Randomized Trial of a Mobile Personal Health Record for Behavioral Health Homes.
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ABSTRACT: Objective
Behavioral health homes, which provide onsite primary medical care in mental health clinics, face challenges in integrating information across multiple health records. This study tested whether a mobile personal health record application improved quality of medical care for individuals treated in these settings.Methods
This randomized study enrolled 311 participants with a serious mental illness and one or more cardiometabolic risk factors across two behavioral health homes to receive a mobile personal health record application (N=156) or usual care (N=155). A secure mobile personal health record (mPHR) app provided participants in the intervention group with key information about diagnoses, medications, and laboratory test values and allowed them to track health goals. The primary study outcome was a chart-derived composite measure of quality of cardiometabolic and preventive services.Results
At 12-month follow-up, participants in the mPHR group maintained high quality of care (70% of indicated services at baseline and at 12-month follow-up), in contrast to a decline in quality for the usual-care group (71% at baseline and 67% at follow-up), resulting in a statistically significant but clinically modest differential impact between the groups. No differences between the study groups were found in secondary self-reported outcomes, including delivery of chronic illness care, patient activation, and quality of life related to mental or general medical health.Conclusions
Use of a mPHR app was associated with a statistically significant but clinically modest differential benefit for quality of medical care among individuals with serious mental illness and comorbid cardiometabolic conditions.
SUBMITTER: Druss BG
PROVIDER: S-EPMC7415646 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background and study aims
The Federal Ministry of Education and Research (BMBF) has funded the development of a patient controlled “Personal Electronic Health Record” (PEPA) as part of their current INFOPAT project. PEPA allows for the exchange of medical data between all interested groups, including the patients thenselves. A PEPA contains medical reports and findings including, for example, x-rays, CT scans and MRIs. The patients can safeguard their information and access all content. The aim of this study is to test the PEPA-prototype for cancer patients being treated at the National Center for Tumor Diseases (NCT) in Heidelberg.
Who can participate?
Adult colorectal cancer patients being treated at the National Center for Tumor Diseases (NCT) in Heidelberg.
What does the study involve?
There are two part to this study. The first part involves focus groups, in which a group of people are asked their opinion and attitudes towards, for example, an idea, product or service. Here, focus groups are set up that involve the patients, doctors and other health professionals to discuss current problems with the coordination of care offered to cancer patients, as well as discuss what people want to get from using PEPA (i.e. user requirements). The PEPA-prototype is then developed taking into account the conclusions from the focus groups. In the second part of the study, patients are encouraged to use the PEPA-prototype to prepare and follow up meetings with their physicians.
| 2424890 | ecrin-mdr-crc
Project description:Personal health record (PHR)-based health care management systems can improve patient engagement and data-driven medical diagnosis in a clinical setting.The purpose of this study was (1) to demonstrate the development of an electronic health record (EHR)-tethered PHR app named MyHealthKeeper, which can retrieve data from a wearable device and deliver these data to a hospital EHR system, and (2) to study the effectiveness of a PHR data-driven clinical intervention with clinical trial results.To improve the conventional EHR-tethered PHR, we ascertained clinicians' unmet needs regarding PHR functionality and the data frequently used in the field through a cocreation workshop. We incorporated the requirements into the system design and architecture of the MyHealthKeeper PHR module. We constructed the app and validated the effectiveness of the PHR module by conducting a 4-week clinical trial. We used a commercially available activity tracker (Misfit) to collect individual physical activity data, and developed the MyHealthKeeper mobile phone app to record participants' patterns of daily food intake and activity logs. We randomly assigned 80 participants to either the PHR-based intervention group (n=51) or the control group (n=29). All of the study participants completed a paper-based survey, a laboratory test, a physical examination, and an opinion interview. During the 4-week study period, we collected health-related mobile data, and study participants visited the outpatient clinic twice and received PHR-based clinical diagnosis and recommendations.A total of 68 participants (44 in the intervention group and 24 in the control group) completed the study. The PHR intervention group showed significantly higher weight loss than the control group (mean 1.4 kg, 95% CI 0.9-1.9; P<.001) at the final week (week 4). In addition, triglyceride levels were significantly lower by the end of the study period (mean 2.59 mmol/L, 95% CI 17.6-75.8; P=.002).We developed an innovative EHR-tethered PHR system that allowed clinicians and patients to share lifelog data. This study shows the effectiveness of a patient-managed and clinician-guided health tracker system and its potential to improve patient clinical profiles.ClinicalTrials.gov NCT03200119; https://clinicaltrials.gov/ct2/show/NCT03200119 (Archived by WebCite at http://www.webcitation.org/6v01HaCdd).
| S-EPMC5740264 | biostudies-literature
Project description:To determine the effects of a personal health record (PHR)-linked medications module on medication accuracy and safety.From September 2005 to March 2007, we conducted an on-treatment sub-study within a cluster-randomized trial involving 11 primary care practices that used the same PHR. Intervention practices received access to a medications module prompting patients to review their documented medications and identify discrepancies, generating 'eJournals' that enabled rapid updating of medication lists during subsequent clinical visits.A sample of 267 patients who submitted medications eJournals was contacted by phone 3 weeks after an eligible visit and compared with a matched sample of 274 patients in control practices that received a different PHR-linked intervention. Two blinded physician adjudicators determined unexplained discrepancies between documented and patient-reported medication regimens. The primary outcome was proportion of medications per patient with unexplained discrepancies.Among 121,046 patients in eligible practices, 3979 participated in the main trial and 541 participated in the sub-study. The proportion of medications per patient with unexplained discrepancies was 42% in the intervention arm and 51% in the control arm (adjusted OR 0.71, 95% CI 0.54 to 0.94, p=0.01). The number of unexplained discrepancies per patient with potential for severe harm was 0.03 in the intervention arm and 0.08 in the control arm (adjusted RR 0.31, 95% CI 0.10 to 0.92, p=0.04).When used, concordance between documented and patient-reported medication regimens and reduction in potentially harmful medication discrepancies can be improved with a PHR medication review tool linked to the provider's medical record.This study was registered at ClinicalTrials.gov (NCT00251875).
| S-EPMC3422826 | biostudies-literature
Project description:BackgroundCancer care coordination addresses the fragmented and inefficient care of individuals with complex care needs. The complexity of care coordination can be aided by innovative technology. Few examples of information technology-enabled care coordination exist beyond the conventional telephone follow-up. For this study, we implemented a custom-designed app, the Personal Health Network (PHN)-a Health Insurance Portability and Accountability Act-compliant social network built around a patient to enable patient-centered health and health care activities in collaboration with clinicians, care team members, caregivers, and others designated by the patient. The app facilitates a care coordination intervention for patients undergoing chemotherapy.ObjectiveThis study aimed to understand patient experiences with PHN technology and assess their perspectives on the usability and usefulness of PHNs with care coordination during chemotherapy.MethodsA two-arm randomized clinical trial was conducted to compare the PHN and care coordination with care coordination alone over a 6-month period beginning with the initiation of chemotherapy. A semistructured interview guide was constructed based on a theoretical framework of technology acceptance addressing usefulness, usability, and the context of use of the technology within the participant's life and health care setting. All participants in the intervention arm were interviewed on completion of the study. Interviews were recorded and transcribed verbatim. A summative thematic analysis was completed for the transcribed interviews. Features of the app were also evaluated.ResultsA total of 27 interviews were completed. The resulting themes included the care coordinator as a partner in care, learning while sick, comparison of other technology to make sense of the PHN, communication, learning, usability, and usefulness. Users expressed that the nurse care coordinators were beneficial to them because they helped them stay connected to the care team and answered their questions. They shared that the mobile app gave them access to the health information they were seeking. Users expressed that the mobile app would be more useful if it was fully integrated with the electronic health record.ConclusionsThe findings highlight the value of care coordination from the perspectives of cancer patients undergoing chemotherapy and the important role of technology, such as the PHN, in enhancing this process by facilitating better communication and access to information regarding their illness.
| S-EPMC7284410 | biostudies-literature
Project description:BackgroundElectronic health records (EHRs) have been widely proposed as a mechanism for improving health care quality. However, rigorous research on the impact of EHR systems on behavioral health service delivery is scant, especially for children and adolescents.ObjectiveThe current study evaluated the usability of an EHR developed to support the implementation of the Wraparound care coordination model for children and youth with complex behavioral health needs, and impact of the EHR on service processes, fidelity, and proximal outcomes.MethodsThirty-four Wraparound facilitators working in two programs in two states were randomized to either use the new EHR (19/34, 56%) or to continue to implement Wraparound services as usual (SAU) using paper-based documentation (15/34, 44%). Key functions of the EHR included standard fields such as youth and family information, diagnoses, assessment data, and progress notes. In addition, there was the maintenance of a coordinated plan of care, progress measurement on strategies and services, communication among team members, and reporting on services, expenditures, and outcomes. All children and youth referred to services for eight months (N=211) were eligible for the study. After excluding those who were ineligible (69/211, 33%) and who declined to participate (59/211, 28%), a total of 83/211 (39%) children and youth were enrolled in the study with 49/211 (23%) in the EHR condition and 34/211 (16%) in the SAU condition. Facilitators serving these youth and families and their supervisors completed measures of EHR usability and appropriateness, supervision processes and activities, work satisfaction, and use of and attitudes toward standardized assessments. Data from facilitators were collected by web survey and, where necessary, by phone interviews. Parents and caregivers completed measures via phone interviews. Related to fidelity and quality of behavioral health care, including Wraparound team climate, working alliance with providers, fidelity to the Wraparound model, and satisfaction with services.ResultsEHR-assigned facilitators from both sites demonstrated the robust use of the system. Facilitators in the EHR group reported spending significantly more time reviewing client progress (P=.03) in supervision, and less time overall sending reminders to youth/families (P=.04). A trend toward less time on administrative tasks (P=.098) in supervision was also found. Facilitators in both groups reported significantly increased use of measurement-based care strategies overall, which may reflect cross-group contamination (given that randomization of staff to the EHR occurred within agencies and supervisors supervised both types of staff). Although not significant at P<.05, there was a trend (P=.10) toward caregivers in the EHR group reporting poorer shared agreement on tasks on the measure of working alliance with providers. No other significant between-group differences were found.ConclusionsResults support the proposal that use of EHR systems can promote the use of client progress data and promote efficiency; however, there was little evidence of any impact (positive or negative) on overall service quality, fidelity, or client satisfaction. The field of children's behavioral health services would benefit from additional research on EHR systems using designs that include larger sample sizes and longer follow-up periods.Trial registrationClinicalTrials.gov NCT02421874; https://clinicaltrials.gov/ct2/show/NCT02421874 (Archived by WebCite at http://www.webcitation.org/6yyGPJ3NA).
| S-EPMC6024107 | biostudies-literature
Project description:PurposeTo examine the impact of a personal health record (PHR) in patients with hypertension measured by changes in biological outcomes, patient empowerment, patient perception of quality of care, and use of medical services.MethodsA cluster-randomized effectiveness trial with PHR and no PHR groups was conducted in two ambulatory clinics. 453 of 1686 (26.4%) patients approached were included in the analyses. A PHR tethered to the patient's electronic medical record (EMR) was the primary intervention and included security measures, patient control of access, limited transmission of EMR data, blood pressure (BP) tracking, and appointment assistance. BP was the main outcome measure. Patient empowerment was assessed using the Patient Activation Measure and Patient Empowerment Scale. Quality of care was assessed using the Clinician and Group Assessment Score (CAHPS) and the Patient Assessment of Chronic Illness Care. Frequency of use of medical services was self-reported.ResultsNo impact of the PHR was observed on BP, patient activation, patient perceived quality, or medical utilization in the intention-to-treat analysis. Sub-analysis of intervention patients self-identified as active PHR users (25.7% of those with available information) showed a 5.25-point reduction in diastolic BP. Younger age, self-reported computer skills, and more positive provider communication ratings were associated with frequency of PHR use.ConclusionsFew patients provided with a PHR actually used the PHR with any frequency. Thus simply providing a PHR may have limited impact on patient BP, empowerment, satisfaction with care, or use of health services without additional education or clinical intervention designed to increase PHR use.Clinical trial registration numberhttp://ClinicalTrials.gov Identifier: NCT01317537.
| S-EPMC3384099 | biostudies-literature
Project description:BackgroundGay, bisexual, and other men who have sex with men (GBMSM) face the highest burden of HIV in the United States, and there is a paucity of efficacious mobile health (mHealth) HIV prevention and care interventions tailored specifically for GBMSM. We tested a mobile app combining prevention messages and access to core prevention services for GBMSM.ObjectiveThis study aims to measure the efficacy of the Mobile Messaging for Men (M-cubed) app and related services to increase HIV prevention and care behaviors in diverse US GBMSM.MethodsWe conducted a randomized open-label study with a waitlist control group among GBMSM in 3 groups (low-risk HIV-negative group, high-risk HIV-negative group, and living-with-HIV [LWH] group) recruited online and in venues in Atlanta, Detroit, and New York City. Participants were randomly assigned to receive access to the app immediately or at 9 months after randomization. The app provided prevention messages in 6 domains of sexual health and offered ordering of at-home HIV and sexually transmitted infection test kits, receiving preexposure prophylaxis (PrEP) evaluations and navigation, and service locators. Serostatus- and risk-specific prevention outcomes were evaluated at baseline, at the end of the intervention period, and at 3, 6, and 9 months after the intervention period.ResultsIn total, 1226 GBMSM were enrolled and randomized; of these 611 (49.84%) were assigned to the intervention group and 608 (99.51%) were analyzed, while 615 (50.16%) were assigned to the control group and 612 (99.51%) were analyzed. For high-risk GBMSM, allocation to the intervention arm was associated with higher odds of HIV testing during the intervention period (adjusted odds ratio [aOR] 2.02, 95% CI 1.11-3.66) and with higher odds of using PrEP in the 3 months after the intervention period (aOR 2.41, 95% CI 1.00-5.76, P<.05). No changes in HIV prevention or care were associated with allocation to the intervention arm for the low-risk HIV-negative and LWH groups.ConclusionsAccess to the M-cubed app was associated with increased HIV testing and PrEP use among high-risk HIV-negative GBMSM in 3 US cities. The app could be made available through funded HIV prevention providers; additional efforts are needed to understand optimal strategies to implement the app outside of the research setting.Trial registrationClinicalTrials.gov NCT03666247; https://clinicaltrials.gov/ct2/show/NCT03666247.International registered report identifier (irrid)RR2-10.2196/16439.
| S-EPMC8851328 | biostudies-literature
Project description:BACKGROUND:Although there is a rise in the use of mobile health (mHealth) tools to support chronic disease management, evidence derived from theory-driven design is lacking. OBJECTIVE:The objective of this study was to determine the impact of an mHealth app that incorporated theory-driven trigger messages. These messages took different forms following the Fogg behavior model (FBM) and targeted self-efficacy, knowledge, and self-care. We assess the feasibility of our app in modifying these behaviors in a pilot study involving individuals with diabetes. METHODS:The pilot randomized unblinded study comprised two cohorts recruited as employees from within a health care system. In total, 20 patients with type 2 diabetes were recruited for the study and a within-subjects design was utilized. Each participant interacted with an app called capABILITY. capABILITY and its affiliated trigger (text) messages integrate components from social cognitive theory (SCT), FBM, and persuasive technology into the interactive health communications framework. In this within-subjects design, participants interacted with the capABILITY app and received (or did not receive) text messages in alternative blocks. The capABILITY app alone was the control condition along with trigger messages including spark and facilitator messages. A repeated-measures analysis of variance (ANOVA) was used to compare adherence with behavioral measures and engagement with the mobile app across conditions. A paired sample t test was utilized on each health outcome to determine changes related to capABILITY intervention, as well as participants' classified usage of capABILITY. RESULTS:Pre- and postintervention results indicated statistical significance on 3 of the 7 health survey measures (general diet: P=.03; exercise: P=.005; and blood glucose: P=.02). When only analyzing the high and midusers (n=14) of capABILITY, we found a statistically significant difference in both self-efficacy (P=.008) and exercise (P=.01). Although the ANOVA did not reveal any statistically significant differences across groups, there is a trend among spark conditions to respond more quickly (ie, shorter log-in lag) following the receipt of the message. CONCLUSIONS:Our theory-driven mHealth app appears to be a feasible means of improving self-efficacy and health-related behaviors. Although our sample size is too small to draw conclusions about the differential impact of specific forms of trigger messages, our findings suggest that spark triggers may have the ability to cue engagement in mobile tools. This was demonstrated with the increased use of capABILITY at the beginning and conclusion of the study depending on spark timing. Our results suggest that theory-driven personalization of mobile tools is a viable form of intervention. TRIAL REGISTRATION:ClinicalTrials.gov NCT04132089; http://clinicaltrials.gov/ct2/show/NCT004122089.
| S-EPMC7105932 | biostudies-literature
Project description:BackgroundDespite the large body of literature demonstrating the effectiveness of cognitive behavioral treatments for agoraphobia, many patients remain untreated because of various barriers to treatment. Web-based and mobile-based interventions targeting agoraphobia may provide a solution to this problem, but there is a lack of research investigating the efficacy of such interventions.ObjectiveThe objective of our study was to evaluate for the first time the effectiveness of a self-guided mobile-based intervention primarily targeting agoraphobic symptoms, with respect to a generic mobile app targeting anxiety.MethodsA Web-based randomized controlled trial (RCT) compared a novel mobile app designed to target agoraphobia (called Agoraphobia Free) with a mobile app designed to help with symptoms of anxiety in general (called Stress Free). Both interventions were based on established cognitive behavioral principles. We recruited participants (N=170) who self-identified as having agoraphobia and assessed them online at baseline, midpoint, and end point (posttreatment) over a period of 12 weeks. The primary outcome was symptom severity measured by the Panic and Agoraphobia Scale.ResultsBoth groups had statistically significant improvements in symptom severity over time (difference -5.97, 95% CI -8.49 to -3.44, P<.001 for Agoraphobia Free and -6.35, 95% CI -8.82 to -3.87, P<.001 for Stress Free), but there were no significant between-group differences on the primary outcome (difference 0.38, 95% CI -1.96 to 3.20, P=.64).ConclusionsThis is, to our knowledge, the first RCT to provide evidence that people who identify as having agoraphobia may equally benefit from a diagnosis-specific and a transdiagnostic mobile-based intervention. We also discuss clinical and research implications for the development and dissemination of mobile mental health apps.Trial registrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 98453199; http://www.isrctn.com /ISRCTN98453199 (Archived by WebCite at http://www.webcitation.org/6uR5vsdZw).
| S-EPMC5722980 | biostudies-literature
Project description:BackgroundThis study is one of the first randomized controlled trials investigating cognitive behavioral therapy for insomnia (CBT-I) delivered by a fully automated mobile phone app. Such an app can potentially increase the accessibility of insomnia treatment for the 10% of people who have insomnia.ObjectiveThe objective of our study was to investigate the efficacy of CBT-I delivered via the Sleepcare mobile phone app, compared with a waitlist control group, in a randomized controlled trial.MethodsWe recruited participants in the Netherlands with relatively mild insomnia disorder. After answering an online pretest questionnaire, they were randomly assigned to the app (n=74) or the waitlist condition (n=77). The app packaged a sleep diary, a relaxation exercise, sleep restriction exercise, and sleep hygiene and education. The app was fully automated and adjusted itself to a participant's progress. Program duration was 6 to 7 weeks, after which participants received posttest measurements and a 3-month follow-up. The participants in the waitlist condition received the app after they completed the posttest questionnaire. The measurements consisted of questionnaires and 7-day online diaries. The questionnaires measured insomnia severity, dysfunctional beliefs about sleep, and anxiety and depression symptoms. The diary measured sleep variables such as sleep efficiency. We performed multilevel analyses to study the interaction effects between time and condition.ResultsThe results showed significant interaction effects (P<.01) favoring the app condition on the primary outcome measures of insomnia severity (d=-0.66) and sleep efficiency (d=0.71). Overall, these improvements were also retained in a 3-month follow-up.ConclusionsThis study demonstrated the efficacy of a fully automated mobile phone app in the treatment of relatively mild insomnia. The effects were in the range of what is found for Web-based treatment in general. This supports the applicability of such technical tools in the treatment of insomnia. Future work should examine the generalizability to a more diverse population. Furthermore, the separate components of such an app should be investigated. It remains to be seen how this app can best be integrated into the current health regimens.Trial registrationNetherlands Trial Register: NTR5560; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5560 (Archived by WebCite at http://www.webcitation.org/6noLaUdJ4).
| S-EPMC5405291 | biostudies-literature