Table 1 Outcomes and measures
Outcomes | Outcome measures | Description | Scoring | When | Source |
|---|---|---|---|---|---|
Primary outcome | Decisional conflict | 16-items on a 1–5-point Likert scale. Measures uncertainty around a decision, whether they feels informed, clear about their personal values, and supported in their decision-making [55] | Scores range 0–100; lower scores indicate less conflict | Baseline, follow-up | Caregiver reported |
Secondary outcomes | Decision-making self-efficacy | 11 items on a 5-point Likert scale. Measures of self-confidence or belief in their ability to make decisions [62] | Scores range 0–100; higher scores indicate more self-efficacy | Baseline, follow-up | Caregiver reported |
Intention to be screened | Three items. Two items assess propensity to get person with ADRD screened. One item asks how many more mammograms they think the patient will get | Yes vs. those who are unsure or plan not to be screened | Baseline, follow-up | Caregiver reported; patient reported | |
Receipt of screening | Discussion with caregiver | Yes vs. no | 15-month follow-up | Caregiver reported | |
Review primary-care notes, radiology reports, and documentation on screening and preventive care; caregiver report. | Yes vs. no | 15- and 24-month follow-ups | Patient EMR | ||
Knowledge | 16-items (6 multiple choice and 10 true/false) [48] | Sum of correct answers | Baseline, follow-up | Caregiver reported | |
Burden of screening on patient | Review patient’s EMR for additional diagnostic procedures due to false-positive results, identification of an abnormality on screening exam but further work-up declined, identification of a clinically unimportant cancer; documentation of depressive symptoms, anxiety, or pain related to the screening experience | Yes or no | 15- and 24-month follow-ups | Patient EMR | |
Burden of screening on caregiver | Measure perceptions about the burden of the mammography for the patient; semi-structured questions about patient’s mammogram experience and perceived burden of screening | Descriptive | 15-month follow-up | Caregiver reported; patient reported | |
Role in decision-making | Assesses preferences for and involvement in making decisions on their own or sharing responsibility with their family or doctor [71] | Active vs. passive/shared with doctor (since aim of decision aids is to help dyads be more active in decision-making) | Follow-up | Caregiver reported; patient reported | |
|  | Acceptability of the materials | Assess caregivers’ and patients’ perceptions about the length, clarity, and helpfulness of the decision aid and their willingness to recommend it. The number of times they reviewed it, how many pages they read, how long it took them to read it, how they would prefer to receive it if not part of a study | Descriptive | Follow-up | Caregiver reported; patient reported |