PICOT Proposal



Synthesis PaperPricilla PuenteUniversity of South FloridaAbstract Deep vein thrombosis (DVT) is a problem among many hospitalized patients. Many patients in the hospital are on a DVT prophylaxis medication, such as subcutaneous low molecular weight heparin (LMWH) to prevent post thrombotic syndrome and treat DVT. The researcher will be comparing the efficacy of nurse driven interventions, such as the use of sequential compression devices (SCDs) and ambulation versus bed rest to treat acute DVT and prevent post thrombotic syndrome (PTS). DVT treatment in hospitalized patients is important at Tampa General Hospital because if a patient contracts a post thrombotic syndrome related to the DVT at the hospital, the hospital is at risk of being for being sued for malpractice. Also, if a patient contracts a post thrombotic syndrome at the hospital, the patient may need to stay in the hospital longer to treat the pulmonary embolism (PE), for example, which puts a patient at risk for death. The search engine used was PubMed. Key words include deep vein thrombosis, pulmonary embolism, sequential compression devices, early ambulation, bed rest, and venous thromboembolism. Studies prove that compression and walking exercises reduce pain and swelling much faster and more effectively than bed rest does. They also reveal that there are not significant differences between bedridden and ambulant patients. This challenges the traditional dogma that bed rest should be used to treat acute DVT. Including the use of SCDs and early ambulation along with the use of LMWH to treat acute DVT and prevent PTS can prevent unintended further complications and longer hospital stays in the treatment of acute DVT at Tampa General Hospital. Synthesis Paper According to the Center for Disease Control and Prevention (2012), an estimated 300,000 to 600,000 American citizens are affected by deep vein thrombosis (DVT). About 33% of people with DVT will have a recurrence within 10 years and approximately 60,000-100,000 Americans die of DVT. DVT is a problem among many hospitalized patients in America. DVT treatment in hospitalized patients is important at Tampa General Hospital because if a patient contracts a post thrombotic syndrome (PTS) related to the DVT at the hospital, the hospital is at risk of being for being sued for malpractice. Also, if a patient contracts a PTS at the hospital, the patient may need to stay in the hospital longer to treat the pulmonary embolism (PE), for example, which puts a patient at risk for death. Many patients in the hospital are on a DVT prophylaxis medication, such as subcutaneous low molecular weight Heparin (LMWH) to prevent and treat DVT. Bed rest along with anticoagulation medications for treatment of acute DVT and to prevent PE has been recommended to prevent the dislodging of clots causing PE. Partsch (2005) believes that another reason bed rest is preferred is for the belief that pain and swelling would improve faster by immobilization. However, only a few studies question these beliefs and the amount of physical activity is not mentioned in study protocols. The researcher will be comparing the efficacy of nurse driven interventions, such as the use of SCDs and ambulation versus bed rest to treat acute DVT and prevent PTS. The goal for the review of literature is to discover, in patients with acute DVT, what is the efficacy of the use of sequential compression devices (SCDs) and ambulation versus bed rest to treat acute deep vein thrombosis (DVT) and prevent post-thrombotic syndrome upon discharge?Literature SearchThe search engine used to search for relevant literature was PubMed through the USF Health Shimberg Library’s website. The research librarian was a resource used to find reliable evidence based articles on PubMed. Some key terms used to search for evidence based studies and references include deep vein thrombosis, pulmonary embolism, sequential compression devices, early ambulation, bed rest, and venous thromboembolism. Literature ReviewFor the following studies, see the Literature Review table in Appendix A for a summary of all the studies being compared. Partsch and Warner (2000) evaluated the benefits of compression and walking compared to bed rest in the acute stage of proximal DVT. The method they included forty-five patients with proximal DVT who were randomized into three groups. The sample included one hundred forty-eight consecutive mobile patients older than 18 years with proximal DVT; the duration of their symptoms had to be less than 14 days. Patients were excluded if compression or heparin therapy had already started, if there was an indication for thrombolysis or thrombectomy, and if they had symptomatic pulmonary embolism or severe associated diseases. The design of this randomized control trial included three groups of treatment methods in patients with acute DVT. The three groups include Inelastic Unna boot bandages and walking exercises (group A), elastic compression stockings and walking (group B), and bed rest and no compression (group C). The results revealed that compression and exercises reduced pain and swelling faster and more effectively than bed rest did. Improvements of the clinical scores were significantly better in the ambulation groups compared with the bed rest group (p < 0.01). The progression of thrombi in the femoral vein occurred more frequently in the bed rest group than in the other two groups (p = not significant). According to Roumen-Klappe et al. (2009), inflammation plays a significant role in the development of PTS in patients with DVT. Roumen-Klappe et al. investigated whether increased levels of inflammatory markers in the acute phase of DVT are associated with the development of clinical PTS. Between 2002 and 2005 consecutive outpatients with symptomatic DVT, were considered for inclusion in the Post Thrombosis Study. Exclusion criteria were previous DVT, active malignancy, life expectancy <2 years, underlying infection, arterial insufficiency, use of anti-inflammatory meds, previous venous insufficiency, surgery, trauma or pregnancy in the 4 weeks prior to the DVT and the use of LMWH or oral anticoagulants before blood sampling. Participants were treated with LMWH and vitamin K antagonists for at least 3 months. They were asked to wear elastic stockings for at least 2 years. After 1 year patients were assessed by a dermatologist who was blind of the study. The severity of PTS was scored according to a clinical score scale which ranged from zero to six with class zero representing no visible or palpable signs of PTS. The results of this study revealed that inflammation plays a role in the development of PTS. The median number of days that stockings were worn during a week were 6.3 for patients with PTS (p = 0.63). The strengths of this source are a great background for the researcher’s PICOT question as the researcher is attempting to prove what nurse driven interventions are most effective in the treatment of DVT to prevent PTS. As a result of the Roumen-Klappe et al study, it is evident that inflammation does play a role in the development of PTS. Thus, the researcher can conclude that nurse driven interventions, such as application of sequential compression devices (SCDs), are useful to prevent inflammation which plays a role in PTS. In order to determine which nurse driven interventions are most effective in the treatment of DVT, the researcher must first understand the pathophysiologic process of deep vein thrombosis and the development of post-thrombotic syndrome. Aissaoui, Martins, Mouly, Weber, & Meune (2009) compared ambulation versus bed rest, in addition to anticoagulation in the management of DVT and PE in their study. The study compares the outcomes of patients with DVT, PE, or both, managed with bed rest versus early ambulation in addition to anticoagulation. Data regarding the incidence of new PE, new or progression of DVT, and death from all causes were used to calculate relative risks (RR) and 95% confidence intervals (CI). The outcome revealed that when compared to bed rest, early ambulation is not associated with a higher incidence of a new PE (RR 1.03; 95% CI 0.65-1.63; p = 0.90). Early ambulation is associated with a lower incidence of a new PE and DVT when compared to bed rest (RR 0.79; 95% CI 0.55-1.14; p = 0.21). Trujillo-Santos, et. al (2005) compared the clinical characteristics, details of anticoagulant therapy, and clinical outcomes of patients with and without strict bed rest prescribed during the first 15 days of diagnosis. The sample included 2,650 patients (DVT, 2,038 patients; PE, 612 patients) with confirmed, symptomatic acute DVT or PE. The 2,650 patients consisted of 1,118 men and 1,532 women, aged 14 to 98 years of age. Of the 2,650 patients, 1,050 DVT patients (52%) and 385 PE patients (63%) were prescribed strict bed rest. Patients were excluded if they were currently participating in a therapeutic clinical trial or if they were not available for follow-up. Patients with immobility prior to venous thromboembolism (VTE) development, initial thrombolytic therapy, massive PE, or recent bleeding were not included, as they were unable to be assigned to the walking group. All patients were followed up for the first three months. A commercial software package was used to calculate odds ratios (ORs) and corresponding 95% confidence intervals (CIs) and a p value of < 0.05 was considered to be statistically significant. The results revealed that new events of symptomatic, confirmed PE developed in 11 patients with DVT (0.5%) and 4 patients with PE (0.7%). Five of these 15 patients (33%) died as a result of their PE. There were no significant differences between bedridden and ambulant patients in terms of new PE events, fatal PE, or bleeding complications.According to the Scottish Intercollegiate Guidelines Network (2010), patients potentially at risk for VTE include patients undergoing surgery, medical patients, women who are pregnant, delivering, or in the puerperium, women on oral contraceptives and hormone replacement therapy, men and women undergoing undergoing long distance travel. The current clinical guidelines for management of VTE include assessment of clinical signs and symptoms of DVT and PE, use of validated clinical decision rule in initial assessment, use of D-dimer test, venous ultrasound for suspected DVT, chest x-ray, full clinical history and examination to detect underlying conditions contributing to thrombosis, initiation of treatment with LMWH, treatment with Warfarin, and the use of graduated compression stockings to prevent post-thrombotic syndrome. The guidelines do not mention anything about bed rest or ambulation to treat or prevent DVTs.SynthesisIn the clinical setting, it is the goal of healthcare providers to treat patients and prevent further complications during their stay in the hospital. It is Tampa General Hospital’s protocol to use SCDs as a method to prevent DVT in immobile patients. However, Tampa General Hospital has not addressed the use of compression devices as a treatment of acute DVT. According to Roumen-Klappe et al. (2009), it is evident that inflammation plays a role in the development of PTS as inhibition of inflammation decreases vein wall injury and stiffness; thus the relation between inflammation and PTS can also be influenced by other variables determining PTS, such as the use of compression devices, as the use of compression devices presents the development of PTS. In order to determine which nurse driven interventions are most effective in the treatment of deep vein thrombosis, researchers must first understand the pathophysiologic process of deep vein thrombosis, the role of inflammation, and the development of post-thrombotic syndrome. It is evident that nurse driven interventions such as the use of compression devices are useful for DVT treatment and prevention, especially to prevent PTS. However, the effectiveness of immediate ambulation or bed rest is still being determined. Symptoms of an acute DVT include severe pain (related to the thrombus) and swelling (related to the inflammation). Partsch and Werner (2000) proved that compression and walking exercises reduce pain and swelling much faster and more effectively than bed rest does. Trujillo-Santos et al. (2005) revealed that there are not significant differences between bedridden and ambulant patients. This challenges the traditional dogma that bed rest should be used to treat acute DVT. The studies reviewed suggest that early ambulation does not increase the risk for PE in patients with acute DVT. This may make it possible to increase the ambulatory treatment of patients with acute DVT upon discharge. Clinical RecommendationsThe approaches used in these studies offer a clinical pathway to address the question whether SCDs and early ambulation should be used in the treatment and prevention of an acute DVT. Including the use of SCDs and early ambulation along with the use of LMWH to treat acute DVT and prevent PTS can prevent unintended further complications and longer hospital stays in the treatment of acute DVT at Tampa General Hospital. Nurses are on the frontline of providing care to patients with acute DVT and need such findings on which to base their practice and clinical judgment. These studies are examples of how scientific knowledge, combined with clinical expertise, can contribute to better patient outcomes at Tampa General Hospital. References Aissaoui, N., Martins, E., Mouly, S., Weber, S., Meune, C. (2009). A meta-analysis of bed rest versus early ambulation in the management of pulmonary embolism, deep vein thrombosis, or both. International Journal of Cardiology, 137, 37-41. Center for Disease Control and Prevention. (2012). Deep vein thrombosis (DVT)/Pulmonary embolism (PE) –blood clot forming in a vein. Retrieved from . Scottish Intercollegiate Guidelines Network. (2010). Prevention and management of venous thromboembolism. A national clinical guideline. Retrieved from . Partsch, H. (2005). Immediate ambulation and leg compression in the treatment of deep vein thrombosis. Disease a Month, 51, 135-140. Partsch, H., and Werner, B. (2000). Compression and walking versus bed rest in the treatment of proximal deep venous thrombosis with low molecular weight heparin. Journal of Vascular Surgery, 32, 861-869. Roumen-Klappe, E.M., Janssen, M.C., Van Rossum, J., Holewijn, S., Van Bokhoven, M.M., Kaasjager, K., . . . Den Heijer, M. (2009). Inflammation in deep vein thrombosis and the development of post-thrombotic syndrome: A prospective study. Journal of Thrombosis and Hemostasis, 7(4), 582-587. doi: 10.1111/j.1538-7836Trujillo-Santos, J., Perea-Milla, E., Jimenez-Puente, A., Sanchez-Cantalejo, E., Toro, J., Grau, E., Monreal, M. (2005). Bed rest of ambulation in the initial treatment of patients with acute deep vein thrombosis or pulmonary embolism. CHEST, 127, 1631-1636. Appendix ATable A1Literature ReviewReferenceAimsDesign and MeasuresSampleOutcomes / statisticsPartsch and Werner (2000). Compression and walking versus bed rest in the treatment of proximal deep venous thrombosis with low molecular weight heparin. Journal of Vascular Surgery, 32(5), 861-869. To evaluate the benefits of compression and walking exercises in comparison with bed rest in the acute stage of proximal deep venous thrombosis (DVT). Randomized, unblended, control trial. Measures: Three groups of treatment modalities in patients with acute, symptomatic proximal DVT are compared.Inelastic Unna boot bandages + walking exercises (group A)Elastic compression stockings + walking (group B)Bed rest and no compression (group C)148 consecutive mobile patients older than 18 years with proximal DVT; duration of symptoms had to be less than 14 days. Patients were excluded if compression or heparin therapy had already started, if there was an indication for thrombolysis or thrombectomy, and if they had massive symptomatic pulmonary embolism or severe concomitant diseases. Compression and walking exercises reduce pain and swelling much faster and more effectively than bed rest does without a greater risk of pulmonary embolism. Improvement of the clinical scores was significantly better in the ambulation groups compared with the bed rest group (p < 0.01). Progression of thrombi in the femoral vein was greater and occurred more frequently in the bed rest group than in the other two groups (p = not significant). Roumen-Klappe et al. (2009). Inflammation in deep vein thrombosis and the development of post-thrombotic syndrome: a prospective study. Journal of Thrombosis and Haemostasis, 7, 582-587. To investigate whether increased levels of inflammatory markers in the acute phase of DVT are associated with the subsequent development of clinical post-thrombotic syndrome (PTS). All participants treated with LMWH and vitamin K antagonists for at least 3 months. They were instructed to wear sized-to-fit elastic stockings for at least 2 years. After 1 year patients were evaluated by an experienced dermatologist who was unaware of the results of the venous examination the severity of PTS was scored according to the clinical score (range 0-6). Class 0 represents no visible or palpable signs of PTS. Outpatients with symptomatic DVT, confirmed by compression ultrasound. Exclusion criteria were previous DVT, active malignancy, life expectancy <2 years, underlying infection, arterial insufficiency, use of anti-inflammatory meds, previous venous insufficiency, surgery, trauma or pregnancy in the 4 weeks prior to the DVT and the use of LMWH or oral anticoagulation before blood sampling. Patients with elevated inflammatory markers had a higher risk of developing PTS after 1 year. Inflammation might play a role in incomplete thrombus clearance, venous outflow obstruction and the future development of PTS. The median number of days that stockings were worn during a week were 6.3 for patients with PTS (p = 0.63). Aissaoui, N., Martins, E., Mouly, S., Weber, S., Meune, C. (2009). A meta-analysis of bed rest versus early ambulation in the management of pulmonary embolism, deep vein thrombosis or both. International Journal of Cardiology, 137, 37-41. To compare ambulation versus bed rest, in addition to anticoagulation, in the management of DVT and PE. Meta-analysis considers randomized control trials and prospective registries. Compared the outcomes of patients with DVT, PE, or both, managed with bed rest versus early ambulation in addition to anticoagulation. For each study, data regarding the incidence of new PE, new or progression of DVT, and death from all causes were used to calculate relative risks (RR) and 95% confidence intervals (CI). 5 studies included a total of 3048 patients.When compared to bed rest, early ambulation was not associated with a higher incidence of a new PE (RR 1.03; 95% CI 0.65-1.63; p = 0.90). Early ambulation was associated with a trend toward a lower incidence of a new PE and new or progression of DVT than bed rest (RR 0.79; 95% CI 0.55-1.14; p = 0.21) and lower incidence of new PE and overall mortality (RR 0.79; 95% CI 0.402-1.56; p = 0.50). Trujillo-Santos et al. (2005). Bed rest or ambulation in the initial treatment of patients with acute deep vein thrombosis or pulmonary embolism. CHEST 127:1631-1636. To compare the clinical characteristics, details of anticoagulant therapy, and clinical outcomes of enrolled patients with and without strict bed rest prescribed during the first 15 days. 15 day study.Of 2,650 patients, who entered the study, 1,050 DVT patients (52%) and 385 PE patients (63%) were prescribed strict bed rest. 2,650 patients (DVT, 2,038 patients; PE, 612 patients) with objectively confirmed, symptomatic acute DVT or PE. New events of symptomatic, objectively confirmed PE developed in 11 patients with DVT (0.5%) and 4 patients with PE (0.7%). Five of these 15 patients (33%) died as a result of their PE. There were not significant differences between bedridden and ambulant patients in terms of new PE events, fatal PE, or bleeding complications. ................
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