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Electronic self-report assessment for cancer and self-care support: results of a multicenter randomized trial.

ABSTRACT: The purpose of this trial was to evaluate the effect of a Web-based, self-report assessment and educational intervention on symptom distress during cancer therapy.A total of 752 ambulatory adult participants were randomly assigned to symptom/quality-of-life (SxQOL) screening at four time points (control) versus screening, targeted education, communication coaching, and the opportunity to track/graph SxQOL over time (intervention). A summary of the participant-reported data was delivered to clinicians at each time point in both groups. All participants used the assessment before a new therapeutic regimen, at 3 to 6 weeks and 6 to 8 weeks later, completing the final assessment at the end of therapy. Change in Symptom Distress Scale-15 (SDS-15) score from pretreatment to end of study was compared using analysis of covariance and regression analysis adjusting for selected variables.We detected a significant difference between study groups in mean SDS-15 score change from baseline to end of study: 1.27 (standard deviation [SD], 6.7) in the control group (higher distress) versus -0.04 (SD, 5.8) in the intervention group (lower distress). SDS-15 score was reduced by an estimated 1.21 (95% CI, 0.23 to 2.20; P = .02) in the intervention group. Baseline SDS-15 score (P < .001) and clinical service (P = .01) were predictive. Multivariable analyses suggested an interaction between age and study group (P = .06); in subset analysis, the benefit of intervention was strongest in those age > 50 years (P = .002).Web-based self-care support and communication coaching added to SxQOL screening reduced symptom distress in a multicenter sample of participants with various diagnoses during and after active cancer treatment. Participants age > 50 years, in particular, may have benefited from the intervention.

SUBMITTER: Berry DL

PROVIDER: S-EPMC3887477 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

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Electronic self-report assessment for cancer and self-care support: results of a multicenter randomized trial.

Berry Donna L DL Hong Fangxin F Halpenny Barbara B Partridge Ann H AH Fann Jesse R JR Wolpin Seth S Lober William B WB Bush Nigel E NE Parvathaneni Upendra U Back Anthony L AL Amtmann Dagmar D Ford Rosemary R

Journal of clinical oncology : official journal of the American Society of Clinical Oncology 20131216 3

<h4>Purpose</h4>The purpose of this trial was to evaluate the effect of a Web-based, self-report assessment and educational intervention on symptom distress during cancer therapy.<h4>Patients and methods</h4>A total of 752 ambulatory adult participants were randomly assigned to symptom/quality-of-life (SxQOL) screening at four time points (control) versus screening, targeted education, communication coaching, and the opportunity to track/graph SxQOL over time (intervention). A summary of the par ...[more]

PMID: 24344222

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Project description:Rationale & objectiveMost adults with chronic kidney disease (CKD) in the United States are cared for by primary care providers (PCPs). We evaluated the feasibility and preliminary effectiveness of an electronic clinical decision support system (eCDSS) within the electronic health record with or without pharmacist follow-up to improve the management of CKD in primary care.Study designPragmatic cluster-randomized trial.Setting & participants524 adults with confirmed creatinine-based estimated glomerular filtration rates of 30 to 59mL/min/1.73m2 cared for by 80 PCPs at the University of California San Francisco. Electronic health record data were used for patient identification, intervention deployment, and outcomes ascertainment.InterventionsEach PCP's eligible patients were randomly assigned as a group into 1 of 3 treatment arms: (1) usual care; (2) eCDSS: testing of creatinine, cystatin C, and urinary albumin-creatinine ratio with individually tailored guidance for PCPs on blood pressure, potassium, and proteinuria management, cardiovascular risk reduction, and patient education; or (3) eCDSS plus pharmacist counseling (eCDSS-PLUS).OutcomesThe primary clinical outcome was change in blood pressure over 12 months. Secondary outcomes were PCP awareness of CKD and use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker and statin therapy.ResultsAll 80 eligible PCPs participated. Mean patient age was 70 years, 47% were nonwhite, and mean estimated glomerular filtration rate was 56±0.6mL/min/1.73m2. Among patients receiving eCDSS with or without pharmacist counseling (n=336), 178 (53%) completed laboratory measurements and 138 (41%) had laboratory measurements followed by a PCP visit with eCDSS deployment. eCDSS was opened by the PCP for 102 (74%) patients, with at least 1 suggested order signed for 83 of these 102 (81%). Changes in systolic blood pressure were-2.1±1.5mm Hg with usual care, -2.8±1.8mm Hg with eCDSS, and -1.1±1.1 with eCDSS-PLUS (P=0.7). PCP awareness of CKD was 16% with usual care, 26% with eCDSS, and 32% for eCDSS-PLUS (P=0.09). In as-treated analyses, PCP awareness of CKD was significantly greater with eCDSS and eCDSS-PLUS (73% and 69%) versus usual care (47%; P=0.002).LimitationsRecruitment of smaller than intended sample size and limited uptake of the testing component of the intervention.ConclusionsAlthough we were unable to demonstrate the effectiveness of eCDSS to lower blood pressure and uptake of the eCDSS was limited by low testing rates, eCDSS use was high when laboratory measurements were available and was associated with higher PCP awareness of CKD.FundingGrants from government (National Institutes of Health) and not-for-profit (American Heart Association) entities.Trial registrationRegistered at ClinicalTrials.gov with study number NCT02925962.

Project description:BackgroundFamily members of critically ill patients face considerable uncertainty and distress during their close others' intensive care unit (ICU) stay. About 20-60% of family members experience adverse mental health outcomes post-ICU, such as symptoms of anxiety, depression, and posttraumatic stress. Guidelines recommend structured family inclusion, communication, and support, but the existing evidence base around protocolized family support interventions is modest and requires substantiation.MethodsTo test the clinical effectiveness and explore the implementation of a multicomponent, nurse-led family support intervention in ICUs, we will undertake a parallel, cluster-randomized, controlled, multicenter superiority hybrid-type 1 trial. It will include eight clusters (ICUs) per study arm, with a projected total sample size of 896 family members of adult, critically ill patients treated in the German-speaking part of Switzerland. The trial targets family members of critically ill patients with an expected ICU stay of 48 h or longer. Families in the intervention arm will receive a family support intervention in addition to usual care. The intervention consists of specialist nurse support that is mapped to the patient pathway with follow-up care and includes psycho-educational and relationship-focused family interventions, and structured, interprofessional communication, and shared decision-making with families. Families in the control arm will receive usual care. The primary study endpoint is quality of family care, operationalized as family members' satisfaction with ICU care at discharge. Secondary endpoints include quality of communication and nurse support, family management of critical illness (functioning, resilience), and family members' mental health (well-being, psychological distress) measured at admission, discharge, and after 3, 6, and 12 months. Data of all participants, regardless of protocol adherence, will be analyzed using linear mixed-effects models, with the individual participant as the unit of inference.DiscussionThis trial will examine the effectiveness of the family support intervention and generate knowledge of its implementability. Both types of evidence are necessary to determine whether the intervention works as intended in clinical practice and could be scaled up to other ICUs. The study findings will make a significant contribution to the current body of knowledge on effective ICU care that promotes family participation and well-being.Trial registrationClinicalTrials.gov NCT05280691 . Prospectively registered on 20 February 2022.

Project description:Diabetes mellitus is a complex disease with serious complications. Electronic decision support, providing information that is shared and discussed by both patient and physician, encourages timely interventions and may improve the management of this chronic disease. However, it has rarely been tested in community-based primary care.In this pragmatic randomized trial, we randomly assigned adult primary care patients with type 2 diabetes to receive the intervention or usual care. The intervention involved shared access by the primary care provider and the patient to a Web-based, colour-coded diabetes tracker, which provided sequential monitoring values for 13 diabetes risk factors, their respective targets and brief, prioritized messages of advice. The primary outcome measure was a process composite score. Secondary outcomes included clinical composite scores, quality of life, continuity of care and usability. The outcome assessors were blinded to each patient's intervention status.We recruited sequentially 46 primary care providers and then 511 of their patients (mean age 60.7 [standard deviation 12.5] years). Mean follow-up was 5.9 months. The process composite score was significantly better for patients in the intervention group than for control patients (difference 1.27, 95% confidence interval [CI] 0.79-1.75, p < 0.001); 61.7% (156/253) of patients in the intervention group, compared with 42.6% (110/258) of control patients, showed improvement (difference 19.1%, p < 0.001). The clinical composite score also had significantly more variables with improvement for the intervention group (0.59, 95% CI 0.09-1.10, p = 0.02), including significantly greater declines in blood pressure (-3.95 mm Hg systolic and -2.38 mm Hg diastolic) and glycated hemoglobin (-0.2%). Patients in the intervention group reported greater satisfaction with their diabetes care.A shared electronic decision-support system to support the primary care of diabetes improved the process of care and some clinical markers of the quality of diabetes care. (ClinicalTrials.gov trial register no. NCT00813085.).

Project description:BACKGROUND:Patients undergoing cancer treatment experience symptoms that negatively affect their quality of life and adherence to treatment. The early identification and management of treatment-related symptoms are critical to prevent symptom distress due to unmanaged symptoms. However, the early identification and management of treatment-related symptoms are complex as most cancer treatments are delivered on an outpatient basis where patients are granted less face-to-face time with clinicians. The Electronic Symptom Assessment and Self-Care (ESRA-C) promotes participant self-management of treatment-related symptoms by providing participants with communication coaching and symptom self-report, education, and tracking features. While the ESRA-C intervention has been demonstrated to improve symptom distress significantly, little is known as to how the ESRA-C influenced participants' self-management practices and adherence to clinician recommendations for symptom/quality of life issues (SQIs). OBJECTIVE:To compare participant adherence to clinician recommendations and additional self-management strategy use for SQIs between ESRA-C intervention and control (electronic symptom assessment and participant symptom reports alone) group participants. Secondarily, we explored the impact of participant adherence to clinician recommendations and additional self-management strategy use for SQIs on symptom control, symptom management satisfaction, and symptom distress. Lastly, we examined baseline predictors of participant adherence to clinician recommendations and additional self-management strategy use for SQIs. METHODS:This study presents an analysis of a randomized controlled trial. Participants beginning a new chemotherapy or radiotherapy regimen were recruited from oncology outpatient centers and were randomized to receive the ESRA-C intervention or control during treatment. Patients were included in this analysis if they remained on study through the duration of treatment and self-reported at least one bothersome SQI three-to-six weeks after beginning treatment. The Symptom Distress Scale-15 and Self-Management of SQIs Questionnaire were completed two weeks later. Based on Self-Management of SQIs Questionnaire ratings, participants were placed into adherence to clinician recommendations (adhered/did not adhere/did not receive recommendations) and additional self-management strategy use (yes/no) categories. RESULTS:Most participants were adherent to clinician recommendations (273/370, 73.8%), while fewer used additional self-management strategies for SQIs (182/370, 49.2%). There were no differences in the frequency of participant adherence to clinician recommendations (chi-square test, P=.99) or self-management strategy use (chi-square test, P=.80) between intervention (n=182) and control treatment groups (n=188). Participants who received clinician recommendations reported the highest treatment satisfaction (n=355, P<.001 by analysis of variance; ANOVA), although lowest distress was reported by participants who did not follow clinician recommendations (n=322, P=.04 by ANOVA) for top 2 SQIs. Women (n=188) reported greater additional self-management strategy use than men (n=182, P=0.03 by chi-square test). CONCLUSIONS:ESRA-C intervention use did not improve participants' adherence to clinician recommendations or additional self-management strategy use for SQIs in comparison to the control. Future research is needed to determine which factors are important in improving patients' self-management practices and symptom distress following ESRA-C use. TRIAL REGISTRATION:ClinicalTrials.gov NCT00852852; https://clinicaltrials.gov/ct2/show/NCT00852852 (Archived by WebCite at http://www.webcitation.org/73rEhNWkU).

Project description:BACKGROUND:Smokers usually abstain from tobacco while hospitalized but relapse after discharge. Inpatient interventions may encourage sustained quitting. We previously demonstrated that a decision support tool embedded in an electronic health record (EHR) improved physicians' treatment of hospitalized smokers. This report describes the effect on quit rates of this decision support tool and order set for hospitalized smokers. METHODS:In a single hospital system, 254 physicians were randomized 1:1 to receive a decision support tool and order set, embedded in the EHR. When an adult patient was admitted to a medical service, an electronic alert appeared if current smoking was recorded in the EHR. For physicians receiving the intervention, the alert linked to an order set for tobacco treatment medications and electronic referral to the state tobacco quitline. Additionally, "Tobacco Use Disorder" was added to the patient's problem list, and a secure message was sent to the patient's primary care provider (PCP). In the control arm, no alert appeared. Patients were contacted by phone at 1, 6, and 12?months; those reporting tobacco abstinence at 12?months were asked to return to measure exhaled carbon monoxide. Generalized estimating equations were used to model the data. RESULTS:From 2013 to 2016, the alert fired for 10,939 patients (5391 intervention, 5548 control). Compared to control physicians, intervention physicians were more likely to order tobacco treatment medication, populate the problem list with tobacco use disorder, refer to the quitline, and notify the patient's PCP. In a subset of 1044 patients recruited for intensive follow-up, one-year quit rates for intervention and control patients were, respectively, 11.5% and 11.6%, (p?=?0.94), after controlling for age, sex, race, ethnicity, and insurance. Similarly, there were no differences in 1- and 6-month quit rates. CONCLUSIONS:Although we were able to improve processes of care, long-term tobacco quit rates were unchanged. This likely reflects, in part, the need for sustained quitting interventions, and higher-than-expected quit rates in controls. Future enhancements should improve prescription of medications for smoking cessation at discharge, engagement of primary care providers, and perhaps direct engagement of patients in a more longitudinal approach. TRIAL REGISTRATION:ClinicalTrials.gov, NCT01691105 . Registered on September 12, 2012.

Project description:The electronic self report assessment - cancer (ESRA-C), has been shown to reduce symptom distress during cancer therapy The purpose of this analysis was to evaluate aspects of how the ESRA-C intervention may have resulted in lower symptom distress (SD).Patients at two cancer centers were randomized to ESRA-C assessment only (control) or the Web-based ESRA-C intervention delivered to patients' homes or to a tablet in clinic. The intervention allowed patients to self-monitor symptom and quality of life (SxQOL) between visits, receive self-care education and coaching to report SxQOL to clinicians. Summaries of assessments were delivered to clinicians in both groups. Audio-recordings of clinic visits made 6 weeks after treatment initiation were coded for discussions of 26 SxQOL issues, focusing on patients'/caregivers' coached verbal reports of SxQOL severity, pattern, alleviating/aggravating factors and requests for help. Among issues identified as problematic, two measures were defined for each patient: the percent SxQOL reported that included a coached statement, and an index of verbalized coached statements per SxQOL. The Wilcoxon rank test was used to compare measures between groups. Clinician responses to problematic SxQOL were compared. A mediation analysis was conducted, exploring the effect of verbal reports on SD outcomes.517 (256 intervention) clinic visits were audio-recorded. General discussion of problematic SxQOL was similar in both groups. Control group patients reported a median 75% of problematic SxQOL using any specific coached statement compared to a median 85% in the intervention group (p = .0009). The median report index of coached statements was 0.25 for the control group and 0.31 for the intervention group (p = 0.008). Fatigue, pain and physical function issues were reported significantly more often in the intervention group (all p < .05). Clinicians' verbalized responses did not differ between groups. Patients' verbal reports did not mediate final SD outcomes (p = .41).Adding electronically-delivered, self-care instructions and communication coaching to ESRA-C promoted specific patient descriptions of problematic SxQOL issues compared with ESRA-C assessment alone. However, clinician verbal responses were no different and subsequent symptom distress group differences were not mediated by the patients' reports.NCT00852852; 26 Feb 2009.

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Electronic self-report assessment for cancer and self-care support: results of a multicenter randomized trial.

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Electronic self-report assessment for cancer and self-care support: results of a multicenter randomized trial.

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