Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting (TAPER-LTC)
2021年6月2日 更新者：Derelie Mangin、McMaster University
Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting: A Feasibility Randomized Controlled Trial
Medication side effects and interactions between medications are very common in older adults and are related to negative health outcomes.
In this study, the investigators will test a new process aimed at reducing unnecessary medication use and drug side effects in seniors using the best medical evidence and patient preferences for treatment.
This study will assess how feasible the implementation of this intervention is within a long-term care facility as well as if it is possible.
Participants in two long-term care facilities will participate in this study.
Measures will include feasibility outcomes regarding the logistics of the intervention as well as patients outcomes (falls, hospitalizations, and medications) collected before and after implementation.
This trial will be a randomized control trial with an adaptive trial design.
調査の概要
詳細な説明
There are substantial associations between polypharmacy and reduced function from older adults and this is likely to be important in frail older adults both in long term care and in the community.
The reversibility of drug-induced mobility impairment is unclear therefore the investigators plan to investigate signals of any impact of reducing polypharmacy on mobility.
The investigators chose the long-term care setting given the presence of complete medication administration records and this patient population's high prevalence of polypharmacy and risk of adverse drug events.
TaperMD is an electronic tool for systematic medication reduction that incorporates patient priorities, electronic screening for potentially harmful medicines,supporting evidence tools and a monitoring pathway to support medication reduction.
This study will examine the feasibility of this tool in a long-term care setting as well as examine.
Participants in two long-term care facilities will participate in this study.
Measures will include feasibility outcomes regarding the logistics of the intervention as well as patients outcomes (falls, hospitalizations, and medications) collected before and after implementation.
The study will be an adaptive trial design with two phases.
Phase 1 will be an internal pilot.
This will allow the investigators to re-evaluate and modify outcome measures and processes as necessary.
Phase 2 of this trial will allow for continuation after adjustments to the process or design has been made in a larger randomized controlled trial.
研究の種類
介入
入学 (実際)
15
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Ontario
-
Brampton、Ontario、カナダ、L6Y 5P2
- Holland Christian Homes - Faith Manor
-
Brampton、Ontario、カナダ、L6Y 5P2
- Holland Christian Homes - Grace Manor
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
70年歳以上 (高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- residing in 2 long-term care facilities in Brampton, ON
- on 5 or more long-term medications
- 70 years of age or older
- adequate English language
Exclusion Criteria:
- terminal illness or other circumstance precluding 6 month study period
- recent (within 12 months) comprehensive medication review
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：Control Group
Standard of Care as wait list control.
Control group will be offered intervention as part of usual clinical care at 6 months.
|
|
|
実験的：TAPER
The intervention is medication reduction. This arm is comprised of:
|
Systematic approach to reduction in polypharmacy
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Successful Discontinuation (Difference in mean number of medications; reduction in dose)
時間枠：6 months
|
Difference in mean number of medications; number of medications reduced in dose
|
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in level of cognition
時間枠：Baseline, 6 months
|
The Mini Mental Status Examination
|
Baseline, 6 months
|
|
Difference in level of quality of life
時間枠：Baseline, 6 months
|
EuroQol five dimensions questionnaire (EQ5D-5L) will measure quality of life.
Scores range from 0 (low quality of life) to 1 (high quality of life).
|
Baseline, 6 months
|
|
Difference in number of falls
時間枠：Baseline, 6 months
|
Total number of falls resulting in medication consultation or treatment recorded in hospital admission and primary care records, and by patient
|
Baseline, 6 months
|
|
Difference in level of sleep
時間枠：Baseline, 6 months
|
The sleep question on the 15-Dimensional (15-D) scale will be used.
Scores range from 1 (no sleep problems) to 5 (severe sleep problems).
|
Baseline, 6 months
|
|
Changes in medication side effects and symptoms (adverse)
時間枠：1-week, 3 months, 6 months
|
Patient self-report of appearance (new or worsening) of side effects associated with medications
|
1-week, 3 months, 6 months
|
|
Changes in medication side effects and symptoms (positive)
時間枠：1-week, 3 months, 6 months
|
Patient self-report of disappearance (improvement or disappearance) of side effects associated with medications
|
1-week, 3 months, 6 months
|
|
Difference in number of serious adverse events
時間枠：1-week, 3 months, 6 months
|
Any event that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death (Health Canada (2011) Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products)
|
1-week, 3 months, 6 months
|
|
Difference in level of physical functioning capacity and ability
時間枠：Baseline, 6 months
|
Time on the timed-up-and-go test
|
Baseline, 6 months
|
|
Difference in level of performance of activities of daily living
時間枠：Baseline, 6 months
|
Barthel Index will be used to measure performance of activities of daily living.
Ten activities are scored in terms of level of independence or assistance, with higher scores reflecting higher level of independent performance.
|
Baseline, 6 months
|
|
Difference in level of frailty
時間枠：Baseline, 6 months
|
The total score on the Edmonton Frail Scale will be used to measure frailty.
The scale included 11 items, with scores ranging from 0 (not frail) to 17 (severe frailty).
|
Baseline, 6 months
|
|
Difference in level of healthcare utilization use (hospitalizations)
時間枠：Baseline, 6 months
|
Number of hospitalizations
|
Baseline, 6 months
|
|
Difference in level of healthcare utilization use (emergency department visits)
時間枠：Baseline, 6 months
|
Number of emergency department visits
|
Baseline, 6 months
|
|
Difference in level of healthcare utilization use (physician visits)
時間枠：Baseline, 6 months
|
Number of physician visits
|
Baseline, 6 months
|
|
Enrollment rate
時間枠：6 months
|
Number of participants that enroll in study relative to number of participant invited to participant
|
6 months
|
|
Completion rate
時間枠：6 months
|
Number of participants that complete 6-month collection relative to number of participants enrolled
|
6 months
|
|
Time to complete measures
時間枠：Baseline, 6 months
|
Average duration of data collection appointments
|
Baseline, 6 months
|
|
Difference in level of mood
時間枠：Baseline, 6 months
|
The total score on the Geriatric Depression Scale (Short Form) will be used to measure mood.
The scale includes 15 yes/no items and score range from 0 to 15, with high scores indicating depression.
|
Baseline, 6 months
|
|
Difference in level of concern over falling
時間枠：Baseline, 6 months
|
The score on the Falls Efficacy Scale-International (Short Version) will be used to measure falling-related concerns.
The scale includes 7 items, with scores ranging from 7 (no concern) to 28 (severe concern of falling)
|
Baseline, 6 months
|
|
Difference in level of pain
時間枠：Baseline, 6 months
|
The Brief Pain Inventory (short form) will be used to measure pain severity (mean of 4 items, rated 0-10) and pain interference (mean of 7 items, rated 0-10).
Higher scores represent higher pain severity and interference.
|
Baseline, 6 months
|
|
Difference in level of incontinence
時間枠：Baseline, 6 months
|
Frequency of incontinence as recorded in patient electronic medical record
|
Baseline, 6 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Loved one's perspective of deprescribing
時間枠：6 months
|
Perspectives from focus groups
|
6 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Dee Mangin, MBChB, DPH, FRNZC, MD、McMaster University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2019年10月15日
一次修了 (実際)
2021年3月30日
研究の完了 (実際)
2021年3月30日
試験登録日
最初に提出
2019年8月12日
QC基準を満たした最初の提出物
2019年8月12日
最初の投稿 (実際)
2019年8月14日
学習記録の更新
投稿された最後の更新 (実際)
2021年6月7日
QC基準を満たした最後の更新が送信されました
2021年6月2日
最終確認日
2021年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Medication Reductionの臨床試験
-
University of North Carolina, Chapel HillMedical University of South Carolina; National Institute of Mental Health (NIMH); University of... と他の協力者完了HIV/エイズ | 服薬アドヒアランス | HIV | 性的行動 | 性感染症 (HIV や肝炎ではない)アメリカ
-
Fondazione Poliambulanza Istituto Ospedalieroわからない
-
Huazhong University of Science and Technologyまだ募集していません
-
Smiths Medical, ASD, Inc.完了