2011-01-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/646151摘要：國內外研究已顯示34-50%住院老年病患經歷心智、營養和日常活動功能的下降，老年病患功能的下降常導致疾病預後欠佳、生活品質不良及昂貴的醫療支出。在臺灣，接受腹部手術的老年病患已佔所有腹部手術之四成。重大手術對住院老年病患原已常見之功能下降更是雪上加霜，多數老年病患的心智、營養和日常活動功能，均在住院期間達到最低點。美國許多研究指出，內科老年住院病患的功能下降可藉由多元照護模式來有效預防，耶魯大學的 Hospital Elder Life Program (Yale-HELP) 是其中較成功可行的案例，然而對預防外科手術後老年住院病患功能下降之介入措施研究，則國內、外均明顯不足。本研究將以Yale-HELP為概念籃圖，配合本土需求，建立預防外科手術後老年住院病患功能下降之照護模式 (NTU-HELP)。研究目的是以隨機臨床試驗的方式來測試此一新型照護模式在預防手術後醫源性副作用發生和功能下降的成效；並藉此建立術後老年住院病患功能下降及功能變化趨勢的預測模式。研究將分四年以三階段進行： 階段I : 以第一年上半年時間，運用焦點團體方式來發展新型照護模式 (NTU-HELP) 之三大介入方案 ﹝定向感與認知刺激活動、營養進食協助、早期漸進式活動﹞ 及執行錦囊。階段II & 階段III: 以隨機、單盲、單中心、臨床試驗方式；測試新型照護模式 (NTU- HELP) 在減少醫源性副作用﹝術後譫妄、脫水、排氣時間、姿位性低血壓、最大吸氣量、握力﹞及預防功能下降﹝心智、營養和日常活動評分降低﹞之效能。研究將以外科四個病房單位，接受預定腹部直切手術之65歲以上住院病患為實驗對象，一旦符合收案標準且住院天數大於六日者，則在個案同意後予以收案。基礎術前評估完成後，個案將依胃部和腸部手術之不同，分層隨機納入實驗組或臨床常規組。實驗組在其住院期間，除常規外另給予標準化但個別性的護理介入措施 (定向感與認知刺激活動、營養進食協助、早期漸進式活動)，個案出院，手術後二、四、六周後將安排一次面對面追蹤評估；另外，在臨床常規組部分，個案接受臨床常規照護，但入院、出院、及手術後二、四、六周評估均將如實驗組方式進行。所有測量將由不知實驗組別之獨立測量人員執行。依據檢力分析及前置收案經驗，在第二、三、及第四年上半共兩年半期間，兩組將共有350名個案參與階段III研究﹝包含流失個案估計﹞。在階段II，以第一年下半年時間來進行規模為30名個案之前驅研究，此階段將使用完全相同於階段III的實驗設計進行，藉此修正及調整研究設計及介入方案，以確保階段III正式研究之高品質。預計在第四年下半完成所有個案追蹤及資料收集，並在第四年底，根據臨床試驗規範及intention-to-treat 原則分析及報告研究結果。分析將採Mixed Effects Analysis, Generalized Estimating Equations, and Regression Extension of Latent Class Analysis 來判別實驗組及臨床常規組在結果變項發生及改變的差異，並完成二項預測模式的建立，以提出此一新型照護模式 (NTU-HELP) 在接受腹部手術的臺灣老年病患之實證成效，以供日後建立及推動預防手術後老年病患功能下降之照護模式的臨床參考及政策依據。<br> Abstract: Studies have revealed that 34-50% of older patients experienced functional decline and function is by far the most important factor affecting quality of life and health care utilization in old age. To prevent functional decline, defined as a decrement in cognitive, nutritional, and activity of daily living (ADL) functions, the Hospital Elder Life Program (HELP) was developed at Yale University. The aim of this study is to evaluate a newly modified NTU-HELP, for the prevention of iatrogenic complications and functional decline during hospitalization and 6 weeks post surgery. Three specific aims will be accomplished; (1) develop up-to-date evidence-based protocol books of the NTU-HELP core intervention; (2) conduct a single-blind, one-center, randomized controlled trial to test the effects of NTU-HELP in preventing iatrogenic complications (postoperative delirium, posture hypotension, dehydration and compromised sustained maximal inspiration, hand grip strength and time to flatus) and minimizing functional decline {score reductions on mini-mental state examination (MMSE), min-nutritional assessment (MNA) and barthel index (BI)} in older patients during hospitalization and two, four, six weeks post elective midline incision abdominal surgery; and (3) establish predictive models of functional decline(defined by≧10% score reductions on MMSE, MNA, and BI from admission baseline) and functional trajectory (defined as changes in functional scores over multiple points in time). Phase I: Using a focus group approach, we will develop the protocol books and implantation kits for three major core interventions in the first half year from 1/2009-6/2009. Phase II & III: A prospective, single-blind, one-center randomized controlled trial (RCT) using a computer generalized randomization list with a block size of four, will be conducted to test the effects of NTU-HELP in preventing iatrogenic complications and functional decline in older patients from admission baseline (T0) to discharge (T1), two weeks (T2), four weeks (T3), and 6 weeks (T4) post surgery. In phase II, scheduled from 7/2009-12/2009, a pilot study of 30 subjects using identical study protocol will precede the full scope RCT to ensure the feasibility and quality of upcoming trial. Sample will be recruited consecutively from four surgical units, 9A, 9C, 7B, 6A, at NTU hospital with a target population of older patients aged 65 years and older who undergoing elective midline incision abdominal surgery with a length of stay over 6 days. Based on power analysis, a sample size of 350 is sufficient to reach 80% power of analysis. Stratified random assignment by the type of surgery (gastric versus colorectal) to the experimental or the usual care group will be performed to have the most precision of the intervention effect. Strict adherence to the resulting randomization will be ensured. The intervention consisted of a daily care protocol on three core interventions, orientation and cognitive stimulation, nutrition and hydration assistance, and early mobilization on top of hospital routine care. All interventions are tracked daily for full adherence and implementation and all the staff members receive regular performance review for quality assurance. Usual care consisted of standard hospital services and the same attending and resident physicians provide care to patients in both experimental and usual care groups. Data will be analyzed using the SAS statistical package version 9.1 and the R language version 2.6.2. The intention-to-treat principle will be used. Given the hierarchical nature of data, the mixed effects analysis will be performed to evaluate the effect of NTU-HELP. Additionally, Generalized Estimating Equation and Regression Extension of Latent Class Analysis will be performed to develop predictive models of functional decline and functional trajectory. This study will be the first to use a RCT design to test the effect of the HELP approach in preventing older surgical patients from iatrogenic complications and functional decline post surgery. Since more older patients presenting for major surgery, the findings of this study will have implications in both clinical practices and policy making.功能下降口腔衛生早期活動functional declineoral healthearly mobilisation