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. 2022 Oct 22;23:892. doi: 10.1186/s13063-022-06750-7

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