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Evaluating the Impact of a Web-Based Risk Assessment System (CareSage) and Tailored Interventions on Health Care Utilization: Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Soaring health care costs and a rapidly aging population, with multiple comorbidities, necessitates the development of innovative strategies to deliver high-quality, value-based care. OBJECTIVE:The goal of this study is to evaluate the impact of a risk assessment system (CareSage) and targeted interventions on health care utilization. METHODS:This is a two-arm randomized controlled trial recruiting 370 participants from a pool of high-risk patients receiving care at a home health agency. CareSage is a risk assessment system that utilizes both real-time data collected via a Personal Emergency Response Service and historical patient data collected from the electronic medical records. All patients will first be observed for 3 months (observation period) to allow the CareSage algorithm to calibrate based on patient data. During the next 6 months (intervention period), CareSage will use a predictive algorithm to classify patients in the intervention group as "high" or "low" risk for emergency transport every 30 days. All patients flagged as "high risk" by CareSage will receive nurse triage calls to assess their needs and personalized interventions including patient education, home visits, and tele-monitoring. The primary outcome is the number of 180-day emergency department visits. Secondary outcomes include the number of 90-day emergency department visits, total medical expenses, 180-day mortality rates, time to first readmission, total number of readmissions and avoidable readmissions, 30-, 90-, and 180-day readmission rates, as well as cost of intervention per patient. The two study groups will be compared using the Student t test (two-tailed) for normally distributed and Mann Whitney U test for skewed continuous variables, respectively. The chi-square test will be used for categorical variables. Time to event (readmission) and 180-day mortality between the two study groups will be compared by using the Kaplan-Meier survival plots and the log-rank test. Cox proportional hazard regression will be used to compute hazard ratio and compare outcomes between the two groups. RESULTS:We are actively enrolling participants and the study is expected to be completed by end of 2018; results are expected to be published in early 2019. CONCLUSIONS:Innovative solutions for identifying high-risk patients and personalizing interventions based on individual risk and needs may help facilitate the delivery of value-based care, improve long-term patient health outcomes and decrease health care costs. TRIAL REGISTRATION:ClinicalTrials.gov NCT03126565; https://clinicaltrials.gov/ct2/show/NCT03126565 (Archived by WebCite at http://www.webcitation.org/6ymDuAwQA).

SUBMITTER: Palacholla RS

PROVIDER: S-EPMC5966651 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Evaluating the Impact of a Web-Based Risk Assessment System (CareSage) and Tailored Interventions on Health Care Utilization: Protocol for a Randomized Controlled Trial.

Palacholla Ramya Sita RS Fischer Nils C NC Agboola Stephen S Nikolova-Simons Mariana M Odametey Sharon S Golas Sara Bersche SB Op den Buijs Jorn J Schertzer Linda L Kvedar Joseph J Jethwani Kamal K

JMIR research protocols 20180509 5

<h4>Background</h4>Soaring health care costs and a rapidly aging population, with multiple comorbidities, necessitates the development of innovative strategies to deliver high-quality, value-based care.<h4>Objective</h4>The goal of this study is to evaluate the impact of a risk assessment system (CareSage) and targeted interventions on health care utilization.<h4>Methods</h4>This is a two-arm randomized controlled trial recruiting 370 participants from a pool of high-risk patients receiving care ...[more]

PMID: 29743156

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Project description:BackgroundEfforts have multiplied in the past decade to underline the importance of pain management. For both acute and chronic pain management, various barriers generate considerable treatment accessibility issues, thereby providing an opportunity for alternative intervention formats to be implemented. Several systematic reviews on Web-based interventions with a large emphasis on chronic pain and cognitive behavioral therapy have been recently conducted to explore the influence of these interventions on pain management However, to our knowledge, the specific contribution of tailored Web-based interventions for pain management has not been described and their effect on pain has not been evaluated.ObjectiveThe primary aim of this systematic review was to answer the following research question: What is the effect of tailored Web-based pain management interventions for adults on pain intensity compared with usual care, face-to-face interventions, and standardized Web-based interventions? A secondary aim was to examine the effects of these interventions on physical and psychological functions.MethodsWe conducted a systematic review of articles published from January 2000 to December 2015. We used the DerSimonian-Laird random effects models with 95% confidence intervals to calculate effect estimates for all analyses. We calculated standardized mean differences from extracted means and standard deviations, as outcome variables were measured on different continuous scales. We evaluated 5 different outcomes: pain intensity (primary outcome), pain-related disability, anxiety, depression, and pain catastrophizing. We assessed effects according to 3 time intervals: short term (<1 month), medium term (1-6 months), and long term (6-12 months).ResultsAfter full-text review, we excluded 31 articles, resulting in 17 eligible studies. Only 1 study concerned acute pain and was removed from the meta-analysis, resulting in 16 studies available for quantitative assessment. Compared with standard care or a waiting list, tailored Web-based intervention showed benefits immediately after, with small effect sizes (<0.40) for pain intensity (10 randomized controlled trials [RCTs], n=1310, P=.003) and pain-related disability (6 RCTs, n=953, P<.001). No other improvements were observed at follow-up in the medium and long terms. Compared with the active control group, no improvements were found for the primary outcome (pain intensity) or any of the outcomes except for a small effect size on pain catastrophizing (2 RCTs, n=333, P<.001) immediately after the intervention.ConclusionsTailored Web-based interventions did not prove to be more efficacious than standardized Web-based interventions in terms of pain intensity, pain-related disability, anxiety, and depression. An interesting finding was that some efficacy was shown on pain catastrophizing compared with active control interventions. Considering the diversity of approaches used in tailored Web-based interventions for chronic pain management, their efficacy is yet to be explored. Moreover, their contribution to acute pain management is embryonic.Trial registrationInternational prospective register of systematic reviews (PROSPERO): CRD42015027669; http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42015027669 (Archived by WebCite at http://www. webcitation.org/6uneWAuyR).

Project description:BACKGROUND:The rapid advancements in health care can make it difficult for general physicians and specialists alike to keep their knowledge up to date. In medicine today, there are deficiencies in the application of knowledge translation (KT) in clinical practice. Some medical procedures are not required, and therefore, no value is added to the patient's care. These unnecessary procedures increase pressures on the health care system's resources, reduce the quality of care, and expose the patients to stress and to other potential risks. KT tools and better access to medical recommendations can lead to improvements in physicians' decision-making processes depending on the patient's specific clinical situation. These tools can provide the physicians with the available options and promote an efficient professional practice. Software for the Evolution of Knowledge in MEDicine (SEKMED) is a technological solution providing access to high-quality evidence, based on just-in-time principles, in the application of medical recommendations for clinical decision-making processes recognized by community members, accreditation bodies, the recommendations from medical specialty societies made available through campaigns such as Choosing Wisely, and different standards or accreditive bodies. OBJECTIVE:The main objective of this protocol is to assess the usefulness of the SEKMED platform used within a real working clinical practice, specifically the Centre intégré de santé et des services sociaux de l'Outaouais in Quebec, Canada. To achieve our main objective, 20 emergency physicians from the Hull and Gatineau Hospitals participate in the project as well as 20 patient care unit physicians from the Hull Hospital. In addition, 10 external students or residents studying family medicine from McGill University will also participate in our study. METHODS:The project is divided into 4 phases: (1) orientation; (2) data synthesis; (3) develop and validate the recommendations; and (4) implement, monitor, and update the recommendations. These phases will enable us to meet our 6 specific research objectives that aim to measure the integration of recommendations in clinical practices, the before and after improvements in practices, the value attributed by physicians to recommendations, the user's platform experience, the educational benefits according to medical students, and the organizational benefits according to stakeholders. The knowledge gained during each phase will be applied on an iterative and continuous basis to all other phases over a period of 2 years. RESULTS:This project was funded in April 2018 by the Fonds de soutien à l'innovation en santé et en services sociaux for 24 months. Ethics approval has been attained, the study began in June 2018, the data collection will be complete at the end of December 2019, and the data analysis will start in winter 2020. Both major city hospitals in the Outaouais region, Quebec, Canada, have agreed to participate in the project. CONCLUSIONS:If results show preliminary efficacy and usability of the system, a large-scale implementation will be conducted. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/11754.

Project description:Preconception care may be an efficacious tool to reduce risk factors for adverse pregnancy outcomes that are associated with lifestyles and health status before pregnancy. We conducted a web-based cohort study in Italian women planning a pregnancy to assess whether a tailored web intervention may change knowledge and behaviours associated with risks for adverse pregnancy outcomes.The study was entirely conducted on the web on a cohort of Italian women of childbearing age. Data collected at baseline on health status, lifestyles and knowledge of risk factors for adverse pregnancy outcomes were used for generating a tailored document including recommendations for folic acid supplementation, obesity and underweight, smoking, alcohol consumption, vaccinations, chronic and genetic diseases, exposure to medications. Prevalence of risk factors and knowledge was assessed 6 months after the intervention. Logistic regression models were used to explore the factors associated with risk factors after the intervention.Of the 508 enrolled women, 282 (55.5%) completed the study after 6 months since the delivery of tailored recommendations. At baseline, 48% of the participants took folic acid supplementation (95% CI 43.2; 51.9) and 69% consumed alcohol (95% CI 64.7; 72.9). At the follow up 71% of the participants had a preconception visit with a physician. Moreover we observed a decrease of alcohol consumption (-46.5% 95% CI -53.28; -38.75) and of the proportion of women not taking folic acid supplementation (-23.4% 95% CI -31.0; 15.36). We observed an improvement in knowledge of the information about the preconception behaviours to prevent adverse pregnancy outcomes (20.9% 95% CI 14.6%; 27.1%). Having a preconception visit during follow up was significally associated to an increase in folic acid supplementation (OR 2.53 95% CI 1.40; 4.60).Our results suggest that a tailored web intervention may improve general preconception health in women planning a pregnancy. A web preconception intervention may be integrated with classic preconception care by health professionals. Clinical trials should be conducted to confirm these findings.

Project description:BackgroundThe increasing number of internet users presents an opportunity to deliver health interventions to large populations. Despite their potential, many web-based interventions, including those for smoking cessation, face high rates of attrition. Further consideration of how intervention features impact attrition is needed.ObjectiveThe aim of this systematic review is to investigate whether tailored web-based smoking cessation interventions for smokers are associated with reduced rates of attrition compared with active or passive untailored web-based interventions. The outcomes of interest were dropout attrition at 1-, 3-, 6-, and 12-month follow-ups.MethodsLiterature searches were conducted in May 2018 and updated in May 2020 on MEDLINE (Medical Literature Analysis and Retrieval System Online), PsycINFO (Psychological Information), EMBASE (Excerpta Medica dataBASE), CINAHL (Cumulated Index to Nursing and Allied Health Literature), Scopus, and the Cochrane Tobacco Addiction Group Specialized Register with the following search terms: smoking cessation, tailored, or web- or internet-based. Included studies were published in English before or in May 2020 using a randomized controlled trial design. Studies were restricted to those with web-based delivery, a tailored intervention group, an untailored control group, and a reported outcome of smoking cessation. Studies were assessed for methodological quality using the Cochrane Risk of Bias tool. Two reviewers independently extracted the study characteristics and the number of participants lost to follow-up for each treatment group.ResultsA total of 13 studies were included in the systematic review, of which 11 (85%) were included in the meta-analysis. Tailoring had no statistically significant effect on dropout attrition at 1-month (risk ratio [RR]=1.02, 95% CI 0.95-1.09; P=.58; I2=78%), 3-month (RR=0.99, 95% CI 0.95-1.04; P=.80; I2=73%), 6-month (RR=1.00, 95% CI 0.95-1.05; P=.90; I2=43%), or 12-month (RR=0.97, 95% CI 0.92-1.02; P=.26; I2=28%) follow-ups. Subgroup analyses suggested that there was a statistically significant effect of tailoring between the active and passive subgroups at 1-month (P=.03), 3-month (P<.001), and 6-month (P=.02) follow-ups but not at 12-month follow-up (P=.25).ConclusionsThe results suggest that tailoring of web-based smoking cessation interventions may not be associated with reduced rates of dropout attrition at 1-, 3-, 6-, or 12-month follow-ups. Significant differences between studies that include untailored active and passive control groups suggest that the role of tailoring may be more prominent when studies include a passive control group. These findings may be because of variability in the presence of additional features, the definition of smokers used, and the duration of smoking abstinence measured. Future studies should incorporate active web-based controls, compare the impact of different tailoring strategies, and include populations outside of the Western countries.

Project description:BACKGROUND: Feedback is potentially effective in improving the quality of care. However, merely sending reports is no guarantee that performance data are used as input for systematic quality improvement (QI). Therefore, we developed a multifaceted intervention tailored to prospectively analyzed barriers to using indicators: the Information Feedback on Quality Indicators (InFoQI) program. This program aims to promote the use of performance indicator data as input for local systematic QI. We will conduct a study to assess the impact of the InFoQI program on patient outcome and organizational process measures of care, and to gain insight into barriers and success factors that affected the program's impact. The study will be executed in the context of intensive care. This paper presents the study's protocol. METHODS/DESIGN: We will conduct a cluster randomized controlled trial with intensive care units (ICUs) in the Netherlands. We will include ICUs that submit indicator data to the Dutch National Intensive Care Evaluation (NICE) quality registry and that agree to allocate at least one intensivist and one ICU nurse for implementation of the intervention. Eligible ICUs (clusters) will be randomized to receive basic NICE registry feedback (control arm) or to participate in the InFoQI program (intervention arm). The InFoQI program consists of comprehensive feedback, establishing a local, multidisciplinary QI team, and educational outreach visits. The primary outcome measures will be length of ICU stay and the proportion of shifts with a bed occupancy rate above 80%. We will also conduct a process evaluation involving ICUs in the intervention arm to investigate their actual exposure to and experiences with the InFoQI program. DISCUSSION: The results of this study will inform those involved in providing ICU care on the feasibility of a tailored multifaceted performance feedback intervention and its ability to accelerate systematic and local quality improvement. Although our study will be conducted within the domain of intensive care, we believe our conclusions will be generalizable to other settings that have a quality registry including an indicator set available. TRIAL REGISTRATION: Current Controlled Trials ISRCTN50542146.

Project description:BACKGROUND:The prevalence of smoking is declining; however, it continues to be a major public health burden. In England, primary care is the health setting that provides smoking cessation support to most smokers. However, this setting has one of the lowest success rates. The iQuit in practice intervention (iQuit) is a tailored web-based and text message intervention developed for use in primary care consultations as an adjunct to routine smoking cessation support with the aim of increasing success rates. iQuit has demonstrated feasibility, acceptability, and potential effectiveness. OBJECTIVE:This definitive trial aims to determine the effectiveness and cost-effectiveness of iQuit when used as an adjunct to the usual support provided to patients who wish to quit smoking, compared with usual care alone. METHODS:The iQuit in Practice II trial is a two-arm, parallel-group, randomized controlled trial (RCT) with a 1:1 individual allocation comparing usual care (ie, pharmacotherapy combined with multisession behavioral support)-the control-with usual care plus iQuit-the intervention. Participants were recruited through primary care clinics and talked to a smoking cessation advisor. Participants were randomized during the initial consultation, and those allocated to the intervention group received a tailored advice report and 90 days of text messaging in addition to the standard support provided to all patients. RESULTS:The primary outcome is self-reported prolonged abstinence biochemically verified using saliva cotinine at 6 months after the quit date. A sample size of 1700 participants, with 850 per arm, would yield 90% power to detect a 4.3% difference in validated quit rates between the groups at the two-sided 5% level of significance. The Cambridge East Research Ethics Committee approved the study in February 2016, and funding for the study was granted from May 2016. In total, 1671 participants were recruited between August 2016 and July 2019. Follow-up for all participants was completed in January 2020. Data analysis will begin in the summer of 2020. CONCLUSIONS:iQuit in Practice II is a definitive, pragmatic RCT assessing whether a digital intervention can augment the impact of routine smoking cessation support in primary care. Previous research has found good acceptability and feasibility for delivering iQuit among smoking cessation advisors working in primary care. If demonstrated to be cost-effective, iQuit could be delivered across primary care and other settings, such as community pharmacies. The potential benefit would likely be highest where less behavioral support is delivered. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number (ISRCTN): 44559004; http://www.isrctn.com /ISRCTN44559004. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/17160.

Project description:BackgroundDespite pharmacological treatments, patients undergoing cardiac surgery experience severe anxiety and pain, which adversely affect outcomes. Previous work examining pediatric and nonsurgical adult patients has documented the effectiveness of inexpensive, nonpharmacological techniques to reduce anxiety and pain as well as health care costs and length of hospitalization. However, the impact of nonpharmacological interventions administered by a dedicated comfort coach has not been evaluated in an adult surgical setting.ObjectiveThis trial aims to assess whether nonpharmacological interventions administered by a trained comfort coach affect patient experience, opioid use, and health care utilization compared with usual care in adult cardiac surgery patients. This study has 3 specific aims: assess the effect of a comfort coach on patient experience, measure differences in inpatient and outpatient opioid use and postoperative health care utilization, and qualitatively evaluate the comfort coach intervention.MethodsTo address these aims, we will perform a prospective, randomized controlled trial of 154 adult cardiac surgery patients at Michigan Medicine. Opioid-naive patients undergoing first-time, elective cardiac surgery via sternotomy will be randomized to undergo targeted interventions from a comfort coach (intervention) versus usual care (control). The individualized comfort coach interventions will be administered at 6 points: preoperative outpatient clinic, preoperative care unit on the day of surgery, extubation, chest tube removal, hospital discharge, and 30-day clinic follow-up. To address aim 1, we will examine the effect of a comfort coach on perioperative anxiety, self-reported pain, functional status, and patient satisfaction through validated surveys administered at preoperative outpatient clinic, discharge, 30-day follow-up, and 90-day follow-up. For aim 2, we will record inpatient opioid use and collect postdischarge opioid use and pain-related outcomes through an 11-item questionnaire administered at the 30-day follow-up. Hospital length of stay, readmission, number of days in an extended care facility, emergency room, urgent care, and an unplanned doctor's office visit will be recorded as the primary composite endpoint defined as total days spent at home within the first 30 days after surgery. For aim 3, we will perform semistructured interviews with patients in the intervention arm to understand the comfort coach intervention through a thematic analysis.ResultsThis trial, funded by Blue Cross Blue Shield of Michigan Foundation in 2019, is presently enrolling patients with anticipated manuscript submissions from our primary aims targeted for the end of 2020.ConclusionsData generated from this mixed methods study will highlight effective nonpharmacological techniques and support a multidisciplinary approach to perioperative care during the adult cardiac surgery patient experience. This study's findings may serve as the foundation for a subsequent multicenter trial and broader dissemination of these techniques to other types of surgery.Trial registrationClinicalTrials.gov NCT04051021; https://clinicaltrials.gov/ct2/show/NCT04051021.International registered report identifier (irrid)DERR1-10.2196/21350.

Project description:IntroductionPeople living with and beyond cancer are vulnerable to a number of physical, functional and psychological issues. Undertaking a holistic needs assessment (HNA) is one way to support a structured discussion of patients' needs within a clinical consultation. However, there is little evidence on how HNA impacts on the dynamics of the clinical consultation. This study aims to establish (1) how HNA affects the type of conversation that goes on during a clinical consultation and (2) how these putative changes impact on shared decision-making and self-efficacy.Methods and analysisThe study is hosted by 10 outpatient oncology clinics in the West of Scotland and South West England. Participants are patients with a diagnosis of head and neck, breast, urological, gynaecological and colorectal cancer who have received treatment for their cancer. Patients are randomised to an intervention or control group. The control group entails standard care--routine consultation between the patient and clinician. In the intervention group, the patient completes a holistic needs assessment prior to consultation. The completed assessment is then given to the clinician where it informs a discussion based on the patient's needs and concerns as identified by them. The primary outcome measure is patient participation, as determined by dialogue ratio (DR) and preponderance of initiative (PI) within the consultation. The secondary outcome measures are shared decision-making and self-efficacy. It is hypothesised that HNA will be associated with greater patient participation within the consultation, and that shared decision-making and feelings of self-efficacy will increase as a function of the intervention.Ethics and disseminationThis study has been given a favourable opinion by the West of Scotland Research Ethics Committee and NHS Research & Development. Study findings will be disseminated through peer-reviewed publications and conference attendance.Trail registration numberClinical Trials.gov NCT02274701.

Dataset Information

Evaluating the Impact of a Web-Based Risk Assessment System (CareSage) and Tailored Interventions on Health Care Utilization: Protocol for a Randomized Controlled Trial.

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Evaluating the Impact of a Web-Based Risk Assessment System (CareSage) and Tailored Interventions on Health Care Utilization: Protocol for a Randomized Controlled Trial.

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