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EHealth System for Collecting and Utilizing Patient Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care) Among Cancer Patients: Mixed Methods Approach to Evaluate Feasibility and Acceptability.

ABSTRACT: BACKGROUND:Despite accumulating evidence indicating that collecting patient-reported outcomes (PROs) and transferring results to the treating health professional in real time has the potential to improve patient well-being and cancer outcomes, this practice is not widespread. OBJECTIVE:The aim of this study was to test the feasibility and acceptability of PROMPT-Care (Patient Reported Outcome Measures for Personalized Treatment and Care), a newly developed electronic health (eHealth) system that facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions and patient self-management, and data retrieval to support ongoing evaluation and innovative research. METHODS:We developed an eHealth system in consultation with content-specific expert advisory groups and tested it with patients receiving treatment or follow-up care in two hospitals in New South Wales, Australia, over a 3-month period. Participants were recruited in clinic and completed self-report Web-based assessments either just before their upcoming clinical consultation or every 4 weeks if in follow-up care. A mixed methods approach was used to evaluate feasibility and acceptability of PROMPT-Care; data collected throughout the study informed the accuracy and completeness of data transfer procedures, and extent of missing data was determined from participants' assessments. Patients participated in cognitive interviews while completing their first assessment and completed evaluation surveys and interviews at study-end to assess system acceptability and usefulness of patient self-management resources, and oncology staff were interviewed at study-end to determine the acceptability and perceived usefulness of real-time PRO reporting. RESULTS:A total of 42 patients consented to the study; 7 patients were withdrawn before starting the intervention primarily because of changes in eligibility. Overall, 35 patients (13 on treatment and 22 in follow-up) completed 67 assessments during the study period. Mean completeness of patient-reported data was 93%, with 100% accuracy of data transfer. Ten patients completed cognitive interviews, 28 completed evaluation surveys, and 14 completed evaluation interviews at study-end. PROMPT-Care patient acceptability was high-100% (28/28) reported the time to complete the Web-based assessments (average 15 min) as about right, most willing to answer more questions (79%, 22/28 yes), 96% (27/28) found the Web-based assessment easier or same as completing a paper copy, and they valued the self-management resources . Oncology staff (n=5) also reported high acceptability and potential feasibility of the system. CONCLUSIONS:Patients and oncology staff found the PROMPT-Care system to be highly acceptable, and the results suggest that it would be feasible to implement it into an oncology setting. Suggested modifications to the patient assessment survey, clinician access to the reports, and system requirements will be made as part of the next stage of large-scale testing and future implementation of the system as part of routine care. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN1261500135294; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369299&isReview=true (Archived by WebCite at http://www.webcitation.org/6lzylG5A0).

SUBMITTER: Girgis A

PROVIDER: S-EPMC5667931 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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eHealth System for Collecting and Utilizing Patient Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care) Among Cancer Patients: Mixed Methods Approach to Evaluate Feasibility and Acceptability.

Girgis Afaf A Durcinoska Ivana I Levesque Janelle V JV Gerges Martha M Sandell Tiffany T Arnold Anthony A Delaney Geoff P GP

Journal of medical Internet research 20171002 10

<h4>Background</h4>Despite accumulating evidence indicating that collecting patient-reported outcomes (PROs) and transferring results to the treating health professional in real time has the potential to improve patient well-being and cancer outcomes, this practice is not widespread.<h4>Objective</h4>The aim of this study was to test the feasibility and acceptability of PROMPT-Care (Patient Reported Outcome Measures for Personalized Treatment and Care), a newly developed electronic health (eHeal ...[more]

PMID: 28970188

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Project description:Patient-reported outcome (PRO) measures have been used widely to screen for depression, anxiety, and symptoms in cancer patients. Computer-based applications that collect patients' responses and transfer them to the treating health professional in real time have the potential to improve patient well-being and cancer outcomes.This study will test the feasibility and acceptability of a newly developed eHealth system which facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions and patient self-management, and data retrieval to support ongoing evaluation and innovative research.The eHealth system is being developed in consultation with 3 overarching content-specific expert advisory groups convened for this project: the clinical advisory group, technical advisory group, and evaluation advisory group. The following work has already been completed during this phase of the study: the Patient-Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care) eHealth system was developed, patient-reported outcomes were selected (distress, symptoms, unmet needs), algorithms to inform intervention thresholds for clinical and self-management were determined, clinician PRO feedback summary and longitudinal reports were designed, and patient self-management resources were collated. PROsaiq, a custom information technology system, will transfer PRO data in real time into the hospital-based oncology information system to support clinical decision making. The PROMPT-Care system feasibility and acceptability will be assessed through patients completing PROMPT-Care assessments, participating in face-to-face cognitive interviews, and completing evaluation surveys and telephone interviews and oncology staff participating in telephone interviews.Over the course of 3 months, the system will be pilot-tested with up to 50 patients receiving treatment or follow-up care and 6 oncology staff at 2 hospitals in New South Wales, Australia. Data will be collected to determine the accuracy and completeness of data transfer procedures, extent of missing data from participants' assessments, acceptability of the eHealth system and usefulness of the self-management resources (via patient evaluation surveys and interviews), and acceptability and perceived usefulness of real-time PRO reporting (via oncology staff interviews) at the completion of the pilot phase.This research investigates implementation of evidence into real world clinical practice through development of an efficient and user-friendly eHealth system. This study of feasibility and acceptability of the newly developed eHealth system will inform the next stage of larger scale testing and future implementation of the system as part of routine care.Australian New Zealand Clinical Trials Registry ACTRN1261500135294; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369299&isReview=true (Archived by WebCite at http://www.webcitation.org/6lzylG5A0).

Project description:BackgroundDespite the acceptability and efficacy of e-patient-reported outcome (ePRO) systems, implementation in routine clinical care remains challenging.ObjectiveThis pragmatic trial implemented the PROMPT-Care (Patient Reported Outcome Measures for Personalized Treatment and Care) web-based system into existing clinical workflows and evaluated its effectiveness among a diverse population of patients with cancer.MethodsAdult patients with solid tumors receiving active treatment or follow-up care in four cancer centers were enrolled. The PROMPT-Care intervention supported patient management through (1) monthly off-site electronic PRO physical symptom and psychosocial well-being assessments, (2) automated electronic clinical alerts notifying the care team of unresolved clinical issues following two consecutive assessments, and (3) tailored online patient self-management resources. Propensity score matching was used to match controls with intervention patients in a 4:1 ratio for patient age, sex, and treatment status. The primary outcome was a reduction in emergency department presentations. Secondary outcomes were time spent on chemotherapy and the number of allied health service referrals.ResultsFrom April 2016 to October 2018, 328 patients from four public hospitals received the intervention. Matched controls (n=1312) comprised the general population of patients with cancer, seen at the participating hospitals during the study period. Emergency department visits were significantly reduced by 33% (P=.02) among patients receiving the intervention compared with patients in the matched controls. No significant associations were found in allied health referrals or time to end of chemotherapy. At baseline, the most common patient reported outcomes (above-threshold) were fatigue (39%), tiredness (38.4%), worry (32.9%), general wellbeing (32.9%), and sleep (24.1%), aligning with the most frequently accessed self-management domain pages of physical well-being (36%) and emotional well-being (23%). The majority of clinical feedback reports were reviewed by nursing staff (729/893, 82%), largely in response to the automated clinical alerts (n=877).ConclusionsAlgorithm-supported web-based systems utilizing patient reported outcomes in clinical practice reduced emergency department presentations among a diverse population of patients with cancer. This study also highlighted the importance of (1) automated triggers for reviewing above-threshold results in patient reports, rather than passive manual review of patient records; (2) the instrumental role nurses play in managing alerts; and (3) providing patients with resources to support guided self-management, where appropriate. Together, these factors will inform the integration of web-based PRO systems into future models of routine cancer care.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12616000615482; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370633.International registered report identifier (irrid)RR2-10.1186/s12885-018-4729-3.

Project description:BackgroundIncreasing service user and carer involvement in mental health care planning is a key healthcare priority but one that is difficult to achieve in practice. To better understand and measure user and carer involvement, it is crucial to have measurement questionnaires that are both psychometrically robust and acceptable to the end user.MethodsWe conducted a systematic review using the terms "care plan$," "mental health," "user perspective$," and "user participation" and their linguistic variants as search terms. Databases were searched from inception to November 2012, with an update search at the end of September 2014. We included any articles that described the development, validation or use of a user and/or carer-reported outcome measures of involvement in mental health care planning. We assessed the psychometric quality of each instrument using the "Evaluating the Measurement of Patient-Reported Outcomes" (EMPRO) criteria. Acceptability of each instrument was assessed using novel criteria developed in consultation with a mental health service user and carer consultation group.ResultsWe identified eleven papers describing the use, development, and/or validation of nine user/carer-reported outcome measures. Psychometric properties were sparsely reported and the questionnaires met few service user/carer-nominated attributes for acceptability. Where reported, basic psychometric statistics were of good quality, indicating that some measures may perform well if subjected to more rigorous psychometric tests. The majority were deemed to be too long for use in practice.DiscussionMultiple instruments are available to measure user/carer involvement in mental health care planning but are either of poor quality or poorly described. Existing measures cannot be considered psychometrically robust by modern standards, and cannot currently be recommended for use. Our review has identified an important knowledge gap, and an urgent need to develop new user and carer measures of care-planning involvement.

Project description:BackgroundAcross eHealth intervention studies involving children, adolescents, and their parents, researchers have measured user experience to assist with intervention development, refinement, and evaluation. To date, no widely accepted definitions or measures of user experience exist to support a standardized approach for evaluation and comparison within or across interventions.ObjectiveWe conduct a scoping review with subsequent Delphi consultation to identify how user experience is defined and measured in eHealth research studies, characterize the measurement tools used, and establish working definitions for domains of user experience that could be used in future eHealth evaluations.MethodsWe systematically searched electronic databases for published and gray literature available from January 1, 2005, to April 11, 2019. We included studies assessing an eHealth intervention that targeted any health condition and was designed for use by children, adolescents, and their parents. eHealth interventions needed to be web-, computer-, or mobile-based, mediated by the internet with some degree of interactivity. We required studies to report the measurement of user experience as first-person experiences, involving cognitive and behavioral factors reported by intervention users. We appraised the quality of user experience measures in included studies using published criteria: well-established, approaching well-established, promising, or not yet established. We conducted a descriptive analysis of how user experience was defined and measured in each study. Review findings subsequently informed the survey questions used in the Delphi consultations with eHealth researchers and adolescent users for how user experience should be defined and measured.ResultsOf the 8634 articles screened for eligibility, 129 articles and 1 erratum were included in the review. A total of 30 eHealth researchers and 27 adolescents participated in the Delphi consultations. On the basis of the literature and consultations, we proposed working definitions for 6 main user experience domains: acceptability, satisfaction, credibility, usability, user-reported adherence, and perceived impact. Although most studies incorporated a study-specific measure, we identified 10 well-established measures to quantify 5 of the 6 domains of user experience (all except for self-reported adherence). Our adolescent and researcher participants ranked perceived impact as one of the most important domains of user experience and usability as one of the least important domains. Rankings between adolescents and researchers diverged for other domains.ConclusionsFindings highlight the various ways in which user experience has been defined and measured across studies and what aspects are most valued by researchers and adolescent users. We propose incorporating the working definitions and available measures of user experience to support consistent evaluation and reporting of outcomes across studies. Future studies can refine the definitions and measurement of user experience, explore how user experience relates to other eHealth outcomes, and inform the design and use of human-centered eHealth interventions.

Project description:BackgroundThe use of patient-reported outcome measures (PROM) and caregiver-reported outcome measures can raise the patient centeredness of treatment and improve the quality of palliative care. Nevertheless, the everyday implementation of self-report in patients and caregivers is complex, and should be adapted for use in specific settings. We aimed to implement a set of outcome measures that included patient and caregiver self- and proxy-reported outcome measures in specialised outpatient palliative care (SOPC). In this study, we explore how the Integrated Palliative Outcome Scale (IPOS), IPOS Views on Care (IPOS VoC) and the Short-form Zarit Caregiver Burden Interview (ZBI-7) can be feasibly, acceptably and appropriately implemented in the daily care routines of SOPC.MethodsFive SOPC teams were trained, and used the outcome measures in daily practice. Team members were mainly nurses and physicians. To investigate their feedback, we used a multi-method qualitative design consisting of focus groups with SOPC-team members (n = 14), field notes of meetings and conversations with the SOPC teams. In an iterative process, we analysed the findings using qualitative content analysis and refined use of the outcome measures.ResultsWe found that integrating patient and caregiver outcome measures into daily care routines in SOPC is feasible. To improve feasibility, acceptability and appropriateness, the resulting burden on patients and relatives should be kept to a minimum, the usefulness of the measures must be understood, they should be used considerately, and administration must be manageable. We removed ZBI-7 from the set of measures as a result of feedback on its content and wording.ConclusionsSOPC-team members have reservations about the implementation of PROM in SOPC, but with appropriate adjustments, its application in daily care is feasible, accepted and perceived as appropriate. Previous to use, SOPC-team members should be trained in how to apply the measures, in the design of manageable processes that include integration into electronic documentation systems, and in ongoing evaluation and support. They should also be taught how useful the measures can be.Trial registrationMay 19th, 2017, German Clinical Trials Register DRKS-ID: DRKS00012421 .

Project description:BACKGROUND:Evolving regulatory guidelines recommend routine assessment of the acceptability of pediatric oral medicines throughout clinical development processes. However, such assessment is problematic owing to a lack of standard methods or criteria that define acceptability for children and their caregivers. This research aimed to identify the attributes of acceptability for targeted oral formulation types that are important to children, and to develop content-valid patient- and caregiver-reported outcome acceptability measures for use in the context of clinical drug development. METHODS:A concept-focused literature review and two advisory panel meetings involving researchers, clinicians, and measurement scientists were conducted to identify acceptability attributes that may be relevant to children taking targeted oral medicine formulations. The Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQs), including patient (P-OMAQ-P) and caregiver (P-OMAQ-C) versions, were drafted to assess these attributes. Qualitative concept elicitation (CE) and cognitive debriefing (CD) patient and caregiver interviews were conducted to confirm key acceptability attribute concepts for measurement and to evaluate patient and caregiver ability to understand and respond to the questions. RESULTS:A full-text review of 40 articles identified 24 acceptability attributes that were categorized into 10 overarching domains and organized into a preliminary conceptual model. Feedback from the advisory panel refined the preliminary model. In total, 14 attributes were reported during the CE phase of the interviews (n?=?23 pediatric patients, n?=?13 caregivers); six attributes were included in the final model. The draft P-OMAQ was refined over four waves of CD interviews (n?=?31 pediatric patients, n?=?48 caregivers). The final version of the P-OMAQ-P is a 12-item questionnaire designed for young people aged 8-17?years. The P-OMAQ-C is a 19-item questionnaire designed for adult caregivers of young people aged 6?months to 17?years. There are two versions of each questionnaire: one with a 24-h recall period and one with a 7-day recall period. All items are answered on a 5-point numerical rating scale. CONCLUSIONS:This research supports the content validity of the patient and caregiver versions of the P-OMAQ. Both questionnaires appropriately assess the acceptability of oral medicine formulations from the perspective of pediatric patients and their caregivers.

Project description:Interventions: Description of intervention(s) / exposure: Men who are diagnosed with prostate cancer and who have consented to contributing data to the Prostate Cancer Outcomes Registry Victoria (PCOR-VIC) will be eligible to participate in this project. Three different methods of Patient Reported Outcome Measures (PROMs) data collection by telephone or mail or email will be introduced to assess the quality of life of prostate cancer patients using EPIC -26 tools. Details of each of the three different interventions are described below: Men are contacted to confirm that clinical data are accurate and up-to-date and to collect PROMS using the validated EPIC-26 quality of life instrument. Contact is made any time within a window period of 21 days either side of the anniversary date for data collection (henceforth recorded as the Anniversary Date”). This is 12 months from the date of the positive biopsy for patients who do not proceed to active treatment or only receive androgen deprivation therapy; or 12 months from the date on which final initial treatment, or course of treatment, finished. For surgery and low-dose rate (seed) brachytherapy, this is the date of the procedure. For radiotherapy and chemotherapy it is the date that the last dose of therapy was provided; for radiotherapy this is usually six weeks after radiotherapy was commenced and for chemotherapy this is usually 12 months after treatment commenced. Intervention A: PROMs data collection by follow up data collectors over the telephone 1.An attempt to contact patients via phone will be made up until 21 days post diagnosis/treatment. Approximately each day a data collector will make one attempt to contact the patient 2.Patients responding will have PROMS entered directly to the PCOR-VIC web system Primary outcome(s): The primary outcome of interest will be effective successful follow up. Effective successful follow up is defined as providing a response to each of the 26 questions in the survey. A valid response might be that the patient declines to answer a question. [After randomization any time within a window period of 21 days either side of the anniversary date for data collection. Anniversary data is 12 months from the date of the positive biopsy for patients who do not proceed to active treatment or only receive androgen deprivation therapy; or 12 months from the date on which final initial treatment, or course of treatment, finished. For surgery and low-dose rate (seed) brachytherapy, this is the date of the procedure. For radiotherapy and chemotherapy this is the date that the last dose of therapy was provided. ] Study Design: Purpose: Diagnosis; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy

Dataset Information

EHealth System for Collecting and Utilizing Patient Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care) Among Cancer Patients: Mixed Methods Approach to Evaluate Feasibility and Acceptability.

Publications

eHealth System for Collecting and Utilizing Patient Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care) Among Cancer Patients: Mixed Methods Approach to Evaluate Feasibility and Acceptability.

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