Table 4.
NIH BCC Consortium Treatment Fidelity Checklist with Tobacco Treatment-specific Examples Provided
| Treatment fidelity strategy | Examples |
|---|---|
| Treatment design | |
| 1. Treatment dose in the intervention condition(s) | |
| Length of contact session(s) | 30-Minute counseling session |
| Number of contacts | 6 Counseling sessions total |
| Content of treatment | Cognitive behavioral therapy |
| Duration of contact over time | 1 Session per week for 5 weeks |
| 2. Treatment dose in the control or comparison condition | |
| Length of contact session | 10-Minute telehealth call |
| Number of contacts | 3 Text messages per day for 2 weeks |
| Content of treatment | Motivational Interviewing |
| Duration of contact over time | 12-Week treatment phase |
| 3. Provider credentials | Master of Social Work (MSW), Tobacco Treatment Specialist (TTS) |
| 4. Theoretical model or clinical guidelines | Self Regulation Theory, Transtheoretical Model, U.S. Clinical Practice Guidelines |
| 5. Potential confounders that limit the ability to make conclusions | A change in clinics' tobacco treatment practices during the study implementation |
| 6. Plans to address possible setbacks in implementation | With staff turnover, how will new providers be trained to ensure consistency |
| 7. If more than one intervention, describe all equally well | |
| Training providers | |
| 1. How providers were trained | Individual, vs. group, number of trainings over how many hours |
| 2. Standardization of provider training | Standardized training manuals and/or materials, interventionists train together |
| 3. Measurement of provider skill acquisition post training (pre-field implementation) | Written test or observation |
| 4. How provider skills were maintained | Supervision, evaluation of recorded sessions, provider self-report |
| 5. Characteristics being sought in a treatment provider | Education level, years experience |
| 6. Fit between the provider and the intervention at the hiring stage | Someone who is psychoanalytic for a cognitive behavioral therapy trial |
| Delivery of treatment | |
| 1. Method to ensure that the content of the intervention was being delivered as specified | Review of audio or video recordings |
| 2. Method to ensure that the dose of the intervention was being delivered as specified | Track timing of interventions |
| 3. Mechanism to assess if the provider actually adhered to the intervention plan | Review of audio or video recordings |
| 4. Evaluation of non-specific treatment effects (eg perceived warmth) | Provider- and client-focused assessment of alliance and rapport; interpersonal relationship; interaction style |
| 5. Treatment manual | Or checklist or protocol |
| 6. Plan for assessment of whether active ingredients were delivered | Video or audio recording and coding |
| 7. Plan for assessment of whether proscribed components were excluded | Video or audio recording and coding |
| 8. Plan for how will contamination between conditions be prevented | Unique providers for each treatment arm |
| 9. A priori specification of treatment fidelity | Audio recordings of sessions and agreement among coders of intervention delivered |
| 10. Post-activation adaptations or modifications in treatment delivery | Reduction in number of text messages due to participant reports of excessive texts |
| Receipt of treatment | |
| 1. Assessing subject comprehension of the intervention during the intervention period | Teach back activity |
| 2. Strategy to improve subject comprehension of the intervention | Offered in oral and visual formats |
| 3. Assessing subject ability to perform the intervention skills during the intervention period | Role playing |
| 4. Strategy to improve subject performance of intervention skills during the intervention period | Specific skill practice assignments |
| 5. Multi-cultural factors considered in the development and delivery of the intervention | Language intervention is provided in, incorporation of culturally relevant constructs (eg importance of family) |
| Enactment of treatment skills | |
| 1. Subject performance of the intervention skills assessed | If using short-acting NRT is viewed as a coping skill for cravings in a risky situation, this could be better assessed and reported |
| 2. Strategy to improve subject performance of the intervention | Setting a timer to prompt pharmacotherapy use |