Faculty Bibliography

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 !

BACKGROUND: Telephone smoking cessation counseling is effective in the general population, but it is not clear how feasible telephone cessation programs are for smokers with housing problems. We compared the feasibility and acceptability of telephone tobacco cessation treatment among non-homeless veterans, homeless veterans residing in long-term VA housing (HUD-VASH), and homeless veterans not residing in HUDVASH housing. METHODS: These data were collected as part of a six-site VA trial evaluating the implementation of a telephone care coordination program for smokers who use VA mental health services. Mental health providers referred patients to the program. We collected housing status on all referred patients via medical record review at the time of referral. We categorized referred patients as "non-homeless" if they did not have any medical record documentation of homelessness in the year prior to their referral. We categorized patients as "HUD-VASH" if there was documentation that they were enrolled in the VA's HUD-VASH housing program at the time of referral. We categorized patients as "homeless" if they had medical record documentation of homelessness in the year prior to their referral and they were not enrolled in the VA's HUD-VASH program at the time of referral. All referred patients were contacted by phone to offer enrollment in the treatment program. Participants who enrolled were offered self-help materials, smoking cessation medications, and proactive multi-call telephone counseling. We used chi-square analyses to examine the ability of the program to reach and engage non-homeless, HUD-VASH, and homeless patients into treatment. RESULTS: This report describes the first 1074 patients referred to the program. 912 patients were classified as non-homeless, 87 as HUDVASH, and 75 as homeless. Non-homeless patients and HUD-VASH patients were equally likely to be reached by phone to offer treatment (79% versus 74%; OR=1.32, CI=.80-2.18), but homeless patients were significantly less likel!

BACKGROUND Diabetes mellitus is common in the elderly, and therapy offers many benefits but also has many risks. Experts suggest a hbA1c of < 8% indicates better care for people > 80 years old, but evidence-based guidelines specific to the elderly are scarce. OBJECTIVES To correlate serious episodes of hypoglycemia (blood sugar < 65 with symptoms) with patient-specific factors and medication use. METHODS Prospectively designed retrospective explicit electronic chart review of 140 patients randomly selected out of a pool of 525 consecutive patients with diabetes that visited our clinic 8/1-10/30/2010. We excluded subjects as follows: age < 65 (n=3), mislabeled as diabetics (n=6), no follow up visit 4/1-10/30/2011 (n=6), or no follow up HbA1c after enrollment (n=8). Serious hypoglycemia was defined as blood sugar less than 65 with reported symptoms. Chi2 and logistic regression techniques were used to investigate the efficacy (levels of HbA1c, LDL) and safety (serious hypoglycemia) of chosen medication classes and achieved therapeutic goals. RESULTS The mean age was 78+/-8 years (range 65-100). Other baseline characteristics and univariate results are shown in table 1. 96% were on statins, yet only 32% had an LDL <100. Serious hypoglycemia was found in 23 patients (20%), and on multivariable analysis was associated with use of sulfonylurea and insulin but not with age, chronic kidney disease, cognitive impairment or HbA1c level. CONCLUSION Serious hypoglycemia in the elderly was associated with medication class but not co-morbidities or level of diabetes control. (Figure presented)

BACKGROUND: Most smokers do not receive comprehensive, evidence-based treatment for tobacco use that includes intensive behavioral counseling along with pharmacotherapy. Further, the use of proven, tobacco treatments is lower among minorities than among Whites. The primary objectives of this study are to: (1) Assess the effect of a proactive care intervention (PRO) on population-level smoking abstinence rates (i.e., abstinence among all smokers including those who use and do not utilize treatment) and on utilization of tobacco treatment compared to reactive/usual care (UC) among a diverse population of smokers, (2) Compare the effect of PRO on population-level smoking abstinence rates and utilization of tobacco treatments between African American and White smokers, and (3) Determine the cost-effectiveness of the proactive care intervention. METHODS/DESIGN: This prospective randomized controlled trial identifies a population-based sample of current smokers from the Department of Veterans Affairs (VA) electronic medical record health factor dataset. The proactive care intervention combines: (1) proactive outreach and (2) offer of choice of smoking cessation services (telephone or face-to-face). Proactive outreach includes mailed invitation materials followed by an outreach call that encourages smokers to seek treatment with choice of services. Proactive care participants who choose telephone care receive VA telephone counseling and access to pharmacotherapy. Proactive care participants who choose face-to-face care are referred to their VA facility's smoking cessation clinic. Usual care participants have access to standard smoking cessation services from their VA facility (e.g., pharmacotherapy, smoking cessation clinic) and from their state telephone quitline. Baseline data is collected from VA administrative databases and participant surveys. Outcomes from both groups are collected 12 months post-randomization from participant surveys and from VA administrative databases. The primary outcome is self-reported smoking abstinence, which is assessed at the population-level (i.e., among those who utilize and those who do not utilize tobacco treatment). Primary analyses will follow intention-to-treat methodology. DISCUSSION: This randomized trial is testing proactive outreach strategies offering choice of smoking cessation services, an innovation that if proven effective and cost-effective, will transform the way tobacco treatment is delivered. National dissemination of proactive treatment strategies could dramatically reduce tobacco-related morbidity, mortality, and health care costs. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov: NCT00608426.

Research-based queries about patients' experiences often uncover suicidal thoughts. Human subjects review requires suicide risk management (SRM) protocols to protect patients, yet minimal information exists to guide researchers' protocol development and implementation efforts. The purpose of this study was to examine the development and implementation of an SRM protocol employed during telephone-based screening and data collection interviews of depressed primary care patients. We describe an SRM protocol development process and employ qualitative analysis of de-identified documentation to characterize protocol-driven interactions between research clinicians and patients. Protocol development required advance planning, training, and team building. Three percent of screened patients evidenced suicidal ideation; 12% of these met protocol standards for study clinician assessment/intervention. Risk reduction activities required teamwork and extensive collaboration. Research-based SRM protocols can facilitate patient safety by (1) identifying and verifying local clinical site approaches and resources and (2) integrating these features into prevention protocols and training for research teams.