INTERVENTION THEORY

ACTIVE INGREDIENTS

5.1 INTERVENTION THEORY

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Nursing and Health Interventions: Design, Evaluation, and Implementation, Second Edition.

Souraya Sidani and Carrie Jo Braden.

C H A P T E R 5

The importance of developing the theory of the problem, the theory of implementation, and the theory of change is well recognized and emphasized in recent guidance for the design, delivery, and evaluation of health interventions (Bar- tholomew et al., 2016; Medical Research Guidance, 2019). The theory of the problem makes explicit the aspects of the health problem amenable to change and addressed by the intervention. The theory of implementation describes and justifies the active ingredients, operationalized into specific components that characterize the intervention. The theory of change delineates the mechanism through which the intervention produces beneficial outcomes related to the prevention, management, or resolution of the health problem and the mitigation of its consequences. Whereas each of these theories is important and useful for designing an intervention, their integration into the intervention theory is critical for a comprehensive understanding of the intervention, the context of its delivery, and its mechanism of action.

This understanding forms the foundation for the development of materials and the mobilization of resources needed to deliver the intervention; the actual delivery of the intervention with fidelity, which is necessary to initiate its mechanism of action;

and the design and conduct of a study to evaluate the intervention. In this chapter, the elements of the intervention theory are described. The importance of the theory in guiding the actual delivery of the intervention, and the design and conduct of an evaluation study is discussed.

The intervention theory describes the health problem, the intervention, and the outcomes; explains the associations among them; specifies the conditions that may influence the associations; and offers directions for implementing the intervention (Dalkin et al., 2015; Davidoff et al., 2015; Slater & Kothari, 2014).

Three configurations are proposed to organize the elements of the intervention theory. The terms used in these configurations are presented in Table 5.1.

Despite differences in terminology, the following specific elements are commonly identified.

5.1.1 Experience of the Health Problem

The intervention theory: (1) identifies and defines, at the conceptual and operational levels, the health problem addressed by the intervention; (2) clarifies and defines, at the conceptual and operational levels, the aspects (indicators, determinants) of the problem that are potentially modifiable and targeted by the intervention; and (3) explains the reasons for focusing on the selected aspects of the problem. For tailored and adaptive interventions, the theory describes variability in clients’ characteristics and/or experience of the problem (i.e. tailoring variables) that should be attended and accounted for in the process of customizing the intervention.

TABLE 5.1 Configurations of intervention theory.

Configuration 1 Configuration 2 Configuration 3

Field Program evaluation Healthcare organization Realist evaluation Sources Chen et al. (2018)

US General Accountability office (2012)

Sidani and Sechrest (1999) Dalkin et al. (2015) De Souza (2013)

Greenhalgh et al. (2015) Pawson and Manzano- Santaella (2012) Wong et al. (2012) Elements and

definitions Situation = problem that intervention attempts to address and context in which intervention is delivered

Input = resources required for intervention delivery

Activities = actions, therapies, or processes comprising intervention Outcomes = changes in clients’ condition, including intended and unintended immediate, intermediate, and ultimate outcomes

Structure = characteristics of clients receiving intervention, characteristics of health professionals delivering intervention, characteristics of context in which

intervention is delivered Process = intervention components

Outcomes = series of changes leading to ultimate outcomes

Context = conditions or circumstances in which intervention is introduced, encompassing resources and contextual factors that may moderate (enable or prevent) mechanisms and outcomes

Mechanism = processes through which intervention components produce outcomes

Outcome = intended and unintended changes in clients’ condition

5.1 Intervention Theory

103 5.1.2 Client Factors

The intervention theory identifies client factors that influence their: experience of the health problem, perception of the intervention, capacity to engage in the planned intervention activities, ability to enact the treatment recommendations, and experience of the immediate and intermediate (i.e. mediators) outcomes, as well as the ultimate outcomes. The theory explains why and how the factors exert their influence.

Influential client factors can be categorized into personal and health or clinical characteristics, and accessibility of resources, as mentioned and illustrated in Chapter 3. Personal characteristics encompass sociodemographic profile, and personal or cultural beliefs about health in general and the health problem and its treatment.

Health or clinical characteristics represent individuals’ physical, cognitive, and psychosocial functioning, presence of concurrent comorbid physical or mental conditions, and receipt of pharmacological and non-pharmacological therapies to manage the health problem and the comorbid conditions. Accessibility reflects the availability and clients’ ability to access or use resources required to engage in the intervention (e.g. transportation to attend the group sessions in-person) and to enact treatment recommendations (e.g. physical, social, financial resources). For tailored and adaptive interventions, the theory identifies, in addition to these characteristics, client factors that form the basis for tailoring and explains the rationale for selecting them to inform the customization process.

5.1.3 Resources

The intervention theory specifies the material and human resources needed to enable the delivery of the intervention (Ball et al., 2017; Chen et al., 2018). Material resources are inferred from the description of the intervention’s components (including content and activities) and mode of delivery (see Chapter 4 for examples). Material resources include the equipment (e.g. projector, models for demonstration of a skill like location of pressure points); infrastructure (e.g. room, access to computer or telephone); supplies (e.g. USB keys, folders) and written documents such as intervention manual that guides health professionals in implementing the intervention, and pamphlets, booklets, or modules that clients refer to when carrying out the treatment recommendations.

Human resources refer to all personnel involved in the delivery of the intervention. The specification of human resources should be consistent with local professional regulations; these indicate the qualifications of health professionals who can be entrusted the delivery of the intervention. The personnel involved in the delivery of the intervention may include: (1) support staff responsible for screening clients; (2) IT personnel responsible for developing technology-based interventions, and for supporting clients in the use of the respective technology; and (3) health professionals responsible for providing the intervention (face-to-face or distance) to clients. The characteristics of health professionals in direct contact with clients are of particular importance because they play a role in the implementation, and conse- quently the effectiveness of the intervention (see Chapter 8). Accordingly, the intervention theory specifies the salient personal attributes (e.g. communication skills) and professional qualifications (e.g. educational background) of health professionals that enable or limit the adequate implementation and subsequently, the mechanism of action, of the intervention (Dalkin et al., 2015; De Souza 2013; Green- halgh et al., 2015).

5.1.4 Contextual Factors

The intervention theory describes the features in the context that are needed for an optimal implementation of the intervention. The features may be related to the physical, psychosocial, and/or political factors inherent in the setting in which health professionals deliver the intervention and the environment or life circumstances in which clients apply the treatment recommendations. The physical features are exemplified in the seating arrangement, lighting, and ambient temperature in the room where health professionals facilitate a face-to-face group therapy, and the safety of the neighborhood where clients are expected to walk. The psychosocial features are illustrated with effective communication and collaboration among all personnel involved in the delivery of the intervention, and with social support that clients need to carry out the treatment recommendations. The political features are related to decision makers’ or community leaders’ endorsement of the implementation of the intervention, and enforcement of policies and rules that ensure clients’ accessibility to resources required for carrying out the treatment recommendations.

The intervention theory also clarifies the pathways (or how) through which contextual factors affect the implementation of the intervention. It may also explain if and how these factors interfere with the initiation of the intervention’s mechanism of action and/or the achievement of the ultimate outcomes.

5.1.5 Intervention

The intervention theory describes the intervention at the conceptual and operational levels. At the conceptual level, the intervention is characterized in terms of its overall goal (e.g. prevention, management or resolution of the problem and its consequences) and active ingredients (see Chapter 4). The theory provides the rationale for the selection of the active ingredients. At the operational level, the intervention theory indicates how and why the active ingredients are operationalized into the respective specific components. For each component, the theory specifies its goal, content, activities, and mode of delivery. Furthermore, the theory clarifies the time point in the trajectory of the health problem (before or after its experience) at which the intervention is given; the sequence for providing the components; and the optimal dose at which the intervention is given. For tailored and adaptive interventions, the theory presents an overview of the customization or tailoring algorithm. The algorithm consists of decision rules that match the interventions, components, modes of delivery, and/or dose to the respective tailoring variables (e.g. client characteristics).

5.1.6 Mechanism

The intervention theory explains how the intervention’s active ingredients, operationalized in the respective specific components, are expected to produce the desired changes in the immediate and intermediate outcomes that mediate the effects of the intervention on the ultimate outcomes (see Chapter 5). The theory provides a conceptual definition of each mediator. It also delineates the anticipated sequence with which the mediators occur with, during, and following exposure to the intervention. In addition, the theory indicates the timing surrounding delivery of the

5.1 Intervention Theory

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intervention at which the desired changes in the mediators can be observed and the pattern or trajectory (i.e. direction and rate) of change anticipated for these variables.

For example, some interventions yield small but incremental changes, whereas others induce large changes in the mediators, within a short time period following intervention delivery, and these changes are maintained over time.

5.1.7 Outcomes

The intervention theory identifies the ultimate outcomes expected of the intervention. It delineates and explains how the desired changes in the aspects of the problem and/or the mediator contribute to changes in the ultimate outcomes. In addition, the theory defines the ultimate outcomes at the conceptual and operational levels and indicates the timing at which changes in the ultimate outcomes occur and the expected pattern of change over time.

There is increasing recognition that health interventions could result in unintended outcomes. These could be either beneficial (e.g. developing a more structured lifestyle with sleep restriction therapy) or harmful (e.g. increased anxiety) (Bonell et al., 2015). Where possible (based on theoretical predictions or available empirical evidence), the theory highlights potential unintended outcomes.

The intervention theory is presented in text and depicted in a logic model. The text format provides ample opportunity to describe the elements of the theory in detail, to define the main concepts (health problem, determinants, active ingredients of the intervention, outcomes) at the conceptual level, and to delineate and explain the proposed direct and indirect (moderated and mediated) relationships among the elements. The logic model depicts the relationships in a diagram as illustrated in Figure 5.1 or a flowchart as shown in Figure 5.2. The logic model, traditionally used in program evaluation, has resurged as a tool that is useful for conveying information about the intervention; it provides an overview or blueprint of the intervention which facilitates its understanding by various stakeholder groups. A review of the logic model helps (1) clarify the logic underpinning the intervention; (2) understand the strengths and weaknesses of the intervention as designed, in producing the anticipated outcomes; (3) identify the resources needed for its delivery; and (4) inform the implementation and evaluation of the intervention (Anderson et al., 2011; Ball et al., 2017; Baxter et al., 2014; Brousselle &

Champagne, 2011).

Client factors

Contextual factors Intervention Mediators Ultimate outcomes

Health professional factors

FIGURE 5.1 Logic model—diagram of relationships proposed by intervention theory.

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