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Drug-Related Problems and Healthcare Utilization Post-Hospital Discharge

2014年11月11日 更新者:Duke University

The Effect of Pharmacist-Provided Counseling Combined With Outpatient Dispensing at Hospital Discharge on the Incidence of Post-Discharge Drug-Related Problems and Healthcare Utilization

The goal of this study is to investigate whether pharmacist provided counseling and medication dispensing at the patient's bedside can provide better outcomes than the current discharge process at Duke University Hospital. This study will be single-site, prospective, randomized, cohort study. Patients who meet the inclusion and exclusion criteria, and provide consent will be included in this study.

調査の概要

詳細な説明

Two Adult General Medicine Services, which do not have a rounding pharmacist (RPh), will be identified by the investigators. Permission to approach the patients on each service will be obtained from the attending physician of each respective General Medicine Service at the beginning of each attending physician's time on service. The attending physician will be asked to communicate to the study personnel of situations in which patients should not be approached (i.e., patient has communicated disinterested in being approached about study participation opportunities and/or, in the opinion of the attending physician, the patient should not be approached).

Patients who will be recruited from pre-specified medical services will be screened for eligibility and, if deemed eligible, then will be approached by study personnel and asked if they would like to enroll in this study. If the patient accepts, written informed consent will be obtained and the patient will enter the study. Patients will be randomly assigned to either the intervention or control arm. Patients randomized to the intervention arm will receive discharge medications and pharmacist-provided discharge medication counseling prior to hospital discharge, and patients randomized to the control group will receive standard discharge procedures and obtain discharge medications per their usual process. After the patient has been enrolled in the study, study personnel will collect patient demographic data for study purposes, utilizing patient medical records and/or patient interviews. At discharge, patients will receive either the intervention or standard of care defined by the arm of the study to which each patient has been randomly assigned. After discharge, a maximum of seven attempts will be made via phone to contact all patients in both arms for follow up at 30 (+/- 7) days after discharge. During the follow phone call, a blinded pharmacist will conduct a structured interview to collect data for the study endpoints. The pharmacist conducting the interview will have the most recent discharge medication list (the list the patient received at his/her hospital discharge) from the patient's medication record to be used for comparison to the information gathered from the patient's interview 30 days post discharge.

Intervention Arm - After enrollment, a pharmacy technician not associated with the study will collect information necessary to process and fill the patient's discharge prescriptions by the Duke Outpatient Pharmacy. On the day of discharge, a pharmacist will perform a chart review and medication reconciliation on all patients' discharge medications (for patients randomized to the intervention arm). Any medication discrepancies will be addressed with the patient's primary care team. At the time of discharge, the patient will receive his/her discharge medications dispensed from the Duke Outpatient Pharmacy, along with medication counseling by a licensed pharmacist.

Control Arm - Patients will receive the standard discharge process provided by nurses and/or physicians. Patients will obtain outpatient medications per usual care.

Data Evaluation - After a patient has completed the phone follow up interview, two pharmacist co-investigators who have not been involved in the inpatient care of the patients will review the collected data to assess for adverse drug reactions and drug-drug interactions. When there is a disagreement between the pharmacists concerning the occurrence of an adverse reaction (including causality or severity), or a drug interaction (including severity), a third pharmacist co-investigator who was not involved in the inpatient care of the patient will review the patient's data to make a final decision concerning the disagreement. All patients who complete the follow up survey will be evaluated in this manner.

研究の種類

介入

入学 (実際)

44

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

    • North Carolina
      • Durham、North Carolina、アメリカ、27710
        • Duke University Hospital

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

18年歳以上 (大人、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:

  • Adult patients age 18 years or older scheduled for discharge to self-care from a Duke University Hospital Adult General Medicine Service that does not have a rounding pharmacist
  • Able to be contacted via phone within 30 days post-discharge
  • Able to speak and understand English
  • (For intervention patients) Have at least one prescription filled by Duke Outpatient Pharmacy and receive medication counseling by a pharmacist at the time of discharge
  • Of sufficient physical or mental capacity to provide informed consent, understand the medication counseling, manage their own medications, and answer the telephone questionnaire

Exclusion Criteria:

  • Patients receiving medication-related counseling from other pharmacists (e.g., transplant patients or new start warfarin patients) or other healthcare providers (e.g., diabetes educators) during their hospital stay and/or at time of hospital discharge
  • Patients without a telephone for follow up
  • Patients with hearing and/or visual impairment
  • Patients discharged to police custody
  • Patients who are likely to be discharged the same day as admission
  • Patients who, in the judgment of the Attending Physician, are not candidates for this study

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: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)

武器と介入

参加者グループ / アーム
介入・治療
実験的:RPh Counseling + Outpatient Dispensing
On the day of discharge, a pharmacist will perform a chart review and medication reconciliation on all patients' discharge medications (for patients randomized to the intervention arm). Any medication discrepancies will be addressed with the patient's primary care team. At the time of discharge, the patient will receive his/her discharge medications dispensed from the Duke Outpatient Pharmacy, along with medication counseling by a licensed pharmacist.
On the day of discharge, a pharmacist will perform a chart review and medication reconciliation on all patients' discharge medications (for patients randomized to the intervention arm). Any medication discrepancies will be addressed with the patient's primary care team. At the time of discharge, the patient will receive his/her discharge medications dispensed from the Duke Outpatient Pharmacy, along with medication counseling by a licensed pharmacist
アクティブコンパレータ:Routine Med Dispensing + Counseling
At hospital discharge, patients will receive standard discharge procedures and obtain discharge medications per their usual process
At hospital discharge, patients will receive standard discharge procedures and obtain discharge medications per their usual process

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
時間枠
Drug-related problems (composite of adverse drug reactions, drug interactions, and failure to receive drugs) during the first 30 days post-hospital discharge
時間枠:30 days post-hospital discharge
30 days post-hospital discharge

二次結果の測定

結果測定
メジャーの説明
時間枠
Healthcare utilization
時間枠:30 days post-hospital discharge
Number of emergency department visits, urgent care visits, and unanticipated visits to outpatient providers
30 days post-hospital discharge
Hospital readmissions
時間枠:30 days post-hospital discharge
Number of hospital readmissions
30 days post-hospital discharge
Treatment delays
時間枠:Within 24 hours after hospital discharge
Number of patients who experience treatment delays, defined as inability to obtain medications prescribed at discharge
Within 24 hours after hospital discharge

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:Paul W. Bush, PharmD, MBA、Department of Pharmacy, Duke University Hospital

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

2013年3月1日

一次修了 (実際)

2014年4月1日

研究の完了 (実際)

2014年5月1日

試験登録日

最初に提出

2013年3月5日

QC基準を満たした最初の提出物

2013年3月5日

最初の投稿 (見積もり)

2013年3月7日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年11月13日

QC基準を満たした最後の更新が送信されました

2014年11月11日

最終確認日

2014年4月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • Pro00042998

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。

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