Table 3.
Study endpoints
| Objectives | Endpoints | Hypothesisa |
|---|---|---|
| Primary | ||
| To measure whether use of individualized preventive care recommendations is likely to help patients live a longer, healthier life | Change in quality-adjusted life expectancy (QALE) at 6 months, in patients whose providers are in the intervention arm, as compared with the control arm.b | Higher |
| Secondary | ||
| To measure whether use of individualized preventive care recommendations is likely to help patients live a longer, healthier life | Change in QALE at each of the following time points: 12 months, all follow-up time points. | Higher |
| To measure whether use of individualized preventive care recommendations is likely to help patients live a longer life | Change in life expectancy (not quality-adjusted) at each of the following time points: 6 months, 12 months, all follow-up time points. | Higher |
| To assess comprehension of the decision tool |
Comprehension of preventive services most likely to impact a patient’s quality-adjusted life expectancy, assessed by correct identification of each of the following: a. Service most likely to improve his/her QALE b. Service least likely to improve his/her QALE c. Correct identification of a patient’s true age (the age most commonly associated with his/her quality-adjusted life expectancy), in relation to his/her biological age |
Higher |
| To assess readiness to change | Share of preventive services ready to change over the next 1 month, assessed by percent of patients with a mean score ≥6 on a 7-point scale for the (a) top-ranked and (b) bottom-ranked individualized preventive care recommendations.b | Higher |
| To assess use of use of shared decision-making | Use of shared decision-making (SDM), assessed by score on SDM-Q-9 survey [25, 26] | Higher |
| To assess utilization of specific servicesc | Change in weight, systolic BP, HbA1c, 10-year ASCVD risk score, LDL, total cholesterol, dietary quality (Starting the Conversation assessment) [27, 28], physical activity (modified International Physical Activity Questionnaire-Short Form) [29, 30], alcohol misuse (AUDIT-C) [31, 32], tobacco cessation; receipt of screening for cancers of the breast, cervix, colorectum, lung. | Improved (higher or lower depending on service) |
| Select tertiary/exploratory | ||
| To assess reach | % of eligible patients for whom provider accesses individualized recommendations | None |
| To assess adoption | % of providers approached by the study team who agree to enroll; patient self-rating of: how helpful s/he found the recommendations, how interested s/he is in seeing individualized recommendations again in the future | None |
| To assess implementation | Adaptations made to intervention; known issues with fidelity | None |
| To assess maintenance | Provider reach at quarterly intervals post-enrollment; helpfulness of individualized recommendations 6 months after enrollment, self-reported by patient survey. | None |
This table shows primary, secondary, and select tertiary/exploratory study endpoints. See the study protocol for all tertiary/exploratory endpoints
a In patients of intervention arm providers, as compared with patients of control arm providers
b “Top-” (“bottom-”) ranked individualized preventive care recommendations are defined as follows: top (bottom) 3 for patients with ≥6 recommendations, 2 for patients with 4–5 recommendations, 1 for patients with 3 recommendations, not applicable for patients with ≤2 recommendations. Only collected for preventive services that a patient states his/her provider discussed during the baseline encounter
c Assessed for the subgroup of patients recommended each service. Only considered when follow-up data are available for ≥30 high patients of intervention arm providers and ≥30 patients of control arm providers