Dataset Information

Financial Incentives and Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM): a trial protocol.

ABSTRACT:

Introduction

Given the burden of diabetes in ethnic minorities and emerging data on the efficacy of financial incentives in type 2 diabetes mellitus (T2DM), it is critical to examine the efficacy of financial incentives across and within racial/ethnic groups.

Methods and analysis

This trial is an ongoing 5-year, randomised clinical trial designed to test the efficacy of a Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM) intervention composed of (1) nurse education, (2) home telemonitoring and (3) structured financial incentives; compared with an active control group (nurse education and home telemonitoring alone). The study also will evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (ie, 18 months post-randomisation) and whether the intervention is differentially efficacious across racial/ethnic groups. Participants will include 450 adults with a clinical diagnosis of T2DM and HbA1c of 8% or higher who self-identify as White, African American or Hispanic. Participants will be randomised to one of two groups: the FINANCE intervention or Active Control. The location and setting of this study include primary care clinics at the Medical College of Wisconsin (MCW) in Milwaukee, WI and community partner sites affiliated with the Center for Advancing Population Science at MCW.

Ethics and dissemination

This trial was approved by IRB at MCW under PRO00033788.

Trial registration number

Registration for this trial on the United States National Institute of Health Clinical Trials Registry can be found under ID: NCT04203173 and online (https://clinicaltrials.gov/ct2/show/NCT04203173?id=NCT04203173&draw=2&rank=1).

SUBMITTER: Egede LE

PROVIDER: S-EPMC7757449 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Financial Incentives and Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM): a trial protocol.

Egede Leonard E LE Walker Rebekah R Williams Joni S JS Knapp Rebecca R Dismuke Clara Elizabeth CE Davidson Tatiana T Campbell Jennifer A JA

BMJ open 20201222 12

<h4>Introduction</h4>Given the burden of diabetes in ethnic minorities and emerging data on the efficacy of financial incentives in type 2 diabetes mellitus (T2DM), it is critical to examine the efficacy of financial incentives across and within racial/ethnic groups.<h4>Methods and analysis</h4>This trial is an ongoing 5-year, randomised clinical trial designed to test the efficacy of a <u>F</u>inancial <u>In</u>centives <u>A</u>nd <u>N</u>urse <u>C</u>oaching to <u>E</u>nhance Diabetes Outcomes ...[more]

PMID: 33371048

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Project description:BACKGROUND:Chronic diseases, including diabetes mellitus, are the leading cause of mortality and disability in the United States. Current solutions focus primarily on diagnosis and pharmacological treatment, yet there is increasing evidence that patient-centered models of care are more successful in improving and addressing chronic disease outcomes. OBJECTIVE:The objective of this clinical trial is to evaluate the impact of a mobile health (mHealth) enabled nurse health coaching intervention on self-efficacy among adults with type-2 diabetes mellitus. METHODS:A randomized controlled trial was conducted at an academic health system in Northern California. A total of 300 participants with type-2 diabetes were scheduled to be enrolled through three primary care clinics. Participants were randomized to either usual care or intervention. All participants received training on use of the health system patient portal. Participants in the intervention arm received six scheduled health-coaching telephone calls with a registered nurse and were provided with an activity tracker and mobile application that integrated data into the electronic health record (EHR) to track their daily activity and health behavior decisions. All participants completed a baseline survey and follow-up surveys at 3 and 9 months. Primary and secondary outcomes include diabetes self-efficacy, hemoglobin A1c (HbA1c), and quality of life measures. RESULTS:Data collection for this trial, funded by the Patient-Centered Outcomes Research Institute, will be completed by December 2017. Results from the trial will be available mid-2018. CONCLUSIONS:This protocol details a patient-centered intervention using nurse health coaching, mHealth technologies, and integration of patient-generated data into the EHR. The aim of the intervention is to enhance self-efficacy and health outcomes by providing participants with a mechanism to track daily activity by offering coaching support to set reasonable and attainable health goals, and by creating a complete feedback loop by bringing patient-generated data into the EHR. TRIAL REGISTRATION:ClinicalTrials.gov NCT02672176; https://clinicaltrials.gov/ct2/show/NCT02672176 (Archived by WebCite at http://www.webcitation.org/6xEQXe1M5).

Project description:BACKGROUND:Many employers offer worksite wellness programs, including financial incentives to achieve goals. Evidence supporting such programs is sparse. OBJECTIVE:To assess whether diabetes and cardiovascular risk factor control in employees improved with financial incentives for participation in disease management and for attaining goals. DESIGN:Retrospective cohort study using insurance claims linked with electronic medical record data from January 2008-December 2012. PARTICIPANTS:Employee patients with diabetes covered by the organization's self-funded insurance and propensity-matched non-employee patient comparison group with diabetes and commercial insurance. INTERVENTION:Financial incentives for employer-sponsored disease management program participation and achieving goals. MAIN MEASURES:Change in glycosylated hemoglobin (HbA1c), low-density lipoprotein (LDL), systolic blood pressure (SBP), and weight. RESULTS:A total of 1092 employees with diabetes were matched to non-employee patients. With increasing incentives, employee program participation increased (7 % in 2009 to 50 % in 2012, p?<?0.001). Longitudinal mixed modeling demonstrated improved diabetes and cardiovascular risk factor control in employees vs. non-employees [HbA1c yearly change -0.05 employees vs. 0.00 non-employees, difference in change (DIC) p <0.001]. In their first participation year, employees had larger declines in HbA1c and weight vs. non-employees (0.33 vs. 0.14, DIC p?=?0.04) and (2.3 kg vs. 0.1 kg, DIC p?<?0.001), respectively. Analysis of employee cohorts corresponding with incentive offerings showed that fixed incentives (years 1 and 2) or incentives tied to goals (years 3 and 4) were not significantly associated with HbA1c reductions compared to non-employees. For each employee cohort offered incentives, SBP and LDL also did not significantly differ in employees compared with non-employees (DIC p?>?0.05). CONCLUSIONS:Financial incentives were associated with employee participation in disease management and improved cardiovascular risk factors over 5 years. Improvements occurred primarily in the first year of participation. The relative impact of specific incentives could not be discerned.

Project description:BACKGROUND:Smoking is the leading preventable cause of death in the United States, but evidence-based smoking cessation therapy is underutilized. Financial incentive strategies represent an innovative approach for increasing the use of counseling and pharmacotherapy. If effective, they could supplement or supplant resource-intensive policy options, particularly in populations for whom smoking has substantial societal costs. FIESTA (Financial IncEntives for Smoking TreAtment) will randomize hospitalized smokers to receive usual smoking cessation care alone or usual smoking care augmented with financial incentives. We aim to compare the impact of these two strategies on 1) smoking abstinence, 2) use of counseling and nicotine replacement therapy, and 3) quality of life of participants. We also will evaluate the short-term and long-term return on the investment of incentives. The FIESTA Oral Microbiome Substudy will compare the oral microbiome of smokers and nonsmokers to longitudinally assess whether smoking cessation changes oral microbiome composition. METHODS:We will enroll 182 inpatient participants from the Manhattan campus of the Veterans Affairs New York Harbor Healthcare System. All participants receive enhanced usual care, including screening for tobacco use, counseling while hospitalized, access to nicotine replacement therapy, and referral to a state Quitline. Patients in the financial incentive arm receive enhanced usual care and up to $550 for participating in the New York Smoker's Quitline, using nicotine replacement therapy (NRT), and achieving biochemically confirmed smoking cessation at 2 months and 6 months. In the microbiome substudy, we enroll nonsmoking control participants matched to each recruited smoker's hospital ward, sex, age, diabetes status, and antibiotic use. After discharge, participants are asked to complete periodic phone interviews at 2 weeks, 2 months, 6 months, and 12 months and provide expired carbon monoxide and saliva samples at 2 months, 6 months, and 12 months for cotinine testing and oral microbiome analysis. DISCUSSION:The incentive interventions of FIESTA may benefit hospitalized smokers, an objective made all the more critical because smoking rates among hospitalized patients are higher than those in the general population. Moreover, the focus of FIESTA on evidence-based therapy and bioconfirmed smoking cessation can help guide policy efforts to reduce smoking-related healthcare costs in populations with high rates of tobacco use and costly illnesses. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02506829 . Registered on 1 July 2014.

Dataset Information

Financial Incentives and Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM): a trial protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Financial Incentives and Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM): a trial protocol.

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