Increasing Uptake of EHR-enabled Population Health Outreach Strategies to Improve Diabetes Screening

Обзор

The study team's central hypothesis is that the Parkland Diabetes Detection Program (PDDP) screening invitations targeted by race/ethnicity with culturally concordant messaging and tailored by glycemic risk (known PDM vs. unknown glycemic state) plus phone-based navigation of non-responders will be more effective at closing screening gaps than PDDP generic screening invitations and usual care, opportunistic screening alone.

Подробное описание

The research team will conduct a pragmatic, split cluster randomized controlled trial (clinic=cluster; patient randomization) in 12 community-based primary care clinics in an integrated safety net health system serving a high-risk, racially/ethnically diverse population.

Вмешательства

• Поведенческое Parkland Diabetes Detection Program (PDDP) Screening Invitation
  The PDDP is designed to supplement and close screening gaps that persist despite opportunistic screening. Program staff order diabetes screening tests for randomized patients, then mail screening invitation letters to inform patients that they are at risk for diabetes. The letter informs them that a screening test has been ordered, and requests that they complete testing at their clinic lab. Patients who were mailed the letter but have not completed screening after 30 days are tracked and are se

Первичные конечные точки

• Invitation efficacy [Срок оценки: 60 days]
• Program effectiveness [Срок оценки: 12 months]
• Direct costs [Срок оценки: 12 months]
• Cost effectiveness as measured by costs per patient screened [Срок оценки: 12 months]
• Cost effectiveness as measured by cost per case found [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Patient is alive at time of data extraction
• Age >= 18 at time of data extraction and <76
• Visit with PCP at Parkland clinic in the last 18 months (548 days), where Encounter type = Virtual Visit or Encounter type = Office Visit
• Patient NOT included in Parkland Diabetes Registry
• Preferred language is Spanish or English
• Ethnicity is Hispanic or Non-Hispanic
• Race is White or Black
• Patient is not pregnant in last 12 months

Exclusion Criteria for Study Population 1: Prediabetes Glycemic Risk Group

• Last A1C value <5.7 (normal)
• Last A1C value >6.4 (diabetes)
• Last A1C value = blank (unchecked)
• Last A1C date occurred within last 12 months from date of export

Exclusion Criteria for Study Population 2: Score-Based Glycemic Risk Group

• Risk score <9
• Last A1C date occurred in last 30 months from date of export
• Last A1C value was >5.7 (PDM/DM)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 1 центр

• Parkland Health — Dallas

Идентификаторы

NCT: NCT05730582 · STU 2022-0996 · R01MD016101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗