| 摘要: | 最近專家共?已強?指出?床研究者應積極發展和執?有效的失智?人照護方案以評估和管?失 智?人的疼痛。然而截至目前為止，除?系?試驗介入措施 (the Serial Trial Intervention; STI)曾被提出 可用以評估和管?末期失智患者的未滿足需求外，長期照護?域仍缺乏整合型的疼痛評估與管?介入 方案。為彌補現存的研究缺口，本三?期的研究計畫將企圖發展一個含蓋多面向疼痛評估取徑模式， 及統合非藥物和疼痛藥物處置的新?床照護方案 (又稱疼痛確認和治?照護方案)；此外也進而比較此 方案和系?試驗介入措施及失智?人疼痛評估與管?教育計畫於改善疼痛確認與治?的成效。本計畫 將分成三大階段進?，第一階段 (第一?計畫) 的目的主在藉由綜合討? (Panel discussion) 探究系? 試驗介入措施於台灣機構?床執?的可?性；另並將以焦點團體 (Focus group) 瞭解機構照顧者、機構 負責人和?人學醫師三方對於機構執?疼痛藥物和非藥物處置的態?和接受?，並建議機構可?的疼 痛處置策?；此外也將?基於過往研究發現和文獻查證結果，採用德爾菲專家調查法確?本土可?的 疼痛確認與治?照護方案；在資?的分析上，將以內容分析法分析訪談結果，並以描述性統計分析樣 本特性及?字型的統計資?。第二階段 (第二?計畫) 的目的主在針對所需研究?表進?初步信、效 ?的驗證，並針對疼痛確認與治?照護方案和系?試驗介入措施進?前趨測試，以為後續大型介入方 案的進?作準備。前趨測試期預計將邀請?家失智專區的住民共72 位，和主要健康照顧者?與研究進 ?，在方案的進?中，除將先?對機構護?相關人員進?八小時熟悉方案的教育訓?外，也將組成跨 專業團隊為機構照顧人員提供咨詢服務，並於機構定期舉辦個案討?會。最後第三階段 (第三?計畫) 則採?實驗研究設計，於?所附有失智中心之養護中心進?方案介入計收案210 位住民，以比較疼痛 確認與治?照護方案 (實驗組一)、系?試驗介入措施 (實驗組二) 和失智?人疼痛評估與處置教育方 案 (控制組) 這三種方案對改善失智?人疼痛確認和治?困境的成效，資?的收集上則進?前測評估 及後測一個月、三個月和?個月的追蹤，再由機構層面、照顧人員層面和病人層面分析影響方案成效 的因子。於統計分析上將以描述性統計分析樣本特性，並以GEE 檢定?同介入方案於?同時間點的 成效，另也以HLM 檢視影響介入方案成效的因子。
Recently, there has been a strong expert consensus that clinical investigators should urgently develop and implement an effective protocol for assessing and managing pain for older people with dementia. However, until now, besides the Serial Trial Intervention (STI), an innovative clinical protocol developed for assessment and management of unmet needs in people with late-stage dementia, lack of integrated intervention protocol for better pain recognition and control in the long-term care facilities. Therefore, based on the current weakness, the three-year proposed study will attempt to develop a new clinical protocol, called the pain recognition and treatment protocol, consisted of multidimensional approach for pain assessment, different kinds of pain-relieving therapies for people with different level of cognitive impairment, and to examine and compare the effects of the new protocol (Experimental Group I), the STI (Experimental Group II) and the pain education program about pain assessment and management among demented older people (Control Group). This three-year proposal will be divided into three main phases. The aims of phase I (the first year) are 1) to use panel discussion for determining the feasibility of STI applying in Taiwan, 2) to use focus group data to develop recommendations for the reasonable use of non-pharmacological and pharmacological strategies on managing pain in demented people, and 3) to use Delphi method for developing a new comprehensive assessment and treatment protocol to recognize and treat pain. The interviews will be analyzed using content analysis methods, and descriptive statistics will be used to analyze demographic data and numeric data. The aims of phase II (the second year) are 1) to translate and validate some English-language instruments related to pain clues of demented people, and 2) to preliminarily test the feasibility of the new protocol and also the STI. 72 residents and their institutional caregivers will be recruited from 2 dementia special care units. Besides 8-hours educational training for making institutional caregivers familiar with the two protocols, an interdisciplinary team will be formulated for providing counseling and a regular case conference will be hold at each institution. Finally, the aims of phase III (the third year) are 1) to determine the effectiveness of the new protocol (Experimental Group I), the STI (Experimental Group II), and the pain education program (Control Group), and 2) to explore the factors influencing the effect of these approaches. A randomized controlled trial with measuring before treatment (baseline, T1), end of one month (T2), the end of three month, and the end of six month will be conducted. The 6 dementia special care units, including 210 residents, will be randomly assigned to each study group. Descriptive statistics will be used to analyze demographic data, and after controlling residents’ age and severity of dementia, GEE will be used to determine the differences of percentage of pain recognition, percentage of non-pharmacological and pharmacological strategies use, severity of symptoms related to pain, pain complication, hospital admissions and mortality. In addition, HLM will be used to determine the influence of the older people’s, caregivers’ characteristics and institutional characteristics. |
