Effectiveness of home-centered care through telemedicine applications for overweight and obese patients: a randomized controlled trial.

OBJECTIVE: To determine if home-centered monitoring through telemedicine has an impact on clinical characteristics, metabolic profile and quality of life in overweight and obese patients. DESIGN: Randomized controlled trial, 6-month duration. SETTING: Tertiary care academic hospital. SUBJECTS: A total of 122 patients were eligible to participate as they met the inclusion criteria of increased body mass index (BMI>25 kg/m(2)), age>18 and <70 y and ability to operate electronic microdevices. INTERVENTIONS: All patients in the control group (n=77) received standard hospital care. Patients in the intervention group (n=45), additionally, measured three times a week, for 6 months, their blood pressure and body weight and transmitted them to an automated call center. These values were not shared with the patients' physician or dietician. MAIN OUTCOME MEASURES: Clinical (body weight, BMI, blood pressure), laboratory (fasting plasma glucose, triglycerides, HDL-cholesterol, total cholesterol) and quality of life parameters (SF-36((R)), Visual Analog Scale of European Quality-5 Dimensions, Obesity Assessment Survey). Data were analyzed in an intention-to-treat-way (last observation carried forward). RESULTS: Drop-out rate was similar in the control and intervention groups: 12 vs 11 percent, respectively, P=NS. There were no significant differences at baseline between intervention and control groups in all main outcome parameters. There were significant decreases for patients in the intervention group in body weight (from 101.6+/-22.4 to 89.2+/-14.7 kg, P=0.002, P=0.05 vs controls at 6 months), total cholesterol (from 247.6+/-42.0 to 220.7+/-42.6 mg/dl, P=0.002, P=0.05 vs controls at 6 months) and triglycerides (from 148.4+/-35.0 to 122.3+/-31.4 mg/dl, P=0.001, P=0.01 vs controls at 6 months). Intervention group patients made a total of 1997 phone contacts. The number of phone contacts was correlated positively with Social Functioning (SF), Vitality (VT) and Mental Health (MH) scores of SF-36((R)) at baseline (r=0.48, r=0.41, r=0.41, respectively, P=0.05) but not with weight loss. CONCLUSIONS: Home-centered, intense treatment through the use of telemedicine can be effective in improving short-term obesity outcomes.

Patient acceptance of educational voice messages: a review of controlled clinical studies.

OBJECTIVES: The objective of this study was to evaluate controlled evidence on the impact of automated computer-based telephone messaging technology upon health outcomes, cost savings and acceptance by patients, caregivers and care providers. METHODS: Systematic searches of electronic databases were conducted to find controlled clinical studies of automated phone messaging used in patient care. Studies were selected based on the three criteria: 1) randomized controlled trials or controlled trials; 2) patients receiving health care related education, information, advice or reminder for a specific action to be taken in their home setting; and 3) use of automated computer-based phone technology to deliver the messages. Information abstracted from studies included information about the institution, persons targeted, intervention and its effect on health outcomes, costs and acceptance by patients and caregivers. RESULTS: A total of nineteen studies were identified for review. Sixteen studies were randomized controlled trials and three were controlled studies with no randomization. Studies were placed in two categories, preventive care education and chronic care studies. Preventive care education studies covered childhood immunizations, medication compliance, influenza vaccinations, tuberculosis and health prevention activities and chronic care studies were related to cholesterol, diabetes, hypertension and congestive heart failure. More than 80% of studies showed significant impact upon measurable health outcomes. CONCLUSIONS: Controlled evidence substantiates the efficacy of automated telephone communication in improving the quality of care. Educational voice messages are acceptable in patients and represent an important opportunity to enhance telemedicine and telehealth applications.

Improving preventive care by prompting physicians.

OBJECTIVES: To assess the impact of prompting physicians on health maintenance, answer questions regarding the mode of delivery, and identify opportunities and limitations of this information intervention. METHODS: Systematic electronic and manual searches (January 1, 1966, to December 31, 1996) were conducted to identify clinical trial reports on prompting clinicians. Three eligibility criteria were applied: (1) randomized controlled clinical trial, (2) clinician prompt, alert, or reminder in the study group and no similar intervention in the control group, and (3) measurement of the intervention effect on the frequency of preventive care procedures. Data were abstracted by independent reviewers using a standardized abstraction form, and quality of methodology was scored. A series of meta-analyses on triggering clinical actions was performed using the random-effects method. The statistical analyses included 33 eligible studies, which involved 1547 clinicians and 54 693 patients. RESULTS: Overall, prompting can significantly increase preventive care performance by 13.1% (95% confidence interval [CI], 10.5%-15.6%). However, the effect ranges from 5.8% (95% CI, 1.5%-10.1%) for Papanicolaou smear to 18.3% (95% CI, 11.6%-25.1%) for influenza vaccination. The effect is not cumulative, and the length of intervention period did not show correlation with effect size (R = -0.015, P = .47). Academic affiliation, ratio of residents, and technique of delivery did not have a significant impact on the clinical effect of prompting. CONCLUSIONS: Dependable performance improvement in preventive care can be accomplished through prompting physicians. Vigorous application of this simple and effective information intervention could save thousands of lives annually. Health care organizations could effectively use prompts, alerts, or reminders to provide information to clinicians when patient care decisions are made.

Evidence-based quality measurement.

There is a strong need to provide scientific evidence supporting the effectiveness of specific health care interventions. Guidelines alone are unlikely to persuade physicians to modify their practice styles, unless research evidence having a motivational impact is also provided. Process-outcome parameters provide a solution for linking the process and outcome of health care and incorporate potentially motivating research evidence.

Effect of linking practice data to published evidence. A randomized controlled trial of clinical direct reports.

OBJECTIVES: The purpose of this study was to evaluate the effect of clinical direct reports (practice data with pertinent evidence from the literature) on dialysis modality selection for patients with end-stage renal disease. METHODS: A randomized controlled clinical trial was conducted at five dialysis centers. Five of the 10 physician participants were assigned through centralized computerized randomization to the intervention group (who received 12 center-specific clinical direct reports encouraging the consideration of peritoneal dialysis), and five were assigned to the control group, who received usual information but no similar report. One hundred fifty-two patients were eligible for monitoring. RESULTS: The number of patients allocated to peritoneal dialysis was significantly higher in the intervention group than in the control group (15.3% versus 2.4%; P = 0.044). Due to a need for transient initial hemodialysis by some patients, the percentage of patients receiving peritoneal dialysis further increased through the end of the 3-month follow-up (18.0% versus 4.9%, P = 0.041). CONCLUSIONS: There were no significant differences between the intervention and control groups in meeting patient preferences, metabolic status, and complication rates. The results of this study show that linking pertinent published evidence to actual practice data can support the implementation of practice recommendations and influence the selection of dialysis treatment for new patients.

Interpreting cost analyses of clinical interventions.

OBJECTIVE: In the present era of cost containment, physicians need reliable data about specific interventions. The objectives of this study were to assist practitioners in interpretation of economic analyses and estimation of their own costs of implementing recommended interventions. DATA SOURCES: MEDLINE search from 1966 through 1995 using the text words cost or expense and medical subject heading (MeSH) terms costs and cost analysis, cost control, cost of illness, cost savings, or cost-benefit analysis. STUDY SELECTION: The 4 eligibility criteria were clinical trial with random assignment; health care quality improvement intervention tested; effects measured on the process or outcome of care; and cost calculation mentioned in the report. DATA EXTRACTION: After independent abstraction and after consensus development, financial data were entered into a costing protocol to determine which costs related to the intervention were provided. DATA SYNTHESIS: Of 181 articles, 97 (53.6%) included actual numbers on the costs of the intervention. Of 97 articles analyzed, the most frequently reported cost figures were in the category of operating expenses (direct cost, 61.9%; labor, 42.3%; and supplies, 32.0%). General overhead was not presented in 91 (93.8%) of the 97 studies. Only 14 (14.4%) of the 97 studies mentioned start-up costs. The text word $ in the abstract and the most useful MeSH index term of cost-benefit analysis appeared with nearly equal frequency in the articles that included actual cost data (37.1 % vs 35.1%). Two thirds of articles indexed with the MeSH term cost control did not include cost figures. CONCLUSIONS: Statements regarding cost without substantiating data are made habitually in reports of clinical trials. In clinical trial reports presenting data on expenditures, start-up costs and general overhead are frequently disregarded. Practitioners can detect missing information by placing cost data in a standardized protocol. The costing protocol of this study can help bridge care delivery and economic analyses.

Computerized management of diabetes: a synthesis of controlled trials.

Computerized management of diabetes is the use of information technology to improve diabetic patient outcomes. The computer can be used to provide educational information to patients and facilitate the storage and transmittal of clinical data between patients and clinicians. The objective of this paper was to evaluate computerized management of diabetes in changing the health outcomes. Clinical trial reports were identified through systematic electronic database and manual searches. Four eligibility criteria were applied: diabetes clinical area; prospective, contemporaneously controlled clinical trial with random assignment of the intervention; computer generated information for patients in the intervention group and no similar intervention in the control group; and measurement of effect on the outcome of care (health status, social functioning, patient/family satisfaction). Data were abstracted using a standardized abstraction form and the quality of methodology was scored. Of 15 eligible clinical trials, 12 (80%) reported positive outcomes or significant benefits. A total of 48 outcome measures were reported, an average of 3.2/study. Significantly improved clinical outcomes included Hemoglobin A1c (HbA1c), blood glucose, and hypoglycemic events. Patient-computer interaction appears to be a valuable supplement to interaction with clinicians. Considering the need to enhance patient participation in the care of chronic illnesses, initial evidence indicates computers can play a more significant role in the future.

Clinical trials of interactive computerized patient education: implications for family practice.

A systematic review of randomized clinical trials was conducted to evaluate the acceptability and usefulness of computerized patient education interventions. The Columbia Registry, MEDLINE, Health, BIOSIS, and CINAHL bibliographic databases were searched. Selection was based on the following criteria: (1) randomized controlled clinical trials, (2) educational patient-computer interaction, and (3) effect measured on the process or outcome of care. Twenty-two studies met the selection criteria. Of these, 13 (59%) used instructional programs for educational intervention. Five studies (22.7%) tested information support networks, and four (18%) evaluated systems for health assessment and history-taking. The most frequently targeted clinical application area was diabetes mellitus (n = 7). All studies, except one on the treatment of alcoholism, reported positive results for interactive educational intervention. All diabetes education studies, in particular, reported decreased blood glucose levels among patients exposed to this intervention. Computerized educational interventions can lead to improved health status in several major areas of care, and appear not to be a substitute for, but a valuable supplement to, face-to-face time with physicians.

Electronic communication with patients. Evaluation of distance medicine technology.

OBJECTIVE: To evaluate controlled evidence on the efficacy of distance medicine technologies in clinical practice and health care outcome. DATA SOURCES: Systematic electronic database and manual searches (1966-1996) were conducted to identify clinical trial reports on distance medicine applications. STUDY SELECTION: Three eligibility criteria were applied: prospective, contemporaneously controlled clinical trial with random assignment of the intervention; electronic distance technology application in the intervention group and no similar intervention in the control group; and measurement of the intervention effect on process or outcome of care. DATA EXTRACTION: Data were abstracted by independent reviewers using a standardized abstraction form and the quality of methodology was scored. Distance technology applications were described in 6 categories: computerized communication, telephone follow-up and counseling, telephone reminders, interactive telephone systems, after-hours telephone access, and telephone screening. DATA SYNTHESIS: Of 80 eligible clinical trials, 61 (76%) analyzed provider-initiated communication with patients and 50 (63%) reported positive outcome, improved performance, or significant benefits, including studies of computerized communication (7 of 7), telephone follow-up and counseling (20 of 37), telephone reminders (14 of 23), interactive telephone systems (5 of 6), telephone access (3 of 4), and telephone screening (1 of 3). Significantly improved outcomes were demonstrated in studies of preventive care, management of osteoarthritis, cardiac rehabilitation, and diabetes care. CONCLUSIONS: Distance medicine technology enables greater continuity of care by improving access and supporting the coordination of activities by a clinician. The benefits of distance technologies in facilitating communication between clinicians and patients indicate that application of telemedicine should not be limited to physician-to-physician communication.

In search of controlled evidence for health care quality improvement.

The purpose of this study was to measure the efficiency of simple searches in retrieving controlled evidence about specific primary health care quality improvement interventions and their effects. Searches were conducted to retrieve evidence on seven interventions and seven effect variables. Specific words and the closest Medical Subject Headings (MeSH) recommended by professional librarians were used to search the MEDLINE database. Searches were restricted to the MeSH publication type "randomized controlled trial." Two reviewers independently judged retrieved citations for relevancy to the selected interventions and effects. In selecting MeSH terms, the average agreement among librarians was 64.3% (+/-26.1) for interventions and 57.1% (+/-19.9) for effects. Analysis of the 755 retrieved reports showed that MeSH term searches had an overall recall rate of 58% while the same rate for textword searches was significantly lower (11%, p < .001). The difference in overall precision rates was nonsignificant (26% versus 33%, p = .15). In the group of MeSH searches, overall precision and recall was significantly lower for effects than for interventions (12% versus 52%, p < .001 and 41% versus 69%, p < .001). Two textwords appeared in more than 25% of the benchmark collection: reminder (25.7%) and cost (25.0%). The results of this study indicate that information needs for health care quality improvement cannot be met by simple literature searches. Certain MeSH terms and combinations of textwords yield moderately efficient recall and precision in literature searches for health care quality improvement. Clinicians and physician executives gaining direct access to bibliographic database could probably be better served by structured indexing of critical aspects of randomized controlled clinical trials: design, sample, interventions, and effects.

Effect of physician profiling on utilization. Meta-analysis of randomized clinical trials.

OBJECTIVES: An American Medical Association survey reported that more than half of physicians are subjects of either clinical or economic profiling. This multilevel meta-analysis was designed to assess the clinical effect of peer-comparison feedback intervention (profiles) in changing practice patterns. METHODS: Systematic computerized and manual searches were combined to retrieve articles on randomized controlled clinical trials testing profiling reports. Eligible studies were randomized, controlled clinical trials that tested peer-comparison feedback intervention and measured utilization of clinical procedures. To use all available information, data were abstracted and analyzed on three levels: (1) direction of effects, (2) p value fro the statistical comparison, and (3) odds ratio (OR). MAIN RESULTS: In the 12 eligible trials, 553 physicians were profiled. The test result was p < .05 for the vote-counting sign test of 12 studies (level 1) and p < .05 for the z-transformation test of 8 studies (level 2). There were 5 trials included in the OR analysis (level 3). The primary effect variable in two of the 5 trials had a nonsignificant OR. However, the overall OR calculated by the Mantel-Haenszel method was significant (1.091, confidence interval: 1.045 to 1.136). CONCLUSIONS: Profiling has a statistically significant, but minimal effect on the utilization of clinical procedures. The results of this study indicate a need for controlled clinical evaluations before subjecting large numbers of physicians to utilization management interventions.