Study protocol for targeted interventions to prevent chronic low back pain in high-risk patients: A multi-site pragmatic cluster randomized controlled trial (TARGET Trial).

BACKGROUND: Low back pain (LBP) is one of the most prevalent and potentially disabling conditions for which people seek health care. Patients, providers, and payers agree that greater effort is needed to prevent acute LBP from transitioning to chronic LBP. METHODS AND STUDY DESIGN: The TARGET (Targeted Interventions to Prevent Chronic Low Back Pain in High-Risk Patients) Trial is a primary care-based, multisite, cluster randomized, pragmatic trial comparing guideline-based care (GBC) to GBC + referral to Psychologically Informed Physical Therapy (PIPT) for patients presenting with acute LBP and identified as high risk for persistent disabling symptoms. Study sites include primary care clinics within each of five geographical regions in the United States, with clinics randomized to either GBC or GBC + PIPT. Acute LBP patients at all clinics are risk stratified (high, medium, low) using the STarT Back Tool. The primary outcomes are the presence of chronic LBP and LBP-related functional disability determined by the Oswestry Disability Index at 6 months. Secondary outcomes are LBP-related processes of health care and utilization of services over 12 months, determined through electronic medical records. Study enrollment began in May 2016 and concluded in June 2018. The trial was powered to include at least 1860 high-risk patients in the randomized controlled trial cohort. A prospective observational cohort of approximately 6900 low and medium-risk acute LBP patients was enrolled concurrently. DISCUSSION: The TARGET pragmatic trial aims to establish the effectiveness of the stratified approach to acute LBP intervention targeting high-risk patients with GBC and PIPT. TRIAL REGISTRATION: ClinicalTrials.govNCT02647658 Registered Jan. 6, 2016.

No Difference in Average Interdialytic Weight Gain Observed in a Randomized Trial With a Technology-Supported Behavioral Intervention to Reduce Dietary Sodium Intake in Adults Undergoing Maintenance Hemodialysis in the United States: Primary Outcomes of the BalanceWise Study.

OBJECTIVE: To evaluate the efficacy of behavioral counseling combined with technology-based self-monitoring for sodium restriction in hemodialysis (HD) patients. DESIGN: Randomized clinical trial. SUBJECTS: English literate adults undergoing outpatient, in-center intermittent HD for at least 3 months. INTERVENTIONS: Over a 16-week period, both the intervention and the attention control groups were shown 6 educational modules on the HD diet. The intervention group also received social cognitive theory-based behavioral counseling and monitored their diets daily using handheld computers. MAIN OUTCOME MEASURES: Average daily interdialytic weight gain (IDWGA) was calculated for every week of HD treatment over the observation period by subtracting the post-dialysis weight at the previous treatment time (t-1) from the pre-dialysis weight at the current treatment time (t), dividing by the number of days between treatments. Three 24-hour dietary recalls were obtained at baseline, 8 weeks, and 16 weeks and evaluated using the Nutrient Data System for Research. RESULTS: A total of 179 participants were randomized, and 160 (89.4%) completed final measurements. IDWGA did not differ significantly by treatment group at any time point considered (P > .79 for each). A significant differential change in dietary sodium intake observed at 8 weeks (-372 mg/day; P = .05) was not sustained at 16 weeks (-191 mg/day; P = .32). CONCLUSION: The BalanceWise Study intervention appeared to be feasible and acceptable to HD patients although IDWGA was unchanged and the desired behavioral changes observed at 8 weeks were not sustained. Unmeasured factors may have contributed to the mixed findings, and further research is needed to identify the appropriate patients for such interventions.

Physical activity counseling in overweight and obese primary care patients: Outcomes of the VA-STRIDE randomized controlled trial.

The purpose of this 2-arm randomized clinical trial was to evaluate the effectiveness of a 12-month, expert system-based, print-delivered physical activity intervention in a primary care Veteran population in Pittsburgh, Pennsylvania. Participants were not excluded for many health conditions that typically are exclusionary criteria in physical activity trials. The primary outcome measures were physical activity reported using the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire and an accelerometer-based activity assessment at baseline, 6, and 12 months. Of the 232 Veterans enrolled in the study, 208 (89.7%) were retained at the 6-month follow-up and 203 (87.5%) were retained at 12 months. Compared to the attention control, intervention participants had significantly increased odds of meeting the U.S. recommended guideline of ≥ 150 min/week of at least moderate-intensity physical activity at 12 months for the modified CHAMPS (odds ratio [OR] = 2.86; 95% CI: 1.03-7.96; p = 0.04) but not at 6 months (OR = 1.54; 95% CI: 0.56-4.23; p = 0.40). Based on accelerometer data, intervention participants had significantly increased odds of meeting ≥ 150 min/week of moderate-equivalent physical activity at 6 months (OR = 6.26; 95% CI: 1.26-31.22; p = 0.03) and borderline significantly increased odds at 12 months (OR = 4.73; 95% CI: 0.98-22.76; p = 0.053). An expert system physical activity counseling intervention can increase or sustain the proportion of Veterans in primary care meeting current recommendations for moderate-intensity physical activity. Trial Registration Clinical trials.gov identifier: NCT00731094 URL: http://www.clinicaltrials.gov/ct2/show/NCT00731094.

Recruitment of veterans from primary care into a physical activity randomized controlled trial: the experience of the VA-STRIDE study.

BACKGROUND: Much of the existing literature on physical activity (PA) interventions involves physically inactive individuals recruited from community settings rather than clinical practice settings. Recruitment of patients into interventions in clinical practice settings is difficult due to limited time available in the clinic, identification of appropriate personnel to efficiently conduct the process, and time-consuming methods of recruitment. The purpose of this report is to describe the approach used to identify and recruit veterans from the Veterans Affairs (VA) Pittsburgh Healthcare System Primary Care Clinic into a randomized controlled PA study. METHODS: A sampling frame of veterans was developed using the VA electronic medical record. During regularly scheduled clinic appointments, primary care providers (PCPs) screened identified patients for safety to engage in moderate-intensity PA and willingness to discuss the study with research staff members. Research staff determined eligibility with a subsequent telephone screening call and scheduled a research study appointment, at which time signed informed consent and baseline measurements were obtained. RESULTS: Of the 3,482 veterans in the sampling frame who were scheduled for a primary care appointment during the study period, 1,990 (57.2%) were seen in the clinic and screened by the PCP; moderate-intensity PA was deemed safe for 1,293 (37.1%), 871 (25.0%) agreed to be contacted for further screening, 334 (9.6%) were eligible for the study, and 232 (6.7%) enrolled. CONCLUSIONS: Using a semiautomated screening approach that combined an electronically-derived sampling frame with paper and pencil prescreening by PCPs and research staff, VA-STRIDE was able to recruit 1 in 15 veterans in the sampling frame. Using this approach, a high proportion of potentially eligible veterans were screened by their PCPs. TRIAL REGISTRATION: Clinical trials.gov identifier: NCT00731094.

The Diabetes Telemonitoring Study Extension: an exploratory randomized comparison of alternative interventions to maintain glycemic control after withdrawal of diabetes home telemonitoring.

BACKGROUND: Telemonitoring interventions featuring transmission of home glucose records to healthcare providers have resulted in improved glycemic control in patients with diabetes. No research has addressed the intensity or duration of telemonitoring required to sustain such improvements. PURPOSE: The DiaTel study (10 January 2005 to 1 November 2007) compared active care management (ACM) with home telemonitoring (n=73) to monthly care coordination (CC) telephone calls (n=77) among veterans with diabetes and suboptimal glycemic control. The purpose of the DiaTel Extension was to assess whether initial improvements could be sustained with interventions of the same or lower intensity among participants who re-enrolled in a 6-month extension of DiaTel. METHODS: DiaTel participants receiving ACM were re-assigned randomly to monthly CC calls with continued telemonitoring but no active medication management (ACM-to-CCHT, n=23) or monthly CC telephone calls (ACM-to-CC, n=21). DiaTel participants receiving CC were re-assigned randomly to continued CC (CC-to-CC, n=28) or usual care (UC, ie, CC-to-UC, n=29). Hemaglobin A1c (HbA1c) was assessed at 3 and 6 months following re-randomization. RESULTS: Marked HbA1c improvements observed in DiaTel ACM participants were sustained 6 months after re-randomization in both ACM-to-CCHT and ACM-to-CC groups. Lesser HbA1c improvements observed in DiaTel CC participants were sustained in both CC-to-CC and CC-to-UC groups. No benefit was apparent for continued transmission of glucose data among DiaTel ACM participants or continued monthly telephone calls among DiaTel CC participants 6 months after re-randomization. CONCLUSION: Significant improvements in HbA1c achieved using home telemonitoring and active medication management for 6 months were sustained 6 months later with interventions of decreased intensity in VA Health System-qualified veterans. CLINICAL TRIAL REG. NO: NCT00245882, http://www.clinicaltrials.gov.

Active care management supported by home telemonitoring in veterans with type 2 diabetes: the DiaTel randomized controlled trial.

OBJECTIVE We compared the short-term efficacy of home telemonitoring coupled with active medication management by a nurse practitioner with a monthly care coordination telephone call on glycemic control in veterans with type 2 diabetes and entry A1C > or =7.5%. RESEARCH DESIGN AND METHODS Veterans who received primary care at the VA Pittsburgh Healthcare System from June 2004 to December 2005, who were taking oral hypoglycemic agents and/or insulin for > or =1 year, and who had A1C > or =7.5% at enrollment were randomly assigned to either active care management with home telemonitoring (ACM+HT group, n = 73) or a monthly care coordination telephone call (CC group, n = 77). Both groups received monthly calls for diabetes education and self-management review. ACM+HT group participants transmitted blood glucose, blood pressure, and weight to a nurse practitioner using the Viterion 100 TeleHealth Monitor; the nurse practitioner adjusted medications for glucose, blood pressure, and lipid control based on established American Diabetes Association targets. Measures were obtained at baseline, 3-month, and 6-month visits. RESULTS Baseline characteristics were similar in both groups, with mean A1C of 9.4% (CC group) and 9.6% (ACM+HT group). Compared with the CC group, the ACM+HT group demonstrated significantly larger decreases in A1C at 3 months (1.7 vs. 0.7%) and 6 months (1.7 vs. 0.8%; P < 0.001 for each), with most improvement occurring by 3 months. CONCLUSIONS Compared with the CC group, the ACM+HT group demonstrated significantly greater reductions in A1C by 3 and 6 months. However, both interventions improved glycemic control in primary care patients with previously inadequate control.

Implementation of an inpatient management and discharge strategy for patients with community-acquired pneumonia.

OBJECTIVE: To assess the effectiveness and safety of implementing an inpatient management and discharge strategy based on empiric antibiotic therapy with ceftriaxone sodium and a guideline to promote timely discharge for clinically stable patients hospitalized with community-acquired pneumonia. STUDY DESIGN: A cluster randomized controlled clinical trial with 30 days of patient follow-up at 8 teaching hospitals and 17 nonteaching hospitals nationwide. METHODS: Participants included 240 intervention patients and 209 control patients admitted by 85 physician groups between December 1998 and December 1999. Within each hospital, defined physician practice groups were randomized to the intervention arm (physician notification coupled with ceftriaxone sodium as empiric therapy) or control arm (neither component). Physicians in the intervention arm were notified when their patients met guideline criteria for clinical stability; physicians in the control arm were not contacted. RESULTS: The median length of stay was 4 days in both study arms. The observed reduction in costs associated with the intervention was not statistically significant when cost outliers were excluded. Mortality, serious adverse event, and rehospitalization rates did not differ significantly across study arms. CONCLUSIONS: Implementation of an inpatient management strategy based on physician reminders coupled with empiric use of ceftriaxone sodium did not reduce length of stay or associated medical care costs for patients hospitalized with community-acquired pneumonia. These negative findings are most likely due to insufficient potency of the intervention, inadequate guideline implementation, or imbalances in baseline patient characteristics.

The emergency department community-acquired pneumonia trial: Methodology of a quality improvement intervention.

Community-acquired pneumonia causes more than 4 million episodes of illness each year and has high morbidity, mortality, and total cost of care. Nationwide, nearly 75% of community-acquired pneumonia patients are initially evaluated and treated in hospital-based emergency departments (EDs). Substantial variation exists in illness severity assessment, hospital admission decisions, and performance of recommended processes of care. We designed an ED-based quality improvement trial focused on the initial care of patients with community-acquired pneumonia. We used the Pneumonia Severity Index and level of arterial oxygenation to identify patients at low risk for 30-day mortality and to guide admission decisionmaking. We assessed the performance of recommended "best practices," consisting of assessment of arterial oxygenation, the collection of blood cultures for inpatients, and the timely initiation of appropriate empiric antibiotic therapy for inpatients and outpatients. We conducted a 32-site, cluster-randomized trial in Pennsylvania and Connecticut, comparing the effectiveness and safety of 3 guideline implementation strategies of increasing intensity. The multifaceted implementation plans were carried out in conjunction with each state's quality improvement organization. This article describes the background, objectives, and methodology of this trial to translate evidence-based knowledge on the quality and efficiency of care for community-acquired pneumonia into clinical practice.

Implementation of an evidence-based guideline to reduce duration of intravenous antibiotic therapy and length of stay for patients hospitalized with community-acquired pneumonia: a randomized controlled trial.

PURPOSE: Patients with pneumonia often remain hospitalized after they are stable clinically, and the duration of intravenous antibiotic therapy is a rate-limiting step for discharge. The purpose of this study was to determine whether implementation of an evidence-based guideline would reduce the duration of intravenous antibiotic therapy and length of stay for patients hospitalized with pneumonia. METHODS: In a seven-site, cluster randomized clinical trial, we enrolled 325 control and 283 intervention patients who were admitted by one of 116 physician groups. Within site, physician groups were assigned randomly to receive a practice guideline alone (control arm) or a practice guideline that was implemented using a multifaceted strategy (intervention arm). The effectiveness of guideline implementation was measured by the duration of intravenous antibiotic therapy and length of stay; differences in the rates of discontinuation and hospital discharge were assessed with proportional hazards models. Medical outcomes were assessed at 30 days. RESULTS: Intravenous antibiotic therapy was discontinued somewhat more quickly in the intervention group (hazard ratio [HR] =1.23; 95% confidence interval [CI]: 1.00 to 1.52; P = 0.06) than in the control group. Intervention patients were discharged more quickly, but the difference was not statistically significant (HR = 1.16; 95% CI: 0.97 to 1.38; P = 0.11). Fewer intervention (55% [157/283]) than control (63% [206/325]) patients had medical complications during the index hospitalization (P = 0.04), with no differences in other medical outcomes, including mortality, rehospitalization, and return to usual activities, between treatment arms. CONCLUSIONS: The multifaceted guideline implementation strategy resulted in a slight reduction in the duration of intravenous antibiotic therapy and a nonsignificant reduction in length of stay, without affecting patient outcomes.