Clinical Pharmacist-Led Bundled Care Model on Preventable Polypharmacy and Cost Avoidance
Impact of a Clinical Pharmacist-Led Bundled Care Model on Preventable Polypharmacy and Cost Avoidance Among Hospitalized Adults in Oman: A Prospective Randomized Controlled Study
This study aims to evaluate whether a clinical pharmacist-led bundled care model can improve medication use and health outcomes in hospitalized adult patients with preventable polypharmacy. Preventable polypharmacy refers to the use of multiple medications when some may no longer be necessary, may be inappropriate, or may increase the risk of medication-related harm.
Participants will be randomly assigned to receive either the pharmacist-led bundled care intervention in addition to usual hospital care or usual hospital care alone. The intervention includes comprehensive medication reconciliation, assessment of medication appropriateness, identification of potentially inappropriate medications, individualized deprescribing recommendations when appropriate, patient and caregiver education, discharge medication reconciliation, and follow-up after hospital discharge.
The study will compare important clinical outcomes between the two groups, including hospital readmissions, emergency department visits, adverse drug events, medication appropriateness, quality of prescribing, and healthcare costs. The findings will help determine whether integrating a clinical pharmacist-led bundled care model into routine hospital practice can improve patient safety, optimize medication use, and reduce unnecessary healthcare utilization.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
参加基準
適格基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adults aged 18 years or older.
- Admitted under an adult medical specialty at one of the participating hospitals.
- Receiving five or more regular medications at the time of hospital admission.
- Expected hospital stay of at least 48 hours.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Admission under obstetric, pediatric, or psychiatric services.
- Admission to an intensive care unit.
- Terminal illness with an expected survival of less than three months.
- Unable to provide informed consent and without an available legal representative.
- Declines participation in the study.
研究計画
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：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
アクティブコンパレータ：Control Arm: Usual Care
|
Participants randomized to the control arm will receive usual hospital care provided according to the standard practices of the participating institutions.
This includes routine medical and nursing care, medication prescribing and review by the treating healthcare team, and standard discharge processes.
No structured clinical pharmacist-led bundled care intervention, standardized comprehensive medication review, protocol-driven deprescribing, or post-discharge pharmacist follow-up will be provided as part of the study.
Clinical pharmacy services that are routinely available at the participating hospitals may be provided as part of usual care but will not follow the standardized intervention protocol.
|
|
アクティブコンパレータ：Intervention Arm: Clinical Pharmacist-Led Bundled Care
|
Participants randomized to the intervention arm will receive a structured clinical pharmacist-led bundled care model in addition to usual hospital care.
The intervention includes medication reconciliation at admission, comprehensive medication review, identification and resolution of medication-related problems, assessment of medication appropriateness using validated tools, deprescribing of potentially inappropriate medications when clinically indicated, dose optimization, evaluation of drug-drug interactions and medication safety, individualized pharmaceutical care planning, participation in multidisciplinary care with recommendations to the treating team, patient and caregiver medication counseling, discharge medication reconciliation, provision of an updated medication list, and post-discharge follow-up to reinforce medication adherence, identify medication-related problems, and optimize ongoing therapy.
All interventions will be delivered according to a standardized study protocol
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total Healthcare Cost Avoidance per Participant
時間枠：90 days after hospital discharge
|
The difference between the intervention and control groups in total healthcare cost avoidance per participant associated with the clinical pharmacist-led bundled care model. Total cost avoidance will include direct medication and investigation cost reductions and indirect costs avoided through prevention of adverse drug events, reduced hospital length of stay, and reductions in unplanned hospital readmissions and emergency department visits. Cost avoidance will be calculated using institutional healthcare utilization and costing data and standardized cost-avoidance values for accepted pharmacist interventions. |
90 days after hospital discharge
|
|
Prevalence of Preventable Polypharmacy at Hospital Discharge
時間枠：through study completion, an average of 1 week during admission
|
The proportion of participants with one or more unnecessary, inappropriate, duplicative, or potentially harmful medications at hospital discharge, compared between the pharmacist-led bundled care group and the usual-care group.
Preventable polypharmacy will be assessed using predefined clinical criteria, comprehensive medication review, and validated medication-appropriateness tools.
|
through study completion, an average of 1 week during admission
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Medications Deprescribed per Participant
時間枠：through study completion, an average of 1 week during admission
|
The number of unnecessary, inappropriate, duplicative, or potentially harmful medications discontinued following medication review.
Only deprescribing recommendations accepted and implemented by the treating medical team will be counted.
|
through study completion, an average of 1 week during admission
|
|
Incidence of Adverse Drug Events
時間枠：From hospital admission through 90 days after discharge
|
During the index hospitalization and at 90 days after hospital discharge
|
From hospital admission through 90 days after discharge
|
|
All-Cause Hospital Readmission
時間枠：30 days and 90 days after hospital discharge
|
The proportion of participants with at least one unplanned all-cause hospital readmission following discharge, compared between the intervention and control groups.
|
30 days and 90 days after hospital discharge
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Medication-Related Problems Identified and Resolved
時間枠：through study completion, an average of 1 week during admission
|
The number and type of medication-related problems identified by clinical pharmacists and the proportion resolved following acceptance and implementation of pharmacist recommendations.
|
through study completion, an average of 1 week during admission
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- 188/2026
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。