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A pilot randomized trial of technology-assisted goal setting to improve physical activity among primary care patients with prediabetes

Mann, Devin M; Palmisano, Joseph; Lin, Jenny J
Lifestyle behavior changes can prevent progression of prediabetes to diabetes but providers often are not able to effectively counsel about preventive lifestyle changes. We developed and pilot tested the Avoiding Diabetes Thru Action Plan Targeting (ADAPT) program to enhance primary care providers' counseling about behavior change for patients with prediabetes. Primary care providers in two urban academic practices and their patients with prediabetes were recruited to participate in the ADAPT study, an unblinded randomized pragmatic trial to test the effectiveness of the ADAPT program, including a streamlined electronic medical record-based goal setting tool. Providers were randomized to intervention or control arms; eligible patients whose providers were in the intervention arm received the ADAPT program. Physical activity (the primary outcome) was measured using pedometers, and data were gathered about patients' diet, weight and glycemic control. A total of 54 patients were randomized and analyzed as part of the 6-month ADAPT study (2010-2012, New York, NY). Those in the intervention group showed an increase total daily steps compared to those in the control group (+ 1418 vs - 598, p = 0.007) at 6 months. There was also a trend towards weight loss in the intervention compared to the control group (- 1.0 lbs. vs. 3.0 lbs., p = 0.11), although no change in glycemic control. The ADAPT study is among the first to use standard electronic medical record tools to embed goal setting into realistic primary care workflows and to demonstrate a significant improvement in prediabetes patients' physical activity.
PMCID:4929067
PMID: 27413670
ISSN: 2211-3355
CID: 2305002

Integrating data from an online diabetes prevention program into an electronic health record and clinical workflow, a design phase usability study

Mishuris, Rebecca Grochow; Yoder, Jordan; Wilson, Dan; Mann, Devin
BACKGROUND: Health information is increasingly being digitally stored and exchanged. The public is regularly collecting and storing health-related data on their own electronic devices and in the cloud. Diabetes prevention is an increasingly important preventive health measure, and diet and exercise are key components of this. Patients are turning to online programs to help them lose weight. Despite primary care physicians being important in patients' weight loss success, there is no exchange of information between the primary care provider (PCP) and these online weight loss programs. There is an emerging opportunity to integrate this data directly into the electronic health record (EHR), but little is known about what information to share or how to share it most effectively. This study aims to characterize the preferences of providers concerning the integration of externally generated lifestyle modification data into a primary care EHR workflow. METHODS: We performed a qualitative study using two rounds of semi-structured interviews with primary care providers. We used an iterative design process involving primary care providers, health information technology software developers and health services researchers to develop the interface. RESULTS: Using grounded-theory thematic analysis 4 themes emerged from the interviews: 1) barriers to establishing healthy lifestyles, 2) features of a lifestyle modification program, 3) reporting of outcomes to the primary care provider, and 4) integration with primary care. These themes guided the rapid-cycle agile design process of an interface of data from an online diabetes prevention program into the primary care EHR workflow. CONCLUSIONS: The integration of external health-related data into the EHR must be embedded into the provider workflow in order to be useful to the provider and beneficial for the patient. Accomplishing this requires evaluation of that clinical workflow during software design. The development of this novel interface used rapid cycle iterative design, early involvement by providers, and usability testing methodology. This provides a framework for how to integrate external data into provider workflow in efficient and effective ways. There is now the potential to realize the importance of having this data available in the clinical setting for patient engagement and health outcomes.
PMCID:4940704
PMID: 27401606
ISSN: 1472-6947
CID: 2305012

Pilot and Feasibility Test of a Mobile Health-Supported Behavioral Counseling Intervention for Weight Management Among Breast Cancer Survivors

M Quintiliani, Lisa; Mann, Devin M; Puputti, Marissa; Quinn, Emily; Bowen, Deborah J
BACKGROUND:Health behavior and weight management interventions for cancer survivors have the potential to prevent future cancer recurrence and improve long-term health; however, their translation can be limited if the intervention is complex and involves high participant burden. Mobile health (mHealth) offers a delivery modality to integrate interventions into daily life routines. OBJECTIVE:The objective of this study was to evaluate the effects of a one-group trial with a pre-post evaluation design on engagement (use and acceptability), physiological (weight), behavioral (diet and physical activity), and other secondary outcomes. METHODS:The 10-week intervention consisted of mHealth components (self-monitoring of selected diet behaviors via daily text messages, wireless devices to automatically track weight and steps) and 4 motivational interviewing-based technology-assisted phone sessions with a nonprofessionally trained counselor. Participants were overweight breast cancer survivors who had completed treatment and owned a smartphone. Weight was measured objectively; diet and physical activity were measured with brief self-reported questionnaires. RESULTS:Ten women participated; they had a mean age of 59 years (SD 6), 50% belonged to a racial or ethnic minority group, 50% had some college or less, and 40% reported using Medicaid health insurance. Engagement was high: out of 70 days in total, the mean number of days recording steps via the wristband pedometer was 64 (SD 7), recording a weight via the scale was 45 (SD 24), and responding to text messages was 60 (SD 13); 100% of participants completed all 4 calls with the counselor. Most (90%) were very likely to participate again and recommend the program to others. Mean weight in pounds decreased (182.5 to 179.1, mean change -3.38 [SD 7.67]), fruit and vegetable daily servings increased (2.89 to 4.42, mean change 1.53 [SD 2.82]), and self-reported moderate physical activity increased in metabolic equivalent of task (MET) minutes per week (2791 to 3336, mean change 545 [SD 1694]). CONCLUSIONS:Findings support the conduct of a fully powered trial to evaluate the efficacy of mHealth as a feasible intervention modality for breast cancer survivors. Future research should employ accelerometer-based physical activity assessment and consider development of an all-in-one app to integrate devices, messaging, and educational content and other mHealth approaches to support behavioral counselors conducting weight management interventions. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT02387671; https://clinicaltrials.gov/ct2/show/NCT02387671 (Archived by WebCite at http://www.webcitation.org/6hGEuttbZ).
PMCID:5066594
PMID: 28410174
ISSN: 2369-1999
CID: 4673322

THINK ALOUD AND NEAR LIVE USABILITY TESTING OF TWO PRIMARY CARE CLINICAL DECISION SUPPORT TOOLS [Meeting Abstract]

Richardson, Safiya; Mishuris, Rebecca G.; McCullagh, Lauren; Mann, Devin
ISI:000392201601261
ISSN: 0884-8734
CID: 4181272

Academic Medical Center R&D: A Call for Creating an Operational Research Infrastructure within the Academic Medical Center

Mann, Devin M; Hess, Rachel
PMCID:5351151
PMID: 26728948
ISSN: 1752-8062
CID: 2173232

Healthcare provider perceptions of clinical prediction rules

Richardson, Safiya; Khan, Sundas; McCullagh, Lauren; Kline, Myriam; Mann, Devin; McGinn, Thomas
OBJECTIVES: To examine internal medicine and emergency medicine healthcare provider perceptions of usefulness of specific clinical prediction rules. SETTING: The study took place in two academic medical centres. A web-based survey was distributed and completed by participants between 1 January and 31 May 2013. PARTICIPANTS: Medical doctors, doctors of osteopathy or nurse practitioners employed in the internal medicine or emergency medicine departments at either institution. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was to identify the clinical prediction rules perceived as most useful by healthcare providers specialising in internal medicine and emergency medicine. Secondary outcomes included comparing usefulness scores of specific clinical prediction rules based on provider specialty, and evaluating associations between usefulness scores and perceived characteristics of these clinical prediction rules. RESULTS: Of the 401 healthcare providers asked to participate, a total of 263 (66%), completed the survey. The CHADS2 score was chosen by most internal medicine providers (72%), and Pulmonary Embolism Rule-Out Criteria (PERC) score by most emergency medicine providers (45%), as one of the top three most useful from a list of 24 clinical prediction rules. Emergency medicine providers rated their top three significantly more positively, compared with internal medicine providers, as having a better fit into their workflow (p=0.004), helping more with decision-making (p=0.037), better fitting into their thought process when diagnosing patients (p=0.001) and overall, on a 10-point scale, more useful (p=0.009). For all providers, the perceived qualities of useful at point of care, helps with decision making, saves time diagnosing, fits into thought process, and should be the standard of clinical care correlated highly (>/=0.65) with overall 10-point usefulness scores. CONCLUSIONS: Healthcare providers describe clear preferences for certain clinical prediction rules, based on medical specialty.
PMCID:4563244
PMID: 26338684
ISSN: 2044-6055
CID: 2173242

Association of visit-to-visit variability of hemoglobin A1c and medication adherence

Ramachandran, Ambili; Winter, Michael; Mann, Devin M
BACKGROUND: Medication nonadherence is widespread, but there are few efficient means of detecting medication nonadherence at the point of care. Visit-to-visit variability in clinical biomarkers has shown inconsistent efficiency to predict medication adherence. OBJECTIVE: To examine the performance of visit-to-visit variability (VVV) of hemoglobin A1c to predict nonadherence to antidiabetic medications. METHODS: In this cross-sectional study using a clinical and administrative database, adult members of a managed care plan at a safety-net medical center from 2008 to 2012 were included if they had >/= 3 noninsulin antidiabetic prescription fills within the same class and >/= 3 A1c measurements between the first and last prescription fills. The independent variable was VVV of A1c (within-subject standard deviation of A1c), and the dependent variable was medication adherence (defined by medication possession ratio) determined from pharmacy claims. Unadjusted and adjusted multivariate logistic regression models were created to examine the relationship between VVV of A1c and medication nonadherence. Receiver-operating characteristic (ROC) curves assessed the performance of the adjusted model at discriminating adherence from nonadherence. RESULTS: Among 632 eligible subjects, mean A1c was 7.7% +/- 1.3%, and 83% of the sample was nonadherent to antidiabetic medications. Increasing quintiles of VVV of A1c and medication nonadherence were both associated with increased within-subject mean A1c and younger subject age. The logistic regression model (adjusted for age, sex, race/ethnicity, within-subject mean A1c, number of A1c measurements, number of days between the first and last antidiabetic medication prescription fills, and rate of primary care visits during the study period) showed a nonsignificant association of VVV of A1c and medication nonadherence (OR = 1.19, 95% CI = 0.42-3.38 for the highest quintile of VVV). Adding VVV of A1c to a model including age, sex, and race only modestly improved the C-statistic of the ROC curve from 0.6786 to 0.7064. CONCLUSIONS: VVV of A1c is not a robust predictor of antidiabetic medication nonadherence. Further innovation is needed to develop novel methods of detecting nonadherence.
PMID: 25726032
ISSN: 2376-1032
CID: 2173262

A Framework for Usable and Effective Clinical Decision Support: Experience from the iCPR Randomized Clinical Trial

Kannry, Joseph; McCullagh, Lauren; Kushniruk, Andre; Mann, Devin; Edonyabo, Daniel; McGinn, Thomas
INTRODUCTION: The promise of Clinical Decision Support (CDS) has always been to transform patient care and improve patient outcomes through the delivery of timely and appropriate recommendations that are patient specific and, more often than not, are appropriately actionable. However, the users of CDS-providers-are frequently bombarded with inappropriate and inapplicable CDS that often are not informational, not integrated into the workflow, not patient specific, and that may present out of date and irrelevant recommendations. METHODS: The integrated clinical prediction rule (iCPR) project was a randomized clinical trial (RCT) conducted to determine if a novel form of CDS, i.e., clinical prediction rules (CPRs), could be efficiently integrated into workflow and result in changes in outcomes (e.g., antibiotic ordering) when embedded within a commercial electronic health record (EHR). We use the lessons learned from the iCPR project to illustrate a framework for constructing usable, useful, and effective actionable CDS while employing off-the-shelf functionality in a production system. Innovations that make up the framework combine the following: (1) active and actionable decision support, (2) multiple rounds of usability testing with iterative development for user acceptance, (3) numerous context sensitive triggers, (4) dedicated training and support for users of the CDS tool for user adoption, and (5) support from clinical and administrative leadership. We define "context sensitive triggers" as being workflow events (i.e., context) that result in a CDS intervention. DISCUSSION: Success of the framework can be measured by CDS adoption (i.e., intervention is being used), acceptance (compliance with recommendations), and clinical outcomes (where appropriate). This framework may have broader implications for the deployment of Health Information Technology (HIT). RESULTS AND CONCLUSION: iCPR was well adopted(57.4% of users) and accepted (42.7% of users). Usability testing identified and fixed many issues before the iCPR RCT. The level of leadership support and clinical guidance for iCPR was key in establishing a culture of acceptance for both the tool and its recommendations contributing to adoption and acceptance. The dedicated training and support lead to the majority of the residents reporting a high level of comfort with both iCPR tools strep pharyngitis (64.4 percent) and pneumonia (62.7 percent) as well as a high likelihood of using the tools in the future. A surprising framework addition resulted from usability testing: context sensitive triggers.
PMCID:4537146
PMID: 26290888
ISSN: 2327-9214
CID: 2173252

Longitudinal adoption rates of complex decision support tools in primary care

McCullagh, Lauren; Mann, Devin; Rosen, Lisa; Kannry, Joseph; McGinn, Thomas
Translating research findings into practice promises to standardise care. Translation includes the integration of evidence-based guidelines at the point of care, discerning the best methods to disseminate research findings and models to sustain the implementation of best practices.By applying usability testing to clinical decision support(CDS) design, overall adoption rates of 60% can be realised.What has not been examined is how long adoption rates are sustained and the characteristics associated with long-term use. We conducted secondary analysis to decipher the factors impacting sustained use of CD Stools. This study was a secondary data analysis from a clinical trial conducted at an academic institution in New York City. Study data was identified patients electronic health records (EHR). The trial was to test the implementation of an integrated clinical prediction rule(iCPR) into the EHR. The primary outcome variable was iCPR tool acceptance of the tool. iCPR tool completion and iCPR smartest completion were additional outcome variables of interest. The secondary aim was to examine user characteristics associated with iCPR tool use in later time periods. Characteristics of interest included age, resident year, use of electronic health records (yes/no) and use of best practice alerts (BPA) (yes/no). Generalised linear mixed models (GLiMM) were used to compare iCPR use over time for each outcome of interest: namely, iCPR acceptance, iCPR completion and iCPR smartset completion.GLiMM was also used to examine resident characteristics associated with iCPR tool use in later time periods; specifically, intermediate and long-term (ie, 90+days). The tool was accepted, on average, 82.18% in the first 90 days (short-term period). The use decreases to 56.07% and 45.61% in intermediate and long-term time periods, respectively. There was a significant association between iCPR tool completion and time periods(p<0.0001). There was no significant difference in iCPR tool completion between resident encounters in the intermediate and long-term periods (p<0.6627). There was a significant association between iCPR smartset completion and time periods (p<0.0021). There were no significant associations between iCPR smartest completion and any of the four predictors of interest. We examined the frequencies of components of the iCPR tool being accepted over time by individual clinicians. Rates of adoption of the different components of the tool decreased substantially over time. The data suggest that over time and prolonged exposure to CDS tools, providers are less likely to utilise the tool. It is not clear if it is fatigue with the CDS tool, acquired knowledge of the clinical prediction rule, or gained clinical experience and gestalt that are influencing adoption rates. Further analysis of individual adoption rates over time and the impact it has on clinical outcomes should be conducted.
PMID: 25238769
ISSN: 1473-6810
CID: 2173292

Dietary Approaches to Stop Hypertension: Lessons Learned From a Case Study on the Development of an mHealth Behavior Change System

Mann, Devin M; Quintiliani, Lisa M; Reddy, Shivani; Kitos, Nicole R; Weng, Michael
BACKGROUND: Evidence-based solutions for changing health behaviors exist but problems with feasibility, sustainability, and dissemination limit their impact on population-based behavior change and maintenance. OBJECTIVE: Our goal was to overcome the limitations of an established behavior change program by using the inherent capabilities of smartphones and wireless sensors to develop a next generation mobile health (mHealth) intervention that has the potential to be more feasible. METHODS: In response to the clinical need and the growing capabilities of smartphones, our study team decided to develop a behavioral hypertension reduction mHealth system inspired by Dietary Approaches to Stop Hypertension (DASH), a lifestyle modification program. We outline the key design and development decisions that molded the project including decisions about behavior change best practices, coaching features, platform, multimedia content, wireless devices, data security, integration of systems, rapid prototyping, usability, funding mechanisms, and how all of these issues intersect with clinical research and behavioral trials. RESULTS: Over the 12 months, our study team faced many challenges to developing our prototype intervention. We describe 10 lessons learned that will ultimately stimulate more effective and sustainable approaches. CONCLUSIONS: The experiences presented in this case study can be used as a reference for others developing mHealth behavioral intervention development projects by highlighting the benefits and challenges facing mHealth research.
PMCID:4259967
PMID: 25340979
ISSN: 2291-5222
CID: 2173282