Enrollment Cap Policy for IDEAS Study Dementia Specialists -11.17.2016

Enrollment Cap Policy

The IDEAS Study has instituted an enrollment cap for each referring physician (dementia expert) participating in the study.

The policy’s intent is to increase study generalizability by promoting diversity in dementia expert representation and patient recruitment across socio-demographic and geographic populations.

For each individual referring physician, the maximum number of patients throughout the entire study that may be enrolled is 250. The distribution of cases enrolled also will vary based on the study’s aim outlined below.

Study Aims

Aim 1: To assess the impact of amyloid PET on the management of patients meeting appropriate use criteria. The prospectively-recruited sample size of amyloid PET-known participants for Aim 1 is 11,050 participants (assuming a distribution of 40% dementia and 60% MCI).

Aim 2: To assess the impact of amyloid PET on hospital admissions and emergency room visits in the study cohort (amyloid PET-known) compared to matched patients not in the cohort (amyloid PET-naïve) over 12 months. The prospectively-recruited sample size of amyloid PET-known participants for Aim 2 is 18,488 participants.

The enrollment cap is distributed as follows:

160 for an individual referring physician in Aim 1 (which has an estimated national accrual total of 11,050 and includes participants for whom both a pre- and post- PET clinical assessment case report forms are completed).

90 for an individual referring physician in Aim 2 (which has a national accrual goal of an additional 7,438 patients for whom only pre-PET clinical case report forms will be collected).

The Operations Office will alert individual physicians when 140 participants have been enrolled to enable planning.

Comments are closed.