Impact of Pharmacist-Led Intervention on Adult Oncology Outpatients
薬剤師主導の薬剤調整、カウンセリングおよびフォローアップが成人外来がん患者の服薬アドヒアランス、投薬過誤および薬剤関連入院に及ぼす影響
Background and Rationale: Cancer patients receiving outpatient therapy often manage complex medication regimens that include anticancer agents, supportive care medications, and treatments for chronic comorbidities. This polypharmacy greatly increases the risk of medication discrepancies, potential drug-drug interactions, and unintentional errors. Moreover, because most oncology care is delivered in outpatient settings, patients are primarily responsible for self-administering their medications, making adherence a key determinant of treatment success and patient safety (Lindenmeyer et al., 2022; Alshehri et al., 2024). Medication errors and poor adherence among oncology patients are widely recognized global concerns. Research indicates that nearly half of cancer patients experience at least one medication discrepancy during transitions of care, and nonadherence to oral anticancer therapies can exceed 40%. Such issues can result in reduced treatment efficacy, increased toxicity, avoidable hospitalizations, higher healthcare costs, and poorer quality of life (Weingart et al., 2018; Wu et al., 2020; Patel et al., 2021). Pharmacists, as essential members of the multidisciplinary oncology team, are uniquely positioned to address these medication-related challenges. Their pharmacotherapy expertise and patient-education roles enable them to detect discrepancies, optimize medication use, and enhance patient understanding of treatment regimens. Evidence from various healthcare settings shows that pharmacist-led interventions such as medication reconciliation, individualized counseling, and structured follow-up can improve medication safety and adherence (de Clercq et al., 2021; Boeni et al., 2022). Despite strong evidence supporting each of these interventions individually, few studies have examined the combined effect of pharmacist-led reconciliation, counseling, and follow-up in outpatient oncology practice. Adult cancer patients face additional challenges, including complex dosing schedules, emotional distress, and financial burdens, all of which can impair medication adherence. An integrated pharmacist led program may create a continuous safety net that detects medication discrepancies early, reinforces correct use, and sustains adherence throughout treatment (Gellad et al., 2022; ISPOR Report, 2023). Therefore, this study aims to evaluate the impact of a comprehensive pharmacist-led program encompassing medication reconciliation, individualized counseling, and systematic follow-up on enhancing medication adherence and reducing medication errors among adult outpatient cancer patients. Demonstrating the effectiveness of this integrated care model may provide strong evidence to support the routine inclusion of pharmacists in outpatient oncology services to improve patient outcomes and medication safety (Alshehri et al., 2024; Boeni et al., 2022).
Study Hypothesis: Adult oncology outpatients are frequently prescribed complex medication regimens upon leaving the hospital. Therefore, this study aims to evaluate whether a comprehensive pharmacist-led outpatient program improves medication adherence and reduces medication errors among this population.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Dr
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Cairo、Dr、エジプト、11829
- Badr University in Cairo
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Cairo、Dr、エジプト、11829
- National Cancer Institute, Cairo University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
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• Adult medical oncology outpatient at NCI, Cairo University with different diagnoses.
- Receiving ≥5 medication
Exclusion criteria:
- Cognitive impairment,
- Palliative care
- Language barriers
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:支持療法
- 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)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ:PH-LED
Pharmacist led intervention |
Medication Reconciliation, Counseling and Follow-Up |
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アクティブコンパレータ:ST- CARE
Standard care |
Counselling
他の名前:
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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 |
|---|---|---|
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medication adherence
時間枠:at baseline and after ONE MONTH
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• To measure medication adherence score in both groups using the Morisky (MMAS-8) scale at baseline and after one month to assess improvement in adherence after the pharmacist-led intervention compared to usual care where 8 = High adherence, 6 to <8 = Medium adherence ,<6 = Low adherence |
at baseline and after ONE MONTH
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Detection of medication errors
時間枠:Number of medication errors within ONE MONTH from baseline
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• To identify and detect the number of medication errors in both groups |
Number of medication errors within ONE MONTH from baseline
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- References: Alshehri, M., Althumairi, A., Alharbi, K., & Alharbi, F. (2024). The impact of pharmacist-led medication reconciliation on patient safety outcomes: A systematic review. International Journal of Medical Toxicology and Legal Medicine, 27(2), 87-95. Boeni, F., Spinatsch, M., Suter, K., Hersberger, K. E., & Arnet, I. (2022). Effectiveness of pharmacist-led counseling on medication adherence in cancer outpatients: A systematic review and meta-analysis. Journal of Oncology Pharmacy Practice, 28(5), 1123-1134. de Clercq, L., Van Camp, Y., De Winter, S., & Simoens, S. (2021). Pharmacist-led medication review and reconciliation in oncology: A scoping review. International Journal of Clinical Pharmacy, 43(4), 929-940. Gellad, W. F., Zhao, X., Thorpe, C. T., & Donohue, J. M. (2022). Pharmacist interventions to improve medication use and safety in oncology outpatients. BMC Health Services Research, 22(1), 1147. Hasen G, Negeso B. Patients Satisfaction with Pharmaceutical Care and Associated Factors in the Southwestern Ethiopia. Patient Prefer Adherence. 2021 Sep 21;15:2155-2163. doi: 10.2147/PPA.S332489. PMID: 34584408; PMCID: PMC8464365 ISPOR Report. (2023). Pharmacist-led interventions to improve medication adherence in cancer patients: A systematic review. Value in Health, 26(Suppl 1), S123-S131. Joy AM, UP N, Chand S, Shetty JK, George SM, Chacko CS, Joel JJ. Role of clinical pharmacist in the medication adherence behaviour of cancer patients: An interventional study. Le Pharmacien Hospitalier et Clinicien. 2021; 56:291-297. Lindenmeyer, A., Oliveira, T., Santos, R., & Mendes, E. (2022). Medication discrepancies among oncology patients: The importance of pharmacist involvement. Journal of Hospital Pharmacy Services, 9(3), 55-63. Patel, J., Wong, A., & Clark, C. (2021). Medication errors and patient outcomes in ambulatory oncology. American Journal of Health-System Pharmacy, 78(14), 1275-1282. Weingart, S. N., Brown, E., Bach, P. B., Engelhardt, K. E., Johnson, S
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- HOSPITAL2601-511-149-206
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
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