Table 2.
Outcomes | Outcome Measure | Description | Scoring | When | DA group |
Control group |
From |
---|---|---|---|---|---|---|---|
Primary Outcome | Receipt of screening | Review primary care notes, radiology records, and screening sheets; will contact patients or their proxy if follow-up is not complete in the medical records. | Yes vs. no | 15 months | X | X | Medical records |
Secondary Outcomes | Intentions to be screened | Predisposition/choice: a validated 15-point scale to assess one's propensity to being screened. We will categorize scores as 1-5 (yes), 6-10 (unsure), or 11-15 (no) [23]. | Yes vs. those who are unsure or plan not to be screened | Baseline, Follow-upa,b | X | X | Participant reported |
Knowledge | 10 questions (2 multiple choice and 8 true/false); 7 were adapted from other studies [75-78] and 3 were developed based on the material in the DA. | Sum of correct answers | Folow-up | X | X | Participant reported | |
Decisional Conflict Scale (DCS) | A validated 16 item scale (each item is scored on a 5-point Likert scale) to measure uncertainty around a decision, whether one feels informed, clear about their personal values, and supported in their decision-making (Cronbach's alpha=0.78 to 0.92) [15,79,80]. | Scores range 0-100; lower scores indicate less conflict | Folow-up | X | X | Participant reported | |
Preferred decision-making role | The Control Preferences Scale (CPS) assesses whether patients prefer to make medical decisions on their own or share responsibility with their doctor or have their doctor make their decision [49,80]. | Active vs. passive/shared with doctor (since aim of decision aids is to help patients be more active in decision-making) | Folow-up | X | X | Participant reported | |
Preparation for decision-makingc | A validated 10 item index (each item scored on a 5 point Likert scale) to see if the DA prepares patients to communicate with clinicians about mammography (Cronbach's alpha=0.92-0.96) [50,51]. For the control arm, we will modify this index to ask participants how the pamphlet affects their thoughts for making their home safer. | Scores range 0-100; higher scores indicate greater preparation | Folow-up | X | X | Participant reported | |
Acceptability of the materials | Will assess participant perceptions about length, clarity, and whether they found the materials helpful or would recommend them to a friend [81]. For the DA only, we will ask whether the information is slanted towards or against getting a mammogram or whether the information is balanced. | Descriptive | Folow-up | X | X | Participant reported | |
Anxiety | We will examine whether the educational materials provoke anxiety using the Spielberger State-Trait Anxiety Inventory short-form (6 items on a 4 point Likert scale) [52]. | Scores range from 6 -24 with lower scores indicating less anxiety | Folow-up | X | X | Participant reported | |
Balanced mammography discussion | Per patient report and per review of primary care notes up to 6 months after participation (in case patients choose to bring up screening at the next visit rather than the index visit) we plan to assess whether discussions on the benefits and harms of mammography screening and/or home safety discussions occurred. | Yes vs. no | 15 months | X | X | Medical records |
Since screening intentions are assessed at the end of the DA, these data will also be recorded from the intervention group then.
An RA will attempt to administer the follow-up interview immediately after a participant has read the DA and has met with her PCP (but no longer than seven days after the PCP visit).
Since the home safety pamphlet is not a decision aid, the questions in the preparation for decision-making index will be modified in the control arm so that the questions ask participants how the pamphlet affects their thoughts around home safety.