Considerations when developing a fidelity plan include tailoring to the particular characteristics of an intervention study and the level of complexity needed to achieve an adequate approach.

With regard to tailoring, there is no single plan, form, questionnaire, or approach that can be used across all intervention studies to address fidelity. Strategies need to be customized to the nuances of the study. To illustrate the tailoring of strategies to a study and the range of approaches available to investigators, we highlight the fidelity plan by Washington and colleagues (2014) for their educational intervention (Families Matter in Long-Term Care) to improve family involvement and promote better resident, family, and staff outcomes in 6 nursing homes and 18 residential care/assisted living settings. The authors describe their plan as follows:

Several fidelity strategies were conceived at the design phase. First, a participant would receive a full dose of the intervention by attending the entire workshop and implementing a service plan. To encourage workshop attendance, letters were mailed to families and an announcement about the upcoming workshop was posted in the community newsletter. To track attendance, participants were asked to sign in. Also, all participants received a certificate of completion, and staff members who attended the workshop received continuing education credits. During the workshop, participants practiced creating meaningful service plans. A supply list was provided to families to aid in the development of the service plans. These supplies were made available to families to ensure that they possessed the materials required to successfully perform the activities (for example, watering pots, pedometers, art supplies). To track adherence to the service plans, families were to have ongoing contact with the interventionist by way of follow-up telephone calls at one month, three months, and five months after service plan development and postcard reminders at months two and four. During the calls, participants would be asked whether a service plan was created; if not, why not; and if so, to what extent it was being followed as planned. (Washington et al., 2014, pp. 2-3)

Another important consideration in developing a fidelity plan is the level of its complexity. The complexity of a fidelity plan may range from high to low depending upon several factors including the characteristics of the intervention, study design, and resources available to the investigative team. Multicomponent interventions and complex study designs will necessitate complex, multifaceted fidelity plans. Alternately, a simple intervention and design require less fidelity monitoring and measurement. This simple linear relationship between complexity of the study design and intervention and the subsequent fidelity plans is expressed in Figure 12.2.

Relationship between intervention and fidelity with respect to their complexities

Figure 12.2 Relationship between intervention and fidelity with respect to their complexities.

Consider a single focused intervention such as one offering education on a particular topic (e.g., pain management in cancer care). When compared to a no-treatment control group, the fidelity plan would be rather straightforward and focus on the delivery of education, that is, whether the information provided was adequately received and understood by participants. In comparison, a fidelity plan for a multicomponent intervention that has several objectives (e.g., pain reduction, functional improvement, and improved activity engagement during cancer care) and multiple activities (e.g., education, behavioral activation, compensatory strategies) would be more complex. Enhancements, monitoring, and measuring of each treatment component and key activities would need to occur.

Take, for example, the multicomponent home-based intervention Get Busy Get Better: Helping Older Adults Beat the Blues (GBGB). GBGB, an intervention for African Americans 55 years of age or older with depressive symptoms (Gitlin et al., 2012, 2013), is designed to reduce depressive symptoms and improve overall well-being. Delivered by a social worker at home over eight 1-hour sessions, the intervention involves five treatment components: care management, referral and linkage, depression education and symptom detection, stress reduction, and behavioral activation. A fidelity plan for this type of intervention is necessarily multifaceted and complex. It involves enhancements to delivery, receipt, and enactment of each of its five treatment components, as well as monitoring and measuring them throughout the trial. For this trial, enhancements included creating treatment manuals, a standard training and certification approach for interventionists, structured clinical supervision, and use of motivational interviewing techniques to increase likelihood of enacting behavioral activation plans. To measure fidelity, randomly selected audiotapes were reviewed and rated for interventionist adherence, along with case presentations with feedback and the introduction of course corrections. This monitoring revealed that, at the start of the trial, a few of the interventionists were deviating from the protocol, which necessitated retraining, closer supervision, and, in one case, dismissal of the interventionist from the trial. As highly complex treatments increase the risk of lapses in treatment integrity, a carefully crafted fidelity plan is important.

The complexity of a trial design will also impact the intricacy of the fidelity plan. Trial designs that involve two or more treatment conditions or a comparative effectiveness study in which two active treatments are compared will require more complex fidelity plans. A fidelity plan would have to ensure integrity of the delivery, receipt, and enactment of each treatment condition and also how differentiation between the two treatment groups will be determined.

Illustrating this point is a study by Carpenter and colleagues (2013), which used a three-group randomized controlled trial comparing slow deep breathing (intervention), fast shallow breathing (attention control), and treatment as usual for management of menopausal hot flashes. They describe their fidelity plan as follows:

The three-group design enabled blinding of participants and staff who were told the study compared two breathing programs to usual care. The breathing programs differed on the active ingredient (e.g., breath rate) but were otherwise similar in terms of appearance and content. Materials were delivered via an express mailing courier with delivery confirmation. Participants interacted with non-blinded staff to ensure that they understood and could use the materials (treatment receipt), but were otherwise using the materials at home on their own to self-manage their hot flashes. . . . Staff developed and closely followed a detailed set of standard operating procedures to ensure that study blinding, random assignment, and participant contacts occurred as planned. Any deviations to standard operating procedures were recorded carefully into a protocol deviations log, including any instances where staff or participants were unblinded to study condition. The log included the participant number, date of the event, study visit number, description of the event, reasons for the event, and any corrections or response to the event that were necessary. (Carpenter et al., 2013, p. 61)

As shown, various strategies were employed to assure adherence to each of the three conditions.

Staffing and budgetary resources also influence the level of complexity of a fidelity plan. Complex study designs and interventions require greater resources to enhance, monitor, and measure fidelity than simpler designs and interventions. When resources are limited, then identifying the most important elements that need to be enhanced, monitored, and measured is critical.

In the initial development and also evaluation phases, a minimal fidelity plan might include basic enhancements to delivery such as use of a manual and training protocol as well as monitoring delivery through direct observation of select intervention sessions or review of select audiotaped sessions. In the translation and implementation phases, attention to the adequate training of interventionists and assuring that the essential components of an intervention are delivered as intended are basic considerations. For dissemination, specification of what can be modified and what is immutable could minimally be provided.

Comprehensive and more elaborate fidelity plans, if resources permit, may include extensive measurement strategies that combine qualitative and quantitative approaches, or mixed methods. A mixed-methods approach may provide a fuller and more nuanced evaluation of fidelity (see Chapter 11; see also Albright, Gechter, & Kempe, 2013) and may afford multiple ways of seeing, hearing, and making sense of the implementation of a behavioral intervention (Greene, 2007). For example, an education intervention, administering a standardized scale to quantify knowledge attainment, could be combined with focus group methodology to obtain an in-depth understanding of how participants received and engaged with the intervention (e.g., treatment receipt and enactment). A mixed-methods approach complements the strengths and offsets the relative disadvantages of any one particular methodological approach and, therefore, provides important understandings of implementation processes (Albright et al., 2013).

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