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A Patient-Centered PaTH to Address Diabetes: Protocol for a Study on the Impact of Obesity Counseling.

ABSTRACT: BACKGROUND:Overweight and obesity are America's number one health concern. The prevalence of obesity in the United States is greater than 36%, a rate that has doubled since 1970. As the second most preventable cause of death, obesity is a risk factor for diabetes, cardiovascular disease, stroke, and cancer, all major causes of death. Primary care clinics may be an ideal setting for weight control interventions to help manage and prevent diabetes. For this reason, the Centers for Medicare and Medicaid Services (CMS) implemented a health care procedure coding system code for intensive behavioral therapy (IBT) for obesity within primary care in 2012 to facilitate payment for addressing obesity, which was followed by broader coverage by most insurers for IBT for adults in 2013. However, the impact of this coverage on patient-centered outcomes is largely unknown. OBJECTIVE:The overarching goal of this study is to understand the comparative effectiveness of obesity counseling as covered by CMS and other insurers in improving weight loss for adults either with or at increased risk for type 2 diabetes. METHODS:This study leverages the novel infrastructure of the Patient-Centered Outcomes Research Institute-funded PaTH Clinical Data Research Network. The PaTH network is comprised of Geisinger Health System, Johns Hopkins University, Johns Hopkins Health System, Lewis Katz School of Medicine at Temple University, Temple Health System, Penn State College of Medicine, Penn State Milton S Hershey Medical Center, University of Pittsburgh, UPMC and UPMC Health Plan, and the University of Utah. Electronic health record (EHR) data will originate from the 6 PaTH health systems. Specifically, we will (1) evaluate the impact of broader preventive service coverage for obesity screening and counseling on weight loss, diabetes incidence, and diabetes outcomes in patients with diabetes or at increased risk for diabetes (defined by body mass index [BMI] ?25). We will determine how the annual probability of receiving obesity and/or nutritional counseling changed pre- and postpolicy across all insurers in a cohort of patients with diabetes and at high risk for diabetes. We will (2) compare patient weight loss and diabetes-related outcomes among those who receive obesity screening and counseling with those who do not, following implementation of preventive service coverage. We will examine postpolicy impact of obesity screening and counseling in a cohort of patients with diabetes and at increased risk for diabetes. Specific outcomes to be examined include weight loss, diabetes incidence, and diabetes outcomes. Exploratory outcomes will include patient-reported outcomes. Furthermore, we will determine patient characteristics, including demographics, and practice characteristics, including provider type. RESULTS:Our PCORI-funded study is underway. To date, we have obtained our second data extraction from the PaTH CDRN and are performing data editing and cleaning. Next steps include analysis of early policy change. CONCLUSIONS:Given patients who are overweight are at highest risk for diabetes, improved weight management services could prevent diabetes and its negative health outcomes. Comparing weight and diabetes outcomes in 3 states using EHRs and claims data before and after this policy was implemented using the PaTH Network will allow important insight into policy effectiveness. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/12054.

SUBMITTER: Kraschnewski JL

PROVIDER: S-EPMC6538312 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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A Patient-Centered PaTH to Address Diabetes: Protocol for a Study on the Impact of Obesity Counseling.

Kraschnewski Jennifer L JL Kong Lan L Francis Erica E Yeh Hsin-Chieh HC Bryce Cindy C Poger Jennifer J Lehman Erik E

JMIR research protocols 20190404 4

<h4>Background</h4>Overweight and obesity are America's number one health concern. The prevalence of obesity in the United States is greater than 36%, a rate that has doubled since 1970. As the second most preventable cause of death, obesity is a risk factor for diabetes, cardiovascular disease, stroke, and cancer, all major causes of death. Primary care clinics may be an ideal setting for weight control interventions to help manage and prevent diabetes. For this reason, the Centers for Medicare ...[more]

PMID: 30946024

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Project description:BackgroundLiving with type 1 diabetes is challenging, and to support self-management, repeated consultations in specialist outpatient care are often required. The emergence of new digital solutions has revolutionized how health care services can be patient centered, providing unprecedented opportunities for flexible, high-quality care. However, there is a lack of studies exploring how the use of digital patient-reported outcome measures (PROMs) for flexible specialist care affects diabetes self-management. To provide new knowledge on the relevance of using PROMs in standard care, we have designed a multimethod prospective study.ObjectiveThe overall aim of this protocol is to describe our prospective multimethod observational study designed to investigate digital PROMs in a routine specialist outpatient setting for flexible patient-centered diabetes care (DigiDiaS).MethodsThis protocol outlines the design of a multimethod prospective observational cohort study that includes data from electronic health records, self-reported questionnaires, clinical consultation field observations, and individual in-depth interviews with patients and diabetes health care personnel. All patients with type 1 diabetes at a designated outpatient clinic were invited to participate and use the digital PROM implemented in clinical care. Both users and nonusers of the digital PROM were eligible for the prospective study, allowing for a comparison of the two groups. Data were collected at baseline and after 12 months, including self-management as the primary outcome assessed using the Patient Activation Measure, along with the secondary outcomes of digital health literacy, quality of life, health economy, and clinical variables such as glycated hemoglobin.ResultsThe digital solution was implemented for routine clinical care in the department in November 2021, and data collection for the prospective study started in October 2022. As of September 6, 2023, 84.6% (186/220) of patients among those in the digital PROM and 15.5% (34/220) of patients among the nonusers have consented to participate. We expect the study to have enough participants by the autumn of 2023. With 1 year of follow-up, the results are expected by spring 2025.ConclusionsIn conclusion, a multimethod prospective observational cohort study can offer valuable insights into the relevance, effectiveness, and acceptability of digital tools using PROMs in diabetes specialist care. Such knowledge is crucial for achieving broad and successful implementation and use of these tools in a large diabetes outpatient clinic.International registered report identifier (irrid)DERR1-10.2196/52766.

Project description:PurposeThere is robust research examining the negative impact of racial and socioeconomic implicit bias on healthcare provider clinical decision-making. However, other under-studied important biases are likely to impact clinical care as well. The goal of this study was to explore the presence of bias against people with physical disability among a heterogeneous group of healthcare workers and trainees and to evaluate the effect of implicit association testing and an educational module on this bias.MethodThe study was composed of a one-hour web-based survey and educational module. The survey included an explicit disability bias assessment, disability Implicit Association Tests (IATs), demographic collection, and pre- and post- module clinical vignettes of prenatal patient scenarios. In addition to providing counseling to hypothetical patients, participants also indicated their personal preferences on genetic testing and termination. The educational module focused on the principles of patient-centered counseling.ResultsThe collected data reflects responses from 335 participants. Within this sample, there were both explicit and implicit biases towards individuals with physical disabilities. Prior to the IAT and educational module, when respondents were tasked with providing genetic testing recommendations, implicit biases and personal preferences for genetic testing and termination influenced respondents' clinical recommendations. Importantly, having previous professional experience with individuals with disabilities diminished biased clinical recommendations prior to the intervention. In response to the IAT and educational intervention, the effect of implicit bias and personal preferences on clinical recommendations decreased.ConclusionsThis study demonstrates how bias against a marginalized group exists within the medical community and that personal opinions can impact clinical counseling. Importantly, our findings suggest that there are strategies that can be easily implemented into curricula to address disability bias, including formal educational interventions and the addition of professional experiences into healthcare professional training programs.

Project description:BackgroundDespite the potential to significantly reduce complications, many patients do not consistently receive diabetes preventive care. Our research team recently applied user-centered design sprint methodology to develop a patient portal intervention empowering patients to address selected diabetes care gaps (eg, no diabetes eye examination in last 12 months).ObjectiveThis study aims to evaluate the effect of our novel diabetes care gap intervention on completion of selected evidence-based diabetes preventive care services and secondary outcomes.MethodsWe are conducting a pragmatic randomized controlled trial of the effect of the intervention on diabetes care gaps. Adult patients with diabetes mellitus (DM) are recruited from primary care clinics affiliated with Vanderbilt University Medical Center. Participants are eligible if they have type 1 or 2 DM, can read in English, are aged 18-75 years, have a current patient portal account, and have reliable access to a mobile device with internet access. We exclude patients with medical conditions that prevent them from using a mobile device, severe difficulty seeing, pregnant women or women who plan to become pregnant during the study period, and patients on dialysis. Participants will be randomly assigned to the intervention or usual care. The primary outcome measure will be the number of diabetes care gaps among 4 DM preventive care services (diabetes eye examination, pneumococcal vaccination, hemoglobin A1c, and urine microalbumin) at 12 months after randomization. Secondary outcomes will include diabetes self-efficacy, confidence managing diabetes in general, understanding of diabetes preventive care, diabetes distress, patient portal satisfaction, and patient-initiated orders at baseline, 3 months, 6 months, and 12 months after randomization. An ordinal logistic regression model will be used to quantify the effect of the intervention on the number of diabetes care gaps at the 12-month follow-up. For dichotomous secondary outcomes, a logistic regression model will be used with random effects for the clinic and provider variables as needed. For continuous secondary outcomes, a regression model will be used.ResultsThis study is ongoing. Recruitment was closed in February 2022; a total of 433 patients were randomized. Of those randomized, most (n=288, 66.5%) were non-Hispanic White, 33.5% (n=145) were racial or ethnic minorities, 33.9% (n=147) were aged 65 years or older, and 30.7% (n=133) indicated limited health literacy.ConclusionsThe study directly tests the hypothesis that a patient portal intervention-alerting patients about selected diabetes care gaps, fostering understanding of their significance, and allowing patients to initiate care-will reduce diabetes care gaps compared with usual care. The insights gained from this study may have broad implications for developing future interventions to address various care gaps, such as gaps in cancer screening, and contribute to the development of effective, scalable, and sustainable approaches to engage patients in chronic disease management and prevention.Trial registrationClinicalTrials.gov NCT04894903; https://classic.clinicaltrials.gov/ct2/show/NCT04894903.International registered report identifier (irrid)DERR1-10.2196/56123.

Project description:BackgroundMidwives are a large proportion of Ethiopia's health care workforce, and their attitudes and practices shape the quality of reproductive health care, including safe abortion care (SAC) services. This study examines how midwives' conceptions of their professional roles and views on women who have abortions relate to their willingness to provide respectful SAC.MethodsThis study uses a cross-sectional, mixed methods design to conduct a regionally representative survey of midwives in Ethiopia's five largest regions (Oromia; Amhara; Southern Nations, Nationalities, and Peoples [SNNP]; Tigray; and Addis Ababa) with a multistage, cluster sampling design (n = 944). The study reports survey-weighted population estimates and the results of multivariate logistic regression analyzing factors associated with midwives' willingness to provide SAC. Survey data were triangulated with results from seven focus group discussions (FGDs) held with midwives in the five study regions. Deductive and inductive codes were used to thematically analyze these data.ResultsThe study surveyed 960 respondents. An estimated half of midwives believed that providing SAC was a professional duty. Slightly more than half were willing to provide SAC. A belief in right of refusal was common: two-thirds of respondents said that midwives should be able to refuse SAC provision on moral or religious grounds. Modifiable factors positively associated with willingness to provide SAC were SAC training (AOR 4.02; 95% CI 2.60, 6.20), agreeing that SAC refusal risked women's lives (AOR 1.69; 95% CI 1.20, 2.37), and viewing SAC provision as a professional duty (AOR 1.72; 95% CI 1.23, 2.39). In line with survey findings, a substantial number of FGD participants stated they had the right to refuse SAC. Responses to client scenarios revealed "directive counseling" to be common: many midwives indicated that they would actively attempt to persuade clients to act as they (the midwives) thought was best, rather than support clients in making their own decisions.ConclusionFindings suggest a need for new guidelines to clarify procedures surrounding conscientious objection and refusal to provide SAC, as well as initiatives to equip midwives to provide rights-based, patient-centered counseling and avoid directive counseling.

Project description:BackgroundThe potential of mHealth technologies in the care of patients with diabetes and other chronic conditions has captured the attention of clinicians and researchers. Efforts to date have incorporated a variety of tools and techniques, including Web-based portals, short message service (SMS) text messaging, remote collection of biometric data, electronic coaching, electronic-based health education, secure email communication between visits, and electronic collection of lifestyle and quality-of-life surveys. Each of these tools, used alone or in combination, have demonstrated varying degrees of effectiveness. Some of the more promising results have been demonstrated using regular collection of biometric devices, SMS text messaging, secure email communication with clinical teams, and regular reporting of quality-of-life variables. In this study, we seek to incorporate several of the most promising mHealth capabilities in a patient-centered medical home (PCMH) workflow.ObjectiveWe aim to address underlying technology needs and gaps related to the use of mHealth technology and the activation of patients living with type 2 diabetes. Stated differently, we enable supporting technologies while seeking to influence patient activation and self-care activities.MethodsThis is a multisite phased study, conducted within the US Military Health System, that includes a user-centered design phase and a PCMH-based feasibility trial. In phase 1, we will assess both patient and provider preferences regarding the enhancement of the enabling technology capabilities for type 2 diabetes chronic care management. Phase 2 research will be a single-blinded 12-month feasibility study that incorporates randomization principles. Phase 2 research will seek to improve patient activation and self-care activities through the use of the Mobile Health Care Environment with tailored behavioral messaging. The primary outcome measure is the Patient Activation Measure scores. Secondary outcome measures are Summary of Diabetes Self-care Activities Measure scores, clinical measures, comorbid conditions, health services resource consumption, and technology system usage statistics.ResultsWe have completed phase 1 data collection. Formal analysis of phase 1 data has not been completed. We have obtained institutional review board approval and began phase 1 research in late fall 2016.ConclusionsThe study hypotheses suggest that patients can, and will, improve their activation in chronic care management. Improved activation should translate into improved diabetes self-care. Expected benefits of this research to the scientific community and health care services include improved understanding of how to leverage mHealth technology to activate patients living with type 2 diabetes in self-management behaviors. The research will shed light on implementation strategies in integrating mHealth into the clinical workflow of the PCMH setting.Trial registrationClinicalTrials.gov NCT02949037. https://clinicaltrials.gov/ct2/show/NCT02949037. (Archived by WebCite at http://www.webcitation.org/6oRyDzqei).

Project description:BackgroundMost adults with diabetes who are at high risk for complications have family or friends who are involved in their medical and self-care ("family supporters"). These family supporters are an important resource who could be leveraged to improve patients' engagement in their care and patient health outcomes. However, healthcare teams lack structured and feasible approaches to effectively engage family supporters in patient self-management support. This trial tests a strategy to strengthen the capacity of family supporters to help adults with high-risk diabetes engage in healthcare, successfully enact care plans, and lower risk of diabetes complications.Methods/designWe will conduct a randomized trial evaluating the CO-IMPACT (Caring Others Increasing EnageMent in Patient Aligned Care Teams) intervention. Two hunded forty adults with diabetes who are at high risk for diabetes complications due to poor glycemic control or high blood pressure will be randomized, along with a family supporter (living either with the patient or remotely), to CO-IMPACT or enhanced usual primary care for 12 months. CO-IMPACT provides patient-supporter dyads: it provides one coaching session addressing supporter techniques for helping patients with behavior change motivation, action planning, and proactive communication with healthcare providers; biweekly automated phone calls to prompt dyad action on new patient health concerns; phone calls to prompt preparation for patients' primary care visits; and primary care visit summaries sent to both patient and supporter. Primary outcomes are changes in patient activation, as measured by the Patient Activation Measure-13, and change in 5-year cardiac event risk, as measured by the United Kingdom Prospective Diabetes Study cardiac risk score for people with diabetes. Secondary outcomes include patients' diabetes self-management behaviors, diabetes distress, and glycemic and blood pressure control. Measures among supporters will include use of effective support techniques, burden, and distress about patient's diabetes care.DiscussionIf effective in improving patient activation and diabetes management, CO-IMPACT will provide healthcare teams with evidence-based tools and techniques to engage patients' available family or friends in supporting patient self-management, even if they live remotely. The core skills addressed by CO-IMPACT can be used by patients and their supporters over time to respond to changing patient health needs and priorities.Trial registrationClinicalTrials.gov, NCT02328326 . Registered on 31 December 2014.

Project description:BackgroundHealth systems and providers across America are increasingly employing telehealth technologies to better serve medically underserved low-income, minority, and rural populations at the highest risk for health disparities. The Patient-Centered Outcomes Research Institute (PCORI) has invested US $386 million in comparative effectiveness research in telehealth, yet little is known about the key early lessons garnered from this research regarding the best practices in using telehealth to address disparities.ObjectiveThis paper describes preliminary lessons from the body of research using study findings and case studies drawn from PCORI seminal patient-centered outcomes research (PCOR) initiatives. The primary purpose was to identify common barriers and facilitators to implementing telehealth technologies in populations at risk for disparities.MethodsA systematic scoping review of telehealth studies addressing disparities was performed. It was guided by the Arksey and O'Malley Scoping Review Framework and focused on PCORI's active portfolio of telehealth studies and key PCOR identified by study investigators. We drew on this broad literature using illustrative examples from early PCOR experience and published literature to assess barriers and facilitators to implementing telehealth in populations at risk for disparities, using the active implementation framework to extract data. Major themes regarding how telehealth interventions can overcome barriers to telehealth adoption and implementation were identified through this review using an iterative Delphi process to achieve consensus among the PCORI investigators participating in the study.ResultsPCORI has funded 89 comparative effectiveness studies in telehealth, of which 41 assessed the use of telehealth to improve outcomes for populations at risk for health disparities. These 41 studies employed various overlapping modalities including mobile devices (29/41, 71%), web-based interventions (30/41, 73%), real-time videoconferencing (15/41, 37%), remote patient monitoring (8/41, 20%), and store-and-forward (ie, asynchronous electronic transmission) interventions (4/41, 10%). The studies targeted one or more of PCORI's priority populations, including racial and ethnic minorities (31/41, 41%), people living in rural areas, and those with low income/low socioeconomic status, low health literacy, or disabilities. Major themes identified across these studies included the importance of patient-centered design, cultural tailoring of telehealth solutions, delivering telehealth through trusted intermediaries, partnering with payers to expand telehealth reimbursement, and ensuring confidential sharing of private information.ConclusionsEarly PCOR evidence suggests that the most effective health system- and provider-level telehealth implementation solutions to address disparities employ patient-centered and culturally tailored telehealth solutions whose development is actively guided by the patients themselves to meet the needs of specific communities and populations. Further, this evidence shows that the best practices in telehealth implementation include delivery of telehealth through trusted intermediaries, close partnership with payers to facilitate reimbursement and sustainability, and safeguards to ensure patient-guided confidential sharing of personal health information.

Project description:BackgroundTo achieve informed choice within the framework of reproductive autonomy, family planning programs have begun to adopt user-centered approaches to service provision, which highlight the individual client as the focal point of interaction and key decision maker. However, little is known about how user-centered approaches to family planning, particularly family planning counseling, shape contraceptive preferences and choices.ObjectiveWe conducted a multiarmed randomized controlled trial to identify the causal impact of user-centered approaches to family planning counseling on women's contraceptive decision making in urban Malawi. This study aims to determine how a tailored, preference-driven approach to family planning counseling and the involvement of male partners during the counseling process may contribute to shaping women's contraceptive preferences and choices.MethodsMarried women aged 18-35 years were recruited and randomly assigned to 1 of the 3 intervention arms or a control arm characterized by the following two interventions: an intervention arm in which women were encouraged to invite their husbands to family planning counseling (husband invitation arm) and an intervention arm in which women received targeted, tailored counseling on up to five contraceptive methods (as opposed to up to 13 contraceptive methods) that reflected women's stated preferences for contraceptive methods. Women were randomized into a control arm, T0 (no husband invitation, standard counseling); T1 (husband invitation, standard counseling); T2 (no husband invitation, targeted counseling); and T3 (husband invitation, targeted counseling). Following counseling, all women received a package of family planning services, which included free transportation to a local family planning clinic and financial reimbursement for family planning services. Follow-up surveys were conducted with women 1 month after counseling.ResultsA total of 785 women completed the baseline survey, and 782 eligible respondents were randomized to 1 of the 3 intervention groups or the control group (T1, n=223; T2, n=225; T3, n=228; T0, n=108). Furthermore, 98.1% (767/782) of women were contacted for follow-up. Among the 767 women who were contacted, 95.3% (731/767) completed the follow-up survey. The analysis of the primary outcomes is ongoing and is expected to be completed by the end of 2021.ConclusionsThe results from this trial will fill knowledge gaps on the effectiveness of tailored family planning counseling and male involvement in family planning on women's stated and realized contraceptive preferences. More generally, the study will provide evidence on how user-centered counseling may affect women's willingness to use and continue contraception to realize their contraceptive preferences.Trial registrationAmerican Economics Association's Registry for Randomized Controlled Trials AEARCTR-0004194; https://www.socialscienceregistry.org/trials/4194/history/46808. Registry for International Development Impact Evaluations RIDIE-STUDY-ID-5ce4f42bbc2bf; https://ridie.3ieimpact.org/index.php?r=search/detailView&id=823.International registered report identifier (irrid)DERR1-10.2196/24884.

Dataset Information

A Patient-Centered PaTH to Address Diabetes: Protocol for a Study on the Impact of Obesity Counseling.

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A Patient-Centered PaTH to Address Diabetes: Protocol for a Study on the Impact of Obesity Counseling.

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