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Towards a conceptual model for the use of home healthcare medical devices: The multi-parameter monitor case.

ABSTRACT: In the last decade there has been an increase in the use of medical devices in the home environment. These devices are commonly the same as those used in hospitals by healthcare professionals. The use of these these devices by lay users outside of a clinical environment may become unsafe. This study presents a methodology that allows decision makers to identify potential risk situations that may arise when lay users operate healthcare medical devices at home. Through a usability study based on the Grounded Theory methodology, we create a conceptual model in which we identified problems and errors related to the use of a multi-parameter monitor in a home environment by a group of lay users. The conceptual model is reified as a graphical representation, which allows stakeholders to identify (i) the weaknesses of the device, (ii) unsafe operation modes, and (iii) the most suitable device for a specific user.

SUBMITTER: Reyes P

PROVIDER: S-EPMC6285365 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Towards a conceptual model for the use of home healthcare medical devices: The multi-parameter monitor case.

Reyes Pablo P Larée Dominique D Weinstein Alejandro A Jara Álvaro Á

PloS one 20181207 12

In the last decade there has been an increase in the use of medical devices in the home environment. These devices are commonly the same as those used in hospitals by healthcare professionals. The use of these these devices by lay users outside of a clinical environment may become unsafe. This study presents a methodology that allows decision makers to identify potential risk situations that may arise when lay users operate healthcare medical devices at home. Through a usability study based on t ...[more]

PMID: 30532224

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Project description:BACKGROUND:Through the Multi-Payer Advanced Primary Care Practice (MAPCP) Demonstration, Medicare, Medicaid, and private payers offered supplemental payments to 849 primary care practices that became patient-centered medical homes (PCMHs) in eight states; practices also received technical assistance and data reports. Average Medicare payments were capped at $10 per beneficiary per month in each state. OBJECTIVE:Since there was variation in the eight participating states' demonstration designs, experiences, and outcomes, we conducted a qualitative multi-case analysis to identify the key factors that differentiated states that were estimated to have generated net savings for Medicare from states that did not. PARTICIPANTS:States' MAPCP Demonstration initiatives were comprehensively profiled in case studies based on secondary document review, three rounds of annual interviews with state staff, payers, practices, and other stakeholders, and other data sources. APPROACH:Case study findings were summarized in a case-ordered predictor-outcome matrix, which identified the presence or absence of key demonstration design features and experiences and arrayed states based on the amount of net savings or losses they generated for Medicare. We then used this matrix to identify initiative features that were present in at least three of the four states that generated net savings and absent from at least three of the four states that did not generate savings. RESULTS:A majority of the states that generated net savings: required practices to be recognized PCMHs to enter the demonstration, did not allow late entrants into the demonstration, used a consistent demonstration payment model across participating payers, and offered practices opportunities to earn performance bonuses. Practices in states that generated net savings also tended to report receiving the demonstration payments and bonuses they expected to receive, without any issues. CONCLUSIONS:Designers of future PCMH initiatives may increase their likelihood of generating net savings by incorporating the demonstration features we identified.

Project description:BackgroundLarge scale implementation of new strategies and healthcare delivery standards in academic medical centers (AMCs) requires training of healthcare workforce at different stages of their medical career. The patient-centered medical home (PCMH) model for healthcare delivery involves adoption by all members of the healthcare workforce, including seasoned professionals and trainees. Though widely known, the PCMH model has been implemented sporadically at large AMCs and methods to implement the model across healthcare workforce have not been well-documented.MethodsTo meet all PCMH standards and achieve sustainable level 3 recognition, the authors implemented in 2014-2015 a multi-pronged approach that capitalized on existing educational infrastructure among faculty, residents, and medical students. Within 18 months, the authors applied new interdisciplinary practices and policies, redesigned residency training in continuity practices and extensively modified medical school curricula.ResultsThese innovative transformational education efforts addressed the six PCMH standards for faculty, residents, and undergraduate medical students. Faculty played a major role as system change agents and facilitators of learning. Residents learned to better understand patients' cultural needs, identify 'at-risk' patients, ensure continuity of care, and assess and improve quality of care. Medical students were exposed to PCMH core standards throughout their training via simulations, training in the community and with patients, and evaluation tasks. By implementing these changes across the healthcare workforce, the AMC achieved PCMH status in a short time, changed practice culture and improved care for patients and the community. Since then, the AMC has been able to maintain PCMH recognition annually with minimal effort.ConclusionsSuccessful strategies that capitalize on existing strengths in infrastructure complemented by innovative educational offerings and inter-professional partnerships can be adapted by other organizations pursuing similar transformation efforts. This widespread transformation across the healthcare workforce facilitate a deep-rooted change that enabled our academic medical center to sustain PCMH recognition.

Project description:Circadian and other physiological rhythms play a key role in both normal homeostasis and disease processes. Such is the case of circadian and infradian seizure patterns observed in epilepsy. However, these rhythms are not fully exploited in the design of active implantable medical devices. In this paper we explore a new implantable stimulator that implements chronotherapy as a feedforward input to supplement both open-loop and closed-loop methods. This integrated algorithm allows for stimulation to be adjusted to the ultradian, circadian and infradian patterns observed in patients through slowly-varying temporal adjustments of stimulation and algorithm sub-components, while also enabling adaption of stimulation based on immediate physiological needs such as a breakthrough seizure or change of posture. Embedded physiological sensors in the stimulator can be used to refine the baseline stimulation circadian pattern as a "digital zeitgeber," i.e., a source of stimulus that entrains or synchronizes the subject's natural rhythms. This algorithmic approach is tested on a canine with severe drug-resistant idiopathic generalized epilepsy exhibiting a characteristic diurnal pattern correlated with sleep-wake cycles. Prior to implantation, the canine's cluster seizures evolved to status epilepticus (SE) and required emergency pharmacological intervention. The cranially-mounted system was fully-implanted bilaterally into the centromedian nucleus of the thalamus. Using combinations of time-based modulation, thalamocortical rhythm-specific tuning of frequency parameters as well as fast-adaptive modes based on activity, the canine experienced no further SE events post-implant as of the time of writing (7 months). Importantly, no significant cluster seizures have been observed either, allowing the reduction of rescue medication. The use of digitally-enabled chronotherapy as a feedforward signal to augment adaptive neurostimulators could prove a useful algorithmic method in conditions where sensitivity to temporal patterns are characteristics of the disease state, providing a novel mechanism for tailoring a more patient-specific therapy approach.

Project description:BackgroundStudies on the usability of health care devices are becoming more common, although usability standards are not necessarily specified and followed. Yet, there is little knowledge about the impact of the context of use on the usability outcome. It is specified in the usability standard (ISO 9241-11, 2018) of a device that it may be affected by its context of use and especially by the characteristics of its users. Among these, prior health knowledge (ie, knowledge about human body functioning) is crucial. However, no study has shown that prior health knowledge influences the usability of medical devices.ObjectiveOur study aimed to fill this gap by analyzing the relationship between the usability of two home medical devices (soon to be used in the context of ambulatory surgery) and prior health knowledge through an experimental approach.MethodsFor assessing the usability of two home medical devices (blood pressure monitor and pulse oximeter), user tests were conducted among 149 students. A mixed-methods approach (subjective vs objective) using a variety of standard instruments was adopted (direct observation, video analysis, and questionnaires). Participants completed a questionnaire to show the extent of their previous health knowledge and then operated both devices randomly. Efficiency (ie, handling time) and effectiveness (ie, number of handling errors) measures were collected by video analysis. Satisfaction measures were collected by a questionnaire (system usability scale [SUS]). The qualitative observational data were coded using inductive analysis by two independent researchers specialized in cognitive psychology and cognitive ergonomics. Correlational analyses and clusters were performed to test how usability relates to sociodemographic characteristics and prior health knowledge.ResultsThe results indicated a lack of usability for both devices. Regarding the blood pressure monitor (137 participants), users made approximately 0.77 errors (SD 1.49), and the mean SUS score was 72.4 (SD 21.07), which is considered "satisfactory." The pulse oximeter (147 participants) appeared easier to use, but participants made more errors (mean 0.99, SD 0.92), and the mean SUS score was 71.52 (SD 17.29), which is considered "satisfactory." The results showed a low negative and significant correlation only between the effectiveness of the two devices and previous knowledge (blood pressure monitor: r=-0.191, P=.03; pulse oximeter: r=-0.263, P=.001). More subtly, we experimentally identified the existence of a threshold level (χ²2,146=10.9, P=.004) for health knowledge to correctly use the pulse oximeter, but this was missing for the blood pressure monitor.ConclusionsThis study has the following two contributions: (1) a theoretical interest highlighting the importance of user characteristics including prior health knowledge on usability outcomes and (2) an applied interest to provide recommendations to designers and medical staff.

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Towards a conceptual model for the use of home healthcare medical devices: The multi-parameter monitor case.

Publications

Towards a conceptual model for the use of home healthcare medical devices: The multi-parameter monitor case.

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