ORIGINAL CONTRIBUTION

Multiple Risk Factor Counseling to Promote

Heart-healthy Lifestyles in the Chest Pain
Observation Unit: Pilot Randomized
Controlled Trial
David A. Katz, MD, MSc, Mark Graber, MD, Patricia Lounsbury, BSN, MEd,
Mark W. Vander Weg, PhD, Emily K. Phillips, BSN, Christina Clair, MS,
Phillip A. Horwitz, MD, Xueya Cai, PhD, and Alan J. Christensen, PhD

ABSTRACT
Objective: Admission to the chest pain observation unit (CPOU) may be an advantageous time for patients to
consider heart-healthy lifestyle changes while undergoing diagnostic evaluation to rule out myocardial ischemia.
The aim of this pragmatic trial was to assess the effectiveness of a multiple risk factor intervention in changing
CPOU patients’ health beliefs and readiness to change health behaviors. A secondary aim was to obtain
preliminary estimates of the intervention’s effect on diet, physical activity, and smoking.

Methods: We conducted a pilot randomized controlled trial of a moderate-intensity counseling intervention that
aimed to build motivation to change and problem-solving skills in 140 adult patients with at least one modifiable
cardiovascular risk factor (CRF) who were admitted to the CPOU of an academic emergency department (ED)
with symptoms of possible acute coronary syndrome. Study patients were randomly assigned to full counseling
(face-to-face cardiovascular risk assessment and personalized counseling on nutrition, physical activity, and
smoking cessation in the ED, plus two telephone follow-up sessions) or minimal counseling (brief instruction [<5
minutes] on benefits of modifying cardiovascular risk factors) by a cardiac rehabilitation specialist. We measured
Health Belief Model constructs for ischemic heart disease, stage of change, and self-reported CRF-related
behaviors (diet, exercise, and smoking) during 6-month follow-up using previously validated measures. We used
linear mixed models and logistic regression (with generalized estimating equations) to compare continuous and
dichotomous behavioral outcomes across treatment arms, respectively.

Results: Approximately 20% more patients in the full counseling arm reported having received counseling on
diet and physical activity during CPOU admission, compared to the minimal counseling arm; a similar proportion
of patients in both counseling arms reported having received advice or assistance in quitting smoking. There
were no significant differences between treatment arms for any cardiovascular health beliefs, readiness to
change, or CRF-related behaviors during longitudinal follow-up. In secondary analyses in both treatment arms
combined, however, patients showed significant differences between follow-up and baseline measurements:
increases in the perceived benefits of improving CRF-related behaviors (27.7 vs. 26.6 on a scale from 7 to 35,
p = 0.0001) and increased readiness to change dietary behavior and physical activity during follow-up—intake of
saturated fat (83% vs. 49%), readiness to change fruit and vegetable consumption (83% vs 56%), and readiness

From the Department of Medicine (DAK, MWVW, EKP, PAH, XC) and the Department of Emergency Medicine (MG), University of Iowa Carver
College of Medicine; the Comprehensive Access & Delivery Research and Evaluation (CADRE) Center, Iowa City VA Medical Center (DAK,
MWVW); Cardiovascular Health, Assessment, Management, and Prevention Services, University of Iowa Hospital and Clinics (PL, CC); and the
Department of Psychological and Brain Sciences, University of Iowa College of Liberal Arts (MWVW, AJC), Iowa City, IA.
Received January 23, 2017; revision received April 28, 2017; accepted May 18, 2017.
The authors have no relevant financial information or potential conflicts to disclose.
The views expressed in this article are those of the author(s) and do not necessarily represent the views of the Department of Veterans Affairs.
Supervising Editor: Matthew C. Gratton, MD.
Address for correspondence and reprints: David A. Katz, MD, MSc; e-mail: david-katz@uiowa.edu.
ACADEMIC EMERGENCY MEDICINE 2017;24:968–982.

ISSN 1069-6563 © 2017 by the Society for Academic Emergency Medicine

968 PII ISSN 1069-6563583 doi: 10.1111/acem.13231
ACADEMIC EMERGENCY MEDICINE • August 2017, Vol. 24, No. 8 • www.aemj.org 969

to perform regular exercise (34% vs. 14%) at 6 months and baseline, respectively (p < 0.0001 for all comparisons
in both treatment arms combined).

Conclusions: A multiple risk factor intervention that focused on increasing motivation to change and
problem-solving skills did not significantly improve behavioral outcomes, compared to minimal counseling.
Patients admitted to the CPOU demonstrated sustained changes in several cardiovascular health beliefs and
risk-related behaviors during follow-up; this provides further evidence that the CPOU visit is a “teachable
moment” for cardiovascular risk reduction. Future studies should evaluate the effectiveness of ED-initiated
counseling interventions to engage patients in changing cardiovascular risk behaviors, in coordination with
primary care.

A pproximately 7 million patients present to the

emergency department (ED) annually with symp-
toms suggestive of acute coronary syndrome (ACS),
which is often the initial manifestation of ischemic
heart disease (IHD).1 Increasingly, patients for whom
a nonischemic etiology of symptoms cannot be identi-
fied undergo further evaluation to rule out myocardial
ischemia and appraisal of cardiovascular risk factors
(CRFs) in chest pain observation units (CPOUs).
Although patients with nonspecific or atypical chest
pain are generally considered to be at low risk of
ACS, these patients tend to have higher levels of tradi-
tional CRFs than those reporting no chest pain and
many have an increased long-term risk of cardiovascu-
lar events and IHD-related mortality.2–4 Prior studies
have demonstrated a large unmet need for attention to
CRFs in this population.5
The CPOU visit may represent a “teachable moment”
for these patients to consider heart-healthy lifestyle
changes and more aggressive management of CRFs.6 In
addition to increasing perceptions of personal risk and
positive outcome expectancies for health behavior
change, the teachable moment may also prompt a strong
affective response (i.e., fear)7,8 and redefine the patient’s
self-concept.9 CPOU admission may also be an advanta-
geous time to motivate patients to make needed changes
in health behaviors, as many patients lose interest in
modifying CRFs and may decline to participate when
counseling is delayed until outpatient follow-up.10
Although many patients desire preventive services to be
initiated in the ED,11 promoting health behavior change
can be a daunting task in CPOU patients who may not
have any history of IHD (and for whom the threat of
IHD is uncertain), who often have challenging psychoso-
cial circumstances, and who may not have regular access
to primary care for follow-up.
There are little data on the utility of multiple CRF
interventions in the ED; however, several moderate- to
high-intensity intervention trials have shown the utility
of motivational and problem-solving approaches to car-
diovascular health behaviors (diet, physical activity,
smoking) in primary care12–14 and in the post–myocar-
dial infarction setting.15,16 Developing strategies to
help CPOU patients develop healthier self-care behav-
iors requires a thorough understanding of the patient’s
health beliefs, perceptions of self-efficacy, and readi-
ness to change. Interventions should also capitalize on
the potential synergies across risk behaviors17 and be
implementable by existing hospital staff without
disrupting ED workflow. Thus, we conducted a pilot
randomized controlled trial (RCT) to assess the effec-
tiveness of a multiple risk factor counseling interven-
tion in changing CPOU patients’ health beliefs and
behavioral intentions and to obtain preliminary esti-
mates of the intervention’s effect on CRF-related
behaviors.
METHODS
Study Design
We conducted a pilot RCT of a moderate-intensity
behavioral intervention (with initial face-to-face counsel-
ing and follow-up telephone counseling at 3–5 days
and at 4–6 weeks post-CPOU admission) in ED
patients who were evaluated for symptoms of possible
ACS Self-reported behavioral outcomes were assessed
at 2 and 6 months. Patients were enrolled over a
16-month period from September 2007 to January
2009. This study was approved by the University of
Iowa Institutional Review Board.
For the purpose of designing and evaluating the
study intervention in the context of CPOU admission,
the concept of teachable moments was incorporated
into the Health Belief Model (HBM),18,19 as illustrated
in Figure 1. Specifically, the proposed intervention
was designed to provide patients with tailored informa-
tion on their cardiovascular risk and to increase
970 Katz et al. • CPOU RISK REDUCTION TRIAL

Figure 1. Conceptual framework of CRF-related health behaviors in the CPOU context. The HBM postulates that health-related action depends
on the simultaneous occurrence of three factors: 1) “cues to action,” which are internal or external prompts that must be present in sufficient mag-
nitude to trigger the decision-making process, 2) the belief that one is susceptible to a health threat (perceived susceptibility), and 3) the belief that
a particular health recommendation is beneficial in reducing the health threat at an acceptable cost (perceived benefit).20 Self-efficacy, “the convic-
tion that one can successfully execute the behavior required to produce the outcomes,”21 was later added to the HBM to increase its explanatory
power.22 In this framework, CRF-related counseling may act synergistically with other cues to action to make the ED visit a teachable moment for
cardiovascular risk reduction. ACS = acute coronary syndrome; CPOU = chest pain observation unit; CRF = cardiovascular risk factor; HBM =
health belief model; IHD = ischemic heart disease. (*IHD events include unstable angina, myocardial infarction, and sudden cardiac death.)

motivation and problem-solving skills required to over-
come barriers to change.
Study Population and Setting
We recruited CPOU patients from the University of
Iowa Emergency Department, which serves approxi-
mately 60,000 adult patients annually. All patients were
selected for CPOU admission based on American Heart
Association (AHA) guideline criteria.23 Those admitted
to the CPOU received continuous telemetry monitoring,
serial troponin measurements, and provocative testing
(exercise treadmill testing, unless unable to exercise). His-
torically, the vast majority of these patients (~90%) have
negative test results and are discharged home; approxi-
mately 10% of patients have positive test results and are
admitted for further investigation.
Only adult CPOU patients age 30 or older with at
least one modifiable CRF (smoking, hyperlipidemia,
hypertension, diabetes mellitus, obesity) were eligible.
Patients with one or more cardiac risk factors are more
likely to perceive the risk associated with specific life-
style factors24 and to have an elevated risk of first
myocardial infarction.25 Patients with evidence of
myocardial ischemia at initial testing, high-risk unsta-
ble angina, or medical instability (e.g., severe hypoten-
sion, acute respiratory distress) were not eligible for
observation in the CPOU. We also excluded patients
who were terminally ill (expected to survive less than 3
months), those known to be unavailable for 6-month
follow-up, those who could not be contacted by
telephone, institutionalized persons (prisoners, nursing
home residents), and those who were unable to pro-
vide consent because of impaired mental status.
Patients with known coronary artery disease (CAD)
were eligible as long as they were being evaluated for
possible ACS in the observation unit. To maximize
recruitment, the study research assistant (RA) checked
the CPOU several times a day for potentially eligible
patients and obtained consent from eligible patients.
Study Protocol
Eligible patients who completed the baseline assess-
ment were randomly assigned (based on a list of ran-
domly generated numbers) in a 1:1 distribution to
either full counseling or minimal counseling. ED clini-
cians and nursing staff were blinded to treatment
assignment. We were unable to include a true control
group, because hospital leadership believed that with-
holding CRF-related counseling altogether in CPOU
patients was not consistent with the current standard
of care at our facility. Because of the relatively small
sample size of this trial, we performed stratified
randomization by history of known IHD or diabetes
mellitus, as these patients are more likely to have pre-
viously received counseling on CRFs.
Full Counseling Intervention
Under supervision of the program director of cardiac
rehabilitation (PL), one health educator (CC) had
primary responsibility for providing face-to-face
ACADEMIC EMERGENCY MEDICINE • August 2017, Vol. 24, No. 8 • www.aemj.org
counseling in the CPOU plus telephone counseling
during follow-up (booster). In preparation for the
intervention, she received approximately 6 hours of
training in the following areas: nutrition, exercise,
smoking cessation, and weight management. Training
included role play to practice counseling techniques
for hypothetical patients at various stages of change
and emphasized principles of motivational interview-
ing.26 The health educator was instructed to complete
the initial CPOU counseling session in 1 hour and
two follow-up sessions in approximately 30 minutes
per session. At the initial follow-up session (3–5 days
following the ED visit), the health educator reviewed
the patient’s priorities for behavior change, assisted
him or her in developing a change plan, and focused
on problem solving skills. During the follow-up phone
call at 4–6 weeks, the health educator reviewed the
patient’s progress and addressed any special concerns
or topics that were not discussed in earlier sessions.
Patients also received a general informational handout
on self-management of CRFs (AHA brochure “Con-
trolling Your Risk Factors”).
Cardiovascular Risk Assessment. Based on
the results of baseline questionnaires and CPOU labo-
ratory assessment, the health educator generated a per-
sonalized computerized report that outlined the
patient’s CRFs, Framingham risk score,27 the goal for
each risk factor based on national guidelines, and rec-
ommended actions for achieving each goal. The order
of intervention components was negotiated based on
the magnitude of specific risks and the patient’s readi-
ness and priorities for change. For each risk-related
behavior, the health educator focused on environmental
factors and cognitive processes (increasing knowledge,
understanding benefits of changing a behavior, setting
specific and attainable goals, enlisting social support,
using rewards, controlling stimuli for unhealthy behav-
iors, and building confidence).28 During telephone fol-
low-up, the health educator reviewed diary entries with
the patient and reassessed his/her goals. Counseling for
specific risk behaviors is briefly summarized below.
Nutrition Counseling. Data from an abbreviated
food frequency questionnaire were used to generate a
baseline analysis of the patient’s dietary pattern and
formed the basis for prioritized dietary change goals.
Dietary intervention had the following aims: 1) to
reduce saturated fat intake to less than 7% of daily
energy intake, 2) to reduce cholesterol intake to less
971
than 200 mg/day, and 3) to increase fruit and veg-
etable intake to five or more servings/day based on
National Cholesterol Education Program (NCEP)
guidelines.29 More recent evidence supports NCEP
dietary recommendations for prevention of coronary
heart disease.30,31 Individuals with evidence of meta-
bolic syndrome or glucose intolerance were strongly
encouraged to lose 5% to 10% of their body weight.32
Physical Activity. At the initial counseling ses-
sion, the health educator reviewed the patient’s level
of physical activity; assessed barriers to exercise, includ-
ing any fears regarding the onset of cardiac symptoms;
and determined motivational readiness to engage in
physical activity.33,34 Based on these data (and the
results of exercise stress testing), the health educator
negotiated a task that was appropriate to the patient’s
physical condition and stage of change. Patients were
instructed to maintain an exercise diary, how to warm
up, and how to recognize and respond to cardiac
symptoms.
Smoking Cessation. The baseline interview
included an assessment of the patient’s smoking pat-
tern, reasons for continued smoking, and reasons for
quitting.35 The health educator then reviewed the ben-
efits of smoking cessation (with an emphasis on car-
diac health) and provided all patients who were
contemplating cessation with the Agency for Health-
care Research and Quality Patient Guide to smoking
cessation. Patients who were willing to set a quit date
were assisted in developing an action plan.36 For
patients who were not ready to quit smoking, readi-
ness to quit smoking was revisited at the 4- to 6-week
follow-up session.
Providing Feedback to Primary Care Clini-
cian. As advice and encouragement from primary
care physicians (PCPs) helps to reinforce risk-related
behavior changes, a report was sent to the patient’s
PCP (if any) shortly after CPOU admission. In addi-
tion to providing the results of provocative cardiac test-
ing, this report summarized the cardiovascular risk
assessment described above, a list of topics covered,
and the patient’s priorities for change.
Minimal Counseling
For patients assigned to the minimal counseling inter-
vention, the health educator provided brief counseling
(<5 minutes) on the benefits of changing lifestyle and
972
the AHA brochure on self-management of CRFs men-
tioned above. This was consistent with the standard of
care in the study ED at the time of this trial. In
addition, patients were mailed the personalized cardio-
vascular risk assessment report described above at the
end of 6-month follow-up.
Data Collection
Baseline questionnaires (including health beliefs, stage
of change measures, and CRF-related health behav-
iors) were administered by the research assistant
shortly after physician evaluation and after at least
one negative troponin measurement. We recorded
data on systolic blood pressure and cholesterol for all
study patients (used to calculate the Framingham
Risk Score). CPOU patients at the University of
Iowa routinely received measurements of HDL and
total cholesterol (based on a standard spectrophoto-
metric assay), high-sensitivity C-reactive protein, and
blood glucose. We also recorded weight and height
to calculate body mass index.37 Electronic forms were
developed for all questionnaires and case report
forms, and the data were transferred into a Microsoft
Access database.
Shortly after CPOU discharge, the RA (blinded to
treatment arm) contacted patients by telephone to
determine whether they had received any specific
advice regarding diet, exercise, and smoking cessation
(if applicable) during the ED visit. To assess counsel-
ing regarding saturated fat, for example, patients were
asked the following: “Did any of the medical staff
advise you to reduce your intake of saturated fat dur-
ing this emergency department visit?” (If yes, patients
were asked to recall whether a nonphysician and/or
physician had provided this advice). This measure
helped to assess the fidelity with which the interven-
tion was delivered.38 At 2- and 6-month follow-up, the
blinded RA interviewed all study patients by telephone
to collect data on HBM variables and CRF-related
behaviors (Data Supplement S1, available as support-
ing information in the online version of this paper,
which is available at https://doi.org/onlinelibrary.wile
y.com/doi/10.1111/acem.13231/full). To minimize
attrition during follow-up, repeated attempts were
made until successful contact was made (up to 12
attempts). Patients who still could not be reached had
a letter and questionnaires sent to their home (with
return self-addressed stamped envelope). If these
measures failed, the patient was considered lost to
follow-up.
Katz et al. • CPOU RISK REDUCTION TRIAL
Dependent Variables: Health Belief
Measures. We assessed several HBM variables that
were expected to show greater changes in the full coun-
seling arm (relative to minimal counseling). To measure
the patient’s perceived benefits of adopting recommended
risk-related behaviors, we used the corresponding sub-
scale of the Health Motivation Assessment Inventory
(HMAI), which is specific for cardiovascular risks.39 To
measure the patient’s perceived seriousness of and per-
ceived susceptibility to developing IHD (or experiencing
IHD-related events), we modified a previously validated
questionnaire, the Osteoporosis Health Belief Scale
(OHBS), by substituting “ischemic heart disease” for
“osteoporosis.”22 We used the following published
scales to measure self-efficacy for diet, exercise, and
smoking cessation: 1) the Cardiac Dietary Self Efficacy
Index (CDSEI),40 2) a brief measure of exercise self-effi-
cacy,41 and 3) the Smoking Self-efficacy Questionnaire
(SEQ-12), which measures confidence in ability to
refrain from smoking when facing internal stimuli (e.g.,
feeling depressed) and external stimuli (e.g., being with
other smokers).42
Stage of dietary change was measured for two con-
sumption behaviors: 1) decreasing saturated fat intake
and 2) increasing fruit and vegetable intake, based on
a series of questions derived from Prochaska and
DiClemente’s model for smoking cessation.43 Stage of
dietary change has been shown to be a valid predictor
of intake; precontemplators consume significantly
more total and saturated fat, and fewer fruits and veg-
etables, than individuals in the action stage.44 A five-
item measure was used to categorize patients according
to stage of change for exercise. Previous studies of this
measure have shown acceptable test–retest reliability
(j = 0.78 over a 2-week period), concurrent validity
with 7-day physical activity recall (PAR) scores,45,46
and responsiveness to change in intervention trials of
physical activity counseling.34,47 Patients who reported
regular physical exercise (at least five times a week for
at least 20 minutes each time) were considered to be
in the action or maintenance stages.41 Based on a
widely used algorithm,43,48 we assessed stage of
change for smoking cessation, which has been shown
to be a significant predictor of short- and long-term
cessation.49,50
Secondary Outcomes: Cardiovascular Risk
Behaviors. We used a rapid food screening survey
to measure saturated fat, cholesterol, and fruit/veg-
etable intake.51 This screener has been shown to be
ACADEMIC EMERGENCY MEDICINE • August 2017, Vol. 24, No. 8 • www.aemj.org
effective in identifying persons with high fat intake or
low fruit/vegetable intake, which was moderately corre-
lated (r = 0.6–0.7) with estimates obtained using a
full-length (100-item) validated questionnaire. We used
the 7-day PAR questionnaire to estimate the average
number of minutes per day spent in moderate to vig-
orous levels of physical activity during a 1-week period;
activity categories were classified by their average
energy requirements (in METs).52 Test–retest reliability
of the PAR at 2 weeks was 0.67 for estimated energy
expenditure (kcal/day) in a community-based popula-
tion sample;52 validity is supported by the finding that
change in estimated energy expenditure was signifi-
cantly correlated with maximum oxygen uptake and
percent body fat composition at 6 month follow-up
(r = 0.33 and –0.50, respectively).53 For those who
were current smokers at baseline, we assessed the aver-
age number of cigarettes smoked daily and abstinence
from tobacco use during the 7 days prior to follow-up
(7-day point prevalence abstinence [PPA]).54
Additional Variables. To better characterize the
study sample, we collected data on demographic fac-
tors (age, sex, race, marital status, and education level),
medical comorbidities,55 and self-rated overall health56
(Data Supplement S1). Given their potential influence
on HBM variables and health-protective behaviors, we
also measured previsit depression and anxiety (using
the Hospital Anxiety and Depression Scale
[HADS]),57 psychological stress,58 social support,59
and sense of control,60 at baseline.
Data Analysis
A target sample of 192 patients (96 in each group)
was determined to have at least 80% power (two-tailed
a = 0.05) to detect a 20-percentage-point difference in
the proportion of intervention versus control group
patients who were in the action-maintenance stage of
change for exercise, saturated fat intake, and fruit/veg-
etable intake at 2-month follow-up.
We hypothesized that patients who were random-
ized to the full counseling intervention would demon-
strate greater readiness to change cardiovascular risk
behaviors, compared to control patients at 2- and
6-month follow-up. Baseline characteristics of the two
treatment arms were compared using the two-indepen-
dent-sample t-test, Wilcoxon rank-sum, or chi-square
tests as appropriate for the type of data. We used gen-
eralized estimating equations with a logarithmic link
function and an unstructured covariance matrix to
973
analyze stage of change outcomes (dichotomized at
action or maintenance vs. other) and 7-day PPA dur-
ing longitudinal follow-up. We used mixed-effects lin-
ear models to compare continuous behavioral
outcomes across full and minimal counseling arms at
follow-up, under the assumption that data were miss-
ing at random. The interaction term for treatment
group and time was used as an independent variable
to determine whether changes in behavioral outcomes
during 6-month follow-up differed between treatment
groups; we used intercepts to model random effects at
the participant level. In secondary analysis, we evalu-
ated the trend over time in behavioral outcomes for
each of the two treatment arms; if the change in out-
comes was similar for both treatment arms, we also
tested the trend over time for both arms combined.
Regression diagnostics were performed to assess viola-
tions of model assumptions; because of nonnormality
of the residuals, physical activity and cigarette intake
were transformed (natural log and square root, respec-
tively) prior to linear regression.
We adjusted all models for a set of potential con-
founders that were felt to be particularly relevant to
changes in CRF-related behaviors a priori: race (non-
white vs. white), marital status (married vs. unmar-
ried), education (≤12 years vs. > 12 years), health
status (excellent-very good vs. other),61 Framingham
risk score categories (categorized as <6, 6–20, and
>20%62), family history of premature CAD, history of
myocardial infarction and/or known CAD, and
HADS-depression score.57 In a systematic review of
the literature, the HADS-D (depression subscale)
showed an average internal consistency reliability of
0.82.63 In noncancer medical patients, the mean sensi-
tivity and specificity of the HADS-D in detecting clini-
cal depression were 0.83 and 0.79, respectively (using
a cutoff score of >8).63 We also added two covariates
that differed significantly across treatment groups at
baseline (see below).64
All analyses were performed using an intent-to-treat
approach. STATA, Version 12, and SAS program-
ming language, Version 9.3, were used for all analy-
ses. All tests were two-sided and a p-value of <0.05
was defined as statistically significant; p-values were
not adjusted for multiple comparisons.
RESULTS
Figure 2 summarizes the screening, recruitment, and
follow-up of study patients. The study ended before
974 Katz et al. • CPOU RISK REDUCTION TRIAL

Table 1
Baseline Characteristics

Minimal
Full Counseling Counseling
Variable (n = 70) (n = 70)
Demographics
Age (y), mean (SD) 48.9 (10) 49.6 (10)
Sex, % male 49 51
Race, % white 91 86
Married, % 50 54
Education (y), 13.7 (2.4) 13.8 (2.6)
mean (SD)
CRFs, %
Hypertension 59 61
Diabetes 16 20
Hypercholesterolemia 44 40
Current smoking 40* 26
Body mass index (kg/m2) 34.8 35.0
Family history of 43 48
premature IHD
Laboratory parameters (mean)
Total cholesterol 179 178
HDL cholesterol 44 42
Triglycerides 163 178
Glucose 108 116
C-reactive protein 6.1 6.9
Chief complaint: chest pain 84 77
Attribution of acute 46 51
symptoms to IHD, %†
Cardiovascular history, %
Known coronary 13 10
artery disease
History of myocardial 10 4
infarction
Comorbidity: Charlson 0.6 0.6
Figure 2. Screening, enrollment, and follow-up of CPOU Risk score, mean
Reduction Trial participants. ACS = acute coronary syndrome;
CRF = cardiovascular risk factor; CPOU = chest pain observation Psychosocial variables, mean (SD)
unit. *Patients with evidence of myocardial ischemia at initial test- HADS-depression 5.0 (3.4) 5.2 (3.9)
ing, high risk unstable angina, medical instability (e.g., severe hypo- HADS-anxiety 7.4 (3.6) 7.8 (4.3)
tension, acute respiratory distress) were not eligible for the CPOU.
Perceived stress 9.1 (4.1)‡ 8.5 (1.8)
**Patients who were terminally ill (expected to survive less than 3
months), those known to be unavailable for 6-month follow-up, insti- Sense of control 6.4 (3.4) 6.1 (3.9)
tutionalized persons (prisoners, nursing home residents), those who Social support 18.6 (4.1) 19.1 (4.5)
were unable to provide consent because of impaired mental status,
and those who had previously received a cardiac rehabilitation con- CRFs = cardiovascular risk factors; IHD = ischemic heart disease,
sult within the prior 6 months were excluded. HADS = Hospital Anxiety and Depression Scale
*p = 0.07
†Percentage responding “very much” or “extremely” (on a 5-point
Likert-type scale).
the enrollment target was reached on account of lower ‡p = 0.02
than expected recruitment (and insufficient funding to
extend the trial). Of those patients with symptoms of predominantly middle-aged, white, and well educated,
possible ACS and at least one CRF, 49% were and 81% presented with a chief complaint of chest
determined to be suitable candidates for the CPOU. pain (Table 1). Demographic and clinical characteris-
Sixty-six percent of the 225 eligible patients agreed to tics of patients in both arms of the trial were similar,
participate and 140 were randomized to the full versus except for the following: those in the full counseling
minimal counseling intervention. There were no sig- arm were more likely to smoke (40 vs. 26%,
nificant differences between enrollees and those who p = 0.07) and reported significantly greater perceived
refused to participate. The study population was stress (9.1 vs. 8.5, p = 0.02). Framingham risk score
ACADEMIC EMERGENCY MEDICINE • August 2017, Vol. 24, No. 8 • www.aemj.org 975

Table 2 statistically significant changes were observed. Both

Receipt of Preventive Care Counseling in the CPOU treatment arms demonstrated a modest increase in the
Minimal perceived benefits of improving cardiovascular risk
Full Counseling Counseling
Variable (%) [n = 67] (%) [n = 66] behaviors at 2 months, compared to baseline (27.7 vs.
Any dietary advice: 41* 23 26.6 on a scale from 7–35, p = 0.0001 in both arms
saturated fats combined), with similar results at 6 months (Table 3).
Health educator 34* 9 Perceived susceptibility to IHD did not change during
EP or cardiologist 9 6
follow-up in the full counseling arm, but dropped sig-
Any dietary advice: 43* 20
fruits and vegetables nificantly in the minimal counseling arm at 2 months
Health educator 35* 10 only (13.7 vs. 14.7 on a 20-point scale, p = 0.01).
EP or cardiologist 7 4 Patients in the full counseling arm also showed a sig-
Any assistance in 29* 9 nificant increase in perceived seriousness of IHD at 2
changing diet
months only (18.2 vs. 17.5 on a 25-point scale, p =
Health educator 26* 4
0.04). We observed statistically significant improve-
EP or cardiologist 1 0
ments in dietary self-efficacy within each treatment arm
Any advice to increase 44* 23
physical activity at 2- and 6-month follow-up (~0.3 point on a 5-point
Health educator 37* 12 scale). Exercise and smoking self-efficacy did not
EP or cardiologist 16 4 improve during follow-up; in contrast, we observed a
Any assistance in 31* 11 significant decline in the external domain of smoking
increasing
physical activity self-efficacy in the full counseling arm (18.0 vs. 20.3
Health educator 29* 6 on a 30-point scale, p = 0.01 at 2 months).
EP or cardiologist 4 1 With regard to readiness to change health behaviors,
Any advice to quit smoking† 59 61 there were no significant differences between treatment
Health educator 33 29 arms from baseline to follow-up. In secondary analysis
EP or cardiologist 43 33 of both treatment arms combined, however, we
Any assistance in 52 41
quitting smoking†
observed significant differences between 2-month fol-
Health educator 37 29 low-up and baseline measurements. Specifically, there
EP or cardiologist 25 6 were substantial gains in the proportion of patients in
CPOU = chest pain observation unit; EP = emergency physician.
the action or maintenance stages of change for dietary
*p < 0.05 intake of saturated fat (80% vs. 49%), fruit and veg-
†Based on 28 and 18 current smokers in the full and minimal
counseling groups, respectively.
etable consumption (76% vs. 56%), and regular exer-
cise (31% vs. 14%) at 2 months and baseline,
was similar in both treatment arms (median = 4, respectively (p = 0.0001 for all comparisons); these
interquartile range = 1–9). gains were maintained at 6-month follow-up (Figure 3).
A significantly greater proportion of patients in the Analysis of cardiovascular risk behaviors also
full counseling arm reported receiving any dietary showed no significant differences between treatment
advice, assistance in changing diet, advice to increase arms (Figure 4). In secondary analysis, however, we
physical activity, and assistance in changing physical observed significant improvements in health behaviors
activity (absolute difference was approximately 20% for during follow-up, except physical activity, within each
these variables; Table 2). No significant differences in treatment group. In both treatment arms combined,
smoking cessation advice or assistance in quitting were percentage of calories from saturated fat (9.2% vs.
observed. Most of the above differences were 9.7%, adjusted difference = –0.5% [95% CI = –0.2
accounted for by the health educator; a minority of to –0.9%]) and daily intake of cholesterol (235 mg vs.
patients in both groups received counseling regarding 258 mg, adjusted difference = –18 mg [95% CI = –8
cardiovascular risk behaviors by an emergency physi- to –28]) were modestly lower at 2 months, compared
cian (EP) or cardiologist, with no significant difference to baseline. In addition, daily intake of fruits and veg-
between groups. etables was significantly higher (4.5 servings vs. 3.9
Longitudinal analyses showed no significant differ- servings, adjusted difference = +0.6 servings [95%
ences between treatment arms for any of the HBM CI = +0.2 to 0.9]). Although 7-day PPA did not sig-
domains. Within treatment arm, however, several nificantly change during follow-up, patients reported
976 Katz et al. • CPOU RISK REDUCTION TRIAL

Table 3
Health Belief Measures at Baseline and Follow-up

Adjusted Difference
Measure Baseline 2 months 6 months 2 months vs. 0 months 6 months vs. 0 months p-value
Perceived benefits
Full counseling 26.5 (3.0) 27.5 (2.6) 27.6 (2.8) 0.9 (0.2 to 1.6)* 0.9 (0.2 to 1.5)* 0.64
Minimal counseling 26.6 (2.7) 27.9 (2.4) 27.8 (2.5) 1.4 (0.7 to 2.1)* 1.2 (0.6 to 1.9)*
Perceived susceptibility
Full counseling 13.6 (3.1) 13.2 (3.6) 13.0 (3.4) –0.3 (–1.0 to 0.4) –0.4 (–1.1 to 0.3) 0.78
Minimal counseling 14.7 (2.7) 13.7 (3.6) 14.1 (3.7) –0.9 (–1.7 to –0.2)* –0.6 (–1.4 to 0.1)
Perceived seriousness
Full counseling 17.5 (2.6) 18.2 (3.1) 17.6 (3.1) 0.7 (0.4 to 1.4)* 0.1 (–0.6 to 0.8) 0.17
Minimal counseling 18.1 (2.9) 18.4 (3.2) 18.9 (3.3) 0.3 (–0.4 to 1.0) 0.8 (0.1 to 1.5)*
Dietary self-efficacy
Full counseling 3.2 (0.8) 3.5 (0.7) 3.6 (0.8) 0.3 (0.1 to 0.4)* 0.3 (0.2 to 0.5)* 0.24
Minimal counseling 3.3 (0.6) 3.6 (0.6) 3.5 (0.7) 0.3 (0.1 to 0.4)* 0.2 (0.1 to 0.4)*
Exercise self-efficacy
Full counseling 12.8 (4.8) 13.7 (5.1) 14.3 (6.0) 0.7 (–0.4 to 1.8) 0.9 (–0.3 to 2.0) 0.66
Minimal counseling 13.5 (4.7) 13.2 (4.9) 13.6 (4.7) –0.3 (–1.4 to 0.8) 0.3 (–0.8 to 1.4)
Smoking self-efficacy (internal)
Full counseling 14.9 (5.3) 16.8 (7.1) 18.7 (6.9) 1.7 (–1.6 to 4.9) 3.3 (–0.1 to 6.7) 0.58
Minimal counseling 16.4 (5.4) 18.6 (6.2) 18.6 (7.5) 1.7 (–2.4 to 5.9) 2.0 (–2.1 to 6.0)
Smoking self-efficacy (external)
Full counseling 20.3 (4.6) 18.0 (4.3) 17.1 (5.5) –2.4 (–4.2 to –0.5)* –3.2 (–5.1 to –1.3)* 0.54
Minimal counseling 20.3 (4.7) 18.9 (4.1) 17.4 (4.8) –1.2 (–3.6 to 1.2) –2.1 (–4.5 to 0.1)

Data are reported as mean (SD) or mean (95% CI).

The treatment group by time interaction was tested in mixed effects regression models, with adjustment for the following patient covari-
ates at baseline: race, marital status, education, self-reported health status, Framingham risk score, family history of premature CAD, his-
tory of myocardial infarction and/or known CAD, HADS-depression score, and perceived stress score. The number of cases available for
analysis was 135 for all models, except for smoking self-efficacy models (limited to current smokers, n = 45). Perceived benefits scale
ranges from 7 to 35 (higher scores indicate greater perceived benefit). Perceived susceptibility scale ranges from 4 to 20 (higher scores
indicate greater perceived susceptibility). Perceived seriousness scale ranges from 5 to 25 (higher scores indicate greater perceived seri-
ousness). Dietary self-efficacy scale ranges from 16 to 80 (higher scores indicate greater confidence in following a healthy diet). Exercise
self-efficacy ranges from 5 to 25 (higher scores indicate greater confidence in participating in regular exercise). Smoking self-efficacy sub-
scales range from 6 to 30 (higher scores indicate greater confidence in refraining from smoking in certain situations).
IHD = ischemic heart disease; HADS = Hospital Anxiety and Depression Scale
*p < 0.05 for contrast within treatment arm.

smoking slightly fewer cigarettes per day at 2 months
compared to baseline (9 cigarettes vs. 11 cigarettes,
respectively, p = 0.02). These behavior changes were
sustained at 6-month follow-up.
DISCUSSION
The CPOU visit represents a potentially teachable
moment during which clinicians and nurses can
engage patients in a discussion about changing
unhealthy behaviors and lowering cardiovascular risk
while awaiting the results of diagnostic studies to rule
out ACS. This pragmatic RCT was designed to evalu-
ate the effectiveness of an opportunistic intervention
in the CPOU that could be performed by cardiac
rehabilitation personnel in the course of their usual
activities. In support of the “teachable moment” con-
cept, our results suggest that admission to the CPOU
is a “cue to action,” as patients in both treatment
arms experienced significant increases in their readi-
ness to change over the short and long term; more-
over, these changes translated into measurable
improvements in several self-reported CRF-related
behaviors during follow-up. We did not, however, find
any significant differences in self-efficacy, readiness to
change, or CRF-related behaviors between treatment
arms in longitudinal analyses.
One possible explanation for this null finding is
that patients in the full counseling arm were only
20% to 25% more likely to report having received
advice and assistance with regard to diet and physical
activity during CPOU admission, compared to those
ACADEMIC EMERGENCY MEDICINE • August 2017, Vol. 24, No. 8 • www.aemj.org 977

Figure 3. Proportion of patients in the action or maintenance stages of change at baseline and follow-up. *p≤.05 for within group contrast
between time 0 and times 2 and 6 months. P-values are shown for the treatment group x time interaction (i.e., whether the changes in out-
come differed between treatment groups during 6-month follow-up).

in the minimal counseling arm. The stress of acute
illness combined with the often chaotic ED environ-
ment may have diminished patients’ recall of CRF-
related counseling. Another explanation for the lack
of difference between treatment arms is that both
groups of patients received information on manage-
ment of CRFs from the health educator; this would
tend to reduce the contrast between treatment arms.
In addition, the lack of booster training65 and speci-
fic performance feedback for the health educator may
have limited the intervention’s effect. Finally, study
patients had a relatively low risk profile (median
Framingham risk score = 4%) and only 49% attribu-
ted their acute symptoms to possible IHD; the effects
of full counseling may have been more resonant in
a study population at higher risk of cardiovascular
events.
Our results differ from those of the Chest Pain
Evaluation in the Emergency Room (CHEER) sub-
study trial, which showed that two sessions of nurse
care management (NCM) in intermediate-risk CPOU
patients significantly increased adherence to a low-fat
diet and amount of exercise per week; in addition,
blood triglycerides and weight were modestly lower in
the NCM arm of the trial.66 In contrast to the cur-
rent trial (which used cardiac rehabilitation special-
ists), nurse care managers in the CHEER substudy
were able to initiate medications for hyperlipidemia
and to order appropriate referrals (e.g., dietary, social
work). Nurse-led management of multiple risk factors
has also demonstrated promising results in primary
care patients at increased risk of CAD across several
CRF-related outcomes: increased readiness to change
health behaviors,67 increased vegetable consumption
978
Figure 4. Self-reported cardiovascular risk behaviors before and after full or minimal counseling. P-values are shown for the treatment
group x time interaction (i.e., whether the changes in outcome differed between treatment groups during 6-month follow-up).
and physical activity,68 and decreased total choles-
terol.69
Longitudinal analyses of both treatment arms
combined extend the findings of our prior observa-
tional study of CPOU patients by demonstrating
that observed changes in psychological and CRF-
related behaviors were sustained during 6-month fol-
low-up. In the current trial, changes in CRF-related
behaviors were relatively modest and of uncertain
clinical significance. It is noteworthy, however, that
the observed change in fruit and vegetable intake
(~0.5 servings/day) was comparable to that of dietary
intervention trials in primary care outpatients.70,71
Moreover, even modest changes in dietary behavior
have been associated with improved serum choles-
terol and cardiovascular risk,72 which may translate
into important reductions in cardiovascular mortality
at the population level.73 In one systematic review, a
5% reduction in daily energy intake from saturated
Katz et al. • CPOU RISK REDUCTION TRIAL
fats (and replacement with polyunsaturated fats) was
associated with a 13% reduction in risk of IHD
events (RR = 0.87, 95% CI = 0.77–0.97).30
LIMITATIONS
There are several limitations of this trial. First, lower-
than-expected enrollment at the study ED reduced sta-
tistical power to detect small differences in CRF-related
behaviors between treatment arms; however, the
observed effect sizes suggest that inadequate sample
size is an unlikely explanation for the lack of meaning-
ful differences between groups. Second, many patients
in both treatment arms did not recall having received
CRF-related counseling during CPOU admission.
More intensive interventions may be needed to pro-
mote greater patient engagement in counseling. Third,
although we monitored counseling records and
patients’ recall of services received, we did not collect
ACADEMIC EMERGENCY MEDICINE • August 2017, Vol. 24, No. 8 • www.aemj.org
data on the quality of behavioral counseling or adher-
ence to motivational interviewing principles. Fourth, it
was not possible to blind the health educator to treat-
ment assignment; however, she was instructed to use a
standardized approach to cardiovascular risk behaviors
in the full and minimal counseling arms. Fifth, relia-
bility and validity of the psychological and CRF-related
behavioral measures have not been specifically evalu-
ated in the ED setting. In addition, two of the HBM
measures were adapted from a previously validated
questionnaire that was developed for patients with
osteoporosis. Future HBM measures should account
for the ED treatment context and should aim to cap-
ture the patient’s emotional reactions to his/her symp-
toms.74 Sixth, CRF-related behaviors at follow-up were
based solely on self-report and may have been influ-
enced by interviewer bias and social desirability
response bias. To minimize interviewer bias, all
research interviewers were blinded to treatment assign-
ment and administered study questionnaires verbatim.
Seventh, approximately 10% to 15% of patients were
lost to follow-up; however, there was no significant dif-
ference in attrition between treatment arms. Eighth, in
the absence of a true control group (e.g., patients with
modifiable CRFs who were not admitted to a CPOU),
we were unable to determine the extent to which the
observed within-treatment changes reflected patients’
reactions to CPOU admission, intervention effects, or
secular trends. With regard to the latter, it is unlikely
that the observed improvements across the behavioral
measures in this study occurred spontaneously. We
believe that the CPOU admission sensitized patients
to the educational intervention (either minimal or full
counseling). Ninth, although the observed contrasts
between baseline and follow-up were statistically signifi-
cant for several HBM and stage of change measures,
the clinical significance of these changes is uncertain.
Finally, the study sample was recruited from an aca-
demic ED and was predominantly white and well edu-
cated, which limits the generalizability of our findings.
CONCLUSIONS
In summary, a pragmatic, moderate-intensity interven-
tion that focused on increasing motivation to change
and problem-solving skills was not associated with
improved behavioral outcomes, compared to a minimal
counseling intervention. Patients who present to the ED
with symptoms of possible acute coronary syndrome,
however, tend to show sustained changes in selected
979
cardiovascular health beliefs and cardiovascular risk fac-
tor–related behaviors during follow-up, adding further
support to the concept that the chest pain observation
unit visit is a “cue to action.” Future research should
evaluate what components of preventive care counseling
are necessary to produce sustainable changes in cardio-
vascular risk factor–related behaviors. In addition, the
effectiveness of mobile health applications as an adju-
vant to cardiovascular risk factor–related behavioral
counseling in difficult-to-reach ED patients deserve fur-
ther study. In this regard, it is noteworthy that text mes-
saging has been shown to increase abstinence from
smoking75,76 and several trials have shown favorable
results in promoting and sustaining healthy cardiovascu-
lar risk factor–related behaviors in patients with known
ischemic heart disease.77 In addition, future interven-
tions should aim to build upon chest pain observation
unit–initiated preventive care in coordination with pri-
mary care or outpatient cardiac rehabilitation.
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Supporting Information
The following supporting information is available in
the online version of this paper available at http://
onlinelibrary.wiley.com/doi/10.1111/acem.13231/full
Data Supplement S1. Summary of key measures.