Using a population health management approach to enroll participants in a diabetes prevention trial: reach outcomes from the PREDICTS randomized clinical trial

Abstract

Population health management (PHM) strategies to address diabetes prevention have the potential to engage large numbers of at-risk individuals in a short duration. We examined a PHM approach to recruit participants to a diabetes prevention clinical trial in a metropolitan health system. We examined reach and representativeness and assessed differences from active and passive respondents to recruitment outreach, and participants enrolled through two clinical screening protocols. The PHM approach included an electronic health record (EHR) query, physician review of identified patients, letter invitation, and telephone follow-up. Data describe the reach and representativeness of potential participants at multiple stages during the recruitment process. Subgroup analyses examined proportional reach, participant differences based on passive versus active recruitment response, and clinical screening method used to determine diabetes risk status. The PHM approach identified 10,177 potential participants to receive a physician letter invitation, 60% were contacted by telephone, 2,796 (46%) completed telephone screening, 1,961 were eligible from telephone screen, and 599 were enrolled in 15 months. Accrual was unaffected by shifting clinical screening protocols despite the increase in participant burden. Relative to census data, study participants were more likely to be obese, female, older, and Caucasian. Relative to the patient population, enrolled participants were less likely to be Black and were older. Active respondents were more likely to have a higher income than passive responders. PHM strategies have the potential to reach a large number of participants in a relatively short period, though concerted efforts are needed to increase participant diversity.

Effects of a Digital Diabetes Prevention Program: An RCT

“…Trial methods and protocol have been described in detail elsewhere. 14,15 Briefly, participants were identified through electronic health records within the Nebraska Medicine health system, initially contacted by telephone, and screened for a nonfasting HbA1c in the prediabetes range (5.7%−6.4% [39−46 mmol/ mol]). 16 Initially, a point of care (POC) HbA1c test (A1CNow+, Professional Multi-test HbA1c system; Polymer Technology System, Inc., Wycombe, United Kingdom) was utilized, but a high proportion of false-positive results (compared with that of a laboratory-derived HbA1c) emerged in the first 6 months of the trial.…”

“…The protocol was amended following the accrual of 254 participants (42% of the total sample), 116 (46%) of which had an HbA1c test outside the prediabetic range (113 had HbA1c <5.7%; 3 had HbA1c >6.4%). 15 The amendment removed POC screening and determined eligibility with an HbA1c result from a venipuncture blood sample. The sample size was increased from 498 to 599 to ensure a minimum analyzable sample of adults with prediabetes confirmed by laboratory-derived HbA1c.…”

“…No other changes were made to the protocol. 15 After confirmation of study eligibility and completion of baseline data collection, participants were randomized to either the d-DPP or to an enhanced standard care, small-group education (SGE) class focused on diabetes prevention and action planning for weight loss. 17 Outcome measurements were repeated at 4 and 12 months.…”

“…Details regarding the recruitment process have been reported previously. 15 Participants were eligible if they were aged ≥19 years (legal adult age in Nebraska), had a BMI ≥25 kg/m 2 (≥22 kg/m 2 if participant self-identified as Asian), and had baseline HbA1c in the prediabetic range (5.7%−6.4% [39−46 mmol/mol]). In addition, participants had to 1. be medically stable (i.e., no uncontrolled hypertension or hyperlipidemia, no current treatment for cancer, no concurrent thyroid or untreated metabolic condition, not a current candidate for bariatric surgery or concurrent antiobesity or antidiabetes therapy); 2. be capable of consent; 3. be willing to be randomized; and 4. have regular access to e-mail and internet.…”

Psychometric Assessment of a Weight Management Social Provisions Survey in a Sample of Adults with Prediabetes

“…BMI between 30 to 34.9 kg/m 2 ; 41.7%) and had less than a four-year college education (43.9%). Additional sample details are available elsewhere [28].…”