Jan Barnsley

Mobile Phone-Based Telemonitoring for Heart Failure Management: A Randomized Controlled Trial

Background Previous trials of telemonitoring for heart failure management have reported inconsistent results, largely due to diverse intervention and study designs. Mobile phones are becoming ubiquitous and economical, but the feasibility and efficacy of a mobile phone-based telemonitoring system have not been determined. Objective The objective of this trial was to investigate the effects of a mobile phone-based telemonitoring system on heart failure management and outcomes. Methods One hundred patients were recruited from a heart function clinic and randomized into telemonitoring and control groups. The telemonitoring group (N = 50) took daily weight and blood pressure readings and weekly single-lead ECGs, and answered daily symptom questions on a mobile phone over 6 months. Readings were automatically transmitted wirelessly to the mobile phone and then to data servers. Instructions were sent to the patients’ mobile phones and alerts to a cardiologist’s mobile phone as required. Results Baseline questionnaires were completed and returned by 94 patients, and 84 patients returned post-study questionnaires. About 70% of telemonitoring patients completed at least 80% of their possible daily readings. The change in quality of life from baseline to post-study, as measured with the Minnesota Living with Heart Failure Questionnaire, was significantly greater for the telemonitoring group compared to the control group (P = .05). A between-group analysis also found greater post-study self-care maintenance (measured with the Self-Care of Heart Failure Index) for the telemonitoring group (P = .03). Brain natriuretic peptide (BNP) levels, self-care management, and left ventricular ejection fraction (LVEF) improved significantly for both groups from baseline to post-study, but did not show a between-group difference. However, a subgroup within-group analysis using the data from the 63 patients who had attended the heart function clinic for more than 6 months revealed the telemonitoring group had significant improvements from baseline to post-study in BNP (decreased by 150 pg/mL, P = .02), LVEF (increased by 7.4%, P = .005) and self-care maintenance (increased by 7 points, P = .05) and management (increased by 14 points, P = .03), while the control group did not. No differences were found between the telemonitoring and control groups in terms of hospitalization, mortality, or emergency department visits, but the trial was underpowered to detect differences in these metrics. Conclusions Our findings provide evidence of improved quality of life through improved self-care and clinical management from a mobile phone-based telemonitoring system. The use of the mobile phone-based system had high adherence and was feasible for patients, including the elderly and those with no experience with mobile phones. Trial Registration ClinicalTrials.gov NCT00778986

Factors affecting the utilization of systematic reviews. A study of public health decision makers.

OBJECTIVE To determine the extent to which public health decision makers used five systematic reviews to make policy decisions, and to determine which characteristics predict their use. METHODS This cross-sectional follow-up study of public health decision makers in Ontario collected primary data using a telephone survey and a short, self-administered organizational demographics questionnaire completed by the administrative assistant for each Medical Officer of Health. Independent variables included characteristics of the innovation, organization, environment, and individual. Data were entered into a computerized database developed specifically for this study, and multiple logistic regression analysis was conducted. RESULTS The participation rate was very high, with 85% of public health units and 96% of available decision makers completing the survey. In addition, 63% of respondents stated they had used at least one of the systematic reviews in the previous 2 years to make a decision. The most important predictors of use were ones position, expecting to use a review in the future, and perceptions that the reviews were easy to use and that they overcame the barrier of limited critical appraisal skills. CONCLUSIONS Utilization of the systematic reviews in Ontario was very high. The utilization rates found in this study were significantly higher than those reported in previous utilization studies. Ones position was found to be the strongest predictor of use, identifying program managers and directors as the most appropriate audience for systematic reviews.

Integrating Learning into Integrated Delivery Systems

Integrated delivery systems that promote learning and flexibility will be better prepared to face the challenges imposed by a complex and competitive environment. The integration of learning into these systems requires a shared vision, facilitative leadership, and highly functioning communication channels within an organic structure. Strategies that promote positive attitudes toward change are necessary for learning as is the provision of resources, training, incentives, and rewards that support learning, and feedback on how new administrative and clinical practices advance the mission and goals of the system.

Perceptions and experiences of heart failure patients and clinicians on the use of mobile phone-based telemonitoring.

Background Previous trials of heart failure telemonitoring systems have produced inconsistent findings, largely due to diverse interventions and study designs. Objectives The objectives of this study are (1) to provide in-depth insight into the effects of telemonitoring on self-care and clinical management, and (2) to determine the features that enable successful heart failure telemonitoring. Methods Semi-structured interviews were conducted with 22 heart failure patients attending a heart function clinic who had used a mobile phone-based telemonitoring system for 6 months. The telemonitoring system required the patients to take daily weight and blood pressure readings, weekly single-lead ECGs, and to answer daily symptom questions on a mobile phone. Instructions were sent to the patient’s mobile phone based on their physiological values. Alerts were also sent to a cardiologist’s mobile phone, as required. All clinicians involved in the study were also interviewed post-trial (N = 5). The interviews were recorded, transcribed, and then analyzed using a conventional content analysis approach. Results The telemonitoring system improved patient self-care by instructing the patients in real-time how to appropriately modify their lifestyle behaviors. Patients felt more aware of their heart failure condition, less anxiety, and more empowered. Many were willing to partially fund the use of the system. The clinicians were able to manage their patients’ heart failure conditions more effectively, because they had physiological data reported to them frequently to help in their decision-making (eg, for medication titration) and were alerted at the earliest sign of decompensation. Essential characteristics of the telemonitoring system that contributed to improved heart failure management included immediate self-care and clinical feedback (ie, teachable moments), how the system was easy and quick to use, and how the patients and clinicians perceived tangible benefits from telemonitoring. Some clinical concerns included ongoing costs of the telemonitoring system and increased clinical workload. A few patients did not want to be watched long-term while some were concerned they might become dependent on the system. Conclusions The success of a telemonitoring system is highly dependent on its features and design. The essential system characteristics identified in this study should be considered when developing telemonitoring solutions. Key Words

Self-care and quality of life of heart failure patients at a multidisciplinary heart function clinic.

Background:Multidisciplinary heart function clinics aim to improve self-care through patient education and to provide clinical management. Objective:The objectives of the present study were to investigate the self-care and quality of life of patients attending a multidisciplinary heart function clinic and to explore the relationship between self-care and quality of life. Methods:One hundred outpatients attending a multidisciplinary heart function clinic were asked to complete a questionnaire. The questionnaire included the Self-care of Heart Failure Index (SCHFI) and the Minnesota Living With Heart Failure Questionnaire, which were used to assess self-care behavior and quality of life, respectively. Self-care practices and perceived barriers were also assessed through semistructured interviews with each patient. Results:The returned questionnaires (n = 94) were used to compute the following SCHFI maintenance, management, and confidence scores: 60.8 (SD, 19.3), 62.0 (SD, 20.7), and 55.9 (SD, 19.7), respectively. Higher SCHFI scores indicate better self-care. None of the self-care dimensions reached the self-care adequacy cut point of 70. The average score on the Minnesota Living With Heart Failure Questionnaire was 49.9 (SD, 25.4), indicating a moderate health-related quality of life. Lower ejection fraction, older age, and better quality of life were associated with better self-care. Determinants of better quality of life were older age, better functional capacity, higher self-care confidence, and fewer comorbidities. The patient interviews revealed that better quality of life is associated with higher self-care confidence and barriers to self-care caused anxiety to the patients. The self-care barriers were found to include lack of self-care education, financial constraints, lack of perceived benefit, and low self-efficacy. Conclusions:Patients attending a large multidisciplinary Canadian heart failure clinic do not perform adequate self-care as measured with the SCHFI and report only a moderate quality of life. Increasing self-care through education and tools that target self-care barriers are required and may help improve quality of life.

Allocation techniques for balance at baseline in cluster randomized trials: a methodological review

Reviews have repeatedly noted important methodological issues in the conduct and reporting of cluster randomized controlled trials (C-RCTs). These reviews usually focus on whether the intracluster correlation was explicitly considered in the design and analysis of the C-RCT. However, another important aspect requiring special attention in C-RCTs is the risk for imbalance of covariates at baseline. Imbalance of important covariates at baseline decreases statistical power and precision of the results. Imbalance also reduces face validity and credibility of the trial results. The risk of imbalance is elevated in C-RCTs compared to trials randomizing individuals because of the difficulties in recruiting clusters and the nested nature of correlated patient-level data. A variety of restricted randomization methods have been proposed as way to minimize risk of imbalance. However, there is little guidance regarding how to best restrict randomization for any given C-RCT. The advantages and limitations of different allocation techniques, including stratification, matching, minimization, and covariate-constrained randomization are reviewed as they pertain to C-RCTs to provide investigators with guidance for choosing the best allocation technique for their trial.

Attitudes of heart failure patients and health care providers towards mobile phone-based remote monitoring.

Background Mobile phone-based remote patient monitoring systems have been proposed for heart failure management because they are relatively inexpensive and enable patients to be monitored anywhere. However, little is known about whether patients and their health care providers are willing and able to use this technology. Objective The objective of our study was to assess the attitudes of heart failure patients and their health care providers from a heart function clinic in a large urban teaching hospital toward the use of mobile phone-based remote monitoring. Methods A questionnaire regarding attitudes toward home monitoring and technology was administered to 100 heart failure patients (94/100 returned a completed questionnaire). Semi-structured interviews were also conducted with 20 heart failure patients and 16 clinicians to determine the perceived benefits and barriers to using mobile phone-based remote monitoring, as well as their willingness and ability to use the technology. Results The survey results indicated that the patients were very comfortable using mobile phones (mean rating 4.5, SD 0.6, on a five-point Likert scale), even more so than with using computers (mean 4.1, SD 1.1). The difference in comfort level between mobile phones and computers was statistically significant (P< .001). Patients were also confident in using mobile phones to view health information (mean 4.4, SD 0.9). Patients and clinicians were willing to use the system as long as several conditions were met, including providing a system that was easy to use with clear tangible benefits, maintaining good patient-provider communication, and not increasing clinical workload. Clinicians cited several barriers to implementation of such a system, including lack of remuneration for telephone interactions with patients and medicolegal implications. Conclusions Patients and clinicians want to use mobile phone-based remote monitoring and believe that they would be able to use the technology. However, they have several reservations, such as potential increased clinical workload, medicolegal issues, and difficulty of use for some patients due to lack of visual acuity or manual dexterity.

The incidence of adverse events among home care patients

OBJECTIVE Incidence of adverse events (AEs) among home care patients and preventability ratings were estimated. Risk factors, AE types and factors associated with AEs were identified. DESIGN This study used a stratified, randomized sample of home care patients discharged in the fiscal year 2004/05. Trained nurse reviewers completed retrospective chart abstractions; charts for cases that were positive for screening criteria suggesting the presence of AEs were reviewed by trained physicians to determine the presence of and preventability of AEs. SETTING Three publicly funded home care programs in Ontario, Canada. MAIN OUTCOME MEASURES Prevalence and types of AEs; ratings of preventability. RESULTS At least one screening criterion was positively identified in 286 (66.5%) of 430 cases. Physician reviewers identified 61 AEs in 55 (19.2%) of the 286 (12.8% of the 430) cases. The AE rate was 13.2 per 100 home care cases [95% confidence interval (CI): 10.4-16.6%, standard error 1.6%]. 32.7% (20 of 61 AEs) of the AEs were rated as having >50% probability of preventability; 6 deaths (10.9% of patients with an AE; 1.4% of all patients) occurred in AE-positive patients. The most common AEs were falls and adverse drug events. CONCLUSIONS Providing health care through home care programs creates unintended harm to patients. The incidence rate of AEs of 13.2% suggests a significant number of home care patients experience AEs, one-third of which were considered preventable. Improvements in patient and informal caregiver education, skill development and clinical planning may be useful interventions to reduce AEs.

Developing healthcare rule-based expert systems: Case study of a heart failure telemonitoring system

BACKGROUND The use of expert systems to generate automated alerts and patient instructions based on telemonitoring data could enable increased self-care and improve clinical management. However, of great importance is the development of the rule set to ensure safe and clinically relevant alerts and instructions are sent. The purpose of this work was to develop a rule-based expert system for a heart failure mobile phone-based telemonitoring system, to evaluate the expert system, and to generalize the lessons learned from the development process for use in other healthcare applications. METHODS Semi-structured interviews were conducted with 10 heart failure clinicians to inform the development of a draft heart failure rule set for alerts and patient instructions. The draft rule set was validated and refined with 9 additional interviews with heart failure clinicians. Finally, the clinical champion of the project vetted the rule set. The concerns voiced by the clinicians during the interviews were noted, and methods to mitigate these concerns were employed. The rule set was then evaluated as part of a 6-month randomized controlled trial of a mobile phone-based heart failure telemonitoring system (n=50 for each of the telemonitoring and control groups). RESULTS The developed expert system generated alerts and instructions based on the patients weight, blood pressure, heart rate, and symptoms. During the trial, 1620 alerts were generated, which led to various clinical actions including 105 medication changes/instructions. The findings from the trial indicated the rule set was associated with improved quality of life and self-care. CONCLUSIONS A rule set was developed with extensive input by heart failure clinicians. The results from the trial indicated the rule set was associated with significantly increased self-care and improved the clinical management of heart failure. The developed rule set can be used as a basis for other heart failure telemonitoring systems, but should be validated and modified as necessary. In addition, the process used to develop the rule set can be generalized and applied to create robust and complete rule sets for other healthcare expert systems.

Quality of Communication Between Primary Health Care and Mental Health Care: An Examination of Referral and Discharge Letters

In managing treatment for persons with mental illness, the primary care physician (PCP) needs to communicate with mental health (MH) professionals in various settings over time to provide appropriate management and continuity of care. However, effective communication between PCPs and MH specialists is often poor. The present study reviewed evidence on the quality of information transfer between PCPs and specialist MH providers for referral requests and after inpatient discharge. Twenty-three audit studies were identified that assessed the quality of content and nine that assessed strategies to improve quality. Results indicated that rates of item reporting were variable. Within the limited evidence on interventions to improve quality, use of structured forms showed positive results. Follow-up work can identify a minimum set of items to include in information transfers, along with item definitions and structures for holding this information. Then, methodologies for measuring data quality, including electronically generated performance metrics, can be developed.