Table 3 Study endpoints
From: Personalized Disease Prevention (PDP): study protocol for a cluster-randomized clinical trial
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 |