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. 2023 Apr 3;33:101129. doi: 10.1016/j.conctc.2023.101129

Table 4.

Phase 3 (RCT) implementation process measures and data sources.

RE-AIM OUTCOMES
Reach
  • # and % of the total screened who are aged 21+ years, use tobacco, and identify as Alaska Native or American Indian (based on statewide denominator = 27,212) to gauge future dissemination potential.

  • Participation rate: # and % of randomized index participants/total eligible.

  • Reasons for ineligibility

  • Secondary analysis comparing # and % enrolled from different advertisements and sample representativeness (i.e., sex, Alaska region).

Advertising; screening and enrollment records; Alaska state tobacco surveys, e.g., BRFSS [1], & census data [38]
Effectiveness Biochemically verified smoking abstinence at 6- and 12-months post treatment. Primary outcome: prolonged abstinence at 12 months post treatment. See section 2.6.4
Adoption Descriptive information from potential future adopting settings (Tribal Health Organization #, type, size) Semi-structured interviews conducted at the end of the study
Implementation (fidelity)
  • % of index participants completing all six smoking status check-ins during the 6-month treatment phase, demographic characteristics associated with fidelity, and trial retention of dyads.

  • Description of potential training, workflow, and resource needs and estimates of start-up; implementation costs for future adopting agencies (see cost-effectiveness, below).

Intervention process data; baseline and follow-up measures; research team meeting minutes; program tracking records; interviews
Potential maintenance
  • Individual level: 6- and 12-months post-treatment outcomes.

  • Setting level: index participant, family member, and Alaska Tribal Health System organizational perspectives of intervention and barriers and facilitators to maintenance including:
    • o
      Alaska Tribal Health System stakeholder buy-in, perceived feasibility, alignment with community and organizational priorities.
    • o
      Willingness to allocate resources required to maintain the intervention after the trial, staff availability, workflow capability, costs, Tribal Health Organization policies.
Semi-structured interviews conducted at the end of the study
COST-EFFECTIVENESS
Potential return on investment
  • Actual program delivery costs: incentives and rewards provided per dyad enrolled; gift cards provided per dyad for the six smoking status check-ins completed, research staff time.

  • Intervention costs per index participant quit at 12 months post intervention and estimated health care savings.

Program tracking records; data/models from the literature [71] on estimated reduction in annual health care costs for cessation