Dataset Information

Assessing the Implementation and Effectiveness of the Electronic Patient-Reported Outcome Tool for Older Adults With Complex Care Needs: Mixed Methods Study.

ABSTRACT:

Background

Goal-oriented care is being adopted to deliver person-centered primary care to older adults with multimorbidity and complex care needs. Although this model holds promise, its implementation remains a challenge. Digital health solutions may enable processes to improve adoption; however, they require evaluation to determine feasibility and impact.

Objective

This study aims to evaluate the implementation and effectiveness of the electronic Patient-Reported Outcome (ePRO) mobile app and portal system, designed to enable goal-oriented care delivery in interprofessional primary care practices. The research questions driving this study are as follows: Does ePRO improve quality of life and self-management in older adults with complex needs? What mechanisms are likely driving observed outcomes?

Methods

A multimethod, pragmatic randomized controlled trial using a stepped-wedge design and ethnographic case studies was conducted over a 15-month period in 6 comprehensive primary care practices across Ontario with a target enrollment of 176 patients. The 6 practices were randomized into either early (3-month control period; 12-month intervention) or late (6-month control period; 9-month intervention) groups. The primary outcome measure of interest was the Assessment of Quality of Life-4D (AQoL-4D). Data were collected at baseline and at 3 monthly intervals for the duration of the trial. Ethnographic data included observations and interviews with patients and providers at the midpoint and end of the intervention. Outcome data were analyzed using linear models conducted at the individual level, accounting for cluster effects at the practice level, and ethnographic data were analyzed using qualitative description and framework analysis methods.

Results

Recruitment challenges resulted in fewer sites and participants than expected; of the 176 target, only 142 (80.6%) patients were identified as eligible to participate because of lower-than-expected provider participation and fewer-than-expected patients willing to participate or perceived as ready to engage in goal-setting. Of the 142 patients approached, 45 (32%) participated. Patients set a variety of goals related to self-management, mental health, social health, and overall well-being. Owing to underpowering, the impact of ePRO on quality of life could not be definitively assessed; however, the intervention group, ePRO plus usual care (mean 15.28, SD 18.60) demonstrated a nonsignificant decrease in quality of life (t₂₄=-1.20; P=.24) when compared with usual care only (mean 21.76, SD 2.17). The ethnographic data reveal a complex implementation process in which the meaningfulness (or coherence) of the technology to individuals' lives and work acted as a key driver of adoption and tool appraisal.

Conclusions

This trial experienced many unexpected and significant implementation challenges related to recruitment and engagement. Future studies could be improved through better alignment of the research methods and intervention to the complex and diverse clinical settings, dynamic goal-oriented care process, and readiness of provider and patient participants.

Trial registration

ClinicalTrials.gov NCT02917954; https://clinicaltrials.gov/ct2/show/NCT02917954.

SUBMITTER: Steele Gray C

PROVIDER: S-EPMC8726765 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionPatient-reported outcome measures (PROMs) provide an opportunity for meaningful patient engagement and shared decision-making. The objective of this research programme is to improve health outcomes for paediatric solid organ transplant patients by implementing PROMs into clinical care. The current study aims to create Voxe, a paediatric user-centred electronic PROM platform, by engaging patients and healthcare providers throughout the design and development process.Methods and analysisThe creation of Voxe will occur over two phases that build on previous research. The user interface design phase employs a 'user-centric' approach to identify end-users' needs and iteratively refine the look and layout of Voxe to meet these needs. Transplant recipients, aged 10-17, and healthcare providers will participate in three rounds of testing (24 participants total). Participants will: (1) complete task-based activities (outcomes-effectiveness and efficiency), (2) complete questionnaires (outcome-satisfaction) and (3) participate in a semi-structured interview. The following phase involves software development and Voxe usability testing. Transplant recipients, aged 8-17, and healthcare providers will participate in four rounds of iterative testing (24-40 participants total). The think-aloud technique will be employed, and participants will describe their thoughts and feelings while interacting with a Voxe prototype. Participants will: (1) log into Voxe and complete tasks (outcomes-time on task, successful task completion, frequency of critical and non-critical errors and error-free rate), (2) complete questionnaires (outcome-satisfaction) and (3) participate in a semi-structured interview. Findings will result in the creation and launch of a user-centred electronic PROM platform.Ethics and disseminationResearch ethics board approval has been provided by The Hospital for Sick Children. This research is critical to answering methodological and operational questions to inform Voxe implementation in paediatric clinical settings and facilitate PROM data collection. Future investigations will include an implementation-effectiveness evaluation.

Project description:BACKGROUND:Mobile health (mHealth) technologies are increasingly used in various medical fields. However, the potential of mHealth to improve patient care in radiotherapy by acquiring electronic patient reported outcome measures (ePROMs) during treatment has been poorly studied so far. OBJECTIVE:The aim of this study was to develop and implement a novel Web app (PROMetheus) for patients undergoing radiotherapy. Herein, we have reported our experience with a focus on feasibility, patient acceptance, and a correlation of ePROMs with the clinical course of the patients. METHODS:In the period between January and June 2018, 21 patients used PROMetheus to score side effects, symptoms, and quality of life-related parameters during and after their treatment. Items of the Patient Reported Outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) were chosen based on the primary site of disease, 27 items for head and neck tumors, 21 items for thoracic tumors, and 24 items for pelvic tumors. RESULTS:In total, 17 out of the 21 patients (81%) regularly submitted ePROMs and more than 2500 data points were acquired. An average of 5.2, 3.5, and 3.3 min was required to complete the head and neck, thorax, and pelvis questionnaires, respectively. ePROMS were able to detect the occurrence of both expected and unexpected side effects during the treatment. In addition, a gradual increase in the severity of side effects over the course the treatment and their remission afterward could be observed with ePROMs. In total, 9 out of the 17 patients (53%), mostly those with head and neck and thoracic cancers, reported PRO-CTCAE grade III or IV fatigue with severe impairments of activities of daily life. CONCLUSIONS:This study shows the successful implementation of an ePROM system and a high patient acceptance. ePROMs have a great potential to improve patient care in radiotherapy by providing a comprehensive documentation of symptoms and side effects, especially of ones that are otherwise underreported.

Project description:BackgroundTo realize the broader benefits of electronic patient-reported outcome measures (ePROMs) in routine care, we used the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to inform the translation of a clinically effective ePROM system (hereafter referred to as the PRM system) into practice. The study aimed to evaluate the processes and success of implementing the PRM system in the routine care of patients diagnosed with lung cancer.MethodA controlled before-and-after mixed-methods study was undertaken. Data sources included a self-report questionnaire and interviews with healthcare providers, electronic health record data for PRMs patients and historical controls, and field notes. Descriptive statistics, logistic regression modelling, negative binomial models, generalized estimating equations and repeated measures ANOVA were used to analyze quantitative data. Qualitative data was thematically analyzed.ResultsA total of 48/79 eligible people diagnosed with lung cancer completed 90 assessments during the 5-month implementation period (RE-AIM reach). Every assessment breached the pre-defined threshold and care coordinators reviewed and actioned 95.6% of breaches, resulting in 146 referrals to allied health services, most frequently for social work (25.3%), dietetics (18.5%), physiotherapy (18.5%) and occupational therapy (17.1%). PRMs patients had significantly fewer visits to the cancer assessment unit for problematic symptoms (M = 0.23 vs. M = 0.43; p = 0.035), and were significantly more likely to be offered referrals (71% vs. 29%, p < 0.0001) than historical controls (RE-AIM effect). The levels of 'organizational readiness for implementing change' (ORIC) did not show much differences between baseline and follow-up, though this was already high at baseline; but significantly more staff reported improved confidence when asking patients to complete assessments (64.7% at baseline vs. 88.2% at follow-up, p = 0.0046), and when describing the assessment tool to patients (64.7% at baseline vs. 76.47% at follow-up, p = 0.0018) (RE-AIM adoption). A total of 78 staff received PRM system training, and 95.6% of the PRM system alerts were actioned (RE-AIM implementation); and all lung cancer care coordinators were engaged with the PRM system beyond the end of the study period (RE-AIM maintenance).ConclusionThis study demonstrates the potential of the PRM system in enhancing the routine care of lung cancer patients, through leveraging the capabilities of automated web-based care options. Research has shown the clear benefits of using electronically collected patient-reported outcome measures (ePROMs) for cancer patients and health services. However, we need to better understand how to implement ePROMs as part of routine care. This study evaluated the processes and outcomes of implementing an ePROMs system in the routine care of patients diagnosed with lung cancer. Key findings included: (a) a majority of eligible patients completed the scheduled assessments; (b) patient concerns were identified in every assessment, and care coordinators reviewed and actioned almost all of these, including making significantly more referrals to allied health services; (c) patients completing assessments regularly were less likely to present to the cancer assessment unit with problematic symptoms, suggesting that ePROMs identified patient concerns early and this led to a timely response to concerns; (d) staff training and engagement was high, and staff reporting increased confidence when asking patients to complete assessments and when describing the assessment tool to patients at the end of the implementation period. This study shows that implementing ePROMs in routine care is feasible and can lead to improvements in patient care.

Project description:Objective The aim of the study is to identify and prioritize early intervention (EI) stakeholders' perspectives of supports and barriers to implementing the Young Children's Participation and Environment Measure (YC-PEM), an electronic patient-reported outcome (e-PRO) tool, for scaling its implementation across multiple local and state EI programs.Methods An explanatory sequential (quan > QUAL) mixed-methods study was conducted with EI families (n = 6), service coordinators (n = 9), and program leadership (n = 7). Semi-structured interviews and focus groups were used to share select quantitative pragmatic trial results (e.g., percentages for perceived helpfulness of implementation strategies) and elicit stakeholder perspectives to contextualize these results. Three study staff deductively coded transcripts to constructs in the Consolidated Framework for Implementation Research (CFIR). Data within CFIR constructs were inductively analyzed to generate themes that were rated by national early childhood advisors for their relevance to longer term implementation.Results All three stakeholder groups (i.e., families, service coordinators, program leadership) identified thematic supports and barriers across multiple constructs within each of four CFIR domains: (1) Six themes for "intervention characteristics," (2) Six themes for "process," (3) three themes for "inner setting," and (4) four themes for "outer setting." For example, all stakeholder groups described the value of the YC-PEM e-PRO in forging connections and eliciting meaningful information about family priorities for efficient service plan development ("intervention characteristics"). Stakeholders prioritized reaching families with diverse linguistic preferences and user navigation needs, further tailoring its interface with automated data capture and exchange processes ("process"); and fostering a positive implementation climate ("inner setting"). Service coordinators and program leadership further articulated the value of YC-PEM e-PRO results for improving EI access ("outer setting").Conclusion Results demonstrate the YC-PEM e-PRO is an evidence-based intervention that is viable for implementation. Optimizations to its interface are needed before undertaking hybrid type-2 and 3 multisite trials to test these implementation strategies across state and local EI programs with electronic data capture capabilities and diverse levels of organizational readiness and resources for implementation.

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Project description:ObjectiveThe aim of this paper is to describe the stages undertaken to generate the items and conceptual framework of a new electronic personal assessment questionnaire for vascular conditions.DesignA mixed methods study: First a survey of vascular clinicians was completed to identify the most common conditions treated in vascular clinics and wards. Quantitative systematic reviews were done to identify validated patient-reported outcome measures (PROMs) for direct inclsuion in the new instrument. However, due to scarcity of validated PROMs, the items of the new instrument were mainly based on a large qualitative study of patients and systematic reviews of the qualitative evidence . This was followed by a quantitative clinicians' consensus study and, finally, a qualitative face validity study with patients.ParticipantsVascular patients participated in the primary qualitative study and the face validity study. In the qualitative study, 55 patients were interviewed, and for the face validity, 19 patients gave feedback. Twelve clinicians completed the survey and 13 completed two cycles of the clinicians' consensus study.ResultsThe items and scales in the electronic personal assessment questionnaire for vascular conditions (ePAQ-VAS) were generated based on the results of five systematic reviews evaluating existing PROMs for possible inclusion in ePAQ-VAS, five systematic reviews of qualitative evidence, a primary qualitative study involving 55 patients and clinicians' input. One hundred and sixty-eight items were initially generated, of which 59 were eliminated by the expert panel due to repetition. The instrument was divided into one generic and three disease-specific sections (abdominal aortic aneurysm, carotid artery disease and lower limb vascular conditions). In each section, items were grouped together into putative scales. Fifty-five items were grouped across eight scales; the remaining items were kept as individual items, because of relevance to service users.ConclusionsThis multidimensional electronic questionnaire covers the most common vascular conditions. This is particularly important for patients presenting with mixed symptoms or multiple conditions. This tool captures symptomatology, health related quality of life (HRQoL) and other clinically relevant data, such as experience with services and comorbidities.

Project description:ObjectivesTo examine the acceptability and validity of two patient-reported outcome measures (PROMs) for adult acne, comparing them to the validated Acne-specific Quality of Life (Acne-QoL) measure.DesignMixed-methods validation study.SettingParticipants were recruited by (1) mail-out through primary care if they had ever consulted for acne and received a prescription for acne treatment within the last 6 months, (2) opportunistically in secondary care and (3) poster advertisement in community venues.Participants221 (204 quantitative and 17 qualitative) participants with acne, aged 18-50 years.Outcome measuresQuantitative sub-study participants completed Acne-QoL, Skindex-16 and Comprehensive Acne Quality of Life Scale (CompAQ) at baseline, 24 hours and 6 weeks. Qualitative sub-study participants took part in cognitive think-aloud interviews, while completing the same measures. Transcribed audio recordings were analysed using inductive thematic analysis.ResultsQuantitative analyses suggested high internal consistency (Cronbach's alpha 0.74-0.96) and reliability (intraclass correlation coefficient values 0.88-0.97) for both questionnaires. Both scales showed floor effects on some subdomains. Skindex-16 and CompAQ showed good evidence of construct validity when compared with Acne-QoL with Spearman's correlation coefficients 0.54-0.81, and good repeatability over 24 hours.Qualitative data uncovered wide-ranging views regarding usability and acceptability. Interviewees held strong but differing views about layout, question/response wording, redundant/similar questions and guidance notes. Similarly, interviewees differed in perceptions of acceptability of the different scales, particularly on relatability of questions and emotive reactions to scales.ConclusionsAll PROMs performed well in statistical analyses. No PROM showed superior usability and acceptability in the qualitative study. Any PROM should be acceptable for further research in adult acne but researchers should consider the different domains and whether they will measure only facial or facial and trunk acne before making a selection. A new PROM or further evaluation of novel PROMs may be beneficial.

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