Effect Of Continuing Care Bundles In Health Outcome Of Patients With Preventive Enterostomy

Background:Globally, colorectal cancer (CRC) is the third most common type of cancer and the fourth leading cause of cancer-related death. In China, colorectal cancer is the fourth most common cancer, and the morbidity is obviously rising. According to the report from Guangzhou Center for Disease Control in 2012, the morbidity of colorectal cancer is 45/100,000 in Guangzhou, the morbidity rose to top two from the fifth, and the mortality rose to top three in recent ten years. Besides, most colorectal cancer in our country belongs to the low rectal cancer.Under the previous thought, patients with colorectal cancer which is less than 5 cm from anal edge, should undergo the abdominal perineal joint rectal cancer radical surgery (Miles). The surgery has a big trauma, removes the anus and create a permanent enterostomy in the abdominal wall which seriously damage the patient’s body image, physiological function, and quality of life.With the extensive development of the golden standard of total mesorectum excision of rectal cancer, application of neoadjuvant chemoradiation technology in the middle-late colorectal cancer patients, and the improvement of surgical technique and equipment, more and more patients with low and ultra-low rectal cancer can preserve their anus in the case of complete removal of the tumor. However, these patients have to face the risk of postoperative anastomotic leakage.Preventive enterostomy (also called temporary colostomy or protective intestinal colostomy) means to alleviate the intestinal pressure, and avoid the happening of anastomotic fistula, anastomotic fistula or intestinal contents pollution, the intestinal tube will be lifted to the abdominal wall, and the stoma plays a part of the export of waste. After the anastomotic stomach healing or fistula closed, the bowel function recovers, and the intestinal tube lifted to abdominal wall eventually will also incorporated into the abdominal cavity, patients can live a life like normal people after the fistula closed. Generally, stoma will be closed 3 to 6 months after the colostomy. Except those with rectal tumor is too close to the anal sphincter, anterior resection and preventive enterostomy is the preferred treatment for colorectal cancer surgery.At present, the contradiction between the limited medical resources and the huge medical needs is very intense, hospitalization days of surgical patients is increasingly shorten. Barring special circumstances, postoperative hospital stay of patients with anterior resection and preventive enterostomy is usually a week. In this short week, patients are not only forced to face the stoma and but to suffer trauma pain brought by the surgery itself, together with the body is still in recovery, patients are often reluctant to and cannot master the knowledge and skills about colostomy self-nursing very well. In 3 to 6 months after discharge to ostomy closure, patients and their family members should be at home and care the stoma by themselves. At this time because of the sudden interruption of useful information, professional medical care service, and the relationship between nurses and patients support, patients cannot care their stoma correctly, and this can lead to various effects. For example:(1)Affect the quality of life:Image damage, fecal incontinence, concern about the smell, social, travel restrictions, and the influence of sexual function, all this can have negative influence on daily life and social intercourse of the patients with stoma. (2)Effect on mental health:Colostomy people have to face great mental pressure in the early stage after operation, like depression, loneliness, and worries about whether the stoma can be closed smoothly, seriously damage the patients’ social mental health. (3)Aggravate the economic burden:Daily nursing colostomy itself will produce certain economic burden, if the colostomy is not cared properly, it can lead to repeated treatment, what’s worse, it will further increase the economic burden of patients, and cause the waste of medical resources. (4)Trigger complications:Colostomy stenosis, retraction, artificial fistula-induced hernia, irritant dermatitis and so on are very easy to appear after colostomy and undermine the patient’s physical health. The incidence rate of related complications of patients with preventive enterostomy was 43%, the fatality rate was 1%, the reoperation rate was 6%. (5) Affect the outcome of ostomy closure: Improper stoma care may leads to multiple complications, or even deteriorate the condition, the stoma can’t close as scheduled, or scheduled interval time extends, and even leads to ostomy closure failure, preventive enterostomy turns into permanent stoma, cause greater harm to patients.Therefore during the time from discharge to stoma shut down, patients’ acquaintance of self-care knowledge after colostomy is the key to seasonable ostomy closure, so it’s extremely important to carry out the normative and systemic continuing care to the patients. In 2003, The American Geriatrics Society defines transitional care as a set of actions designed to ensure coordination and continuity of healthcare as patients transfer between different locations or different care levels within the same location. Is a orderly, harmonious and continuous nursing care in the process of safe and timely assist patients to transfer from the hospital to the community.Continuing care is acknowledged as the essential elements of high quality health services which is crucial to health care workers, patients and their main caregivers. In recent years, scholars at home and abroad carried out extensive research on the continuing care of patients with permanent enterostomy, and provide continuing care to them through a variety of forms, promote patients’recovery, improve their quality of life. But there are few reports on continuing care improve the quality of life of patients with preventive enterostomy.The main forms of continuing care at present are telephone-based consuling, family follow-up, patients’ sodality, colostomy outpatient follow-up, network follow-up and communication etc. The carry out time, cycle, content, method and process of the above continuing care have no unified standard and lack of systemic and normative, and implementation condition in different places varies. Use one alone or a combination of several forms of continuing care? So far there is no clear basis.Care bundles also called Cluster treatment or Bundled treatment, is a kind of evidence-based treatment and nursing concept in recent years, which was first proposed by the American National Institutes of Health. Cluster is the collection of a series of evidence-based treatment and nursing measures, to deal with some kind of refractory clinical disorders, to help medical personnel provide patients with optimization health care service, and also an effective measure to improve medical quality and health outcomes of patients. Some studies have confirmed that continuing care is conducive to improve the self-efficacy and the quality of life of patients with chronic obstructive pulmonary disease in the stationary phase. Care bundles should contain 3 to 6 elements, each element is concrete, actionable, and clinical confirmed can improve patients’health outcomes. Care bundles can set the director, and have mutual complementation, collective enforcement is better than separate implementation in improving patients’ outcomes.Integrating evidence-based supported continuing care in the concept of care bundles has great significance to standardize the continuing nursing process, improve the quality of continuing care, improve patient health outcomes. Research on continuing care bundles’ application effect in preventive enterostomy patients’ health outcomes has not yet reported.Objective:Global purpose:To develop continuing care bundles plan, and evaluate the application effect of health outcomes of patients with preventive enterostomy.Specific objectives:(1) To investigate preventive enterostomy patients’ quality of life such as the status of health outcomes and its influencing factors, and develop targeted intervention plan according to the outcome of survey. (2) Formulate continuing care bundles plan which can provide basis for clinical implementation of scientific, standardized, effective continuing care. (3) Evaluation of application effect of continuing care bundles in the preventive enterostomy patients. (4) Finally improve the quality of continuing care, improve patients’ health outcomes, and improve patients’ quality of life, self-efficacy, reduce the incidence of colostomy related complications, ensure the closure of stoma on schedule, and enhance the patients’ satisfaction.Methods:Part 1 Survey on quality of life and associated factors in patients with preventive enterostomy.The object of study:1. With patients who have done anterior resection for rectal cancer and preventive enterostomy as the research objects. Collect corresponding cases of surgical wards in five Class A tertiary general hospitals in Guangzhou by adopting the method of convenience sampling, and study the corresponding cases.2. The content of the investigation:investigate social demographic data, general clinical data, use the Stoma Self-Efficacy Scale (SSES) to investigate the patients’ self-efficacy, use City of Hope-the Quality of Life-Ostomy Questionnaire (COH-QOL-OQ) to investigate the patients’ quality of life, and use the Perceived Social Support Scale (PSSS) to investigate the patients’ social support. Two enterostomy therapists diagnose patients’ ostomy-related complications at the same time.Part 2 Formulation of continuous care bundles plan1. Evaluation of consulting literature materialsCompare randomized controlled trials of conventional nursing and continuity care’s effect on patients with enterostomy; Observation indexes include quality of life, self-efficacy, self-care, colostomy complications and satisfaction.Retrieval strategy and screening methods:Retrieve PubMed, EMBASE, the Cochrane Library and Chinese journal full-text database (CNKI, WANGFAN DATA, and CQVIP). Retrieval words in Chinese "Continuity of care OR continued care OR extended care" AND "stoma". Retrieval words in English:" Continuity of nursing/care OR continuous nursing/care OR continuing nursing/care OR transitional nursing/care" OR "Family Caregiving" OR "follow-up care/nursing" OR "care/nursing after discharge" "post-discharge nursing/care" "telephone" OR "home/family visit" OR "telenursing/telecare" OR "handbook" AND "ostom* OR stoma* OR ileostom* OR colostom* OR enterostom*". Publication year:January 2000-December 2014. First do the text words retrieval and then do the manual retrieval for auxiliary. Two researchers read literature respectively to select the literature which in accordance with the inclusion criteria.2. Consultation of the expertsCriteria for selection of experts:(1) With colostomy therapist certification; (2) Bachelor degree or above; (3)Sub-senior professional title and above; (4)Be engaged in the clinical colostomy care formore than 10 years; (5) Have experience of continuity care.Evaluation standards:Consulting five experts about the practicability and feasibility of telephone-based counseling, family visits, outpatient visits, self-management manual application, patients sodality, informationlized follow-up and ask them to explain the rating reasons. Adopt the Likert Five Points scoring method. The continuing care elements whose total score is 4 points or above can be used as elements in final continuing care bundles plan.3. Evaluation of patientsUsing typical sampling method, a total of 20 patients with preventive enterostomy were extracted. Using the self-designed questionnaire survey to evaluate patients’ degree of willingness to accept the continuing care. Questionnaires including 7 items, using the Likert 5 score method, based on the patient’s subjective judgment and experience rating, according to the very not willing to, don’t want to, neutrality, willing, very willing to, respectively from 1 to 5 points. Higher scores, higher the degree of willingness.Part 3 Effect of continuing care bundles in health outcome of patients with preventive enterostomy1. The object of study:Patients who have done anterior resection of rectum for rectal cancer and preventive enterostomy.2. Recruiting of the objects studied:Using the method of convenience sampling to collect corresponding cases of surgical wards in five Class A tertiary general hospitals in Guangzhouand do clinical trial study.3. The method of grouping:To avoid interrelationship, distribute the six hospitals in accordance with patients’condition and medical care level and then separate them into three hospitals in intervention group and three hospitals in control group.4. The intervention methods:The control group adopts routine nursing. The intervention group accepts continuing care bundles on the basis of conventional nursing, colostomy self-management manual oriented, with periodic telephone follow-up based, with colostomy nursing as the important supplement of continuing care bundles.5. Evaluation index and method5.1 Investigation of baseline data:Use the self-made questionnaire to investigate two groups of social demographic data and the general clinical data. Adopt modified Barthel index evaluation table to evaluate ADL scores.5.2 Investigation of the effect index:Measure repeatedly and record patients’life quality, self-efficacy, and colostomy complications when discharge,1 month after discharge,3 months after discharge till endpoint and record the ostomy closure outcome. Evaluate patient satisfaction with continuing care.(1) Use the colostomy patients quality of life scale (Stoma-QOL) to evaluate quality of life. Chinese version has good reliability and validity, suitable for measuring colostomy patients’ quality of life in China.(2) Use colostomy patients self-efficacy Scale (the Stoma Self-Efficacy Scale, SSES) to evaluate colostomy patients’self-efficacy. Chinese version has good reliability and validity, suitable for measuring the colostomy patients’self-efficacy in China.(3) Stoma complications:Record patients’stoma complications conditions, including local necrosis of the stoma, peripheral skin irritation, stoma retraction stenosis, stoma mucosal prolapse, stoma hernia, intestinal obstruction, stoma bleeding and so on.(4) Ostomy closure outcome:The endpoint is after the closure of the stoma, and patients who have not done ostomy closure are observed till March 1st,2016 and record preventive enterostomy till interval of endpoints of intervals. The positive event is ostomy closure. If patients’ stoma did not close in the observation period as regarded are counted censored. Hourly basis is day.(5) Patients satisfaction:Adopt self-designed single item, let patients who accepted continuing care evaluate their satisfaction. Use the likert 5 level score method. The higher the score, the more satisfied.Results:Part 1 Quality of life and associated factors of patients with preventive enterostomy:A cross-sectional surveyThere are 135 cases which patients completed effective investigation. Respondents’ average age is 53.07±15.37 (19-84); 80 men (59.3%),55 women (40.7%).51 with colostomy (37.8),84 with ileostomy (62.2); 91 without ostomy-related complications (67.4),44 with ostomy-related complications (32.6).The quality of life of respondents with stomas is generally poor, the score was 5.397±1.578.The overall self-efficacy of the respondents was at a moderate level and scored 63.711±19.396, of which only 13.3% of the proportion of high levels of self-efficacy, the proportion of intermediate level and below was 86.7%.Respondents’ overall understanding social support level is high, scored 63.481±11.928, of which the proportion of high level was 62.2%.There was positive correlation between respondents’ life quality and self-efficacy (r= 0.659, P< 0.001), social support. (r= 0.417, P< 0.001). Multiple linear regression analysis showed that there is correlation between the quality of life and self-efficacy(B= 0.037, P< 0.001), and also between the types of colostomy(B= 0.568, P= 0.007), the model calibration R2= 0.481.Part 2 Formulation of continuing care bundles planBring three elements into continuing care plan which are telephone-based counseling, the application of enterostomy self-management manual and enterostomy outpatient visits. Finally plan that colostomy self-management manual oriented, takes telephone-based counseling as the main body, with colostomy nursing as important supplement of continuing care bundles.1. Guided by enterostomy self-management manualThis self-management manual used in this project is designed and verified by research group in the early stage (The design and verification process has been elaborated detailedly in a master’s degree paper). The necessity, rationality and feasibility of the manual got a high degree of recognition and evaluation by experts and patients with stoma.(1) Patients admitted to hospital within 24h were given self-management manual:Guided by the manual, instruct patients to read basic knowledge of enterostomy, stoma self-management knowledge, and daily management knowledge of stoma. (2) Formulate stoma self-management plan in the discharge stage:Formulate individualized stoma self-management plan with patients and their main caregivers within 24h before discharge and records detailedly on the stoma self-management manual. (3) After discharge continues to guide and supervise the execution of manual colostomy self-management solution.2. Take periodic telephone follow-up as the main bodyOn the third to seventh days, the fourteenth to twentieth days, and the eighty-seventh to ninetieth days after patients with enterostomy discharged from hospital, intervention personnel should give a call to the patients respectively, and the call should last for 10-20 minutes each time. Do telephone-based counseling in accordance with the telephone follow-up outline for enterostomy discharge and timely record intervention note list.3. Take ostomy specialist outpatient clinic as important supplementWhen giving discharge guidance, Repeatedly advise the patients and their main caregivers to go for enterostomy specialist outpatient service in the first month after discharging from hospital. Enterostomy therapists assess the patients and make an evaluation judgment, such as dealing with problems on site, instructing the patient some coping methods and matters needing attention after discharging, and write guidance in enterostomy self-management manual.Part 3 Effect of continuing care bundles in health outcome of patients with preventive enterostomy107 patients have completed the entire study, including 50 cases of intervention group, and 57 cases of control group. There are two groups of baseline.Shown by the results of analysis of repeated measurement of variance, the overall quality of life of intervention group is higher than that of the control group (F = 17.988, P< 0.001).The overall quality of life is affected by time factor (F= 16.898, P< 0.001), has improved significantly with the observation point migrating.General self-efficacy of intervention group is higher than the control group (F= 11.881, P= 0.001).General self-efficacy is affected by time factor (F= 11.324, P< 0.001) and has improved remarkably with the migration of observation point.The incidence rate of enterostomy complications in the two groups in discharge has no statistical difference (x2= 0.002, P= 0.965), in the first month after discharge(x2= 4.138, P= 0.042), and in three months after discharge(x2= 4.211, P= 0.040) sometimes have some statistical difference.Survival analysis shows that, the enterostomy closure of intervention group is better than the control group, and there is statistical significance(x2= 5.930, P= 0.015).Control group patients’ satisfaction score is 2.965± 0.844, intervention group was 3.660 ± 0.917, satisfaction scores of the two groups have statistically difference (t= 4.081, P< 0.001).Conclusion:1. Patients with preventive enterostomy have poor quality of life and self-efficacy. Most of the existing researches focus on patients with permanent enterostomy but ignore the need of the preventive enterostomy patients for continuing care. Health caregivers should give more attention to preventive enterostomy patients’ quality of life.2. The quality of life is related to self-efficacy, suggesting the future of health caregivers should focus on strengthening the care for the patients, their confidence of take responsibility of the self-care, improving their ability to overcome colostomy related difficulties, and formulate effective measures to encourage patients to participate in social activities, to increase social efficacy, in order to improve the preventive enterostomy patients’ quality of life.3. The quality of life of patients with ileostomy was lower than those patients with colostomy, prompting that health caregivers should notice preventive enterostomy patients, especially guidance and follow-up for preventive ileostomy patients, help and encourage them to take good care of ileostomy patients.4. Formulated the enterostomy self-management manual oriented, with periodic telephone-based counseling as the main body, and with colostomy nursing as important supplement of continuing care bundles plan.4.1 Telephone-based counseling is feasible, effective and low cost. It suggests that in the future clinical work, we should strengthen the man power, financial and material resources input and support of the telephone-based counseling to ensure patients with enterostomy can access telephone-based counseling of continuing care after discharge. Specific implementation should take corresponding measures to regulate telephone intervention time and cycle, and the telephone-based counseling nurses should undertake the necessary training.4.2 Enterostomy specialist outpatient clinic reflects advantages and characteristics of Guangzhou enterostomy nursing. Colostomy patients still consider face-to-face observation is one of the best way of continuing care. Guangzhou has rich resources of enterostomy outpatient service and ripe conditions, therefore, in addition to the use of telephone-based counseling, also should take enterostomy outpatient visit as an important supplement of continuing care.4.3 Enterostomy self-management manual is portable, practical and low-cost. Distributing enterostomy self-management manuals during hospitalization, regulating discharge guidance does good to help patients to master the knowledge and skills of enterostomy nursing, as well as helping to arouse the subjective initiative of patients, and providing patients with extended information support and psychological support. Enterostomy self-management manual has the characteristic of long-term preservation, convenient to carry, do not need special equipment to check at any time, and worth clinical promotion.5. Continuing care bundles can improve patients’health outcomes, and it’s scientific, practical, feasible, effective and worth popularization. Continuing care bundles uses scientific and reasonable enterostomy self-management manuals to provides practical knowledge and information about enterostomy to patients, and this guarantees the continuity of the effective information; Uses periodic telephone-based counseling, continue to keep track of the colostomy patients, and gives timely encouragement and guidance to ensure the continuity of a good nurse patient relationship; Go to the enterostomy specialist outpatient to do a supervision after discharge in the first month, ensure a comprehensive understanding of the rehabilitant of patients and the enterostomy, patients have problems shall be dealt on the spot, and guarantee the continuity of high quality care. Therefore, continuing care bundles can improve preventive enterostomy patients’ quality of life, self-efficacy, reduce the incidence of colostomy complications, improve the enterostomy closure and improve patient satisfaction. Confirmed by clinical research, continuing care bundles is scientific, reasonable and practical, feasible, effective and worth popularization.