Challenges of Telemonitoring Programs for Complex Chronic Conditions: Randomized Controlled Trial With an Embedded Qualitative Study.

BACKGROUND: Despite the growing prevalence of people with complex conditions and evidence of the positive impact of telemonitoring for single conditions, little research exists on telemonitoring for this population. OBJECTIVE: This randomized controlled trial and embedded qualitative study aims to evaluate the impact on and experiences of patients and health care providers (HCPs) using a telemonitoring system with decision support to manage patients with complex conditions, including those with multiple chronic conditions, compared with the standard of care. METHODS: A pragmatic, unblinded, 6-month randomized controlled trial sought to recruit 146 patients with ≥1 diagnosis of heart failure (HF), uncontrolled hypertension (HT), and insulin-requiring diabetes mellitus (DM) from outpatient specialty settings in Toronto, Ontario, Canada. Participants were randomized into the control and telemonitoring groups, with the latter being instructed to take readings relevant to their conditions. The telemonitoring system contained an algorithm that generated decision support in the form of actionable self-care directives to patients and alerts to HCPs. The primary outcome was health status (36-Item Short Form Health Survey questionnaire). Secondary outcomes included anxiety and depression, self-efficacy in chronic disease management, and self-reported health service use. HF-related quality of life and self-care measures were also collected from patients followed for HF. Within- and between-group change scores were analyzed for statistical significance (P<.05). A convenience sample of HCPs and patients in the intervention group was interviewed about their experiences. RESULTS: A total of 96 patients were recruited and randomized. Recruitment was terminated early because of implementation challenges and the onset of the COVID-19 pandemic. No significant within- and between-group differences were found for the main primary and secondary outcomes. However, a within-group analysis of patients with HF found improvements in self-care maintenance (P=.04) and physical quality of life (P=.046). Opinions expressed by the 5 HCPs and 13 patients who were interviewed differed based on the monitored conditions. Although patients with HF reported benefitting from actionable self-care guidance and meaningful interactions with their HCPs, patient and HCP users of the DM and HT modules did not think telemonitoring improved the clinical management of those conditions to the same degree. These differing experiences were largely attributed to the siloed nature of specialty care and the design of the decision support, whereby fluctuations in the status of HT and DM typically required less urgent interventions compared with patients with HF. CONCLUSIONS: We recommend that future research conceive telemonitoring as a program and that self-management and clinical decision support are necessary but not sufficient components of such programs for patients with complex conditions and lower acuity. We conclude that telemonitoring for patients with complex conditions or within multidisciplinary care settings may be best operationalized through nurse-led models of care. TRIAL REGISTRATION: ClinicalTrials.gov NCT03127852; https://clinicaltrials.gov/ct2/show/NCT03127852. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.8367.

Developing a set of indicators to monitor quality in ambulatory diabetes care using a modified Delphi panel process.

OBJECTIVE: There is a large evidence to practice gap in diabetes care with limited performance assessments that capture the full spectrum of care delivery. Our study aimed to develop a set of ambulatory diabetes quality indicators across six domains (effectiveness, safety, patient-centered, timely, equitable and efficient) to provide a broad view of quality. DESIGN: A modified Delphi panel process was conducted. Phase I involved compiling a list of indicators through literature review and generation of patient and healthcare provider-derived indicators through interviews and surveys, respectively. Phase II involved panelists rating indicators using the Agency for Healthcare Research and Quality measure attributes on 9-point Likert scale, attending a face-to-face meeting followed by re-rating, and final ranking. SETTING: This study was conducted across five adult academic medical centers affiliated with the University of Toronto. PARTICIPANTS: A multi-disciplinary Delphi panel (n = 16) including patients was assembled. MAIN OUTCOME MEASURE: For indicator advancement for ranking, ≥75% of panelists' responses in the top tertile (between 7 and 9) with a median composite score of ≥7 was required. RESULTS: There were 202 indicators included in the Delphi panel process including 171 from a comprehensive literature review, 14 from patient interviews, and 17 from healthcare provider surveys. Following the first round, 40 indicators proceeded directly to ranking, while 162 indicators were re-rated and distilled down to 12 for ranking. In the final ranking round, the 52 indicators were reduced to 35 including 13 effective, 10 safe, 6 patient-centered, 1 equitable, 3 efficient and 2 timely indicators. CONCLUSION: Thirty-five selected indicators developed with broad stakeholder engagement can be used to monitor quality in diabetes care.

Thyroid cancer patient perceptions of radioactive iodine treatment choice: Follow-up from a decision-aid randomized trial.

BACKGROUND: Patient decision aids (P-DAs) inform medical decision making, but longer term effects are unknown. This article describes extended follow-up from a thyroid cancer treatment P-DA trial. METHODS: In this single-center, parallel-design randomized controlled trial conducted at a Canadian tertiary/quaternary care center, early-stage thyroid cancer patients from a P-DA trial were contacted 15 to 23 months after randomization/radioactive iodine (RAI) decision making to evaluate longer term outcomes. It was previously reported that the use of the computerized P-DA in thyroid cancer patients considering postsurgical RAI treatment significantly improved medical knowledge in comparison with usual care alone. The P-DA and control groups were compared for the following outcomes: feeling informed about the RAI treatment choice, decision satisfaction, decision regret, cancer-related worry, and physician trust. In a subgroup of 20 participants, in-depth interviews were conducted for a qualitative analysis. RESULTS: Ninety-five percent (70 of 74) of the original population enrolled in follow-up at a mean of 17.1 months after randomization. P-DA users perceived themselves to be significantly more 1) informed about the treatment choice (P = .008), 2) aware of options (P = .009), 3) knowledgeable about treatment benefits (P = .020), and 4) knowledgeable about treatment risks/side effects (P = .001) in comparison with controls. There were no significant group differences in decision satisfaction (P = .142), decision regret (P = .199), cancer-related worry (P = .645), mood (P = .211), or physician trust (P = .764). In the qualitative analysis, the P-DA was perceived to have increased patient knowledge and confidence in decision making. CONCLUSIONS: The P-DA improved cancer survivors' actual and long-term perceived medical knowledge with no adverse effects. More research on the long-term outcomes of P-DA use is needed.

Exploring the relationship between patients' information preference style and knowledge acquisition process in a computerized patient decision aid randomized controlled trial.

BACKGROUND: We have shown in a randomized controlled trial that a computerized patient decision aid (P-DA) improves medical knowledge and reduces decisional conflict, in early stage papillary thyroid cancer patients considering adjuvant radioactive iodine treatment. Our objectives were to examine the relationship between participants' baseline information preference style and the following: 1) quantity of detailed information obtained within the P-DA, and 2) medical knowledge. METHODS: We randomized participants to exposure to a one-time viewing of a computerized P-DA (with usual care) or usual care alone. In pre-planned secondary analyses, we examined the relationship between information preference style (Miller Behavioural Style Scale, including respective monitoring [information seeking preference] and blunting [information avoidance preference] subscale scores) and the following: 1) the quantity of detailed information obtained from the P-DA (number of supplemental information clicks), and 2) medical knowledge. Spearman correlation values were calculated to quantify relationships, in the entire study population and respective study arms. RESULTS: In the 37 P-DA users, high monitoring information preference was moderately positively correlated with higher frequency of detailed information acquisition in the P-DA (r = 0.414, p = 0.011). The monitoring subscale score weakly correlated with increased medical knowledge in the entire study population (r = 0.268, p = 0.021, N = 74), but not in the respective study arms. There were no significant associations with the blunting subscale score. CONCLUSIONS: Individual variability in information preferences may affect the process of information acquisition from computerized P-DA's. More research is needed to understand how individual information preferences may impact medical knowledge acquisition and decision-making.

Exploring the Needs of Adults Living With Type 1 or Type 2 Diabetes Distress Using the Problem Areas in Diabetes 5 Tool.

OBJECTIVES: This study investigated the feasibility and acceptability of implementing a screening tool as a part of routine care and the subsequent screening experiences of patients and clinicians. Additionally, potential sources of diabetes distress (DD) were identified in this clinical population. METHODS: Our investigation was a cross-sectional, mixed-methods, convenience sample of 203 patients living with type 1 or type 2 diabetes from 2 Canadian tertiary hospital-based clinics. The Problem Areas in Diabetes 5 (PAID5) scale was used to assess DD. Structured telephone interviews of patients with high DD scores and care provider focus group transcriptions were analyzed using a deductive thematic content analysis. RESULTS: The prevalence of DD was 45%. Lack of medication coverage (p=0.02) and presence of neuropathy (p=0.04) were approximately 5- and 2-fold more likely to be predictors of high DD, respectively. Patient interviews identified DD screening as an opportunity to share and feel supported but demonstrated their fear of discussing mental health concerns. Patients found discussion about mental health helpful and often did not require a referral to a mental health specialist. Staff focus groups discussed screening as a feasible tool, but also acknowledged barriers and knowledge gaps that preclude DD screening integration in routine clinical practice. Specialized training for clinicians may help increase confidence and improve uptake of DD screening into routine clinical practice. CONCLUSIONS: The prevalence of DD in outpatient care settings is high. Findings suggest that integrating the PAID5 screening tool into regular clinical practice is feasible by patients and care providers.

Best Current Practice and Research Priorities in Active Surveillance for Prostate Cancer-A Report of a Movember International Consensus Meeting.

BACKGROUND: Active surveillance (AS) is recommended for low-risk and some intermediate-risk prostate cancer. Uptake and practice of AS vary significantly across different settings, as does the experience of surveillance-from which tests are offered, and to the levels of psychological support. OBJECTIVE: To explore the current best practice and determine the most important research priorities in AS for prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: A formal consensus process was followed, with an international expert panel of purposively sampled participants across a range of health care professionals and researchers, and those with lived experience of prostate cancer. Statements regarding the practice of AS and potential research priorities spanning the patient journey from surveillance to initiating treatment were developed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Panel members scored each statement on a Likert scale. The group median score and measure of consensus were presented to participants prior to discussion and rescoring at panel meetings. Current best practice and future research priorities were identified, agreed upon, and finally ranked by panel members. RESULTS AND LIMITATIONS: There was consensus agreement that best practice includes the use of high-quality magnetic resonance imaging (MRI), which allows digital rectal examination (DRE) to be omitted, that repeat standard biopsy can be omitted when MRI and prostate-specific antigen (PSA) kinetics are stable, and that changes in PSA or DRE should prompt MRI ± biopsy rather than immediate active treatment. The highest ranked research priority was a dynamic, risk-adjusted AS approach, reducing testing for those at the least risk of progression. Improving the tests used in surveillance, ensuring equity of access and experience across different patients and settings, and improving information and communication between and within clinicians and patients were also high priorities. Limitations include the use of a limited number of panel members for practical reasons. CONCLUSIONS: The current best practice in AS includes the use of high-quality MRI to avoid DRE and as the first assessment for changes in PSA, with omission of repeat standard biopsy when PSA and MRI are stable. Development of a robust, dynamic, risk-adapted approach to surveillance is the highest research priority in AS for prostate cancer. PATIENT SUMMARY: A diverse group of experts in active surveillance, including a broad range of health care professionals and researchers and those with lived experience of prostate cancer, agreed that best practice includes the use of high-quality magnetic resonance imaging, which can allow digital rectal examination and some biopsies to be omitted. The highest research priority in active surveillance research was identified as the development of a dynamic, risk-adjusted approach.

Endocrinologist-Perceived Factors Affecting the Transition of Thyroid Cancer Patients from Specialist to Primary Care Postcancer Treatment in Ontario, Canada.

Background: Thyroid cancer patient discharge patterns from specialists are heterogeneous, with some specialists following patients for a longer period of time than others. With no well-established transitional plan, such as in breast and colorectal cancer, primary care physicians play a variable role in long-term thyroid cancer care. The objective of this study was to examine endocrinologist-perceived factors affecting the transition of care for thyroid cancer patients through a qualitative and quantitative survey of practicing endocrinologists in Ontario, Canada. Methods: All eligible practicing endocrinologists in Ontario were invited to participate in the study, via an email with an embedded survey link. Consent was assumed if the physician completed the survey. The survey collected physician demographics and asked a series of Likert-scale and open-ended questions on their views regarding transitioning care of their thyroid cancer patients. Quantitative analysis was based on mode and variability. Qualitative analysis was completed using inductive thematic analysis. Results: Seventy physicians completed the survey, with a response rate of 35.5%. Based on the responses to the Likert-scale questions, there was a lack of consensus in terms of discharging criteria for patients who had low-risk papillary thyroid cancer, stable thyrotropin levels, multiple nonthyroid-related comorbidities, and hemithyroidectomy with no disease recurrence. The majority of endocrinologists responded that the main factors affecting discharge included whether the primary care physician was able to follow their recommendations, whether the primary care physician could appropriately adjust levothyroxine doses, and whether the patient was confident that their primary care physician could manage their thyroid cancer follow-up. Themes extracted from the open-ended question also indicated that the main factors affecting the transition of care were related to the primary care physician, the patient, the imaging interpretation, and the discharge guidelines. Conclusion: The lack of consensus among endocrinologists affects the transition of patient care, and there is a need to provide clear and accurate information to primary care physicians and thyroid cancer patients on postcancer treatment care. Efforts should be sought to standardize discharge and long-term care.

Implementing Change Ideas, Interpreting Data and Sustaining Change in a Quality Improvement Project.

This article is the third and final installment in our diabetes quality improvement primer series. It summarizes how to interpret real-time data with run charts and highlights 4 key rules that can be applied to understand whether improvement is statistically significant. We also review the importance of outlining a family of measures, including outcome, process and balancing measures. Finally, we discuss strategies for sustaining change.

Beginning a Diabetes Quality Improvement Project.

There is a large evidence-to-clinical practice gap in diabetes care. Application of quality improvement (QI) strategies can be used to improve gaps in care delivery. In this first of 3 articles in the diabetes QI primer series, we introduce the steps required to plan a QI project by using a case example for improving foot screening of people with diabetes. We review how to select an appropriate QI project, conduct a baseline gap analysis to clarify the QI problem and engage stakeholders to ensure successful implementation. The next 2 articles in the series will focus on root-cause analysis, selection of change ideas to improve care gaps, execution of the QI project using rapid-cycle testing and monitoring to sustain improvement over time.

Determining Root Causes and Designing Change Ideas in a Quality Improvement Project.

In this second article of our diabetes quality improvement primer series, readers will become familiar with various diagnostic tools used to understand the root causes of a quality problem. We discuss change concepts, and specific change ideas are developed to match the root causes. We review the application of a plan-do-study-act cycle from the Model for Improvement quality improvement framework to test 1 change idea and measure for the intended improvements.

Maternal obesity and familial history of diabetes have opposing effects on infant birth weight in women with mild glucose intolerance in pregnancy.

OBJECTIVE: Pregnant women with an abnormal screening glucose challenge test (GCT) but without gestational diabetes mellitus (GDM) on subsequent oral glucose tolerance test (OGTT) are at increased risk of delivering macrosomic and large for gestational age (LGA) neonates. We thus sought to evaluate the maternal constitutional and biochemical factors that determine infant birth weight in this patient population. METHODS: Women with an abnormal GCT were evaluated at the time of their OGTT in late pregnancy. This analysis was restricted to Caucasian women without GDM (N = 86). Maternal demographic and biochemical factors were evaluated in relation to infant birth weight and LGA. RESULTS: After adjustment for length of gestation, birth weight was positively associated with pre-pregnancy body mass index (BMI) (r = 0.31, p = 0.0063) and negatively correlated with maternal serum levels of the insulin-sensitizing protein adiponectin (r = -0.30, p = 0.0084). On multiple linear regression analysis, pre-pregnancy BMI and weight gain in pregnancy were positive independent determinants of infant birth weight, while family history of diabetes emerged as a negative independent correlate. Logistic regression analysis confirmed that pre-pregnancy BMI was a positive predictor of LGA (odds ratio (OR) = 1.25, 95% confidence interval (CI) 1.05-1.49), whereas family history of diabetes was again identified as a negative determinant (OR = 0.10, 95% CI 0.02-0.59). In contrast, neither measures of glycemia nor insulin resistance/sensitivity were independently associated with birth weight or LGA. CONCLUSION: In pregnant women with an abnormal GCT but without GDM, pre-gravid maternal obesity predicts increased infant birth weight, whereas family history of diabetes is independently associated with decreased infant size.

A phosphomimetic mutation at Ser-138 renders iron regulatory protein 1 sensitive to iron-dependent degradation.

Iron regulatory protein 1 (IRP1) binds to mRNA iron-responsive elements (IREs) and thereby controls the expression of IRE-containing mRNAs. In iron-replete cells, assembly of a cubane [4Fe-4S] cluster inhibits IRE-binding activity and converts IRP1 to a cytosolic aconitase. Earlier experiments with Saccharomyces cerevisiae suggested that phosphomimetic mutations of Ser-138 negatively affect the stability of the cluster (N. M. Brown, S. A. Anderson, D. W. Steffen, T. B. Carpenter, M. C. Kennedy, W. E. Walden, and R. S. Eisenstein, Proc. Natl. Acad. Sci. USA 95:15235-15240, 1998). Along these lines, we show here that a highly purified preparation of recombinant human IRP1 bearing a phosphomimetic S138E substitution (IRP1(S138E)) lacks aconitase activity, which is a hallmark of [4Fe-4S] cluster integrity. Similarly, IRP1(S138E) expressed in mammalian cells fails to function as aconitase. Furthermore, we demonstrate that the impairment of [4Fe-4S] cluster assembly in mammalian cells sensitizes IRP1(S138E) to iron-dependent degradation. This effect can be completely blocked by the iron chelator desferrioxamine or by the proteasome inhibitors MG132 and lactacystin. As expected, the stability of wild-type or phosphorylation-deficient IRP1(S138A) is not affected by iron manipulations. Ser-138 and flanking sequences appear to be highly conserved in the IRP1s of vertebrates, whereas insect IRP1 orthologues and nonvertebrate IRP1-like molecules contain an S138A substitution. Our data suggest that phosphorylation of Ser-138 may provide a basis for an additional mechanism for the control of vertebrate IRP1 activity at the level of protein stability.

Self-Management and Clinical Decision Support for Patients With Complex Chronic Conditions Through the Use of Smartphone-Based Telemonitoring: Randomized Controlled Trial Protocol.

BACKGROUND: The rising prevalence of chronic illnesses hinders the sustainability of the health care system because of the high cost of frequent hospitalizations of patients with complex chronic conditions. Clinical trials have demonstrated that telemonitoring can improve health outcomes, but they have generally been limited to single conditions such as diabetes, hypertension, or heart failure. Few studies have examined the impact of telemonitoring on complex patients with multiple chronic conditions, although these patients may benefit the most from this technology. OBJECTIVE: The aim of this study is to investigate the impact of a smartphone-based telemonitoring system on the clinical care and health outcomes of complex patients across several chronic conditions. METHODS: A mixed-methods, 6-month randomized controlled trial (RCT) of a smartphone-based telemonitoring system is being conducted in specialty clinics. The study will include patients who have been diagnosed with one or more of any of the following conditions: heart failure, chronic obstructive pulmonary disease, chronic kidney disease, uncontrolled hypertension, or insulin-requiring diabetes. The primary outcome will be the health status of patients as measured with SF-36. Patients will be randomly assigned to either the control group receiving usual care (n=73) or the group using the smartphone-based telemonitoring system in addition to usual care (n=73). RESULTS: Participants are currently being recruited for the trial. Data collection is anticipated to be completed by the fall of 2018. CONCLUSIONS: This RCT will be among the first trials to provide evidence of the impact of telemonitoring on costs and health outcomes of complex patients who may have multiple chronic conditions. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 41238563; http://www.isrctn.com/ISRCTN41238563 (Archived by WebCite at http://www.webcitation.org/6ug2Sk0af) and Clinicaltrials.gov NCT03127852; https://clinicaltrials.gov/ct2/show/NCT03127852 (Archived by WebCite at http://www.webcitation.org/6uvjNosBC).

A systematic review of randomized controlled trials for management of persistent post-treatment fatigue in thyroid cancer survivors.

BACKGROUND: Fatigue that persists post-treatment is commonly reported by thyroid cancer (TC) survivors. METHODS: A systematic review of published English language randomized controlled trials (RCTs) on interventions for management of persistent post-treatment fatigue in TC was conducted. This review excluded studies on short-term interventions used in preparation for radioactive iodine diagnostic scans or treatment. An electronic search was executed in six databases and supplemented by a hand search. Two reviewers independently reviewed all citations from the electronic search and relevant full-text studies. Two abstractors independently critically appraised included studies and abstracted the data. The data were qualitatively summarized. RESULTS: A total of 1086 unique citations and 25 full-text studies were reviewed. Four studies summarizing the results of three RCTs were included. The interventions included: combination triiodothyronine with levothyroxine (L-T4) therapy compared to L-T4 alone (one RCT), reduction in degree of thyrotropin (TSH) suppression using L-T4 compared to maintenance of TSH suppression (one RCT), and supervised exercise compared to inactivity (two RCTs examining different fatigue outcomes in same population). Trial duration ranged from 10 weeks to six months. All trials had limitations, and the number of TC survivors included in respective RCTs ranged from 15 to 36. Hormonal treatment RCTs had mixed fatigue outcome results within respective trials. However, multiple measures suggesting improvement in fatigue were reported following the exercise intervention. CONCLUSIONS: There is paucity of RCTs to guide evidence-based management of persistent post-treatment fatigue in TC survivors. RCTs of interventions for prevention or treatment of fatigue in TC survivors are needed.

Randomized controlled trial of a computerized decision aid on adjuvant radioactive iodine treatment for patients with early-stage papillary thyroid cancer.

PURPOSE: Decision-making on adjuvant radioactive iodine (RAI) treatment for early-stage papillary thyroid cancer (PTC) is complex because of uncertainties in medical evidence. Using a parallel, two-arm, randomized, controlled trial design, we examined the impact of a patient-directed computerized decision aid (DA) on the medical knowledge and decisional conflict in patients with early-stage PTC considering the choice of being treated with adjuvant RAI or not. The DA describes the rationale, possible risks and benefits, and the medical evidence uncertainty relating to the choice. PATIENTS AND METHODS: We recruited 74 patients with early-stage PTC after thyroidectomy. Participants were assigned by using 1:1 central computerized randomization to either the DA group with usual care (intervention) or usual care alone (control). Medical knowledge about PTC and RAI treatment (the primary outcome), as well as decisional conflict (a secondary outcome), were measured by using validated questionnaires, and the respective scores were compared between groups. RESULTS: Consistent with PTC epidemiology, 83.8% (62 of 74) of the participants were women, and the mean age was 45.8 years (range, 19 to 79 years). Medical knowledge about PTC and RAI treatment was significantly greater and decisional conflict was significantly reduced in the DA group compared with the control group (respective P values < .001). The use of adjuvant RAI treatment was not significantly different between groups (DA group, 11 of 37 [29.7%]; controls, seven of 37 [18.9%]; P = .278). CONCLUSION: A computerized DA improves informed decision making in patients with early-stage PTC who are considering adjuvant RAI treatment. DAs are useful for patients facing decisions subject to medical evidence uncertainty.