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Angeles RN. Developing A Theorethical Framewor For Complex CB Interventions
Angeles RN. Developing A Theorethical Framewor For Complex CB Interventions
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What is This?
1
are complex interventions. This is because of the num- combined composite of myocardial infarction, stroke,
ber and complexity of health risk behaviors targeted by and congestive heart failure (Kaczorowski et al., 2011).
these programs as well as the multiple levels of action CHAP was developed to become a standardized pro-
(individual education, health policy interventions, gram through a series of pilot and demonstration stud-
community education, etc.) required to promote ies. The different components were evaluated through
healthy behaviors. Developing theoretical frameworks empirical testing based on challenges encountered in
for such interventions may not be as straightforward as the field. Studies were undertaken to assess participants’
with single-component interventions. It may require perception of CHAP and develop strategies to enhance
more reflection and discussion with experts, research peer educator retention (Pora, Farrell, Dolovich,
team members, and stakeholders to understand the Kaczorowski, & Chambers, 2005), determine how to best
interaction between different aspects of the interven- invite community residents to participate in CHAP
tion and the setting in which it is applied (Grol et al., (Karwalajtys et al., 2005), and understand the roles and
2007). experiences of peer volunteers delivering the CHAP ses-
The Cardiovascular Health Awareness Program sions (Karwalajtys et al., 2009). However, a comprehen-
(CHAP) is an example of a complex community inter- sive theoretical framework was not developed or
vention with several interacting components affecting formally articulated at the time the project was initiated.
multiple behaviors and populations. It has been This article proposes a guide on how to develop a
designed to be flexible enough so that it can be tailored theoretical framework for complex interventions. This
to fit the local context. Briefly, CHAP is a community- guide is meant for researchers who are involved in
based, primary care–centered, volunteer peer–led, free- developing, implementing, and evaluating health pro-
of-charge, cardiovascular disease (CVD) risk assessment motion and disease prevention programs. It was pre-
and blood pressure (BP)–monitoring program for com- pared based on an extensive literature review of journal
munity-dwelling older adults (Kaczorowski et al., articles and books regarding developing a conceptual
2008). The CHAP intervention consists of regularly or theoretical framework with a special emphasis on
scheduled, community-based, 3-hour BP and cardio- complex interventions. The author applied the guide,
vascular risk factor assessments combined with educa- using the CHAP as an example, and in the process did
tion sessions conducted by trained volunteer peer validation of the theoretical framework by stakeholders
health educators measuring BP using a validated, auto- involved in CHAP.
mated instrument (BpTRU™). BP readings and data on
cardiovascular risk factors are recorded and, with par-
ticipants’ consent, sent to their family physician and
>PROCESS IN DEVELOPING A
THEORETICAL FRAMEWORK
usual pharmacist. Volunteer peer educators promote
self-management by providing participants with a copy Identifying the Essential Elements of CHAP
of their risk profile, risk-specific educational materials, Before developing a theoretical framework for com-
and information on the availability of and access to plex interventions such as CHAP, its essential elements
local community resources. A community health nurse (also called core elements or active ingredients) need
or on-site pharmacist ensures immediate follow-up of to be identified and described (Craig et al., 2008;
participants identified as being at high risk based on Greenhalgh, Robert, Macfarlane, Bate, & Kyriakidou,
their systolic BP level. Fax-to-database technology is 2004). These elements give the intervention its theo-
used to compile and send individual patient data to retical and pragmatic basis and are thought to account
family physicians and pharmacists. Comparative audit for the intervention’s effectiveness (Gearing et al.,
and feedback results are sent to participating family 2011). Essential elements are characteristics that define
physicians. Local lead organizations (LLOs) use opin- the intervention or the minimum requirements for the
ion leaders and peers to gain the support and participa- intervention, without which it cannot be labeled as that
tion of family physicians and pharmacists. The research specified intervention. For CHAP we have categorized
team provided central support and a networking func- these elements into process, organization, and contex-
tion for communities delivering the intervention. The tual components (Table 1).
CHAP website (www.chapprogram.ca) provides easily
accessible, comprehensive, and practical information Developing the Theoretical Framework for CHAP
and tools supporting CHAP implementation and ongo-
ing functioning. A 39-community cluster randomized Developing a theoretical framework is usually a pro-
trial showed that CHAP significantly decreased annual spective process that is done prior to implementation
hospitalization rates at the community level for a of the study or intervention. Although the intervention
example highlighted in this article has already been Another issue to consider is that the dependent
tested, the steps taken can still ably illustrate this pro- variables may be multiple in the case of complex
cess. This article presents a general systematic process, interventions (Craig et al., 2008). There may also be
which is not meant to be a rigid guide but rather is a several mediating variables or outcomes in the process
reflective process so that important aspects in develop- that need to be identified.
ing the theoretical framework will not be missed. In addition, the importance of the context especially
when dealing with complex community interventions
Step 1: Identify the Variables and the Context. Ini- (Wang, Moss, & Hiller, 2006) needs to be described.
tially, the different variables (independent, dependent, This includes population base (culture, personal, social
mediating/intervening, moderating, and control) to be characteristics) context (Gearing et al., 2011), within-
included in the model need to be identified and defined. systems organization and external neighboring organi-
Standard definitions of these variables based on the lit- zation context (Denis, Hébert, Langley, Lozeau, &
erature will be applied. A number of resources can be Trottier, 2002; Greenhalgh et al., 2004), sociopolitical
used to provide standard definitions (Baron & Kenny, context (Fleuren, Wiefferink, & Paulussen, 2004), and
1986; Cresswell & Plano Clark, 2009; Ogilvie et al., others. Some context aspects can be considered moder-
2011); however, a few key points will be emphasized ating (including clustering or nesting variables) or con-
below. trol variables.
The independent variable (complex intervention) can In this step, we use Table 2 as a template to help
be taken as a whole or broken down into its key compo- visualize the many variables involved in the program.
nents (or essential elements)—if component evaluation
is desired (Craig et al., 2008). Component evaluation Step 2: List Down Postulated Mechanisms, Mediating
may not be feasible or necessary for complex interven- Variables, and Postulated Outcomes. A second useful
tions in which the various components are packaged step is to establish the postulated mechanisms of how
together. Nevertheless, itemizing them individually may the independent variable will lead to the dependent
be beneficial to determine if the developers have consid- variable while specifying the different mediating vari-
ered all the mechanisms of the intervention. ables. Each essential element can be viewed separately
Context
NOTE: CHAP = Cardiovascular Health Awareness Program; BP = blood pressure; CV = cardiovascular; MI = myocardial infarction;
CHF = congestive heart failure.
to see how it contributes to influencing the outcome. determine if theoretical frameworks in these studies
For certain complex interventions, the effects of each apply to their planned study.
element cannot be separated from the other elements In the area of complex interventions, combining
but instead the elements exist as uncoordinated cumu- theories may be useful to explain the entire mecha-
lative effects (Dearing, 2008). nism of how the intervention can work (Ogilvie et al.,
The main postulated mechanisms of CHAP are that 2011). This depends on how complex the interven-
it enhances the awareness of the importance of BP tion is, how proximal the relationship of the inde-
monitoring and management and reduction of modifi- pendent variable is to the dependent variable. In the
able cardiovascular risk factors (Kaczorowski et al., case of the CHAP intervention, none of the essential
2008; Pora et al., 2005), raises the participants’ aware- elements are proximally related to the outcome of
ness of their high BP, and informs their pharmacists interest. Our team identified the “diffusion of innova-
and physicians about their CVD risk profiles and cur- tion theory” and the “health belief model” as most
rent BP status (Pora et al., 2005). This and other postu- applicable to CHAP and combined them to develop
lated mechanisms are outlined in Table 3. our framework.
The diffusion of innovation theory, whose earlier ver-
sion was based on rural sociology (Dearing, 2008; Rogers,
Step 3: Identify Existing Theoretical Models Support- 2003; Rogers & Scott, 1997), has evolved, and its applica-
ing the Theoretical Framework Under Development. tion has expanded to include diffusion of health infor-
Identifying and selecting existing theoretical models mation. It states that the process of adoption of innovation
can be challenging step. Grol et al. (2007) provide a (new knowledge or information, practice, behavior) goes
comprehensive list of theories related to patient care. through four main stages—dissemination, adoption,
Researchers can also review related literature and implementation, and continuation (Dingfelder &
Education regarding CV risk factors through the Improved awareness regarding Changes in modifiable risk
CHAP sessions and referrals to family physicians/ susceptibility for CV behaviors
pharmacists and partner organizations complications Increased use of community
Improved awareness regarding health resources
consequences and Better BP control
management of CV risk factors
Awareness regarding the benefit
of CHAP
Improved self-efficacy in the
management of risk factors
Regular BP monitoring through CHAP sessions Improved awareness regarding Better BP control
susceptibility for CV
complications
Improved self-efficacy in the
management of risk factors
BP and CV risk information sent to family physicians/ Better BP control
pharmacists, leading them to initiate medications or
adjust therapy for patients with high BP and help
them adhere to prescribed management guidelines
Partner organization assisting CHAP participants in Improved self-efficacy in the Changes (or improvements)
managing specific risk factors management of risk factors in modifiable risk
behaviors
Mandell, 2011; Fleuren et al., 2004)—and there are spe- The health belief model, on the other hand, was cho-
cific determinants in each stage that promote or dis- sen to explain how individuals attending CHAP were
courage the adoption of the innovation. Furthermore, influenced to adopt healthy behaviors. The health
individuals go through processes of awareness, persua- belief model states that health-related action/behavior
sion, decision, implementation, and continuation depends on three classes of factors: (a) existence of suf-
(Dingfelder & Mandell, 2011; Fleuren et al., 2004), ficient motivation (health concern), (b) belief that one
which are important to understand so that appropriate is susceptible to a serious problem (vulnerability), and
interventions can influence adoption of the innovation. (c) belief that a health recommendation would be ben-
Numerous studies regarding the diffusion theory eficial in reducing the threat at a subjectively accepta-
attempted to identify the determinants of diffusion at dif- ble cost. This also depends on perceived self-efficacy to
ferent levels (individual, social, organizational, profes- adopt the health-related actions (Rosenstock et al.,
sional, community, country). Greenhalgh et al. (2004) 1988). Other theorists coin the factors as perceived
conducted an extensive review of the evidence of the threat (susceptibility and severity), perceived benefit,
determinants of diffusion and summarized the different perceived barriers, and cues to action (motivation;
factors affecting the adoption process based on the user Denison, 2004; Janz & Becker, 1984).
context and outer context (factors related to the innova-
tion, diffusion, and dissemination process). This theory Step 4: Script the Theoretical Model Into Either a Figure
was chosen to explain how the multiple interventions or Sets of Statements. Based on Table 3 (Step 2) and
and strategies used in CHAP mutually influence and with the background knowledge of the theories explain-
reinforce individuals to attend the CHAP sessions (the ing the mechanisms, the theoretical framework can be
innovation). constructed. The theoretical model can be written in
different ways, but the common practice is to draft it as of benefits of attending CHAP, improved self-efficacy in
a series of hypothesis, if–then logic statements, or a management of risk factors) reshaping the health belief
visual model (Cresswell & Plano Clark, 2009). For system of the participants. The combination of the
CHAP, a visual model was chosen to represent its theo- activities during CHAP sessions and actions by family
retical framework (Figure 1). physicians, pharmacists, and partner organizations will
The CHAP framework can be visualized as a series of improve health awareness/self-efficacy and will lead to
interrelated steps. CHAP participants (adopters) undergo individual patient outcomes (increased use of commu-
stages of awareness, persuasion, and adoption of the nity resources, decreased modifiable risk behaviors,
innovation (attendance to CHAP sessions), which is ini- better BP control) as well as community-level outcomes
tially influenced (information and persuasion) through (decrease in hospitalization and deaths because of
CHAP promotion activities by the LLO and family phy- stroke, myocardial infarction, and congestive heart fail-
sicians/pharmacists. Once the participants attend the ure). All these actions and outcomes loop back to make
CHAP sessions, this leads to a series of actions (infor- more community residents aware of CHAP and per-
mation sent to family physicians and referral to com- suade more residents to attend the CHAP sessions
munity health resources), which in turn leads to either through early adopters influencing the social
mediating outcomes (improved awareness of suscepti- environment or through social pressure to adopt an
bility, improved awareness of consequences, awareness innovation that others have done.