Community Ment Health J (2016) 52:667–674

A Randomized Clinical Trial Investigating the Effect

of a Healthcare Access Model for Individuals with Severe
Psychiatric Disabilities
E. Sally Rogers1 • Mihoko Maru1,3 • Megan Kash-MacDonald1,4 • Mariah Archer-Williams1,5 • Lobat
Hashemi1,6 • Judith Boardman2,7

Received: 10 December 2015/Accepted: 7 April 2016/Published online: 2 May 2016

Springer Science+Business Media New York 2016 6
Present Address: Genzyme, Sanofi, Boston, MA, USA
7
Present Address: Salem State University, Salem, MA, USA
Abstract We conducted a randomized trial to examine a
model for integrating primary care into a community mental
health setting. Two hundred individuals were recruited and
randomly assigned to receive primary care delivered by a
nurse practitioner (n = 94) or services-asusual (n = 106),
assessed on health and mental health outcomes, and
followed for 12 months. Intent-to-Treat and exposure
analyses were conducted and suggest that participants who
engaged with the nurse practitioner experienced gains in
perceptions of primary care quality. Health benefits accrued
for individuals having receiving nurse practitioner services
in a mental health setting to address primary care needs. Introduction

Keywords Primary care Integrated care Physical health
Coordination of care Morbidity and mortality
Nurse practitioner
& E. Sally Rogers erogers@bu.edu
1 Health Services Administration 2012; Weber et al. 2011)
Center for Psychiatric Rehabilitation, Boston University, 940
Commonwealth Ave, West, Boston, MA, USA
2 Saha et al. 2007; Currie et al. 2014; Almeida et al. 2014).
Northeast Health Systems/Health and Education Services, Inc.,
Beverly, MA, USA
3
Present Address: Boston University School of Social Work,
Boston, MA, USA
4
Present Address: Institute of Child Health, University
College London (UCL), London, England
5
Present Address: Sharp HealthCare, San Diego, CA, USA
There is burgeoning evidence that individuals with severe
psychiatric disabilities experience higher than average rates
of chronic and life-threatening diseases, including, among
others, diabetes, cardiovascular disease, and pulmonary
diseases, all of which lead to premature mortality and
elevated rates of morbidity within the United States
(Capasso et al. 2008; Chaco´n et al. 2011; Chafetz et al.
2006; Colton and Manderscheid 2006; Lambert et al. 2003;
Scott and Happell 2011; Substance Abuse and Mental
and throughout the world (Harris and Barraclough 1998;
Studies suggests that this excess mortality and morbidity are
influenced by problems of healthcare access,
socioeconomic, and clinical risk factors (Almeida et al.
2014; Druss et al. 2011). This accumulating evidence has
prompted an increased emphasis on improved physical
health as an important dimension in promoting recovery
(Hutchinson et al. 2006; Substance Abuse and Mental

123
668
Health Services Administration, & Center for Behavioral
Health Statistics and Quality 2009; Druss and Mauer 2010),
research on new interventions to promote health and
wellness (Druss et al. 2010a, b), as well as a focus on
comprehensive and coordinated treatment (Parks et al.
2006; President’s New Freedom Commission on Mental
Health 2003; Thompson et al. 2006).
Individuals with psychiatric disabilities may have more
limited access to primary care providers (Crews et al. 1998;
Miller et al. 2003), may fail to seek healthcare (Hahm and
Segal 2005), or may have fewer visits to healthcare
providers than individuals without psychiatric disabilities
even when primary care is accessible to them (Chwastiak et
al. 2008; Copeland et al. 2009; CradockO’Leary et al. 2002).
All of these factors may contribute to the high incidence of
medical co-morbidities and mortality (Crews et al. 1998;
Miller et al. 2003; Lawrence and Kisely 2010; Druss et al.
2011). A lack of coordination and continuity of care as well
as a lack of integration of primary and mental health care
may compromise the medical care that individuals with
psychiatric disabilities do receive (Cradock-O’Leary et al.
2002; McCabe and Leas 2008; Lawrence and Kisely 2010).
Systemic and provider-level factors have also been
implicated in qualitative studies including problems related
access and integration (Pahwa et al. 2010; Kaufman et al.
2012) as well as non-medical reasons such as societal stigma
and self-stigma (Pahwa et al. 2010; Borba et al. 2012; Van
Den Tillaart et al. 2009). Negative attitudes among
healthcare providers have been cited in several studies as an
important factor, leading to poor communication with
primary care providers and the provision of less than
adequate care (McCabe and Leas 2008; Lester et al.
2005;Pahwa et al. 2010; Van Den Tillaart et al. 2009). Taken
together, studies suggest a variety of systemic,
programmatic and patientlevel barriers to providing
healthcare for individuals with mental illness. Some
researchers argue that with the advent of healthcare reform
we are at a pivotal time for affecting the health and
healthcare for individuals with serious mental illness (Druss
and Bornemann 2010).
Recently, interventions have been developed to address
the physical health status of individuals with mental illness,
some with a focus on increasing care integration, access to
services, or the use of education to promote health
awareness, self-care, and weight loss (Brown et al. 2011;
Daumit et al. 2002; Dobscha and Ganzini 2001; Druss et al.
2010b; Felker et al. 1998; Forsberg et al. 2010;
Lindenmayer et al. 2009). At the time this study was
conducted, no research had tested the effectiveness of
adding a nurse practitioner to improve health outcomes. We
undertook this study to examine a model designed to
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Community Ment Health J (2016) 52:667–674
coordinate and integrate primary and mental health care and
hypothesized that this approach would increase access and
improve healthcare integration, functioning, perceived
health status, health locus of control and beliefs, and
symptoms.
All procedures and materials were approved by two
Institutional Review Boards: the Boston University IRB and
the IRB of the Health and Education Services (the partner
behavioral healthcare organization). The authors have no
known Conflicts of Interests to declare.
Methods
We collaborated with a large, not-for-profit healthcare
provider to examine healthcare access and integration as
well as perceived health status of individuals with
psychiatric disabilities being treated in their community
mental health settings. The study was conducted from 2005
to 2010. All adults enrolled in the study provided written
informed consent using IRB approved procedures and
materials.
Sample
Our behavioral health care collaborator provided outpatient
mental health services, psychopharmacological, residential,
and day services for individuals with severe psychiatric
disabilities in three medium-sized cities that served as sites
for the intervention. The behavioral healthcare organization
was part of a larger, parent healthcare organization that
provided both inpatient mental health and physical health
services. Study inclusion criteria targeted individuals: (1)
with serious mental illness who were eligible for public
behavioral healthcare; (2) actively receiving mental health
services-as-usual; (3) who were able to provide full and
knowing consent at the time of enrollment; (4) who were
willing to meet with a nurse practitioner for the purposes of
assessing and improving their health status. Exclusion
criteria included individuals who: (1) were highly
symptomatic at the time of study enrollment; (2) were
unwilling to
participateintheresearchassessments.Foronecliniclocation,a
high number of individuals of Latino/a descent were
enrolled. For that population, we hired a Spanish speaking
interviewer and translated all assessment materials into
Spanish. Recruitment and Enrollment
Research staff visit three community based service delivery
locations as well as day and residential programs of the
behavioral healthcare provider to explain the nature of the
Community Ment Health J (2016) 52:667–674
study and to recruit potentially interested service recipients.
After a complete description of the study and screening for
inclusion criteria, we consented and enrolled n = 200
individuals and performed baseline interviews. Individuals
were then randomly assigned using a computer generated
schedule with n = 94 assigned to the experimental condition
[nurse practitioner (NP) condition] and n = 106 to an
enhanced services-as-usual control condition. We stratified
the randomization on the following factors: (1) perceived
health at baseline that was assessed during screening (very
good, good, poor, or very poor), (2) gender, and (3) race/
ethnicity (minority versus non-minority). Recruitment and
enrollment took place from 2006 until 2009. A total of 279
individuals were screened; of those 79 individuals were not
enrolled because they declined participation or they did not
meet inclusion criteria.
Experimental Intervention
The experimental intervention consisted of appointments
with a nurse practitioner (NP) who was employed by and
stationed in the community mental health setting. The
location of the NP was deemed critical because it facilitated
access for individuals with psychiatric disabilities to obtain
or supplement their primary care services within the agency
where they made frequent visits. In addition to access by the
clients served, the location of the NP facilitated access by
the mental health providers to the NP, which allowed for the
free exchange of information and interaction between about
clients’ health needs. Having the NP employed by the
mental healthcare provider allowed us to go beyond simple
co-location and eliminate systemic barriers related to
confidentiality; this in turn promoted communication,
collaboration, and integration of health and mental health
services. The NP intervention was designed to be patient-
centered and comprehensive. The NP was instructed to: (1)
insure that each experimental study participant was
receiving coordinated healthcare; (2) complement and
coordinate, but not replace, primary healthcare the
individual was already receiving (each participant was told
that they did not have to give up their primary care provider
if they had one); (3) address issues related to the individual’s
psychiatric condition that might be affecting their physical
well-being, i.e., to integrate health and mental healthcare;
(4) promote the individual’s wellness through lifestyle,
nutrition and exercise counseling; and (5) facilitate access
to specialty care (e.g., dental and eye care most frequently).
Individuals were informed that a minimum of three
appointments with the NP were required for the purposes of
assessment and planning, but more appointments were
669
encouraged, as needed and desired by the participant and
agreed upon with the NP. Fidelity of the NP Intervention
The NP intervention was designed provide primary care and
as such, had to be individualized to the participant’s needs
and expressed desire for primary care. Thus, a structured
and manualized intervention was not deemed possible.
However, the NP followed structured practice guidelines
(State of Massachusetts, Department of Health and Human
Services 2015) that included a full health assessment,
diagnosis, and planning. The NP was overseen by a
supervising physician in the community and all intervention
sessions were recorded. Of those exposed to the NP
intervention, the number of visits ranged from 1 to 18 (24 %
had 1 visit; 32 % had 2 visits; 17 % had 3–4 visits and the
remainder had between 5 and 18 visits).
Control Intervention
The control intervention consisted of mental health services-
as-usual and the addition of monthly educational sessions
called ‘‘Wellness Days’’. Control participants received an
invitation to attend 1-h group sessions on topics relevant to
their health such as: Diabetes Awareness, Women’s Health,
Men’s Health, Dental Care, Healthy Sleep, and Foot Care
among others. For logistical reasons, it was not possible to
track the number of individuals who took advantage of these
open-invitation control group sessions.
Research Procedures
Individuals who were recruited into the study were assessed
at baseline by a trained research interviewer and followed
up via face-to-face interviews at 3, 6, and 12 months after
enrollment in the study. The following measures were used
to measure outcomes:
1. The SF-36 was used to measure limitations in physical
and role activities due to health problems, bodily pain,
general health perceptions, vitality, limitations in social
and role activities due to physical and emotional
problems, psychological distress and well-being. We
found good internal consistency in this study using
subscales (.87).
2. The Treatment Outcome Package (TOP), a 58-item
instrument developed by Kraus et al. (2005) was used
to assess physical symptoms, satisfaction with various
domains in life, psychiatric symptoms (e.g., anxiety,
depression), and functioning (e.g., working, performing
in school). The TOP has an excellent factor structure,
good test–retest reliability, promising convergent and
670
discriminant validity. We found good internal
consistency in this study for subscales of this measure
at 0.79.
3. The Multidimensional Health Locus of Control
(MHLC)—Form A (Wallston and Wallston 1982;
Wallston et al. 1978) was used to measure beliefs about
factors exerting control over one’s health reflecting
internal forces, the forces of powerful others, and
chance. Internal consistency in this study was .82.
4. The Health Beliefs Questionnaire was used to measure
individual’s perception of benefits and barriers to
seeking medical care, the severity and susceptibility of
their health, health motivation, and self-efficacy
regarding health issues. The internal consistency
obtained in this study was .87.
5. The Primary Care Assessment Tool (PCAT; Starfield
1998) was used to assess the perceived quality of
primary healthcare including access to, and utilization
of care, ongoing care, comprehensiveness of care,
family and community orientation as well as cultural
sensitivity of their provider, and coordination of care.
The PCAT has demonstrated excellent reliability and
validity (Starfield 1998). (We did not calculate internal
consistency as the instrument does not lend itself to
such calculations).
6. Nutrition, Prevention and Exercise Questions. We used
the Centers for Disease Control and Prevention health
surveys to obtain self-reported smoking habits,
nutritional habits, exercise patterns and the use of
preventative healthcare assessments (U.S. Department
of Health and Human Services 2011a, b). Questions
included whether the individual had recently received
specific preventative exams (e.g., eye or dental exam,
or pap smear for women) as well as questions about
exercise and diet (e.g., questions about smoking, the
amount of physical activity the person engages in, and
eating habits such as consumption of fruits, vegetables,
soda, etc.).
We carefully monitored and followed up with study
participants to prevent attrition and insure complete data
collection. Of the n = 200 study participants enrolled in the
study, 159 (almost 80 %) completed at least 2 followup
assessments. We also monitored delivery of the
experimental services to facilitate the NP intervention for all
experimental participants.
Statistical Analysis
We performed Intent-to-Treat (ITT) analyses on all subjects
who were randomized using SPSS 15.0 and SAS 9.1. After
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checking for accuracy of the data, we conducted t-tests and
Chi square analyses to check for baseline equivalency.
Mixed linear regression analyses were employed to assess
differences between groups across all repeated outcome
measures using baseline scores as covariates and controlling
for gender, age, minority status, and diagnostic category.
Results
Demographics
Study participants at baseline were largely white (85 %),
more often female (67 %), approximately 43.5 (SD = 10.9)
years of age on average, and largely unmarried (only 12 %
reported being married or living with a partner; 54 % were
never married; 30 % were divorced or separated; 5 %
widowed). In terms of educational attainment, 76 % had a
high school degree or beyond. The vast majority were living
independently in the community (about 72 %) and about 12
% were engaged in paid work. A large percentage were
diagnosed with major depressive disorder (40 %), while 21
% were diagnosed with schizophrenia-spectrum disorder,
23 % with bipolar disorder, 11 % with anxiety disorders, and
the remainder, with other disorders. Fully 95 % of
participants were taking psychotropic medication and
almost all reported being on SSI or SSDI (49 % on SSI; 55
% on SSDI and a small percentage on both). An
unexpectedly large percentage of individuals had a primary
healthcare provider at study entry (93 %) as indicated by the
baseline PCAT. There were no statistically significant
differences between the experimental and control conditions
on these variables.
Intent-to-Treat (ITT)
We found two significant differences in outcomes between
the experimental and control groups in outcomes in the ITT
analyses: the PCAT the subscale measuring Continuity of
Care (F = 2.73, df = 3,430, p = .04) and the Community
Orientation of the primary care provider (F = 2.71, df =
3,412, p = .05). Several other trends in the desired direction
were found, but those results did not achieve statistical
significance. Those included the Powerful Others subscale
of the Multi-Dimensional Health Locus of Control (F =
2.44, df = 3,453, p = .06), the Future Health concerns of the
Health Beliefs Questionnaire (F = 2.27, df = 3,450, p = .08),
and the Utilization subscale of the PCAT (F = 2.25, df =
3,433, p = .08).
Community Ment Health J (2016) 52:667–674
Treatment Exposure Analyses
Because the ITT analyses did not take into account actual
receipt of nurse practitioner services and because 25 % of
the experimental group was not exposed at all to the NP
intervention, we conducted additional analyses that factored
in intensity of the experimental intervention. We created an
exposure variable using administrative data provided by the
behavioral healthcare provider. These data were quite
skewed so we calculated a categorical variable with the
following levels: (1) individuals who received no NP
services became the control group—including individuals
originally randomized to the control group as well as
individuals randomized to the E group who did not receive
the NP intervention; (2) individuals who had Moderate
Exposure (between 1 and 3 NP sessions); and (3) individuals
who had the High Exposure (4 or more sessions with the
NP). This 3-level variable was then used in the exposure
analyses to test the effect of intervention intensity on
outcomes.
When we included intervention intensity in the mixed
linear regression models several significant results emerged
on the Primary Care Assessment Tool (PCAT) measuring
access to and integration of primary healthcare. The
Moderate Exposure group, when compared to controls,
showed statistically significant better scores on Access to
primary care (F = 3.56, df = 3,412, p = .01),
Comprehensiveness of Care (F = 3.42, df = 3,419, p = .02)
and Community Orientation of the provider (F = 4.00, df =
3,387, p = .008). The High Exposure group when compared
to controls reported improved scores on the Coordination of
Information and Utilization subscales of the PCAT (F =
2.64, df = 3,414, p = .05). Several trends were also noted:
the High Exposure group, when compared to controls,
experienced an improvement in the subscale measuring
engagement with violence on the TOP and work functioning
(F = 2.21, df = 3,449, p = .09; F = 2.39, df = 3,439, p = .07,
respectively).
There were two paradoxical findings on the SF-36: the
control group made significantly more gains in social
functioning than the High Exposure group (F = 3.93, df =
3,448, p = .01) and more gains than the Moderate Exposure
group in reported general health status (F = 2.30, df = 3,449,
p = .08).
Exercise, Nutrition, and Wellness Outcomes
We examined a variety of additional outcomes, including
questions about participation in exercise, nutritional habits,
and the number of preventative health tests participants had
had (e.g. mammograms or pap smears for women, prostate
671
exams for men over a certain age) from the Center for
Disease Control and Prevention population surveys. We
found no difference between experimental and control
participants over time in their adoption of healthy lifestyle
habits as measured by these questions (results not shown).
The authors assume responsibility for all research
procedures.
Discussion
We conducted this clinical trial to examine the effectiveness
of improving access to and integration of primary health and
behavioral healthcare by having a nurse practitioner
employed by and stationed in a community mental health
setting and delivering services alongside mental health
providers. We found great receptivity for this approach by
clients themselves and by mental healthcare providers and
administrators (Mesidor et al. 2011) and modest evidence of
its effect on perceived health status and functioning. These
findings are similar to a small randomized study testing a
lifestyle intervention program (Forsberg et al. 2010).
Of study participants who did partake of the NP
intervention, improvements in some aspects of their primary
care did accrue. Individuals who received NP services
experienced improvements in access to and coordination of
information around their primary care as well as the
community orientation of their primary care provider. We
considered these findings to be important and consistent
with the aim of the intervention. Disappointingly however,
the NP intervention appeared to have little effect on
perceived health or on adoption of healthy lifestyle
behaviors. Study Limitations
Many of the individuals randomized to the experimental
condition did not engage in the NP intervention despite
expressing strong wishes to do so at recruitment, thus
limiting the conclusions about effectiveness that we could
draw from the Intent-to-Treat (ITT) analyses. Our
secondary analyses were conducted to shed light on trends,
but because it was not as rigorous as the ITT analyses, can
only be considered suggestive. We speculate that though
individuals may have had a desire to receive NP services at
enrollment, many may not have been sufficiently compelled
by serious healthcare problems to follow through with their
NP visits. Further, individuals who did engage with the NP
had more health problems and perceived disability at
baseline. This suggests that very poor perceived health or
significant health problems may be a prerequisite for
individuals to partake of an intervention of this kind.
Including a component that can increase patient activation,
672
or desire to engage in the intervention, may be a logical next
step in research into such health and wellness interventions
for individuals with serious psychiatric disabilities.
Another limitation relates to the ability to generalize out
of the state in which this study took place. Massachusetts
provided greater access to healthcare than many others at the
time the study was conducted (Dhingra et al. 2013). Such
ready access to healthcare may mean that individuals in our
study, compared to other states, may not have perceived as
great a need for NP services given that access to care was
not problematic for them. Another limitation could be the
variety of effects the NP intervention was designed to
address. The overarching goal was to insure comprehensive
and coordinated primary care, which meant that the NP
services were individualized based on each study
participants’ primary and specialty care needs. This may
have diluted the effect that we were able to ascertain. Simply
complementing primary care without a structured and
intensive curriculum to affect lifestyle changes in particular
may be insufficient to affect that outcome.
Conclusions
Having a nurse practitioner employed by and stationed in a
community mental health setting and working alongside
mental health providers may be a viable way to promote
access to and integration of primary mental healthcare for
individuals with significant psychiatric disabilities. This
model may also help to provide a holistic, multidisciplinary
approach to healthcare as recommended by providers
(Vreeland 2007), particularly if the NP is knowledgeable
about medical comorbidities and the psychiatric and health
issues that can arise from psychopharmacological
treatments in this population. Integration can be achieved by
having the NP not simply co-located in the behavioral
healthcare setting, but involved as an integral member of the
mental healthcare team, which can improve formal and
informal communication about clients’ needs. The NP is
also able to deliver wellness services which are critical and
which many mental healthcare providers do not have the
time or expertise to deliver. Despite this, the study also
suggests that changing perceptions of one’s health status or
the adoption of healthy lifestyle behaviors is very difficult
to achieve.
The delivery of integrated care, education to promote
healthy lifestyle and health promotion interventions is an
important consideration given the high rates of
comorbidities and premature mortality among individuals
with severe mental illness (Dixon et al. 2000; Jones et al.
2004; Newcomer 2008). Having an NP employed as part of
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Community Ment Health J (2016) 52:667–674
the mental health team and stationed in a behavioral
healthcare setting is a way of realizing the new direction
needed to promote the health of individuals with psychiatric
disabilities, to go beyond stabilization and maintenance of
psychiatric symptoms, and to achieve overall good health
and wellness as measured by a lifespan that parallels that of
the general population (Substance Abuse and Mental Health
Services Administration, & Center for Behavioral Health
Statistics and Quality 2011).
Acknowledgments This study was funded by the National Institute on
Disability and Rehabilitation Research and the Substance Abuse and
Mental Health Services Administration, #H133B040026. The results
do not express the opinions of the funding bodies. The authors would
like to thank the following individuals who were instrumental in the
conduct of this study: Northeast Health Systems, Louise Sebba and
Kathleen MacDonald.
Compliance with Ethical Standards
Conflict of interest None for any author.
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