Guideline-based consultation to prevent anticoagulant-related bleeding. A randomized, controlled trial in a teaching hospital.

OBJECTIVE: To test the efficacy of consultation designed to prevent anticoagulant-related bleeding. DESIGN: Randomized, controlled trial. SETTING: A large teaching hospital. PATIENTS: A total of 101 patients at increased (greater than 15%) risk for major, in-hospital bleeding while starting long-term anticoagulant therapy who were identified using a validated prediction rule. INTERVENTIONS: Fifty-five patients received usual care under the direction of the attending physician who had initiated anticoagulant therapy. Forty-six patients received guideline-based consultation in addition to usual care. Guideline-based consultation included individualized review of the risks and benefits of anticoagulant therapy and, on the basis of current practice guidelines, recommendations for daily management. MEASUREMENTS: The main outcome was in-hospital bleeding, which was classified using a reliable, explicit index. RESULTS: Major or minor bleeding occurred in 17 of 55 patients (31%) receiving usual care alone, compared with 6 of 46 patients (13%) receiving consultation in addition to usual care (P = 0.03). The protective efficacy of consultation was 58% (95% CI, 3% to 82%). Consultation was associated with similar reductions in the frequencies of major bleeding (from 13% to 4%) and minor bleeding (from 18% to 9%). Consultative recommendations had an 84% compliance rate and directly affected anticoagulant management: In the consult group, nonsteroidal anti-inflammatory agents were stopped in six patients (13%), and therapeutic ranges were achieved more often for activated partial thromboplastin times (52% compared with 45% in the usual care group, P = 0.08) and for prothrombin times (47% compared with 27% in the usual care group, P less than 0.001). Nearly all housestaff and attending physicians (91%) for patients receiving consultation also reported that consultation improved housestaff learning. The consult group had a somewhat lower rate of thromboembolism in the 90 days after discharge (5% compared with 17%, P = 0.06). Death rates and mean lengths of stay were similar in the two groups. CONCLUSION: Guideline-based consultation was associated with reduction in the frequency of anticoagulant-related bleeding in patients at increased risk for major in-hospital bleeding.     

A randomized trial of a multicomponent home intervention to reduce functional difficulties in older adults

OBJECTIVES: To test the efficacy of a multicomponent intervention to reduce functional difficulties, fear of falling, and home hazards and enhance self-efficacy and adaptive coping in older adults with chronic conditions. DESIGN: A prospective, two-group, randomized trial. Participants were randomized to a treatment group or no-treatment group. SETTING: Urban community-living older people. PARTICIPANTS: Three hundred nineteen community-living adults aged 70 and older who reported difficulty with one or more activities of daily living. INTERVENTION: Occupational and physical therapy sessions involving home modifications and training in their use; instruction in strategies of problem-solving, energy conservation, safe performance, and fall recovery techniques; and balance and muscle strength training. MEASUREMENTS: Outcome measures included self-rated functional difficulties with ambulation, instrumental activities of daily living, activities of daily living, fear of falling, confidence performing daily tasks, and use of adaptive strategies. Observations of home hazards were also conducted. RESULTS: At 6 months, intervention participants had less difficulty than controls with instrumental activities of daily living (P=.04, 95% confidence interval (CI)=-0.28-0.00) and activities of daily living (P=.03, 95% CI=-0.24 to -0.01), with largest reductions in bathing (P=.02, 95% CI=-0.52 to -0.06) and toileting (P=.049, 95% CI=-0.35-0.00). They also had greater self-efficacy (P=.03, 95% CI=0.02-0.27), less fear of falling (P=.001, 95% CI=0.26-0.96), fewer home hazards (P=.05, 95% CI=-3.06-0.00), and greater use of adaptive strategies (P=.009, 95% CI=0.03-0.22). Benefits were sustained at 12 months for most outcomes. CONCLUSION: A multicomponent intervention targeting modifiable environmental and behavioral factors results in life quality improvements in community-dwelling older people who had functional difficulties, with most benefits retained over a year.     

A time-limited, problem-orientated psychotherapeutic intervention in Type 1 diabetic patients with complications: a randomized controlled trial.

AIMS: To examine the effects of a time-limited, problem-orientated psychotherapeutic intervention on self-defined psychological problems and metabolic control in Type 1 diabetic patients with microvascular complications. DESIGN: Randomized wait-list controlled trial with a follow-up of 6 months. SETTING: Out-patient clinic of a university diabetes centre. PARTICIPANTS: Forty-six Type 1 diabetic patients with intensified insulin therapy and presence of microvascular diabetic complications. Twenty-four patients were randomly allocated to the intervention group and 22 patients to the control group. INTERVENTION: Participation in a structured, problem-orientated, time-limited psychotherapeutic intervention (IG). The control group (CG) patients received routine diabetes care in a specialized diabetes university clinic. OUTCOME MEASURES: Degree of change of three self-defined main psychological and psychosocial problems (no. 1, no. 2 and no. 3) on a 1-10 graded scale and glycosylated haemoglobin HbA1c values. RESULTS: Two patients (one in each group) died during the study period. All remaining patients were followed for 6 months. Problem scores were high at baseline in both groups: IG/CG (mean values, standard deviation in parentheses): problem no. 1, 7.8 (2.0)/8.3 (1.7); problem no. 2, 7.7 (2.3)/7.6 (1.8); and problem no. 3, 7.7 (2.3)/7.4 (2.6). At follow-up, all problems were significantly lower in the intervention group (IG) when compared with the CG: IG/CG: problem no. 1, 4.3 (2.9)/6.8 (3.0), P = 0.03; problem no. 2, 3.9 (2.4)/5.8 (2.8), P = 0.03; problem no. 3, 4.7 (2.4)/6.8 (2.4), P = 0.02. Mean HbA1c decreased in the intervention group by 0.6 (1.2)% and increased in the control group by 0.1 (0.7)%, P = 0.016. In patients with suboptimal metabolic control, i.e. HbA1c > 8%, mean HbA1c decreased by 1.0 (1.2)% in the IG and increased by 0.1 (0.7)% in the CG, P = 0.011. CONCLUSION: A time-limited, structured, problem-orientated psychotherapeutic intervention decreases the severity of psychological problems and improves metabolic control in Type 1 diabetic patients with microvascular complications and self-management of intensified insulin therapy.     

Yoga to prevent mobility limitations in older adults: feasibility of a randomized controlled trial

Background

The loss of mobility during aging impacts independence and leads to further disability, morbidity, and reduced life expectancy. Our objective was to examine the feasibility and safety of conducting a randomized controlled trial of yoga for older adults at risk for mobility limitations.

Methods

Sedentary older adults (n?=?46; age 60–89) were recruited and randomized to either yoga or a health education comparison group. Yoga sessions (60-min) occurred 2x weekly, and 90-min health education sessions occurred weekly, for 10?weeks. The primary outcomes were recruitment rate, intervention attendance, and retention at assessments. Adverse event rates and participant satisfaction were also measured. Physical performance measures of gait, balance, and strength and self-report outcome measures were administered at baseline and 10-weeks.

Results

Recruitment lasted 6?months. Retention of participants at the 10-week follow-up was high (89% - performance measures; 98% - self-report questionnaires). Attendance was good with 82% of yoga and 74% of health education participants attending at least 50% of the sessions. No serious adverse events were reported. Patient satisfaction with the interventions was high. The mean effect size for the physical performance measures was 0.35 with some over 0.50. The mean effect size for self-report outcome measures was 0.36.

Conclusions

Results indicate that it is feasible to conduct a larger RCT of yoga for sedentary older adults at risk for mobility problems. The yoga and comparison interventions were safe, well accepted, and well attended. Effect sizes suggest yoga may have important benefits for this population and should be studied further.

Trial Registration

ClinicalTrials # NCT03544879; Retrospectively registered 4 June, 2018.

     

Use of tunneled femoral catheters to prevent catheter-related infection. A randomized, controlled trial.

BACKGROUND: The risk for catheter-related infection seems higher with femoral catheters than with catheters inserted at other sites. OBJECTIVE: To evaluate the effect of catheter tunneling on femoral catheter-related infection in critically ill patients. DESIGN: Randomized, controlled trial. SETTING: Three intensive care units at academic hospitals in Paris, France. PATIENTS: 345 adult patients requiring a femoral venous catheter for more than 48 hours. INTERVENTION: Tunneled or nontunneled femoral catheters. MEASUREMENTS: Time to occurrence of systemic catheter-related sepsis, catheter-related bloodstream infection, and quantitative catheter tip culture with a cutoff of 10(3) colony-forming units/mL. RESULTS: Of 345 randomly assigned patients, 336 were evaluable. Probable systemic catheter-related sepsis occurred in 15 of 168 patients who received a nontunneled femoral catheter (controls) and in 5 of 168 patients who received a tunneled femoral catheter (estimated absolute risk reduction, 6% [95% CI, 0.9% to 11%]). Time to occurrence of catheter-related bloodstream infection was not significantly modified (relative risk, 0.28 [CI, 0.03 to 1.92]; P = 0.18); 3 events occurred in the control group and 1 event occurred in the tunneled-catheter group. After stratification by treatment center and adjustment for variables that were prognostic (use of broad-spectrum antimicrobial agents at catheter insertion) or imbalanced between both groups (mechanical ventilation at insertion), tunnelized catheterization reduced the proportion of patients who developed systemic catheter-related sepsis (relative risk, 0.25 [CI, 0.09 to 0.72]; P = 0.005) and positive quantitative culture of the catheter tip (relative risk, 0.48 [CI, 0.23 to 0.99]; P = 0.045). CONCLUSION: The incidence of femoral catheter-related infections in critically ill patients can be reduced by using subcutaneous tunneling.     

Propranolol alone may not be acceptable to prevent first esophageal variceal bleeding in Japanese cirrhotic patients: randomized controlled trial

Background and Aim: In Japan, endoscopic injection sclerotherapy (EIS) is widely used to prevent first esophageal variceal bleeding, in contrast to pharmacological therapy which is the main treatment used in the rest of the world. The present study investigated if propranolol alone is acceptable to prevent first esophageal variceal bleeding in Japanese cirrhotic patients. This was compared with EIS. Methods: Twenty‐five Japanese cirrhotic patients with endoscopically proven, likely to bleed esophageal varices were randomly assigned for propranolol administration (12 patients; group A) and EIS (13 patients; group B) to prevent first esophageal variceal bleeding. Complications, non‐recurrence rate, bleeding rate and probability of survival were compared between the two groups. Results: One patient in group A had severe bradycardia with loss of consciousness that seriously worsened his quality of life. The cumulative non‐recurrence rate of group A was significantly lower compared with that of group B (P < 0.05). In group A, 2 of the 12 patients requested to discontinue taking propranolol and were excluded from the trial. The EIS treatment (group B) showed excellent results. No patient in group A or group B bled from esophageal varices throughout this study. The two groups showed no statistically significant differences in probability of survival. Conclusions: Propranolol alone may not be acceptable to prevent first esophageal variceal bleeding in Japanese cirrhotic patients.     

Primary care-based intervention to reduce at-risk drinking in older adults: a randomized controlled trial

Aims To examine whether a multi‐faceted intervention among older at‐risk drinking primary care patients reduced at‐risk drinking and alcohol consumption at 3 and 12 months. Design Randomized controlled trial. Setting Three primary care sites in southern California. Participants Six hundred and thirty‐one adults aged ≥ 55 years who were at‐risk drinkers identified by the Comorbidity Alcohol Risk Evaluation Tool (CARET) were assigned randomly between October 2004 and April 2007 during an office visit to receive a booklet on healthy behaviors or an intervention including a personalized report, booklet on alcohol and aging, drinking diary, advice from the primary care provider and telephone counseling from a health educator at 2, 4 and 8 weeks. Measurements The primary outcome was the proportion of participants meeting at‐risk criteria, and secondary outcomes were number of drinks in past 7 days, heavy drinking (four or more drinks in a day) in the past 7 days and risk score. Findings At 3 months, relative to controls, fewer intervention group participants were at‐risk drinkers [odds ratio (OR) 0.41; 95% confidence interval (CI) 0.22–0.75]; they reported drinking fewer drinks in the past 7 days [rate ratio (RR) 0.79; 95% CI 0.70–0.90], less heavy drinking (OR 0.46; 95% CI 0.22–0.99) and had lower risk scores (RR 0.77 95% CI 0.63–0.94). At 12 months, only the difference in number of drinks remained statistically significant (RR 0.87; 95% CI 0.76–0.99). Conclusions A multi‐faceted intervention among older at‐risk drinkers in primary care does not reduce the proportions of at‐risk or heavy drinkers, but does reduce amount of drinking at 12 months.     

Efficacy of a comprehensive geriatric intervention in older patients hospitalized for hip fracture: a randomized, controlled trial

OBJECTIVES: To evaluate whether an early multidisciplinary geriatric intervention in elderly patients with hip fracture reduced length of stay, morbidity, and mortality and improved functional evolution. DESIGN: Randomized, controlled intervention trial. SETTING: Orthopedic ward in a university hospital. PARTICIPANTS: Three hundred nineteen patients aged 65 and older hospitalized for hip fracture surgery. INTERVENTION: Participants were randomly assigned to a daily multidisciplinary geriatric intervention (n=155) or usual care (n=164) during hospitalization in the acute phase of hip fracture. MEASUREMENTS: Primary endpoints were in-hospital length of stay and incidence of death or major medical complications. Secondary endpoints were the rate of recovery of previous activities of daily living and ambulation ability at 3, 6, and 12 months. RESULTS: Median length of stay was 16 days in the geriatric intervention group and 18 days in the usual care group (P=.06). Patients assigned to the geriatric intervention showed a lower in-hospital mortality (0.6% vs 5.8%, P=.03) and major medical complications rate (45.2% vs 61.7%, P=.003). After adjustment for confounding variables, geriatric intervention was associated with a 45% lower probability of death or major complications (95% confidence interval=7-68%). More patients in the geriatric intervention group achieved a partial recovery at 3 months (57% vs 44%, P=.03), but there were no differences between the groups at 6 and 12 months. CONCLUSION: Early multidisciplinary daily geriatric care reduces in-hospital mortality and medical complications in elderly patients with hip fracture, but there is not a significant effect on length of hospital stay or long-term functional recovery.     

A randomized controlled trial of a multifactorial falls prevention intervention for older fallers presenting to emergency departments

OBJECTIVES: To investigate the effect of a referral‐based targeted multifactorial falls prevention intervention on the occurrence of recurrent falls and injuries in older people presenting to an emergency department (ED) after a fall and discharged directly home from the ED. DESIGN: Randomized controlled trial. Assessors of outcomes were unaware of group allocation. SETTING: Seven EDs in metropolitan Melbourne, Australia. PARTICIPANTS: Inclusion criteria were community dwelling, aged 60 and older, presenting to an ED after a fall, and discharged directly home. Exclusion criteria were unable to follow simple instructions or walk independently. INTERVENTION: Targeted referrals to existing community services and health promotion recommendations, based on the falls risk factors found in a baseline assessment. MEASUREMENTS: Primary outcome measures were falls and resultant injuries occurring over the 12‐month follow‐up period. Falls and injury data were collected using falls calendars supported by medical record reviews. RESULTS: Three hundred sixty‐one participants were randomized to the standard care group and 351 to the intervention group. No significant difference was found between the two groups over the 12‐month follow‐up period in number of fallers (relative risk (RR)=1.11, 95% confidence interval (CI)=0.95–1.31] or number of participants sustaining an injury from a fall (RR=1.06, 95% CI=0.86–1.29). CONCLUSION: This study does not support the use of a referral‐based targeted multifactorial intervention program to reduce subsequent falls or fall injuries in older people who present to an ED after a fall.     

A theory-based intervention to promote medication adherence in patients with rheumatoid arthritis: A randomized controlled trial

Clinical Rheumatology - Adherence to prescribed medication regimens is fundamental to the improvement and maintenance of the health of patients with rheumatoid arthritis. It is therefore important...     

Recombinant factor VIIa for variceal bleeding in patients with advanced cirrhosis: A randomized, controlled trial

A beneficial effect of recombinant activated factor VII (rFVIIa) in Child-Pugh class B and C patients with cirrhosis who have variceal bleeding has been suggested. This randomized controlled trial assessed the efficacy and safety of rFVIIa in patients with advanced cirrhosis and active variceal bleeding. At 31 hospitals in an emergency setting, 256 patients (Child-Pugh > 8; Child-Pugh B = 26%, C = 74%) were randomized equally to: placebo; 600 microg/kg rFVIIa (200 + 4x 100 microg/kg); or 300 microg/kg rFVIIa (200 + 100 microg/kg). Dosing was intravenous at 0, 2, 8, 14, and 20 hours after endoscopy, in addition to standard vasoactive, prophylactic antibiotic, and endoscopic treatment. The primary composite endpoint consisted of failure to control 24-hour bleeding, or failure to prevent rebleeding or death at day 5. Secondary endpoints included adverse events and 42-day mortality. Baseline characteristics were comparable between groups. Administration of rFVIIa had no significant effect on the composite endpoint compared with placebo (P = 0.37). There was no significant difference in 5-day mortality between groups; however, 42-day mortality was significantly lower with 600 microg/kg rFVIIa compared with placebo (odds ratio 0.31, 95% confidence interval = 0.13-0.74), and bleeding-related deaths were reduced from 12% (placebo) to 2% (600 microg/kg). A marked heterogeneity in the failure rate in all treatment groups was observed across participating centers. Adverse events, including overall thromboembolic events, were comparable between groups. CONCLUSION: Treatment with rFVIIa had no significant effect on the primary composite endpoint compared with placebo. Therefore, decision on the use of this hemostatic agent in acute variceal bleeding should be carefully considered, because results of this study do not support the routine use of rFVIIa in this setting. Adverse events were comparable across groups.