Given the complexity, multisteps, and nuanced considerations as well as the interdependency of staff in the conduct of an intervention study, staff training is critical to all intervention studies irrespective of the phase along the pipeline. There are three basic areas of training to consider for staff, regardless of role or prior experience. First, all staff must have knowledge of, and a clear understanding of, the study goals, research questions, and study protocol and study procedures. However, in single- and double-blinded studies, some staff may not be privy to specific hypotheses, participant group assignment, or intervention specifics. Nevertheless, understanding the study and its design and the intent of blinding is important to ensure that staff are able to perform their roles adequately. Also, staff (e.g., interviewers, interventionists) who interact with study participants will need to field questions and adequately and accurately respond to queries about the study posed by participants.
A second area of training is for staff to learn how to strike the right balance between working independently and keeping a project coordinator/investigator and others on the research team adequately informed about field conditions, coding decisions, adverse events, and related matters. For example, an interviewer may learn information that may impact other staff who will be interacting with a study participant. In the interview process, it may be revealed that a participant will be traveling in the near future, which will affect subsequent data collection efforts. A participant might reveal a recent hospitalization that would be important to document and that may affect outcomes. For interviews that occur in the home, a wide range of noteworthy conditions may be observed such as unsafe environmental conditions (e.g., a hole in the roof), infestation, or presence of smokers or unfriendly pets. This type of information needs to be passed along to other staff members in a systematic way. Using electronic tracking and project management programs can facilitate information sharing. In all cases, tracking contacts with study participants and sharing important information about participants are critical.
When interviewing or conducting an intervention in the home, various challenges can emerge that require independent problem solving: a study participant may become ill and need help; the environment may be uncomfortable or pose a risk to the participant and staff member; the staff member may be invited to eat or drink with the participant; and so forth. The point is that it is not possible to foresee every issue that will emerge in the course of implementing an intervention study. Staff must be armed with knowledge of the study, its purpose, and general guidelines regarding independent problem solving to address issues as they emerge in the field and which are typically not possible to identify a priori. When interacting with people and particularly in their living environments, anything can and will happen (Gitlin, 2003).
A third general area of training is the tracking systems that will be used in the study and instilling an understanding that every action taken by any staff member can have a methodological impact. Even what might appear as simple office work, such as duplicating an interview or consent form or filing study participant information in a locked cabinet, can be a source of measurement error or present as a methodological challenge if not carried out correctly. For example, misfiling consents, duplicating materials incorrectly such that an interview or consent form page is missing, using an outdated informed consent form, or failing to inform another staff member of an unsafe interviewing condition can lead to missing data, breaches in human subject-consenting ethics and procedures, placing others in harm’s way, and analytic difficulties.
A related point is that all data must be considered confidential and locked in stored cabinets and offices. Personnel should have access only to the data they need to perform their particular role. Any information that can identify a study participant (e.g., signed consent form) must be separated from data-coded questionnaires. Team members must be trained to uphold subject confidentiality in every step and process of any study. Losing data by leaving behind a questionnaire in a person’s home or a clinic area is a serious breach of confidentiality.
Thus far we have discussed general staff training. However, there are specific training considerations for assessors/interviewers and interventionists. If the study design involves data capture through face-to-face interviewing, at a minimum, the training of interviewers should cover but may not be limited to the following: (a) study design and study procedures; (b) the interview battery; (c) stopping rules; (d) consenting processes, confidentiality, and human subject ethics; (e) coding and/or scoring data; (f) procedures for reporting adverse events; and (g) personal safety.
We recommend developing a “certification” process that establishes what needs to be done and the specific competencies needed for a study interviewer. Certification requirements might include, for example, completion of readings and participation in face-to-face trainings in study procedures; the completion of three to five practice interviews with project coordinator/investigator and others and demonstration of competencies in explaining the study; obtaining consent; administering an interview battery; handling an adverse event; and problem solving common challenges in the field (e.g., quickly building rapport, redirecting study participants, active listening, accuracy in recording information).
Interventionists also need systematic training. They must be able to juggle protocol requirements with potentially challenging clinical and unpredictable circumstances and remain nimble in their thinking and actions. For example, let’s say a participant expresses suicidal ideation in a treatment session of an intervention that is unrelated to mood disorders (e.g., a physical exercise or chronic disease self-management program). Although depression and suicidal ideation are not the focus of the intervention, this expression cannot be ignored. Interventionists will require training as to how to address this and other matters and also be given the flexibility to make a judgment as to how best to proceed (e.g., call 911 if participant indicates a plan, provide suicide prevention hotline crisis telephone numbers, refer for mental health counseling). Chapter 6 on standardization and Chapter 13 on ethics examine some of these issues as well.
Also, similar to interviewers, interventionists must have knowledge about the study design, when to stop the intervention owing to an adverse condition or event, and how to report adverse events. This is all in addition to the heart of the matter—training in the intervention protocol and documentation of its delivery. A certification process by which interventionists must demonstrate competencies in the delivery of the intervention and handling field conditions can help to promote uniformity and ensure fidelity in intervention delivery. Certification requirements will be specific to the intervention but may include the successful completion of selected readings, participation in face-to-face trainings, role-playing, demonstration of competencies in building rapport, and delivering each treatment component.
Another important consideration is that interventionists must possess confidence in the intervention protocol and firmly believe in its importance and potential to have a positive effect on study participants. If not, their lack of passion or enthusiasm for the intervention may be directly or subtlety conveyed to study participants and have unintended, negative consequences including attrition, poor treatment adherence, and/or the realization of limited treatment benefit. As the strength of the therapeutic alliance is critical to intervention success, the relationship formed with a study participant in effect becomes part of the intervention (Chee, Gitlin, Dennis, & Hauck, 2007). Also, lack of belief in the value of an intervention may lead to independent decision making. Interventionists who do not value the intervention protocol may choose to emphasize one treatment component over another on the basis of their personal preferences or what they think is best, resulting in omissions or commissions in treatment delivery. Chapter 12 discusses fidelity issues in more detail.