Empirical knowledge supports the usefulness of the approaches and methods by providing evidence about their strengths and limitations. Practical knowledge describes the "what" and "how" of the approaches and methods; it provides guidance for its application.
INTRODUCTION
- TREATMENT DECISION-MAKING
- EVIDENCE-BASED PRACTICE
- CLIENT-CENTERED CARE
- COMPLEXITY OF THE REAL WORLD
- Theory of the Health Problem
- Development of Multicomponent Interventions
- Development of the Theory of Change
- Examination of Contextual Factors
- Examination of Client Individuality
- CLIENT ENGAGEMENT IN INTERVENTION RESEARCH
- ADVANCES IN INTERVENTION RESEARCH METHODS
Limited replication is manifested in conflicting and therefore inconclusive evidence of the intervention's effectiveness (Hesselink et al., 2014). Inadequate description of the interventions limits their replication and proper implementation in research and practice (Bach-Mortensen et al., 2018; Levinton, 2017).
AND IMPLEMENTING INTERVENTIONS
Describe in detail the content to be covered and activities to be performed by health professionals (or interventionists) and clients during intervention delivery Training of health.
DEFINITION OF INTERVENTIONS
- Strategies
- Interventions
- Programs
It derives from and is consistent with the conceptualization of a medical problem requiring remediation. As such, the strategy provides general principles to guide the selection and/or design of interventions commensurate with the general conceptualization of the health problem.
INTERVENTION ELEMENTS
- Intervention Goals
- Intervention Components
These three specific techniques are described as replicable behavior change techniques designed to change behavior (Abraham & Michie, 2008; Carey et al., 2018). The non-specific components are techniques used to enable, support, enhance or facilitate the implementation of the specific components of the intervention (Sidani et al., 2020).
CHARACTERISTICS OF INTERVENTIONS
- Mode of Delivery
- Structure
- Dose
However, recent evidence suggests that nonspecific components in combination with the way the intervention is delivered can enhance or undermine its effectiveness (Dombrowski et al., 2016). The tailored approach involves adapting or individualizing the intervention to the clients' characteristics and preferences (Mannion &.
DEVELOPING
INTERVENTIONS
IMPORTANCE OF UNDERSTANDING HEALTH PROBLEMS
Health problems are the drivers for the design of interventions since solving the problem requires its understanding first (Kok et al., 2016). Poor conceptualization of the problem can result in inappropriate and potentially ineffective intervention design, that is, Type III error (Renger, 2011).
THEORY OF THE PROBLEM
- Definition of the Health Problem
- Consequences of the Problem
- Illustrative Example
The severity and duration of the health problem's experience informs the identification of factors that contribute to the problem. Consequences of the health problem represent complications that can arise if the problem is not addressed effectively.
APPROACHES FOR GENERATING THEORY OF THE HEALTH PROBLEM
- Theoretical Approach .1 Overview
- Empirical Approach
- Experiential Approach .1 Overview
- Combined Approach for Understanding the Problem .1 Overview
The theoretical approach has some limitations in gaining a comprehensive understanding of the health problem. The goal is to increase the relevance of the literature to the problem and context of interest.
PROCESS FOR INTERVENTION DESIGN
Health problem analysis is a fundamental step in the intervention design process. In this step, the desired changes are defined for each aspect of the health problem identified as modifiable (Burrell et al., 2019). Techniques must be appropriate to the aspect of the problem and capable of inducing the desired changes.
ACTIVE INGREDIENTS
Theoretical Approach .1 Overview
The advantages of the theoretical approach refer to the delineation of intervention agents that are specific and consistent with the nature of the problem and its soft aspects. The theory points to aspects of a health problem that can be changed and techniques to achieve the desired changes. Limitations of the theoretical approach to delineating intervention effects are related to the following points: (1) many middle-range theories are descriptive and explanatory in that they provide conceptualizations of the health problem but do not suggest how to change the problem; in other words, theories do not explicitly propose specific techniques for solving a problem; (2) each middle-range theory offers a unique conceptualization of the problem that determines a particular set of determinants; reliance on a single theory leads to the design of interventions that target only the determinants in question and may be of limited effectiveness because they do not address the most important factors contributing to the problem as experienced by clients in the context of interest; and (3) some middle-range theories may lack adequate and sufficient empirical support, raising concerns about their utility in designing interventions (Lippke & Ziegelman, 2008).
Empirical Approach .1 Overview
Reports from these studies highlight the results regarding the direct effects of the intervention on the health problem. However, new methods have been used to gather evidence about the mechanisms underlying the intervention's effects (e.g. realistic review of the literature) and the active components included in the intervention (e.g. component analysis). The application of the realist review is illustrated in Robert et al.
Experiential approach .1 Overview
For the target client population, the subgroups are defined by their experience of the problem and its determinants, as well as sociodemographic, cultural and health or clinical characteristics (Leask et al., 2019). As such, the intervention ingredients or techniques are consistent with the beliefs and values of the target client population and feasible within the clients' context (Hawkins et al., 2017). This consistency between problem and techniques is likely to improve the acceptability of the intervention (Leask et al., 2019).
Combined Approach .1 Overview
It is often difficult to recruit groups of participants representing different subgroups of the respective expert categories (Ball et al., 2017; Brendryen et al., 2013).
THEORY OF IMPLEMENTATION .1 Overview
- Illustrative Example
- Elements of the Theory of Implementation
To be useful, implementation theory explains the what, how, and why of the intervention. Relates the active ingredients of the intervention to the potentially modifiable aspects of the problem and the desired changes. Implementation theory provides the blueprint for detailing the 'nuts and bolts' of the intervention (Blamey et al., 2012) in the intervention manual (see Chapter 7).
THEORY OF CHANGE .1 Overview
- Illustrative Example
- Elements of the Theory of Change
Perception includes clients' views on the intervention as a whole and/or its components, activities, method of delivery and dose, as well as treatment recommendations. Immediate outcomes are desired changes that occur when implementing the intervention or its components. Operationalizing the desired changes in the mediators, by specifying the pattern (i.e. magnitude and direction) and timing around intervention delivery at which the changes are expected to occur.
DESIGNING TAILORED INTERVENTIONS .1 Overview
- Types of Tailored Interventions
- Methods
- Strengths
- Limitations
Problem experience and treatment adherence change during the intervention period (Hekler et al., 2018; Lagoa et al., 2014). The theory proposes variables that account for variation in problem experience. For tailored interventions, adaptation variables (eg experience of health problem) are assessed at baseline, prior to delivery of the intervention.
INTERVENTION THEORY
- Experience of the Health Problem
- Client Factors
- Resources
- Contextual Factors
- Intervention
- Mechanism
- Outcomes
Intervention theory: (1) identifies and defines at a conceptual and operational level the health problem addressed by the intervention; (2) at the conceptual and operational level, it explains and defines the aspects (indicators, determinants) of the problem that are potentially changeable and targeted by the intervention; and (3) explains the rationale for focusing on selected aspects of the problem. Material resources are inferred from the description of the components of the intervention (including content and activities) and the manner of implementation (see Chapter 4 for examples). Personnel involved in the implementation of the intervention may include: (1) support personnel responsible for screening clients; (2) IT personnel responsible for the development of technology-based interventions and for supporting clients in the use of the technology in question; and (3) health professionals responsible for providing intervention (face-to-face or remotely) to clients.
IMPORTANCE OF THE INTERVENTION THEORY
Awareness of client and contextual factors that influence the implementation of the intervention helps in identifying elements of the intervention that need to be modified, and how. Understanding the intervention's active ingredients is important for selecting and specifying the comparative treatment. The latter treatment must not incorporate components that operationalize the active ingredients of the intervention (see Chapter 15).
DELIVERING INTERVENTIONS
- VARIATIONS IN INTERVENTION DELIVERY
- Variations in Operationalization of Interventions by Researchers
- Variations in Delivery of Interventions by Interventionists
- Variations in Application of Interventions by Clients
- IMPACT OF VARIATIONS IN INTERVENTION DELIVERY
- Impact on Construct Validity
- Impact on Internal Validity
- Impact on External Validity
- INTERVENTION FIDELITY
- STRATEGIES TO ENHANCE FIDELITY
- Strategies to Promote Fidelity
- Strategies to Assess Fidelity
- Strategies to Monitor Fidelity
- FIDELITY—ADAPTATION DEBATE
To inform the delivery of the intervention, the specifications are captured in the intervention protocol or manual. Overall, variations in providers' and clients' implementation of the intervention affect its effectiveness in research and practice contexts. The inconsistency in the delivery of the intervention by interventionists and health professionals and the associates.
INTERVENTION MANUAL
CONTENT OF AN INTERVENTION MANUAL
- Section 1: Overview of the Intervention
- Section 2: Required Resources
- Section 3: Procedure
- Section 4: Adaptations
- Section 5: Appendices
The first section of the manual provides an overview of intervention and intervention theory. The third section of the intervention manual contains a description of the procedure to be followed when performing the intervention. In the first session, initial steps include general introductions and providing an overview of the intervention.
USE OF THE INTERVENTION MANUAL
In particular, reviewing the manual in preparation for delivery will remind providers of (1) the resources required to deliver the intervention in the selected mode, at each scheduled session; this prompts them to obtain the resources and ensures that they are functioning well before the intervention is implemented; and (2) the nature and sequence of activities to be performed. However, the effort and time spent developing the manual is worthwhile in relation to the benefits (i.e., intervention fidelity) obtained from using the manual, both in research and in practice . Nevertheless, the literature focuses on the role and influence of health professionals in delivering interventions, and their influence on intervention implementation.
ROLE OF INTERVENTIONISTS
It is through these interactions that interventionists and clients are exposed to intervention components. Interventions are required to deliver the specific and non-specific components as defined and detailed in the intervention manual in order to minimize deviations or variations in and increase fidelity of intervention delivery. Such individuality affects interventionists' performance in delivering the intervention and, therefore, effectiveness in producing beneficial client outcomes.
INFLUENCE OF INTERVENTIONISTS
- Traditional Perspective On Interventionists’ Influence
- Evidence of Interventionist Influence
A working alliance is a collaborative relationship in which healthcare professionals and clients develop a common understanding and agreement on the goals and tasks of the intervention (Degnan et al., 2016). Variation in the extent to which interventionists adhered to the intervention was observed in research and practice (e.g., Imel et al., 2011). On average, the working alliance accounted for 8% of the outcome variability (Horvath et al., 2011), which was higher than the percentage of outcome variance attributable to the effects of the intervention (Kaplowitz et al., 2011).
SELECTION OF INTERVENTIONISTS
- Interventionists’ Qualities
- Strategies to Ascertain Interventionists’ Characteristics
Knowledge and attitudes toward the intervention: Interventionists' prior theoretical and practical knowledge of the intervention they are responsible to deliver can improve their training and delivery of the health intervention being evaluated. This theoretical insight helps them appreciate the potential contribution and identify the key components of the intervention. The selected applicants will be trained in the implementation of the intervention (as discussed in section 8.4).
TRAINING OF INTERVENTIONISTS
- Time of Training
- Content of Training
- Methods for Training
- Evaluation of Training
Initial and ongoing training are essential for appropriate and accurate implementation of intervention components. The didactic part of the initial training revolves around the theoretical basis and operationalization of the intervention. Supervised intervention delivery: If resources are available, trained interventionists attend a hands-on, hands-on training session.
INVESTIGATING INTERVENTIONIST EFFECTS
The number of interventionists must be large enough (at least 30) to obtain meaningful estimates of the interventionist effects. Outcomes are those assessed after implementation of the intervention or represented in the level of change in outcomes over time. Representing interventionists as a random factor has the advantage that the observed effects can be generalized to other interventionists with characteristics similar to those of interventionists who were involved in the delivery of treatments (Kim et al., 2006;.
CONCEPTUALIZATION OF FIDELITY
- Terminology
- Frameworks of Fidelity
- Definition of Fidelity
- Simplified Conceptualization of Operational Fidelity
As originally proposed by Bellg et al. 2004) theoretical reliability is related to the design of the intervention. Competence (also called process fidelity by Dumas et al., 2001) focuses on the way in which the interventionists carry out the intervention. Competence refers to the skill of the interventionists in delivering the intervention (Leeuw et al., 2009; Stein et al., 2007).
STRATEGIES AND METHODS FOR ASSESSING THEORETICAL FIDELITY
- Generation of a Matrix
- Content Validation
Experts can also be invited to formally validate the content of the intervention, as described below. It implies that experts validate the agreement between the conceptualization and the operationalization of the intervention. The application of the two strategies is a means of determining the accuracy of the components, activities and actions to reflect the active ingredients of the intervention and thus increase the construct validity of the intervention as delivered.
STRATEGIES AND METHODS FOR ASSESSING OPERATIONAL FIDELITY
- Development of Instruments Measuring Adherence
- Methods for Assessing Interventionist Adherence
The content of the items should reflect the activities that the interventionists are expected to perform. Both carry out the assessment and document execution of the activities on the instrument form, independently. Despite intensive training, some observers may not correctly recognise, interpret and document the performance of the intervention activities.
