Clinical Decision Support Tools for Osteoporosis Disease Management: A Systematic Review of Randomized Controlled Trials

BACKGROUND  Studies indicate a gap between evidence and clinical practice in osteoporosis management. Tools that facilitate clinical decision making at the point of care are promising strategies for closing these practice gaps. OBJECTIVE  To systematically review the literature to identify and describe the effectiveness of tools that support clinical decision making in osteoporosis disease management. DATA SOURCES  Medline, EMBASE, CINAHL, and EBM Reviews (CDSR, DARE, CCTR, and ACP J Club), and contact with experts in the field. REVIEW METHODS  Randomized controlled trials (RCTs) in any language from 1966 to July 2006 investigating disease management interventions in patients at risk for osteoporosis. Outcomes included fractures and bone mineral density (BMD) testing. Two investigators independently assessed articles for relevance and study quality, and extracted data using standardized forms. RESULTS  Of 1,246 citations that were screened for relevance, 13 RCTs met the inclusion criteria. Reported study quality was generally poor. Meta-analysis was not done because of methodological and clinical heterogeneity; 77% of studies included a reminder or education as a component of their intervention. Three studies of reminders plus education targeted to physicians and patients showed increased BMD testing (RR range 1.43 to 8.67) and osteoporosis medication use (RR range 1.60 to 8.67). A physician reminder plus a patient risk assessment strategy found reduced fractures [RR 0.58, 95% confidence interval (CI) 0.37 to 0.90] and increased osteoporosis therapy (RR 2.44, CI 1.43 to 4.17). CONCLUSION  Multi-component tools that are targeted to physicians and patients may be effective for supporting clinical decision making in osteoporosis disease management. Electronic supplementary material  The online version of this article (doi:) contains supplementary material, which is available to authorized users. An erratum to this article can be found at     

Pain Management in Primary Care: A Randomized Controlled Trial of a Computerized Decision Support Tool

BackgroundPrimary care providers manage most patients with chronic pain. Pain is a complex problem, particularly in underserved populations. A technology-enabled, point-of-care decision support tool may improve pain management outcomes.MethodsWe created an electronic health record (EHR)-based decision support tool, the Pain Management Support System–Primary Care (PMSS-PC), and studied the tool-plus-education in 6 Federally Qualified Health Center practices using a randomized, wait-list controlled design. The PMSS-PC generated “best practice alerts,” gave clinicians access to a pain assessment template, psychological distress and substance use measures, guidelines for drug and non-drug therapies, and facilitated referrals. Practices were randomly assigned to early vs delayed (after 6 months) implementation of the intervention, including technical support and 6 webinars. The primary outcome was change in worst pain intensity scores after 6 months, assessed on the Brief Pain Inventory-Short Form. Changes in outcomes were compared between the practices using linear multilevel modeling. The EHR provided clinician data on PMSS-PC utilization.ResultsThe 256 patients in the early implementation practices had significantly improved worst pain (standardized effect size [ES] = −.32) compared with the 272 patients in the delayed implementation practices (ES = −.11). There was very low clinician uptake of the intervention in both conditions.ConclusionsEarly implementation of the PMSS-PC improved worst pain, but this effect cannot be attributed to clinician use of the tool. Further PMSS-PC development is not indicated, but practice-level interventions can improve pain, and studies are needed to identify the determinants of change.     

A Randomized Controlled Trial of Team-Based Care: Impact of Physician-Pharmacist Collaboration on Uncontrolled Hypertension

OBJECTIVE  Evaluate the effectiveness of collaborative management of hypertension by primary care-pharmacist teams in community-based clinics. STUDY DESIGN  A 12-month prospective, single-blind, randomized, controlled trial in the Providence Primary Care Research Network of patients with hypertension and uncontrolled blood pressure. METHODS  As compared to usual primary care, intervention consisted of pharmacy practitioners participating in the active management of hypertension in the primary care office according to established collaborative treatment protocols. At baseline, there was no significant difference in blood pressure between groups. Primary outcome measures were the differences in mean systolic and diastolic blood pressures between arms at study end. Secondary measures included blood pressure goal attainment (<140/90 mmHg), hypertension-related knowledge, medication adherence, home blood pressure monitoring, resource utilization, quality of life, and satisfaction. RESULTS  A total of 463 subjects were enrolled (n = 233 control, n = 230 intervention). Subjects receiving the intervention achieved significantly lower systolic (p = 0.007) and diastolic (p = 0.002) blood pressures compared to control (137/75 mmHg vs. 143/78 mmHg). In addition, 62% of intervention subjects achieved target blood pressure compared to 44% of control subjects (p = 0.003). The intervention group received more total office visits (7.2 vs. 4.9, p < 0.0001), however had fewer physician visits (3.2 vs. 4.7, p < 0.0001) compared to control. Intervention subjects were prescribed more antihypertensive medications (2.7 vs. 2.4, p = 0.02), but did not take more antihypertensive pills per day (2.4 vs. 2.5, p = 0.87). There were minimal differences between groups in hypertension-related knowledge, medication adherence, quality of life, or satisfaction. CONCLUSIONS  Patients randomized to collaborative primary care-pharmacist hypertension management achieved significantly better blood pressure control compared to usual care with no difference in quality of life or satisfaction. The primary author had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.     

A Randomized Controlled Trial of an Automated Telephone Intervention to Improve Blood Pressure Control

The objective of this study was to evaluate the effectiveness of a telephonic outreach program to improve blood pressure (BP) control among patients with hypertension. The authors identified adults 18 years and older with uncontrolled BP within the previous 12 months. Patients received either an automated telephone call advising them to have a walk‐in BP check (n=31,619) or usual care (n=33,154). The primary outcome was BP control at 4 weeks. Significantly more patients who received the intervention achieved BP control compared with the usual care group (32.5% vs 23.7%; P<.0001). Patients in the intervention arm with cardiovascular disease, chronic kidney disease, or diabetes mellitus achieved better BP control. Older age, female sex, and having a household income above the median were associated with BP control. When designing quality‐improvement interventions to increase BP control rates, health care organizations should consider utilizing an automated telephone outreach campaign.     

Effect of Exercise on Blood Pressure in Type 2 Diabetes: A Randomized Controlled Trial

BACKGROUND

Increased blood pressure (BP) in type 2 diabetes (T2DM) markedly increases cardiovascular disease morbidity and mortality risk compared to having increased BP alone.

OBJECTIVE

To investigate whether exercise reduces suboptimal levels of untreated suboptimal BP or treated hypertension.

DESIGN

Prospective, randomized controlled trial for 6 months.

SETTING

Single center in Baltimore, MD, USA.

PATIENTS

140 participants with T2DM not requiring insulin and untreated SBP of 120–159 or DBP of 85–99 mmHg, or, if being treated for hypertension, any SBP <159 mmHg or DBP < 99 mmHg; 114 completed the study.

INTERVENTION

Supervised exercise, 3 times per week for 6 months compared with general advice about physical activity.

MEASUREMENTS

Resting SBP and DBP (primary outcome); diabetes status, arterial stiffness assessed as carotid-femoral pulse-wave velocity (PWV), body composition and fitness (secondary outcomes).

RESULTS

Overall baseline BP was 126.8 ± 13.5 / 71.7 ± 9.0 mmHg, with no group differences. At 6 months, BP was unchanged from baseline in either group, BP 125.8 ± 13.2 / 70.7 ± 8.8 mmHg in controls; and 126.0 ± 14.2 / 70.3 ± 9.0 mmHg in exercisers, despite attaining a training effects as evidenced by increased aerobic and strength fitness and lean mass and reduced fat mass (all p < 0.05), Overall baseline PWV was 959.9 ± 333.1 cm/s, with no group difference. At 6-months, PWV did not change and was not different between group; exercisers, 923.7 ± 319.8 cm/s, 905.5 ± 344.7, controls.

LIMITATIONS

A completion rate of 81 %.

CONCLUSIONS

Though exercisers improve fitness and body composition, there were no reductions in BP. The lack of change in arterial stiffness suggests a resistance to exercise-induced BP reduction in persons with T2DM.KEY WORDS: exercise training, diabetes, high blood pressure, randomized trial     

Additional Antihypertensive Effect of Drugs in Hypertensive Subjects Uncontrolled on Diltiazem Monotherapy: A Randomized Controlled Trial Using Office and Home Blood Pressure Monitoring

The purpose of this study was to compare several diltiazem-based antihypertensive drug combinations and assess the usefulness of home blood pressure monitoring in the evaluation of the efficacy of combination pharmacotherapy. Sixteen general practitioners recruited hypertensive subjects uncontrolled on diltiazem monotherapy, who were randomized to receive eight weeks of add-on therapy with a diuretic (chlorthalidone), a dihydropyridine calcium antagonist (felodipine), an ACE inhibitor (lisinopril), or an angiotensin blocker (valsartan). Sitting office and home blood pressure was measured using electronic devices A&D 767. A total of 211 patients were randomized, and 185 completed the study. Of 52 subjects randomized to felodipine, 15 were withdrawn due to ankle edema. The additional antihypertensive effect of the second drug was smaller in 18 subjects with a white coat effect (p < 0.01). All combinations produced a significant decline in office (21.2 ± 14.8 / 7.7 ± 9.7 mmHg) and home (17.1 ± 11.9 / 6.0 ± 7.0) blood pressure (systolic / diastolic, p < 0.001). There were no differences in the efficacy of the four combinations assessed using office or home blood pressure monitoring. These data suggest that diuretics, dihydropyridines, ACE inhibitors, and angiotensin receptor blockers provide significant additional antihypertensive effects in hypertensive patients uncontrolled on diltiazem monotherapy. The diltiazem-dihydropyridine combination is often intolerable because of ankle edema. Home blood pressure monitoring is useful in the assessment of the efficacy of combination pharmacotherapy and also allows for the detection of subjects who do not require treatment intensification.     

Effect of Hemodiafiltration on the Progression of Neuropathy with Kidney Failure: A Randomized Controlled Trial

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Different Effect of Psyllium and Guar Dietary Supplementation on Blood Pressure Control in Hypertensive Overweight Patients: A Six-Month,Randomized Clinical Trial

In the setting of a six-month, open-label clinical trial, 141 consecutively enrolled, hypertensive, overweight patients were randomized to the oral ingestion of psyllium powder or guar gum 3.5 gr t.i.d., to be taken 20 min before the main two meals, or to standard diet. Both fibers improved significantly BMI, FPG, FPI, HOMA Index, HbA1c, LDL-C, and ApoB. Psyllium supplementation only exerted a significant improvement in plasma TG concentration, in SBP and DBP. In our study, six-month supplementation with psyllium fiber, but not with guar fiber nor standard diet, appears to significantly reduce both SBP and DBP in hypertensive overweight subjects.     

Training Residents to Employ Self-efficacy-enhancing Interviewing Techniques: Randomized Controlled Trial of a Standardized Patient Intervention

Background  Current interventions to enhance patient self-efficacy, a key mediator of health behavior, have limited primary care application. Objective  To explore the effectiveness of an office-based intervention for training resident physicians to use self-efficacy-enhancing interviewing techniques (SEE IT). Design  Randomized controlled trial. Participants  Family medicine and internal medicine resident physicians (N = 64) at an academic medical center. Measurements  Resident use of SEE IT (a count of ten possible behaviors) was coded from audio recordings of the physician-patient portion of two standardized patient (SP) instructor training visits and two unannounced post-training SP visits, all involving common physical and mental health conditions and behavior change issues. One post-training SP visit involved health conditions similar to those experienced in training, while the other involved new conditions. Results  Experimental group residents demonstrated significantly greater use of SEE IT than controls, starting after the first training visit and sustained through the final post-training visit. The mean effect of the intervention was significant [adjusted incidence rate ratio for increased use of SEE IT = 1.94 (95% confidence interval = 1.34, 2.79; p < 0.001)]. There were no significant effects of resident gender, race/ethnicity, specialty, training level, or SP health conditions. Conclusions  SP instructors can teach resident physicians to apply SEE IT during SP office visits, and the effects extend to health conditions beyond those used for training. Future studies should explore the effects of the intervention on practicing physicians, physician use of SEE IT during actual patient visits, and its influence on patient health behaviors and outcomes.     

A Randomized Controlled Trial of an Interactive Voice Response Telephone System and Specialist Nurse Support for Childhood Asthma Management

Objectives. To evaluate the effects of an automated interactive voice response system (IVR) and Specialist Nurse Support to reduce health care utilization and improve health-related quality of life in children with asthma. Study Design. A randomized controlled trial in 121 children with doctor-diagnosed asthma and an acute presentation with asthma in the previous 12 months aged between 3 and 16 years. Children were randomized to one of three groups for a 6-month intervention receiving asthma education and management support from a Specialist Nurse by telephone or e-mail (N = 41), from IVR (N = 39), or receiving usual care (control group; N = 41). Outcomes included health care utilization and use of oral steroid rescue. Health-related quality of life (HRQOL) data using the Pediatric Asthma Quality of Life Questionnaire and Pediatric Quality of Life Inventory were collected at baseline and at the end of the study. Results: There was no statistically significant benefit identified for either the IVR or the Nurse Support interventions for health care utilization, use of oral steroid rescue, or HRQOL compared with controls. Relative to controls, the incremental costs were ?A$225.73 (95% confidence interval [CI]: ?A$840, A$391) per child for the Nurse Support intervention and ?A$451.45 (?A$1075, A$173) per child for IVR. The results were most sensitive to the frequency of admissions to hospital. Conclusion. This study suggested that both IVR and Nurse Support interventions may be cost-saving from a health system perspective, with IVR providing the greatest benefit and this pilot study provides a strong basis for developing larger trials with longer follow-up.     

A Randomized Controlled Trial of a CPR and Intubation Video Decision Support Tool for Hospitalized Patients

BACKGROUND

Decisions about cardiopulmonary resuscitation (CPR) and intubation are a core part of advance care planning, particularly for seriously ill hospitalized patients. However, these discussions are often avoided.

OBJECTIVES

We aimed to examine the impact of a video decision tool for CPR and intubation on patients’ choices, knowledge, medical orders, and discussions with providers.

DESIGN

This was a prospective randomized trial conducted between 9 March 2011 and 1 June 2013 on the internal medicine services at two hospitals in Boston.

PARTICIPANTS

One hundred and fifty seriously ill hospitalized patients over the age of 60 with an advanced illness and a prognosis of 1 year or less were included. Mean age was 76 and 51 % were women.

INTERVENTION

Three-minute video describing CPR and intubation plus verbal communication of participants’ preferences to their physicians (intervention) (N = 75) or control arm (usual care) (N = 75).

MAIN MEASURES

The primary outcome was participants’ preferences for CPR and intubation (immediately after viewing the video in the intervention arm). Secondary outcomes included: orders to withhold CPR/intubation, documented discussions with providers during hospitalization, and participants’ knowledge of CPR/ intubation (five-item test, range 0–5, higher scores indicate greater knowledge).

RESULTS

Intervention participants (vs. controls) were more likely not to want CPR (64 % vs. 32 %, p <0.0001) and intubation (72 % vs. 43 %, p < 0.0001). Intervention participants (vs. controls) were also more likely to have orders to withhold CPR (57 % vs. 19 %, p < 0.0001) and intubation (64 % vs.19 %, p < 0.0001) by hospital discharge, documented discussions about their preferences (81 % vs. 43 %, p < 0.0001), and higher mean knowledge scores (4.11 vs. 2.45; p < 0.0001).

CONCLUSIONS

Seriously ill patients who viewed a video about CPR and intubation were more likely not to want these treatments, be better informed about their options, have orders to forgo CPR/ intubation, and discuss preferences with providers.Trial registration: Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01325519","term_id":"NCT01325519"}}NCT01325519Registry Name: A prospective randomized trial using video images in advance care planning in seriously ill hospitalized patients.     

国产苯磺酸氨氯地平降压效果及安全性的多中心随机临床对照研究

目的　比较国产苯磺酸氨氯地平 (安内真 ) 5mg与进口苯磺酸氨氯地平 (络活喜 ) 5mg每天一次口服治疗原发性轻、中度高血压的有效性和安全性。方法　多中心、随机平行对照研究 ,98例轻、中度高血压患者被随机分入安内真组和络活喜组 ,分别每天一次口服安内真 5mg或络活喜 5mg ,2周后如坐位舒张压 >90mmHg或坐位收缩压 >14 0mmHg ,则改为安内真 10mg或络活喜 10mg、每天一次口服。结果　服药 2 ,4周时 ,安内真与络活喜两组平均舒张压和收缩压均明显下降 ,两组比较无明显差异 ;治疗 4周时两组控制血压的总有效率分别为 75 56% ,77 0 8% ,两组间无明显差异 ;不良反应事件发生率低 ,两组相似。结论　国产苯磺酸氨氯地平 (安内真 ) 5mg或 10mg每日一次治疗原发性轻、中度高血压安全有效 ,其疗效与进口苯磺酸氨氯地平 (络活喜 )等同