JMIR Research Protocols

Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results

“Everybody Brush!”: Protocol for a parallel-group randomized controlled trial of a family-focused primary prevention program with distribution of oral hygiene products and education to increase frequency of toothbrushing

Background: Twice-daily toothbrushing with fluoridated toothpaste is the most widely advocated preventive strategy for dental caries (tooth decay) and is recommended by professional dental associations. Few parents, children, or adolescents follow this recommendation. Objective: This protocol describes the methods for the implementation and evaluation of a quality improvement health promotion program. The goal of the theory-informed, evidence-based program is to improve twice-daily toothbrushing, and oral health-related quality of life and reduce dental caries, dental treatment need and costs. Methods: The design is a parallel-group pragmatic randomized controlled trial. Families of Medicaid-insured children and adolescents within a large dental care organization in central Oregon will participate in the trial (n=approximately 20,000). Families will be assigned to one of three groups: a test intervention, an active control, or a passive control condition. The intervention aims to address barriers and support for twice-daily toothbrushing. Families in the test condition will receive toothpaste and toothbrushes by mail for all family members every three months. In addition, they will receive instruction and social support to encourage toothbrushing via postcards, recorded telephone messages, and an optional participant-initiated telephone help line. Families in the active control condition will receive the kit of supplies by mail but no additional instructional information or telephone support. Families assigned to the passive control will be on a waiting list. The primary outcomes are restorative dental care received and, only for children younger than 36 months at baseline, the frequency of twice-daily toothbrushing. Data will be collected through dental claims records and, for children younger than 36 months at baseline, parent interview and clinical exam. Conclusions: If proven effective, this simple intervention can be sustained by the dental care organization and replicated by other organizations and government. Clinical Trial: ClinicalTrials.gov NCT02327507Oral hygiene; Toothbrushing; Dental devices, home care; Dental care; Communication; Social Support

2015-02-19

We are pleased to announce our forthcoming new journals, all of which have currently no submission or publication fees, and all of which focus on emerging technologies and patient-centered innovations in specific areas, going beyond Internet/webbased interventions: * JMIR Cancer (http://cancer.jmir.org) * JMIR Medical Education (http://mededu.jmir.org) * JMIR Public Health and Surveillance (http://publichealth.jmir.org) We welcome submissions for the inaugural issues of these journals. The following journals have already published articles and are still free of charge to publish in (no submission or publication fees): * JMIR Human Factors (http://humanfactors.jmir.org) * JMIR Rehabilitation and Assistive Technologies (http://rehab.jmir.org) * JMIR Mental Health (http://mental.jmir.org) To submit to these journals, simply append /author to the URLs above (e.g. http://cancer.jmir.org/author), or submit to the main JMIR journal and use the dropdown-box in step 1 to change the journal name. All journals offer careful copyediting and typesetting of manuscripts, and submission to PubMed and PubMed Central (being new journals it may however take a few month until they appear in PubMed). We are also happy to announce that JMIR Medical Informatics and JMIR Serious Games are now indexed in PubMed.

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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) publishes peer-reviewed, openly accessible research ideas and grant proposals, study and trial protocols, reports of ongoing research, current methods and approaches, and preliminary results from pilot studies or formative research informing the design of medical and health-related research and technology innovations.

  • JMIR Res Protoc is a new journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (Impact Factor: 4.7)
  • JMIR Res Protoc publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions
  • JMIR Res Protoc is fully open access, with full text articles deposited in PubMed Central
  • Publishing research protocols, grant proposals, pilot/feasibility studies and early reports of ongoing and planned work encourages collaboration and early feedback, and reduces duplication of effort 
  • JMIR Res Protoc will be a valuable ressource for researchers who want to learn about current research methodologies and how to write a winning grant proposal
  • JMIR Res Protoc creates an early scientific record for researchers who have developed novel methodologies, software, innovations or elaborate protocols
  • JMIR Res Protoc faciliates subsequent publication of results demonstrating that the methodology has already been reviewed, and reduces the effort of writing up the results, as the protocol can be easily referenced
  • JMIR Res Protoc demonstrates to reviewers of subsequent results papers that authors followed and adhered to carefully developed and described a-priori methods
  • Studies whose protocols or grant proposal have been accepted in JMIR Res Protoc are "in principle accepted" for subsequent publication of results in other JMIR journals as long as authors adhere to their original protocol - regardless of study results (even if they are negative), reducing publication bias in medicine
  • Authors publishing their protocols in JMIR Res Protoc will receive a 20% discount on the article processing fee if they publish their results in another journal of the JMIR journal family (for example, JMIR for ehealth studies, i-JMR for others)
 
 

Recent Articles:

  • Developing a Healthy Web-Based Cookbook for Pediatric Cancer Patients and Survivors: Rationale and Methods

    Abstract:

    Background: Obesity has been a growing problem among children and adolescents in the United States for a number of decades. Childhood cancer survivors (CCS) are more susceptible to the downstream health consequences of obesity such as cardiovascular disease, endocrine issues, and risk of cancer recurrence due to late effects of treatment and suboptimal dietary and physical activity habits. Objective: The objective of this study was to document the development of a Web-based cookbook of healthy recipes and nutrition resources to help enable pediatric cancer patients and survivors to lead healthier lifestyles. Methods: The Web-based cookbook, named “@TheTable”, was created by a committee of researchers, a registered dietitian, patients and family members, a hospital chef, and community advisors and donors. Recipes were collected from several sources including recipe contests and social media. We incorporated advice from current patients, parents, and CCS. Results: Over 400 recipes, searchable by several categories and with accompanying nutritional information, are currently available on the website. In addition to healthy recipes, social media functionality and cooking videos are integrated into the website. The website also features nutrition information resources including nutrition and cooking tip sheets available on several subjects. Conclusions: The “@TheTable” website is a unique resource for promoting healthy lifestyles spanning pediatric oncology prevention, treatment, and survivorship. Through evaluations of the website’s current and future use, as well as incorporation into interventions designed to promote energy balance, we will continue to adapt and build this unique resource to serve cancer patients, survivors, and the general public.

  • Example of Social Jet Lag video for viewing on Tumblr, with the attached segment from the linked survey that younger workers used to assess the activity.

    Focus Groups Move Online: Feasibility of Tumblr Use for eHealth Curriculum Development

    Abstract:

    Background: Constructing successful online programs requires engaging potential users in development. However, assembling focus groups can be costly and time consuming. Objective: The aim of this study is to assess whether Tumblr can be used to prioritize activities for an online younger worker risk reduction and health promotion program. Methods: Younger summer parks and recreation employees were encouraged to visit Tumblr using weekly announcements and competitions. Each week, new activities were posted on Tumblr with linked survey questions. Responses were downloaded and analyzed. Results: An average of 36 young workers rated each activity on its likeability and perceived educational value. The method was feasible, efficient, and sustainable across the summer weeks. Ratings indicated significant differences in likeability among activities (P<.005). Conclusions: Tumblr is a means to crowdsource formative feedback on potential curricular components when assembling an online intervention. This paper describes its initial use as well as suggestions for future refinements.

  • Photograph illustrating blood processing.

    Determinants of Weight Gain Prevention in Young Adult and Midlife Women: Study Design and Protocol of a Randomized Controlled Trial

    Abstract:

    Background: Treatment of overweight and obesity through body weight reduction has been monumentally ineffective as few individuals are able to sustain weight loss. Rather than treating weight gain once it has become problematic, prevention of weight gain over time may be more effective. Objective: The aim of this research is to preclude the burden of adult obesity in women by identifying the determinants of weight gain prevention. The objective of this randomized controlled trial (RCT) is to compare a weight gain prevention intervention delivered by the registered dietitian versus counselor. Methods: This is a 12-month parallel-arm weight gain prevention RCT designed to increase self-efficacy, self-regulation, outcome expectations and family and social support through the use of a nutrition education intervention in women, aged 18-45 years, from the Urbana-Champaign (Illinois, USA) area. Women have been randomized to registered dietitian, counselor or wait-list control groups (August 2014) and are undergoing weekly nutrition education sessions for four months, followed by monthly sessions for eight months (through August 2015). Outcome measures, including: (1) dietary intake, (2) physical activity, (3) anthropometric and blood pressure measurements, (4) biochemical markers of health, (5) eating behaviors and health perceptions, and (6) mediators of behavior change, were collected before the intervention began (baseline) and will be collected at 3, 6, 9, and 12 months of the study. Results: In total, 87 women have been randomized to intervention groups, and 81 women have completed first week of the study. Results are expected in early 2016. Conclusions: This RCT is one of the first to examine weight gain prevention in women across normal, overweight, and obese body mass index categories. Results of this research are expected to have application to evidence-based practice in weight gain prevention for women and possibly have implication for policy regarding decreasing the encumbrance of overweight and obesity in the United States.

  • Regular physical activity helps children to develop healthfully. © Canadian Obesity Network.

    Working With Parents to Prevent Childhood Obesity: Protocol for a Primary Care-Based eHealth Study

    Abstract:

    Background: Parents play a central role in preventing childhood obesity. There is a need for innovative, scalable, and evidence-based interventions designed to enhance parents’ motivation to support and sustain healthy lifestyle behaviors in their children, which can facilitate obesity prevention. Objective: (1) Develop an online screening, brief intervention, and referral to treatment (SBIRT) eHealth tool to enhance parents’ concern for, and motivation to, support children’s healthy lifestyle behaviors, (2) refine the SBIRT eHealth tool by assessing end-user acceptability, satisfaction, and usability through focus groups, and (3) determine feasibility and preliminary effectiveness of the refined SBIRT eHealth tool through a randomized controlled trial. Methods: This is a three-phase, multi-method study that includes SBIRT eHealth tool development (Phase I), refinement (Phase II), and testing (Phase III). Phase I: Theoretical underpinnings of the SBIRT tool, entitled the Resource Information Program for Parents on Lifestyle and Education (RIPPLE), will be informed by concepts applied within existing interventions, and content will be based on literature regarding healthy lifestyle behaviors in children. The SBIRT platform will be developed in partnership between our research team and a third-party intervention development company. Phase II: Focus groups with parents, as well as health care professionals, researchers, and trainees in pediatrics (n=30), will explore intervention-related perceptions and preferences. Qualitative data from the focus groups will inform refinements to the aesthetics, content, structure, and function of the SBIRT. Phase III: Parents (n=200) of children—boys and girls, 5 to 17 years old—will be recruited from a primary care pediatric clinic while they await their children’s clinical appointment. Parents will be randomly assigned to one of five groups—four intervention groups and one control group—as they complete the SBIRT. The randomization function is built into the tool. Parents will complete the eHealth SBIRT using a tablet that will be connected to the Internet. Subsequently, parents will be contacted via email at 1-month follow-up to assess (1) change in concern for, and motivation to, support children’s dietary and physical activity behaviors (primary outcome), and (2) use of online resources and referrals to health services for obesity prevention (secondary outcome). Results: This research was successfully funded and received ethics approval. Development of the SBIRT started in summer 2012, and we expect all study-related activities to be completed by fall 2016. Conclusions: The proposed research is timely and applies a novel, technology-based application designed to enhance parents concern for, and motivation to, support children’s healthy lifestyle behaviors and encourage use of online resources and community services for childhood obesity prevention. Overall, this research builds on a foundation of evidence supporting the application of SBIRTs to encourage or “nudge” individuals to make healthy lifestyle choices. Findings from Phase III of this project will directly inform a cluster randomized controlled trial to study the effectiveness of our intervention across multiple primary care-based settings. Trial Registration: ClinicalTrials.gov NCT02330588; http://clinicaltrials.gov/ct2/show/NCT02330588 (Archived by WebCite at http://www.webcitation.org/6WyUOeRlr).

  • Impression of the use of the visual business modeling method during the interactive sessions.

    Care Models of eHealth Services: A Case Study on the Design of a Business Model for an Online Precare Service

    Abstract:

    Background: With a growing population of health care clients in the future, the organization of high-quality and cost-effective service providing becomes an increasing challenge. New online eHealth services are proposed as innovative options for the future. Yet, a major barrier to these services appears to be the lack of new business model designs. Although design efforts generally result in visual models, no such artifacts have been found in the literature on business model design. This paper investigates business model design in eHealth service practices from a design perspective. It adopts a research by design approach and seeks to unravel what characteristics of business models determine an online service and what are important value exchanges between health professionals and clients. Objective: The objective of the study was to analyze the construction of care models in-depth, framing the essential elements of a business model, and design a new care model that structures these elements for the particular context of an online pre-care service in practice. Methods: This research employs a qualitative method of an in-depth case study in which different perspectives on constructing a care model are investigated. Data are collected by using the visual business modeling toolkit, designed to cocreate and visualize the business model. The cocreated models are transcribed and analyzed per actor perspective, transactions, and value attributes. Results: We revealed eight new actors in the business model for providing the service. Essential actors are: the intermediary network coordinator connecting companies, the service dedicated information technology specialists, and the service dedicated health specialist. In the transactions for every service providing we found a certain type of contract, such as a license contract and service contracts for precare services and software products. In addition to the efficiency, quality, and convenience, important value attributes appeared to be: timelines, privacy and credibility, availability, pleasantness, and social interaction. Based on the in-depth insights from the actor perspectives, the business model for online precare services is modeled with a visual design. A new care model of the online precare service is designed and compiled of building blocks for the business model. Conclusions: For the construction of a care model, actors, transactions, and value attributes are essential elements. The design of a care model structures these elements in a visual way. Guided by the business modeling toolkit, the care model design artifact is visualized in the context of an online precare service. Important building blocks include: provision of an online flow of information with regular interactions to the client stimulates self-management of personal health and service-dedicated health expert ensure an increase of the perceived quality of the eHealth service.

  • Cell phone picture for Mobile Insulin Titration Intervention (MITI). (cc) Levy et al. CC-BY-SA-2.0, please cite as (http://www.researchprotocols.org/article/viewFile/4206/1/54204).

    The Mobile Insulin Titration Intervention (MITI) for Insulin Glargine Titration in an Urban, Low-Income Population: Randomized Controlled Trial Protocol

    Abstract:

    Background: Patients on insulin glargine typically visit a clinician to obtain advice on how to adjust their insulin dose. These multiple clinic visits can be costly and time-consuming, particularly for low-income patients. It may be feasible to achieve insulin titration through text messages and phone calls with patients instead of face-to-face clinic visits. Objective: The objectives of this study are to (1) evaluate if the Mobile Insulin Titration Intervention (MITI) is clinically effective by helping patients reach their optimal dose of insulin glargine, (2) determine if the intervention is feasible within the setting and population, (3) assess patient satisfaction with the intervention, and (4) measure the costs associated with this intervention. Methods: This is a pilot study evaluating an approach to insulin titration using text messages and phone calls among patients with insulin-dependent type 2 diabetes in the outpatient medical clinic of Bellevue Hospital Center, a safety-net hospital in New York City. Patients will be randomized in a 1:1 ratio to either the MITI arm (texting/phone call intervention) or the usual-care arm (in-person clinic visits). Using a Web-based platform, weekday text messages will be sent to patients in the MITI arm, asking them to text back their fasting blood glucose values. In addition to daily reviews for alarm values, a clinician will rereview the texted values weekly, consult our physician-approved titration algorithm, and call the patients with advice on how to adjust their insulin dose. The primary outcome will be whether or not a patient reaches his/her optimal dose of insulin glargine within 12 weeks. Results: Recruitment for this study occurred between June 2013 and December 2014. We are continuing to collect intervention and follow-up data from our patients who are currently enrolled. The results of our data analysis are expected to be available in 2015. Conclusions: This study explores the use of widely-available text messaging and voice technologies for insulin titration. We aim to show that remote insulin titration is clinically effective, feasible, satisfactory, and cost saving for low-income patients in a busy, urban clinic. Clinical Trial: Trial Registration: Clinicaltrials.gov NCT01879579; http://clinicaltrials.gov/ct2/show/NCT01879579 (Archived by WebCite at http://www.webcitation.org/6WUEgjZUO).

  • This is a royalty free image by hywards (http://www.freedigitalphotos.net/images/tablet-pc-and-a-stethoscope-photo-p246028).

    “What Is eHealth”: Time for An Update?

    Abstract:

    The annual number of articles reporting on eHealth interventions has increased over the last 10 years. In contrast, the last article in this journal on the definition of eHealth was published in 2006. This leads to the question whether the field itself has reached consensus about the definition and description of eHealth or whether it is in need for a new review of the literature and a new description of the rapidly changing field of eHealth. Since the JMIR community has successfully collaborated on the “CONSORT-eHealth” in the past, we would like to use the same strategy to explore the need for a new definition of eHealth and the creation of a taxonomy for this field. Therefore, we hereby submit a call to all JMIR-readers, to fill out a 4-question survey on their ideas about a refined eHealth definition. Based on these results, we will decide whether or not to engage in a systematic review. Logically, the entire JMIR community is invited to join us in our attempt to further elucidate the field of eHealth.

  • Screenshot of the app isoTimer.

    Clinical Effect Size of an Educational Intervention in the Home and Compliance With Mobile Phone-Based Reminders for People Who Suffer From Stroke: Protocol...

    Abstract:

    Background: Stroke is the third-leading cause of death and the leading cause of long-term neurological disability in the world. Cognitive, communication, and physical weakness combined with environmental changes frequently cause changes in the roles, routines, and daily occupations of stroke sufferers. Educational intervention combines didactic and interactive intervention, which combines the best choices for teaching new behaviors since it involves the active participation of the patient in learning. Nowadays, there are many types of interventions or means to increase adherence to treatment. Objective: The aim of this study is to enable patients who have suffered stroke and been discharged to their homes to improve the performance of the activities of daily living (ADL) in their home environment, based on advice given by the therapist. A secondary aim is that these patients continue the treatment through a reminder app installed on their mobile phones. Methods: This study is a clinical randomized controlled trial. The total sample will consist of 80 adults who have suffered a stroke with moderate severity and who have been discharged to their homes in the 3 months prior to recruitment to the study. The following tests and scales will be used to measure the outcome variables: Barthel Index, the Functional Independence Measure, the Mini-Mental State Examination, the Canadian Neurological Scale, the Stroke Impact Scale-16, the Trunk Control Test, the Modified Rankin Scale, the Multidimensional Scale of Perceived Social Support, the Quality of Life Scale for Stroke, the Functional Reach Test, the Romberg Test, the Time Up and Go test, the Timed-Stands Test, a portable dynamometer, and a sociodemographic questionnaire. Descriptive analyses will include mean, standard deviation, and 95% confidence intervals of the values for each variable. The Kolmogov-Smirnov (KS) test and a 2x2 mixed-model analysis of variance (ANOVA) will be used. Intergroup effect sizes will be calculated (Cohen’s d). Results: Currently, the study is in the recruitment phase and implementation of the intervention has begun. The authors anticipate that during 2015 the following processes should be completed: recruitment, intervention, and data collection. It is expected that the analysis of all data and the first results should be available in early-to-mid 2016. Conclusions: An educational intervention based on therapeutic home advice and a reminder app has been developed by the authors with the intention that patients who have suffered stroke perform the ADL more easily and use their affected limbs more actively in the ADL. The use of reminders via mobile phone is proposed as an innovative tool to increase treatment adherence in this population. Trial Registration: ClinicalTrials.gov NCT01980641; https://clinicaltrials.gov/ct2/show/NCT01980641 (Archived by WebCite at http://www.webcitation.org/6WRWFmY6U).

  • Original photograph of author during study. (cc) Tse et al, CC-BY-SA 2.0, please cite as (http://www.researchprotocols.org/article/viewFile/3285/1/52455).

    Social Media in Adolescent Health Literacy Education: A Pilot Study

    Abstract:

    Background: While health literacy has gained notice on a global stage, the initial focus on seeking associations with medical conditions may have overlooked its impact across generations. Adolescent health literacy, specifically in dentistry, is an underexplored area despite the significance of this formative stage on an individual’s approach to healthy lifestyles and behaviors. Objective: The aim is to conduct a pilot study to evaluate the efficacy of three major social media outlets - Twitter, Facebook, and YouTube - in supporting adolescents’ oral health literacy (OHL) education. Methods: A random sample of 22 adolescents (aged 14-16 years) from an English-medium international school in Hong Kong provided informed consent. Sociodemographic information, including English language background, social media usage, and dental experience were collected via a questionnaire. A pre- and post-test of OHL (REALD-30) was administered by two trained, calibrated examiners. Following pre-test, participants were randomly assigned to one of three social media outlets: Twitter, Facebook, or YouTube. Participants received alerts posted daily for 5 consecutive days requiring online accessing of modified and original OHL education materials. One-way ANOVA ( analysis of variance) was used to compare the mean difference between the pre- and the post-test results among the three social media. Results: No associations were found between the social media allocated and participants’ sociodemographics, including English language background, social media usage, and dental experience. Of the three social media, significant differences in literacy assessment scores were evident for participants who received oral health education messages via Facebook (P=.02) and YouTube (P=.005). Conclusions: Based on the results of the pilot study, Facebook and YouTube may be more efficient media outlets for OHL promotion and education among adolescent school children when compared to Twitter. Further analyses with a larger study group is warranted.

  • (cc) Marceglia et al. CC-BY-SA-2.0, please cite as (http://www.researchprotocols.org/article/viewFile/4044/1/54487).

    Web-Based Telemonitoring and Delivery of Caregiver Support for Patients With Parkinson Disease After Deep Brain Stimulation: Protocol

    Abstract:

    Background: The increasing number of patients, the high costs of management, and the chronic progress of the disease that prevents patients from performing even simple daily activities make Parkinson disease (PD) a complex pathology with a high impact on society. In particular, patients implanted with deep brain stimulation (DBS) electrodes face a highly fragile stabilization period, requiring specific support at home. However, DBS patients are followed usually by untrained personnel (caregivers or family), without specific care pathways and supporting systems. Objective: This projects aims to (1) create a reference consensus guideline and a shared requirements set for the homecare and monitoring of DBS patients, (2) define a set of biomarkers that provides alarms to caregivers for continuous home monitoring, and (3) implement an information system architecture allowing communication between health care professionals and caregivers and improving the quality of care for DBS patients. Methods: The definitions of the consensus care pathway and of caregiver needs will be obtained by analyzing the current practices for patient follow-up through focus groups and structured interviews involving health care professionals, patients, and caregivers. The results of this analysis will be represented in a formal graphical model of the process of DBS patient care at home. To define the neurophysiological biomarkers to be used to raise alarms during the monitoring process, neurosignals will be acquired from DBS electrodes through a new experimental system that records while DBS is turned ON and transmits signals by radiofrequency. Motor, cognitive, and behavioral protocols will be used to study possible feedback/alarms to be provided by the system. Finally, a set of mobile apps to support the caregiver at home in managing and monitoring the patient will be developed and tested in the community of caregivers that participated in the focus groups. The set of developed apps will be connected to the already existing WebBioBank Web-based platform allowing health care professionals to manage patient electronic health records and neurophysiological signals. New modules in the WebBioBank platform will be implemented to allow integration and data exchange with mobile health apps. Results: The results of this project will provide a novel approach to long-term evaluation of patients with chronic, severe conditions in the homecare environment, based on caregiver empowerment and tailored applications developed according to consensus care pathways established by clinicians. Conclusions: The creation of a direct communication channel between health care professionals and caregivers can benefit large communities of patients and would represent a scalable experience in integrating data and information coming from a clinical setting to those in home monitoring.

  • Gold Apollo Pager (Image Source: http://en.wikipedia.org/wiki/Pager#mediaviewer/File:Np88_support.jpg, CC BY-SA 3.0, Uploaded by Liangent).

    Optimizing Inter-Professional Communications in Surgery: Protocol for a Mixed-Methods Exploratory Study

    Abstract:

    Background: Effective nurse-physician communication is critical to delivering high quality patient care. Interprofessional communication between surgical nurses and surgeons, often through the use of pagers, is currently characterized by information gaps and interprofessional tensions, both sources of workflow interruption, potential medical error, impaired educational experience, and job satisfaction. Objective: This study aims to define current patterns of, and understand enablers and barriers to interprofessional communication in general surgery, in order to optimize the use of communication technologies, teamwork, provider satisfaction, and quality and safety of patient care. Methods: We will use a mixed-methods multiphasic approach. In phase 1, a quantitative and content analysis of alpha-numeric pages (ANP) received by general surgery residents will be conducted to develop a paging taxonomy. Frequency, timing (on-call vs regular duty hours), and interval between pages will be described using a 4-week sample of pages. Results will be compared between pages sent to junior and senior residents. Finally, using an inductive analysis, two independent assessors will classify ANP thematically. In Phase 2, a qualitative constructivist approach will explore stakeholders’ experiences with interprofessional communication, including paging, through interviews and shadowing of 40 residents and 40 nurses at two institutions. Finally, a survey will be developed, tested, and administered to all general surgery nurses and residents at the same two institutions, to evaluate their attitudes about the effectiveness and quality of interprofessional communication, and assess their satisfaction. Results: Describing the profile of current pages is the first step towards identifying areas and root causes of IPC inefficiency. This study will identify key contextual barriers to surgical nurse-house staff communication, and existing interprofessional knowledge and practice gaps. Conclusions: Our findings will inform the design of a guideline and tailored intervention to improve IPC in order to ensure high quality patient care, optimal educational experience, and provider satisfaction.

  • Origin – Author Creation: Margeaux Chavez, License/Attribution Information – N/A.

    A Participatory Approach to Designing and Enhancing Integrated Health Information Technology Systems for Veterans: Protocol

    Abstract:

    Background: The Department of Veterans Affairs (VA) has developed health information technologies (HIT) and resources to improve veteran access to health care programs and services, and to support a patient-centered approach to health care delivery. To improve VA HIT access and meaningful use by veterans, it is necessary to understand their preferences for interacting with various HIT resources to accomplish health management related tasks and to exchange information. Objective: The objective of this paper was to describe a novel protocol for: (1) developing a HIT Digital Health Matrix Model; (2) conducting an Analytic Hierarchy Process called pairwise comparison to understand how and why veterans want to use electronic health resources to complete tasks related to health management; and (3) developing visual modeling simulations that depict veterans’ preferences for using VA HIT to manage their health conditions and exchange health information. Methods: The study uses participatory research methods to understand how veterans prefer to use VA HIT to accomplish health management tasks within a given context, and how they would like to interact with HIT interfaces (eg, look, feel, and function) in the future. This study includes two rounds of veteran focus groups with self-administered surveys and visual modeling simulation techniques. This study will also convene an expert panel to assist in the development of a VA HIT Digital Health Matrix Model, so that both expert panel members and veteran participants can complete an Analytic Hierarchy Process, pairwise comparisons to evaluate and rank the applicability of electronic health resources for a series of health management tasks. Results: This protocol describes the iterative, participatory, and patient-centered process for: (1) developing a VA HIT Digital Health Matrix Model that outlines current VA patient-facing platforms available to veterans, describing their features and relevant contexts for use; and (2) developing visual model simulations based on direct veteran feedback that depict patient preferences for enhancing the synchronization, integration, and standardization of VA patient-facing platforms. Focus group topics include current uses, preferences, facilitators, and barriers to using electronic health resources; recommendations for synchronizing, integrating, and standardizing VA HIT; and preferences on data sharing and delegation within the VA system. Conclusions: This work highlights the practical, technological, and personal factors that facilitate and inhibit use of current VA HIT, and informs an integrated system redesign. The Digital Health Matrix Model and visual modeling simulations use knowledge of veteran preferences and experiences to directly inform enhancements to VA HIT and provide a more holistic and integrated user experience. These efforts are designed to support the adoption and sustained use of VA HIT to support patient self-management and clinical care coordination in ways that are directly aligned with veteran preferences.

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  • “Everybody Brush!”: Protocol for a parallel-group randomized controlled trial of a family-focused primary prevention program with distribution of oral hygiene products and education to increase frequency of toothbrushing

    Date Submitted: Mar 30, 2015

    Open Peer Review Period: Mar 31, 2015 - Apr 9, 2015

    Background: Twice-daily toothbrushing with fluoridated toothpaste is the most widely advocated preventive strategy for dental caries (tooth decay) and is recommended by professional dental association...

    Background: Twice-daily toothbrushing with fluoridated toothpaste is the most widely advocated preventive strategy for dental caries (tooth decay) and is recommended by professional dental associations. Few parents, children, or adolescents follow this recommendation. Objective: This protocol describes the methods for the implementation and evaluation of a quality improvement health promotion program. The goal of the theory-informed, evidence-based program is to improve twice-daily toothbrushing, and oral health-related quality of life and reduce dental caries, dental treatment need and costs. Methods: The design is a parallel-group pragmatic randomized controlled trial. Families of Medicaid-insured children and adolescents within a large dental care organization in central Oregon will participate in the trial (n=approximately 20,000). Families will be assigned to one of three groups: a test intervention, an active control, or a passive control condition. The intervention aims to address barriers and support for twice-daily toothbrushing. Families in the test condition will receive toothpaste and toothbrushes by mail for all family members every three months. In addition, they will receive instruction and social support to encourage toothbrushing via postcards, recorded telephone messages, and an optional participant-initiated telephone help line. Families in the active control condition will receive the kit of supplies by mail but no additional instructional information or telephone support. Families assigned to the passive control will be on a waiting list. The primary outcomes are restorative dental care received and, only for children younger than 36 months at baseline, the frequency of twice-daily toothbrushing. Data will be collected through dental claims records and, for children younger than 36 months at baseline, parent interview and clinical exam. Conclusions: If proven effective, this simple intervention can be sustained by the dental care organization and replicated by other organizations and government. Clinical Trial: ClinicalTrials.gov NCT02327507Oral hygiene; Toothbrushing; Dental devices, home care; Dental care; Communication; Social Support

  • Diet quality of young adults enrolling in TXT2BFiT, a mobile-phone based healthy lifestyle intervention

    Date Submitted: Mar 30, 2015

    Open Peer Review Period: Mar 31, 2015 - Apr 9, 2015

    Background: Young adulthood is associated with poor dietary habits and vulnerability to weight gain. Population studies have revealed that inadequate fruit and vegetable intake, excessive sugar-sweete...

    Background: Young adulthood is associated with poor dietary habits and vulnerability to weight gain. Population studies have revealed that inadequate fruit and vegetable intake, excessive sugar-sweetened beverages (SSB) and frequent take-away food consumption are dietary habits requiring intervention. Objective: To examine the dietary patterns and diet quality of overweight young adults upon enrolment into a mobile-phone based healthy lifestyle intervention, TXT2BFiT. Methods: Baseline diets were analyzed using the online Dietary Questionnaire for Epidemiological Studies-version 2. A Healthy Eating Index (HEIFA) based on the 2013 Dietary Guidelines, was used to rate individual diets according to intake of core foods and deleterious nutrients including sugar, sodium, saturated fat and alcohol. Findings were compared with the 2011 Australian National Nutrition Survey (NNS). Gender differences were assessed with t-tests and Chi-squared-tests. Analysis-of-variance models were used to determine linear trends of core and non-core foods intake and nutrients across quartiles of HEIFA scores. Associations between HEIFA score, SSB and take-away food consumption were assessed using linear regression analysis. Results: Diets of 230 participants (141 females, 89 males with a mean body mass index =27 kg/m² (SD 2.5)) were analyzed. The mean diet quality score was 45.4 (range 21.7-77.0), out of 100 points, with no significant difference between genders. Compared with the NNS data of 19-30 year-olds, this cohort had a lower intake of some core foods and higher intake of alcohol and saturated fat. Better quality diets were associated with higher intakes of fruits, vegetables and wholegrains (P < .001). Take-away food (P = .01) and SSB consumption (P < .001) were negatively associated with diet quality. Conclusions: Overweight young adults had poorer diets compared with the reference Australian population within the same age group. This study confirms the need to increase fruit and vegetable intake and restrict alcohol and take-away foods in this population, with additional focus on saturated fat and wholegrain intake.

  • Effectiveness of Mobile Phone Technology in improving adherence and treatment outcomes among HIV positive patients on Antiretroviral Therapy – a Randomized Controlled Trial

    Date Submitted: Mar 29, 2015

    Open Peer Review Period: Mar 30, 2015 - Apr 13, 2015

    Background: Medication adherence is the single most important determinant of antiretroviral treatment success. Several barriers to optimal adherence have been reported in literature. Identifying and i...

    Background: Medication adherence is the single most important determinant of antiretroviral treatment success. Several barriers to optimal adherence have been reported in literature. Identifying and implementing innovative strategies of overcoming these barriers has been the focus of many studies in recent years. Objective: The objective of this study was to determine the effectiveness of mobile phone technology (SMS and Phone call reminders) in improving adherence (clinic attendance and medication adherence) and outcome of treatment among HIV positive patients on ART in Malaysia. Methods: This single-blinded, parallel group Randomized Controlled Clinical Trial involved 242 Malaysian patients from whom data was collected between January and December, 2014. Patients who were assessed and found to be eligible for ART commencement based on 2013 WHO guidelines, and with valid telephone numbers and able to read text messages were included in the study and randomized to either of two treatment arms based on simple, complete randomization technique in a ratio 1:1 for intervention and control groups, respectively. Written allocation of assignment was sealed in individual opaque envelopes marked with study identification numbers which was made available in the study clinic to allocate the target number of participants. Baseline data on socio-demographic factors, clinical symptoms and adherence behavior of respondents was collected using modified, pre-validated AACTG adherence questionnaires. Baseline CD4 count, viral load, weight, full blood count, blood pressure, Liver function and renal profile tests were also conducted and recorded. A “Reminder module” which included weekly SMS medication reminders; SMS reminder 3 days prior to scheduled clinic appointments, telephone call reminder a day prior to scheduled clinic appointment (in addition to standard care - routine adherence counseling) was delivered to respondents in the intervention group by 2 trained PLHIV (research assistants) while respondents in the control group received standard care only. Adherence measurement was repeated at 3 and 6 months follow-up using AACTG follow-up adherence questionnaires while CD4 count, viral load, weight, full blood count and blood pressure measurements were repeated at 6 months follow-up period. Data was analyzed using SPSS version 21 and R software. Results: Patients consisted of 215 (89%) males and 27 (11%) females. 117 (48%) were Malays, 98 (40%) were Chinese, 22 (9%) were Indians while 5 (2%) were of other ethnic minorities. 228 (94%) completed 3 month follow up assessment (118 for the intervention group, and 110 for the control group) while 224 (93%) completed 6 month follow up assessment (116 for the intervention group, and 108 for the control group), giving an overall response rate of about 94%. Conclusions: This RCT is the first to examine and report efficacy of mobile phone intervention in improving adherence and treatment outcomes among HIV positive patients receiving ART in Malaysia. Clinical Trial: Not available

  • The PEARL study design – a non-interventional study on clinical and pharmacoeconomic aspects of multiple sclerosis therapy with disease-modifying treatments in Germany

    Date Submitted: Mar 26, 2015

    Open Peer Review Period: Mar 26, 2015 - Apr 9, 2015

    Background: Patients with multiple sclerosis (MS) require long-term therapy and have a wide variety of needs for health-related support. The efficacy and safety of MS therapy, as assessed by both clin...

    Background: Patients with multiple sclerosis (MS) require long-term therapy and have a wide variety of needs for health-related support. The efficacy and safety of MS therapy, as assessed by both clinicians and patients, are important parameters that need to be considered. However, few studies combine data on efficacy and safety outcomes with pharmacoeconomic data. Objective: Here, we present the study design of the ProspEctive phArmacoeconomic cohoRt evaluation (PEARL), a prospective, multi-center, non-interventional cohort study on patients with relapsing-remitting MS (RRMS) treated with disease-modifying treatments (DMTs). Methods: During a prospective observational phase of 24 months per patient, PEARL evaluated clinical and patient-perceived efficacy and safety measures, as well as pharmacoeconomic data on RRMS patients treated with DMTs (interferon-beta, glatiramer acetate). Measurements of the patients' perception included the assessment of the patient-reported quality of life, treatment satisfaction, and compliance. The study was planned to include 1,800 outpatients from 180 German neurological practices who had continuously been treated with an approved DMT for at least 30 days. The primary statistical analyses of the PEARL study will be descriptive. Particular focus will be on specific subgroups such as patients who switched DMTs during therapy and patients with disease worsening or disease activity. Subgroups will be compared using stratified analyses. Conclusions: PEARL is evaluating both the health status and resource utilization of RRMS patients treated with DMTs in Germany. The combination of pharmacoeconomic data with clinical and patients' self-perceived efficacy and safety outcomes will add useful information to the currently incomplete picture of the overall RRMS burden in Germany.

  • Using an eHealth intervention to stimulate health behavior for the prevention of cognitive decline in Dutch adults aged 40-67 years: study protocol for the Brain Aging Monitor (BAM)

    Date Submitted: Mar 26, 2015

    Open Peer Review Period: Mar 26, 2015 - Apr 9, 2015

    Background: Internet-delivered intervention programs are an effective way of changing health behavior in an aging population. The same population has an increasing number of people with cognitive decl...

    Background: Internet-delivered intervention programs are an effective way of changing health behavior in an aging population. The same population has an increasing number of people with cognitive decline or cognitive impairments. Modifiable lifestyle risk factors such as physical activity, nutrition, smoking, alcohol consumption, sleep, and stress all influence the probability of developing neurodegenerative diseases such as Alzheimer’s disease. In this study we aim to answer two questions. First, we ask whether the use of a self-motivated, complex eHealth intervention is effective in changing multiple health behaviors, related to cognitive aging in Dutch adults in the work force, especially those aged 40 and over. Second, we ask whether this health behavior change results in healthier cognitive aging patterns, and contributes to preventing or delaying future onset of neurodegenerative syndromes. Methods: The Brain Aging Monitor study uses a quasi-experimental 2-year pre- posttest design. The Brain Aging Monitor is an online, self-motivated lifestyle intervention program. Recruitment is done both in medium to large organizations and in the Dutch general population over the age of 40. Main outcome measure is the relationship between lifestyle change and cognitive aging. The program uses different strategies and modalities to aid its users in behavior change such as web content, e-mail, online newsletters and online games. To build self-regulatory skills the Brain Aging Monitor aids its users in goal setting activities, skill building activities, and self-monitoring. Trial Registration: NTR4144. This study was deemed exempt from formal ethical evaluation by the local medical ethics committee (region Arnhem-Nijmegen, registration number: 2014-1268).

  • Research protocol for a multi-centre prospective study to investigate the diagnostic accuracy of the SeHCAT test in measuring bile acid malabsorption

    Date Submitted: Mar 25, 2015

    Open Peer Review Period: Mar 26, 2015 - Apr 9, 2015

    Background: Bile acid malabsorption (BAM) is one possible explanation for chronic diarrhoea. BAM may be idiopathic; result from ileal resection or inflammation including Crohn’s disease; or may be s...

    Background: Bile acid malabsorption (BAM) is one possible explanation for chronic diarrhoea. BAM may be idiopathic; result from ileal resection or inflammation including Crohn’s disease; or may be secondary to other conditions, including cholecystectomy, peptic ulcer surgery, and chronic pancreatitis. No ‘gold standard’ exists for clinical diagnosis of BAM, but response to treatment with a bile acid sequestrant (BAS) is often accepted as confirmation. The SeHCAT (tauroselcholic [selenium-75] acid) test uses a radiolabelled synthetic bile acid and provides a diagnostic test for BAM, but its performance against ‘trial of treatment’ is unknown. Also, fibroblast growth factor 19 (FGF-19) and 7-alpha-hydroxy-4-cholesten-3-one (7αC4) offer potential new biomarkers of BAM. Objective: This protocol describes a multi-centre prospective study to evaluate the diagnostic accuracy of SeHCAT and two biomarkers in predicting BAM as assessed by ‘trial of treatment’. Methods: Participating gastroenterology centres should have a minimum workload of 30 SeHCAT patients per annum. Patients should not be pregnant, on medication that could confound follow-up, or have any severe co-morbidity. All eligible patients attending a gastrointestinal appointment will be invited to participate. On attending for the SeHCAT test, blood and faecal samples will be collected for analysis of FGF-19 by Enzyme-Linked Immunosorbent Assay, and for 7αC4 and fractionated bile acids by liquid chromatography mass spectrometry. A capsule containing radiolabelled SeHCAT will be administered orally and a scan performed to measure SeHCAT activity. Patients will return on day seven to undergo a second scan to measure percentage SeHCAT retention. The test result will be concealed from clinicians and patients. BAS will be dispensed to all patients, with a follow-up gastroenterologist appointment at two weeks for clinical assessment of treatment response and adherence. Patients responding positively will continue treatment for a further two weeks, and all patients will have a final follow-up at eight weeks. The diagnostic accuracy of the SeHCAT test and biomarkers will be analysed at different thresholds using sensitivity, specificity, positive and negative predictive value, likelihood ratios and area under the curve, in a sample of 600 patients. Multivariable logistic regression models will be used to assess the association between presence of BAM and continuous SeHCAT retention levels after adjustment for confounders. Results: Funding is being sought to conduct this research. Conclusions: The SeHCAT test for diagnosis of bile acid malabsorption has been in common use in the UK for over 30 years, and an evidence-based assessment of its accuracy is overdue. The proposed study has some challenges. Some forms of BAS treatment are unpleasant due to the texture and taste of the resin powder, which may negatively affect recruitment and treatment adherence. ‘Trial of treatment’ is not as ‘golden’ a standard as would be ideal, and itself warrants further study.