Cluster-Randomized Trial of Clinical Pharmacist Tobacco Cessation Counseling Among Patients with Cardiovascular Disease

Abstract

Optimal management of patients with cardiovascular disease (CVD) includes evaluation of risk factors using a team-based approach. Tobacco use often receives less attention than other CVD risk factors; therefore, utilization of nonphysician health care providers may be valuable in addressing tobacco use. The purpose of this trial was to assess the impact of brief, structured, telephone tobacco cessation counseling (BST) delivered by clinical pharmacists on tobacco cessation attempts compared to usual care. The BST consisted of 1 to 5 minutes discussing 3 key counseling points, including a recommendation to quit and education about cessation aids. This was a cluster-randomized trial of tobacco-using patients with CVD who were enrolled in a clinical pharmacist-managed, physician-directed, CVD disease state management service. Clinical pharmacists were randomized to provide usual care (control) or BST (intervention) to their tobacco-using patients during a 4-month period. Patients were surveyed 3 months later to assess their tobacco cessation attempts, use of tobacco cessation aids, and self-reported cessation. One hundred twenty patients were enrolled. Subjects were predominately white males, aged ≥65 years, with a history of myocardial infarction. One hundred and four subjects completed the follow-up survey. No differences were detected between the 36.2% and 38.6% of control and intervention subjects, respectively, reporting a tobacco cessation attempt (P=0.804) or in the other outcomes (all P>0.05). A BST delivered by clinical pharmacists may not adequately affect patient motivation enough to increase tobacco cessation attempts in tobacco-dependent patients with CVD. Future research is needed to evaluate other team-based strategies that can decrease tobacco use in patients with CVD. (Population Health Management 2015;18:300–306)

Introduction

Guidelines from the American Heart Association/American College of Cardiology Foundation and European Society of Cardiology note tobacco cessation as an important part of cardiovascular disease (CVD) prevention and strongly advise that all tobacco users be given advice and offered assistance to quit.^1,2 Unfortunately, this key component of secondary prevention of CVD often receives less attention than interventions for other CVD risk factors.³

Empirical evidence indicates that tobacco abstinence rates can be increased following brief, targeted tobacco cessation counseling.⁴ The Treating Tobacco Use and Dependence updated guideline reports the results of a meta-analysis of 43 studies that was conducted to compare the effectiveness of and estimated abstinence rates for various intensities of tobacco cessation counseling.⁴ The analysis identified that even “minimal counseling,” defined as less than 3 minutes of direct patient counseling, increased abstinence rates over no counseling.⁴ This finding led to the recommendation that every tobacco user be offered at least minimal tobacco cessation counseling.⁴

Tobacco dependence is a chronic condition that often requires multiple quit attempts prior to successful cessation. Although physician-delivered care has been found to have the greatest impact on tobacco abstinence rates, care by other health care providers, such as nurses and pharmacists, can increase tobacco abstinence rates more than self-help or no intervention.^4,5 A systematic review by Dent and colleagues identified that pharmacists can successfully deliver tobacco-cessation interventions and are effective in increasing tobacco cessation rates.⁶

At Kaiser Permanente Colorado (KPCO), patients with a history of CVD are enrolled in the Clinical Pharmacy Cardiac Risk Service (CPCRS). The CPCRS is a clinical pharmacist-managed, physician-directed disease state management (DSM) service that provides CVD secondary prevention care to more than 15,000 patients.^7,8 When applicable, a 2-minute or shorter tobacco cessation counseling is delivered by the CPCRS clinical pharmacist as part of “usual care,” which also includes interventions for other CVD risk factors.

Although several strategies have been shown to improve tobacco cessation rates, to date no information has been published that evaluates a tobacco cessation intervention as part of a CVD DSM service. The purpose of this cluster-randomized trial was to determine whether brief, structured, telephonic tobacco cessation counseling (BST) delivered by clinical pharmacists during DSM encounters with tobacco-using patients with CVD impacted tobacco cessation attempts.

Methods

Study design

This was a prospective, cluster-randomized clinical trial. Clinical pharmacists in the CPCRS were randomized and consented to study arms that provided the BST (intervention) or usual care (control) during a routine care encounter with consented tobacco-dependent patients with CVD who were enrolled in a CVD DSM service. Three months after the study encounter, subjects were surveyed via telephone and assessed via administrative data queries for tobacco cessation behaviors. All aspects of the study were reviewed and approved by the KPCO Institutional Review Board prior to study initiation.

Study setting

KPCO is a nonprofit, group model integrated care delivery system that provides care to more than 565,000 members at 28 medical offices in the Colorado Front Range. Members of KPCO with a history of CVD can be enrolled in the CPCRS, a telephonic DSM service that is comprised of 19 full- and part-time clinical pharmacists.⁸ Working closely with physicians via a Collaborative Drug Therapy Management protocol, the focus of CPCRS is long-term medication management to ensure that appropriate lipid-lowering, antiplatelet, cardioprotective, and antihypertensive medications are initiated and adjusted as necessary, and that follow-up monitoring is completed in order to achieve lipid and blood pressure goals. Additionally, the CPCRS clinical pharmacists provide members with healthy lifestyle education specific to components of diet, exercise, and tobacco cessation, as applicable.

The CPCRS clinical pharmacists utilize an electronic medical record (EMR) (Health Connect; Epic, Inc., Madison, WI) that houses patient medical, pharmacy, laboratory, and other health care-related information and enables health care providers to document patient encounters. The CPCRS patients are contacted via telephone, e-mail, or letter to review identified issues and implement recommended plans with appropriate future follow-up (eg, laboratories, blood pressure measurements) ordered via the EMR. Follow-up is managed through HealthTrac, a Web-based, DSM database that, among other functions, generates reminder letters for patients who are due for laboratories. Laboratory results are sent via the EMR to the CPCRS clinical pharmacists for evaluation, comprehensive risk profile review, and development of appropriate recommendations to provide to patients via telephone, e-mail, or letter.

At the time of the study, CPCRS clinical pharmacists were not required to address tobacco cessation each time they had contact with a tobacco-using patient. Each clinical pharmacist was permitted to personalize her or his approach to addressing tobacco use and cessation. This included no action, mailing information to patients about tobacco cessation recommendations and resources, telephone counseling, and/or assistance with tobacco cessation medications. For both intervention and control groups, CPCRS would only follow up if the patient requested additional information or at the discretion of the pharmacist to check on their progress for smoking cessation.

Patient population

Patients were eligible for the study if they were enrolled in the CPCRS during the study time period (December 1, 2011, to March 31, 2012), ≥18 years of age, English speaking, and current tobacco users (cigarettes, pipe, cigar, snuff, and/or chew) as of the date of the routine CPCRS encounter. Potential study enrollees were identified administratively and were anticipated to have a routine CPCRS encounter during the study period. Consented patients who did not have contact with their clinical pharmacist or obtain scheduled laboratory data follow-up (eg, fasting lipid panel) were withdrawn from the study as these patients were not able to appropriately answer the follow-up survey questions.

Clinical pharmacist consent

The CPCRS clinical pharmacists were invited to an in-service to explain the details of the study and requirements of study participation. The attending clinical pharmacists were provided with an informed consent form and the opportunity to ask additional questions prior to consenting to participation. All CPCRS clinical pharmacists agreed to be consented prior to patient enrollment.

Patient consent

After a patient's study eligibility was confirmed, study personnel contacted the patient by telephone approximately 2 weeks prior to her or his scheduled CPCRS encounter to describe the study and obtain verbal consent for enrollment. After a patient agreed to participate in the study, she or he was queried about readiness to quit tobacco,⁴ total number of years using tobacco, and quantity of tobacco used (to calculate pack years if the patient was cigarette using).

Randomization

The CPCRS clinical pharmacists are assigned to specific clinics and provide care to a panel of patients with CVD within the specified clinic. Larger KPCO clinics may have up to 2 CPCRS clinical pharmacists assigned to manage patients. Given that intervention contamination could occur if a clinical pharmacist were to provide care to both control and intervention patients, randomization occurred at the clinical pharmacist level rather than the patient or clinic level. Clinical pharmacists were randomized using computer-generated random numbers in 1:1 fashion to the BST (intervention) or usual care (control) study arms. Each individual clinical pharmacist provided only BST or usual care to all patients contacted by her or him during the study period. Subjects were blinded to study group assignment.

Study intervention

Clinical pharmacists randomized to the intervention group received formal training on study procedures and the BST. Intervention clinical pharmacists were instructed that the BST needed to be verbal but not scripted and to contain 3 key components: (1) a recommendation to quit; (2) a discussion/recommendation of tobacco cessation medications (ie, nicotine replacement therapy, bupropion, varenicline); and (3) a discussion/recommendation of tobacco cessation methods/strategies (ie, classes, webinars, quit line). These components are used by the National Committee for Quality Assurance for HEDIS (Healthcare Effectiveness and Data Information Set) to evaluate medical assistance with tobacco cessation.⁹ The BST was intended to be conversational rather than scripted in order to make it more applicable to a real-world setting.

Clinical pharmacists in both the intervention and control arms contacted subjects during a routine CPCRS encounter (study contact date). Following the BST counseling, intervention clinical pharmacists were instructed to mail subjects a standard KPCO document that contained information about available tobacco cessation resources. Control clinical pharmacists received no formal BST training but were instructed to continue using their current approach to address tobacco use and cessation.

Outcome measures

The primary outcome was the proportion of subjects who reported a tobacco cessation attempt during follow-up. Secondary outcomes included the proportion of subjects who had: (1) at least 1 contact with the Colorado Quitline (COQL), a toll-free telephone counseling service contracted with KPCO; (2) purchased at least 1 tobacco cessation medication aid from a KPCO pharmacy; (3) attended at least 1 KPCO tobacco cessation program or webinar; and (4) reported tobacco abstinence at the time of the follow-up survey. Tobacco cessation medication aids included nicotine replacement therapy, bupropion, and varenicline.

Data collection

Baseline data

Total number of tobacco-using years, pack years, and baseline readiness to quit within the next 30 days were obtained from the patient at the time of consent. The KPCO HealthTrac registry, EMR, and other administrative databases were queried electronically. Tobacco use status was obtained from the EMR and verified at the time of consent. Baseline characteristics including age, sex, and years of enrollment in the CPCRS were obtained from HealthTrac. Socioeconomic status, comorbidities, and a chronic disease score (a validated aggregate measure of chronic illness burden calculated from pharmacy data)¹⁰ were obtained from administrative databases.

Follow-up data

Subjects were surveyed by study personnel via telephone 3 months following the study contact date. The survey was conducted in a standardized manner using a preformatted dialogue that included verification of subject's identity, a brief reminder of how and why the subject was being contacted, as well as a series of questions specific to both the primary and secondary outcomes. Items in the study questionnaire were modified from established health care questionnaires^11,12 and developed specifically for the study (see Supplementary Appendix 1 in the online article at www.liebertpub.com/pop).

Information on COQL participation was obtained from a prevention department within KPCO that tracks these data. Information on participation in tobacco cessation programs and webinars and tobacco medication purchase dates were obtained from administrative databases.

After the follow-up survey, a review of the EMR was conducted by study personnel to assess documentation of subject interaction. Based on clinical pharmacist information in the EMR, subject contact with a study clinical pharmacist was confirmed if written documentation of provision of all components of BST counseling was present for a subject. This review was performed for both the intervention and control clinical pharmacists.

Data analysis

An a priori power calculation indicated that to detect an absolute 25% increase in the 3-month self-reported quit attempt rate (ie, 35% in the intervention arm vs. 10% in the control arm) with 80% power at a 2-sided α of 0.05 and an Intraclass Correlation Coefficient (ICC) of 0.05, 46 patients would need to be included in each arm of the trial. Enrollment was attempted for all eligible subjects during the study period because dropouts and incomplete data were anticipated.

Subject characteristics were reported as means, medians, and standard deviations for interval and ratio-level variables and proportions for nominal and ordinal level variables. Differences in characteristics were assessed with the chi-square test or association (or Fisher exact test, depending on cell distributions) for nominal/ordinal variables and Student t test for continuous interval/ratio variables. As subjects were clustered within randomized clinical pharmacists, the ICC was assessed to measure the strength of the clustering effect for the primary outcome. Using a binomial distribution and the logit link, a generalized estimating equation model was constructed to accommodate the correlations within clinical pharmacists when assessing differences in the primary and secondary outcomes between treatment groups. A 2-sided α level was set at 0.05.

Results

A total of 347 patients were identified as eligible for study participation and 192 (55.3%) were consented (Fig. 1). Seventy-two subjects (37.5%) did not obtain scheduled laboratory data or have contact with a clinical pharmacist during the study time period resulting in 120 subjects, 56 and 64 in the control and intervention groups, respectively, enrolled in the study. Overall, subjects were primarily white males, aged ≥65 years, with at least some college education, and had a history of an acute myocardial infarction (Table 1). Cigarettes were the predominate type of tobacco used. Fewer than half of the subjects reported “Yes” to baseline readiness to quit in the next 30 days. The study arms were balanced on baseline characteristics except for the control arm having a higher median chronic disease score (P=0.013)

FIG. 1

Patient disposition.

Table 1.

Baseline Characteristics

Characteristic	Overall (n=120)	Control (n=56)	Intervention (n=64)	P value
Mean age¹, years (SD)	65.7 (8.7)	64.6 (9.4)	66.6 (8.1)	0.333
Female, n, %	44, 36.7%	16, 28.6%	28, 43.8%	0.085
Race, n, %				0.929
White	97, 80.8%	46, 82.1%	51, 79.7%
Unknown/Undeclared	18, 15.0%	8, 14.3%	10, 15.6%
Black	5, 4.2%	3, 3.6%	3, 4.7%
CVD Type²
Stent, n, %	66, 55.0%	35, 62.5%	31, 48.4%	0.122
AMI, n, %	57, 47.5%	25, 44.6%	32, 50.0%	0.558
CABG, n, %	21, 17.5%	9, 16.1%	12, 18.8%	0.881
PVD, n, %	14, 11.7%	4, 7.1%	10, 15.6%	0.168
CVA, n, %	11, 9.2%	3, 5.4%	8, 12.5%	0.216
Other³, n, %	6, 5.0%	1, 1.6%	5, 8.9%	0.096
Tobacco use type¹, n, %				0.843
Cigarette	112, 93.3%	52, 92.9%	60, 93.8%
Other⁴	7, 5.8%	3. 5.4%	4, 6.3%
Cigarette+Other	1, 0.8%	1, 1.8%	0, 0.0%
Readiness to quit in next 30 days¹, Yes, n, %	46, 38.3%	25, 44.6%	21, 32.8%	0.184
Median chronic disease score¹ (IQR)	5.0 (2.0–7.0)	4.5 (2.0–6.0)	6.0 (4.0–7.5)	0.013
Median family income¹	$61,613	$62,594	$59,583	0.988
Mean % with at least some college education¹ (SD)	62.2% (19.3)	62.8% (19.3)	61.8% (19.3)	0.787
Median years in CPCRS¹ (IQR)	2.8 (1.2–6.1)	2.8 (0.9–6.2)	2.9 (1.2–6.1)	0.996

As of consent date.

Lifetime, subjects can have more than one event.

Heart catheterization only.

Pipe, cigar, snuff, or chew.

AMI, acute myocardial infarction; CABG, coronary artery bypass graft; CPCRS, Clinical Pharmacy Cardiac Risk Service; CVA, cerebrovascular accident; CVD, cardiovascular disease; IQR, interquartile range; PVD, peripheral vascular disease; SD, standard deviation.

Sixteen subjects (9 and 7 in the control and intervention arms, respectively) did not complete the follow-up telephone survey, resulting in 104 subjects (47 and 57 in the control and intervention arm, respectively) available for the survey-based outcome analyses. There were no statistically significant differences identified in the primary (P=0.804) or secondary outcomes (all P>0.05) (Tables 2 and 3).

Table 2.

Follow-Up Survey Responses ¹

Item and Response	Overall (n=104)	Control (n=47)	Intervention (n=57)	P value
General Health—Fair/Poor, (n, %)	35, 33.7%	17, 36%	18, 32%	0.622
Median pack years (IQR)	40 (20–60)	31 (20–50)	45 (20–60)	0.352
Attempted to quit tobacco since speaking with pharmacist (Yes, n, %)	39, 37.5%	17, 36.2%	22, 38.6%	0.804²
Currently using tobacco (Yes, n, %)	91, 87.5%	42, 89.4%	49, 86.0%	0.602
Pharmacist advised to quit tobacco (Yes, n, %)	76, 73.1%	33, 70.2%	43, 75.4%	0.550
Pharmacist recommended/discussed medications for quitting tobacco (Yes, n, %)	59, 56.7%	22, 46.8%	37, 64.9%	0.064
Pharmacist recommended/discussed strategies for quitting tobacco (Yes, n, %)	61, 58.7%	27, 57.5%	34, 59.7%	0.820

Among subjects who responded to follow-up survey.

Adjusted for clustering of subjects by pharmacist.

IQR, interquartile range.

Table 3.

Medication and Strategy Outcomes ¹

Outcome	Overall (n=120)	Control (n=56)	Intervention (n =64)	P value
Participated in Colorado QuitLine (n, %)	3, 2.5%	3, 5.4%	0, 0.0%	0.099
Attend at least one KPCO tobacco cessation program or webinar (n, %)	1, 0.8%	0, 0.0%	1, 1.6%	0.348
Purchased at least one tobacco cessation medication aid (n, %)	18, 15.0%	11, 19.6%	7, 10.9%	0.183

Among all consented patients (n=120).

KPCO, Kaiser Permanente Colorado.

There were more subjects in the intervention versus the control group who had telephone contact with a clinical pharmacist (93% vs. 66%, P<0.001). Additionally, clinical pharmacists in the intervention group were more likely to have documented providing tobacco cessation advice (98% vs. 81%, P=0.003), medication (91% vs. 53%, P<0.001) and strategy (96% vs. 47%, P<0.001) recommendations than clinical pharmacists in the control group. There was a higher percentage of subjects in the intervention group who received a document containing information about available tobacco cessation resources via mail from a clinical pharmacist (96.5% vs. 23.4%, P<0.001).

Discussion

Tobacco cessation confers a significant mortality benefit in patients with CVD.^13,14 In this cluster-randomized trial of a brief, structured, telephone counseling intervention for tobacco cessation among tobacco-using patients with CVD, no statistical difference was found in the proportions of intervention and control subjects who reported at least 1 tobacco quit attempt. In addition, no statistical differences were found between the study arms in other tobacco cessation behaviors. This study was conducted to determine if there is a simple, time-efficient strategy for providing tobacco cessation support to a high-risk patient population in the setting of rising health care costs. The study findings suggest that patients with CVD will require more than a low-intensity tobacco counseling intervention to encourage them to attempt to cease using tobacco products.

This study is unique in that it randomized clinical pharmacists so that they did and did not provide, respectively, the BST intervention to all consented tobacco-using patients they contacted. In addition, only tobacco-using patients with a history of CVD were enrolled. Several studies have assessed tobacco cessation behavioral therapy in recently hospitalized patients with CVD^15,16; however, no studies specifically identified a role for pharmacist involvement in tobacco cessation among patients with CVD.

Overall, trials involving pharmacist-delivered tobacco cessation counseling have reported differing results. Maguire and colleagues enrolled 484 British citizens in a community pharmacy-based smoking cessation program that included structured counseling, an information leaflet, and weekly follow-up for 4 weeks and then monthly as needed. They found statistically significant 12-month abstinence rates of 14.3% and 2.7% in the intervention and control group, respectively.¹⁷ Conversely, Sinclair and colleagues randomized 492 pharmacy customers who smoked tobacco to receive tobacco cessation counseling from trained pharmacy personnel (intervention) or standard pharmacy support (control). They found no statistical differences in abstinence rates after 9 months of follow-up.¹⁸ Findings of the present study resemble more those from Sinclair and colleagues and differed from both studies in that enrollees were patients with CVD from a DSM service, not persons from the general population.

As enrollees were a high-risk secondary prevention patient population, it is likely that these subjects had received tobacco cessation counseling previously. The study managed care organization is focused on preventive care and has other systems in place to address tobacco use on a routine basis. Therefore, although the intervention subjects were receptive to receiving the BST, they may have been more resistant to tobacco cessation than the average tobacco-using patient with CVD. Cohabitation with another smoker, limited social support, comorbid psychiatric illness, and/or low self-confidence in the ability to quit have been identified as significant barriers to cessation.³ Although these barriers were not evaluated in this study, they may have contributed to the interventions' lack of efficacy but could provide an opportunity for future research to evaluate their role in tobacco cessation in patients with CVD.

Another factor that may have contributed to the lack of differences in tobacco cessation behaviors between the study arms was that there was an overall heightened sense of awareness of tobacco cessation in the CPCRS during the conduction of this study. Rather than being segregated, clinical pharmacists in both study arms shared a work area so that they were within hearing distance of each other. As a result, there may have been information contamination between groups. In addition, because there was no tobacco cessation counseling standard of care in the CPCRS, the intervention may have been too similar to the counseling that was being provided by some of the control clinical pharmacists. Documentation in the EMR of advice for both tobacco cessation medications and strategies existed for approximately half of control subjects. In addition, a numerically higher proportion of the control subjects reported using medications and strategies than the intervention group. Future studies with a similar design may want to physically separate those providing the interventions in order to minimize contamination risk.

Although it could be argued that a telephonic cessation counseling intervention is insufficient to encourage patients to attempt cessation, proactive telephone counseling has been shown to be more effective for increasing tobacco abstinence rates than self-help or no intervention.⁴ In addition, telephone counseling has been shown to provide treatment access to individuals who are less willing to seek out counseling.¹⁹

The counseling intervention studied was low intensity. With patients whose overall readiness to quit is low at baseline, a higher intensity intervention may be necessary. Maguire and colleagues used multiple follow-ups to obtain their increased rate of cessation, suggesting that intensity of intervention may play a role in positive outcomes.¹⁷ More intense interventions could include increasing the length and breadth of counseling, adding more counseling sessions, and implementing principles of motivational interviewing, which is designed to focus on the patient's belief regarding tobacco use, reveal any uncertainty the patient may have regarding quitting, and provide the patient with individualized support.⁴ Motivational interviewing varies in technique and intensity and appears to have a modest benefit in this population; however, it is uncertain if it can consistently translate into long-term abstinence.^20
–22

This trial had limitations. Tobacco cessation was not confirmed biochemically but with patient self-report. However, it is unlikely that patients would deny cessation attempts. The research team estimated a 25% absolute difference in the primary outcome between groups, but the observed difference was much smaller than expected. Even if the absolute proportional difference found in this trial held up in a larger sample, the difference detected (2.4% absolute increase in cessation attempts) likely would not be clinically significant. Although the study met the sample size, a larger sample size might have allowed for the detection of smaller differences in secondary outcomes. Predictors of successful interventions in a telephone-based service, no current psychiatric diagnosis, social support, and time to first cigarette in the morning,²³ were not evaluated in this study. Identifying those predictors may be helpful for providing a more targeted approach for tobacco cessation counseling in this type of setting.

Conclusion

Various types of tobacco cessation counseling, including brief counseling, telephonic counseling, and counseling offered by nonphysician health care providers, have been shown to be more effective than no counseling. This study found that a brief telephonic tobacco cessation counseling administered by a clinical pharmacist may not be sufficient enough support for patients with CVD to increase cessation attempts. More intensive intervention, such as increased length and/or number of counseling sessions, may be necessary to encourage and support tobacco cessation attempts in this high-risk and potentially recalcitrant population. As smoking cessation is an essential component of secondary CVD prevention and pharmacists play a vital role in clinical management of patients with CVD, future research should endeavor to assess other team-based tobacco cessation interventions in this patient population.

Footnotes

Author Disclosure Statement

Drs. Adams, Cymbala, Delate, Olson, Youngblood, and Zadvorny, and Ms. Kurz declared no conflicts of interest with respect to the research, authorship, and/or publication of this article. The authors received no financial support for the research, authorship, and/or publication of this article.

Prior Presentation

Portions of this work were presented by Dr. Adams at the Western States Pharmacy Residency Conference in Monterey, California on May 23, 2012.

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