Faculty Bibliography

BACKGROUND: This paper describes an innovative protocol for a type-II hybrid effectiveness-implementation trial that is evaluating a smoking cessation telephone care coordination program for Veterans Health Administration (VA) mental-health clinic patients. As a hybrid trial, the protocol combines implementation science and clinical trial methods and outcomes that can inform future cessation studies and the implementation of tobacco cessation programs into routine care. The primary objectives of the trial are (1) to evaluate the process of adapting, implementing, and sustaining a smoking cessation telephone care coordination program in VA mental health clinics, (2) to determine the effectiveness of the program in promoting long-term abstinence from smoking among mental health patients, and (3) to compare the effectiveness of telephone counseling delivered by VA staff with that delivered by state quitlines. METHODS/DESIGN: The care coordination program is being implemented at six VA facilities. VA mental health providers refer patients to the program via an electronic medical record consult. Program staff call referred patients to offer enrollment. All patients who enroll receive a self-help booklet, mailed smoking cessation medications, and proactive multi-call telephone counseling. Participants are randomized to receive this counseling from VA staff or their state's quitline. Four primary implementation strategies are being used to optimize program implementation and sustainability: blended facilitation, provider training, informatics support, and provider feedback. A three-phase formative evaluation is being conducted to identify barriers to, and facilitators for, program implementation and sustainability. A mixed-methods approach is being used to collect quantitative clinical effectiveness data (e.g., self-reported abstinence at six months) and both quantitative and qualitative implementation data (e.g., provider referral rates, coded interviews with providers). Summative data will be analyzed using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework. DISCUSSION: This paper describes the rationale and methods of a trial designed to simultaneously study the clinical effectiveness and implementation of a telephone smoking cessation program for smokers using VA mental health clinics. Such hybrid designs are an important methodological design that can shorten the time between the development of an intervention and its translation into routine clinical care. TRIAL REGISTRATION: ClinicalTrials.gov NCT00724308.

OBJECTIVE: It is unclear whether training physicians to counsel obese patients leads to weight loss. This study assessed whether a 5-h multimodal longitudinal obesity curriculum for residents on the basis of the 5As (assess, advise, agree, assist, and arrange) was associated with weight loss in their obese patients. DESIGN AND METHODS: Twenty-three primary care internal medicine residents were assigned by rotation schedule to intervention (curriculum) or control groups. We then conducted follow-up chart reviews to determine weight change at up to 12 months following the index visit. 158 obese patients (76 in the intervention group and 82 in the control group) completed exit interviews; 22 patients who presented for acute care at the index visit were excluded. Chart reviews were conducted on the 46 patients in the intervention group and 41 patients in the control group who were seen again within 12 months of the index visit and had follow-up weight measurements. RESULTS: The main outcome of interest was mean change in weight at 12 months compared between the intervention and control groups. Patients of residents in the intervention group had a mean weight loss of -1.53 kg (s.d. = 3.72) although the patients of those in the control group had a mean weight gain of 0.30 kg (s.d. = 3.60), P = 0.03. Six (15.8%) patients in the intervention group and 2 (5.4%) patients in the control group lost >5% body weight (P = 0.14). CONCLUSIONS: Although the magnitude of weight loss was small, this study shows that training physicians to counsel patients can produce measurable patient outcomes.

ABSTRACT: BACKGROUND: Hospitalization may be a particularly important time to promote smoking cessation, especially in the immediate post-discharge period. However, there are few studies to date that shed light on the most effective or cost-effective methods to provide post-discharge cessation treatment, especially among low-income populations and those with a heavy burden of mental illness and substance use disorders. METHODS/DESIGN: This randomized trial will compare the effectiveness and cost-effectiveness of two approaches to smoking cessation treatment among patients discharged from two urban public hospitals in New York City. During hospitalization, staff will be prompted to ask about smoking and to offer nicotine replacement therapy (NRT) on admission and at discharge. Subjects will be randomized on discharge to one of two arms: one arm will be proactive multi-session telephone counseling with motivational enhancement delivered by study staff, and the other will be a faxed or online referral to the New York State Quitline. The primary outcome is 30-day point-prevalence abstinence from smoking at 6-month follow-up post-discharge. We will also examine cost-effectiveness from a societal and a payer perspective, as well as explore subgroup analyses related to patient location of hospitalization, race/ethnicity, immigrant status, and inpatient diagnosis. DISCUSSION: This study will explore issues of implementation feasibility in a post-hospitalization patient population, as well as add information about the effectiveness and cost-effectiveness of different strategies for designing smoking cessation programs for hospitalized patients. TRIAL REGISTRATION: Clinicaltrials.gov ID# NCT01363245.

STATEMENT OF PROBLEM OR QUESTION (ONE SENTENCE): To determine how adding a non-clinical member to primary care teams can improve hypertension and smoking cessation outcomes in Veteran Affairs New York Harbor Healthcare System's (VA NYHHS) implementation of the VA's Patient Centered Medical Home (PCMH) model, known as Patient Aligned Care Teams (PACT). OBJECTIVES OF PROGRAM/INTERVENTION (NO MORE THAN THREE OBJECTIVES): As part of the Program for Research on Outcomes of VA Education (PROVE) study, we sought to define a toolkit of panel management strategies that Panel Management Assistants (PMAs) will use to improve outcomes in smoking cessation and hypertension across patient panels. DESCRIPTION OF PROGRAM/INTERVENTION, INCLUDING ORGANIZATIONAL CONTEXT (E.G. INPATIENTVS. OUTPATIENT, PRACTICE OR COMMUNITY CHARACTERISTICS): Coincident with the nation-wide implementation of PACT across the VA system, PROVE explores the incremental impact of panel management and clinical microsystem education on hypertension and smoking outcomes. Two-thirds of randomly selected PACT teams in ambulatory care clinics at the Brooklyn and Manhattan campuses of the VA NYHHS had a PMA added to the team. Based on literature review and qualitative interviews of clinicians and key stakeholders at VA NYHHS, we developed a core toolkit of strategies utilizing clinical databases to target subsets of smokers and hypertensive patients that could benefit from specialized panel management interventions outside of the patient visit, such as identifying smokers who have not recently received tobacco cessation medications. MEASURES OF SUCCESS (DISCUSS QUALITATIVE AND/OR QUANTITATIVEMETRICSWHICH WILL BE USED TOEVALUATE PROGRAM/INTERVENTION): Prior to PROVE's intervention, we determined baseline rates of hypertension (uncontrolled and controlled) and smoking for all PACT panels. To assess PROVE's effectiveness of integrating panel management strategies by PACT teams, we will survey providers and nurses at baseline, 6 and 12 months to me!

BACKGROUND: Providers and patients are encouraged by reduction in the number of cigarettes smoked, but it is unclear this represents a meaningful outcome. A proactive telephone smoking cessation counseling study in smokers with mental illness examined whether a reduction in number of cigarettes smoked per day (CPD) from baseline to 2 months associated with sustained reduction or abstinence at 6 months. METHODS: Participants (421) from a multi-site VA study evaluating telephone care for VA smokers with mental illness received smoking cessation education, were offered cessation medications and received telephone counseling from the VA or State Quitline. Participants completed a structured assessment upon enrollment, and 2 and 6 months postenrollment. Chi-square analyses examined whether persons who were abstinent or had reduced their CPD by at least 50% by 2 months were more likely to be abstinent or have continued their reduction in smoking at 6 months. RESULTS: 104 participants completed baseline, 2 month and 6 month surveys. 49%(50/104) achieved at least a 50% reduction in CPD by 2 months, 44% (22/50) were abstinent. 50% (26/50) of patients who achieved at least 50%reduction in CPDby 2 months remained at the reduced number of CPD or decreased their CPDmore by 6 months. Patients who reduced CPD by 50%by 2 months were more likely to be abstinent at 6 months compared to patients who had not achieved 50% reduction in CPD by 2 months (44% vs. 19%, OR =3.46, 95%CI 1.43-8.38). Patients who were abstinent by 2months weremore likely to be abstinent at 6 months compared to patients who were not abstinent by 2 months (81% vs. 17%, OR=21.9, 95%CI 6.4-74.5). CONCLUSIONS: Data support short-term harm reduction as a model for long-term abstinence in a mental health population. Referral to smoking cessation counseling and initial harm-reduction steps should be encouraged for patients not ready or able to immediately quit. All smokers, no matter their stage of change, should be offered effective cessation trea!

BACKGROUND: Proactive telephone-based smoking cessation counseling is an emerging approach to helping mental health patients quit smoking, and it is unclear whether all patients benefit equally. We examined whether mental health patients enrolled in a telephone smoking cessation program with higher Global Assessment of Functioning (GAF) scores had better quit rates at 6 month follow-up compared to mental health patients with lower GAF scores. METHODS: We analyzed preliminary data from a multi-site VA study implementing a telephone care coordination program for smokers with mental illness. VA providers referred smoking patients to the program via a CPRS consult, and 366 referred patients enrolled in the program. We randomized participants to receive counseling from either a state Quitline or a VA counselor. We collected patient GAF scores through the CPRS system for those enrolled in counseling using the most recent GAF score received prior to their program enrollment date. Based upon the GAF's definition of functionality and of what constituted serious impairment of functioning, we categorized GAF scores above 50 as "high functioning" and scores 50 and below as "low functioning." Patients completed a phone survey at 6 months that assessed their 30-day point prevalence abstinence. RESULTS: GAF scores were available for 103/180 patients who had enrolled in counseling and completed the 6 month follow-up. Of those patients, 70 (68%) had high GAF scores and 33 (32%) had low GAF scores. At 6-month follow-up, 33/103 (32%) had quit smoking. There was no difference in abstinence rates between the high and low functioning GAF groups (33% versus 30%, OR=1.13, 95%CI=0.46-2.75). The GAF score was completed on average 125 days before the smoking cessation referral, and there was no significant difference in the interval between the high GAF and low GAF groups (99 vs. 181 days; p>.05). CONCLUSIONS: The telephone smoking cessation program produced excellent long-term abstinence rates and was equally effective !