Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol

Abstract

BackgroundHealth information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency. After a randomized controlled trial of a multilingual automated telephone self-management support program (ATSM) improved patient-centered dimensions of diabetes care in safety net clinics, we collaborated with a nonprofit Medicaid managed care plan to translate research into practice, offering ATSM as a covered benefit and augmenting ATSM to promote medication activation. This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project (SMARTSteps).Methods/DesignThis controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English, Cantonese, or Spanish and receive care at 4 publicly-funded clinics. Through language-stratified randomization, participants were assigned to four intervention statuses: SMARTSteps-ONLY, SMARTSteps-PLUS, or wait-list for either intervention. In addition to usual primary care, intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care, medication adherence, safety concerns, psychological issues, and preventive services. Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning. SMARTSteps-PLUS also included health coach calls to promote medication activation, adherence and intensification, if triggered by ATSM-reported non-adherence, refill non-adherence from pharmacy claims, or suboptimal cardiometabolic indicators. Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months. For participants who agreed to structured telephone interviews at baseline and 6 months (n = 252), primary outcomes will be changes in quality of life and functional status with secondary outcomes of 6-month changes in self-management behaviors/efficacy and patient-centered processes of care. We will also evaluate 6-month changes in cardiometabolic (HbA1c, blood pressure, and LDL) and utilization indicators for all participants.DiscussionOutcomes will provide evidence regarding real-world implementation of ATSM within a Medicaid managed care plan serving safety net settings. The evaluation trial will provide insight into translating and scaling up health information technology interventions for linguistically and culturally diverse vulnerable populations with chronic disease.Trial RegistrationClinicalTrials.gov: NCT00683020

Usability of Commercially Available Mobile Applications for Diverse Patients

“…While we did not ask questions about income level, the patient population at this hospital is known to be low income. 35,36 All participants self-identified as having type 2 diabetes, having depressive symptoms, or being a caregiver for someone with a chronic condition in order to participate in the testing of the concordant category of apps. In addition to these conditions, we asked participants if they had asthma or chronic obstructive pulmonary disease (COPD), heart disease, high blood pressure, heart failure, and chronic kidney disease.…”

Automated Telephone Self-Management Support for Diabetes in a Low-Income Health Plan: A Health Care Utilization and Cost Analysis

“…16,27 Briefly, participants were recruited from 4 clinics in the Community Health Network of San Francisco (CHNSF) 26,28,29 SFHP members with diabetes who participated in SMARTSteps were randomized to one of 4 groups: SMARTSteps-ONLY, SMARTSteps-PLUS, or a wait-list for either intervention. The intervention focused on improving selfmanagement related to behaviors such as taking medications appropriately, eating a healthy diet, exercising and being physically active, depressive symptoms, and checking one's blood sugar level and one's feet for wounds and sores.…”

Use of Complementary Health Approaches Among Diverse Primary Care Patients with Type 2 Diabetes and Association with Cardiometabolic Outcomes: From the SF Bay Collaborative Research Network (SF Bay CRN)

“…Through the SMARTSteps program from 2009 to 2013, we enrolled and followed patients with diabetes; these patients were randomly assigned to receive a self-management, automated, and real-time telephonic support program, or usual care. 5,[21][22] The SMARTSteps study included 362 participants aged 18 years or older, who had type 2 diabetes and received primary care at 1 of 4 publicly funded clinics in the Community Health Network of San Francisco (CHNSF) and who spoke English, Cantonese, or Spanish. We assessed diabetes diagnosis through the CHNSF diabetes registry, a combination of SFHP pharmacy claims with confirmation of clinician-documented diagnosis of diabetes, fasting glucose Ն 126 mg/dL, or A1C Ն 7%.…”

“…22,28 Functional health indicators included the SF-12 for the physical and mental health components, and the reported number of bed days in the previous 30 days. 21,22 We calculated descriptive statistics, including percentages for use of CHA and other categorical variables and means and standard deviations for continuous variables. In bivariate analyses, we compared 1) participants who used any CHA to those participants who did not, and 2) participants who used a single CHA modality to those participants with multiple CHA modalities.…”