spent on medication given to SCC patients during the study time period was $51,272. The yearly budgets for 2005, 2006, 2007, and 2008 were $8,615, $12,234, $20,396, and $10,027, respectively. The average cost per successfully abstinent patient at the 3-month time point was $1231, $1529, $2266, and $1671 for 2005, 2006, 2007, and 2008 respectively.