Effect of Pharmacist Provided Drug Information Services After Hospital Discharge
Effect of Pharmacist Provided Drug Information Services After Hospital Discharge: Patient Satisfaction and Sense Of Security Regarding Drug Treatment.
Objective:
The aim of this study is to evaluate if offering drug counseling from a hospital pharmacy increases patient satisfaction and sense of security regarding drug treatment after hospital discharge.
調査の概要
詳細な説明
Method and design:
This study was estimated to include 250 participants in a clinical randomized controlled trial. The participants were included from the Acute Medical Ward and the Department of Respiratory Medicine at Bispebjerg Hospital when discharged. The participants were randomized to one of two groups with unequal sizes: the control (50 participants) or intervention group (200 participants). This study used blocked randomization with block sizes of 5/10/15/20/25. The control group received the normal care following the Danish standard procedure. Participants in the intervention group also received the normal care but was also offered the possibility to contact a hospital pharmacy department by phone or mail and ask questions regarding drug-related issues.
Data for the primary outcome measures was collected 14 days after discharge through structured phone interviews. An interview guide with a semi-structured questionnaire and already validated questions were developed, pre-tested and optimized. The participants were asked to answer open-ended questions, closed-ended question and rate statements or questions on a five-point scale.
The participants in the control group were asked to answer 13 items (seven questions or statements on a five-point scale, four closed-ended questions and two open-ended questions).
The participants in the intervention group who did not make any queries were asked the same questions as the participants in the control group and additionally three closed-ended questions. A total of 16 items.
The participants in the intervention group who made queries were asked the same questions as the participants in the intervention group who did not make any queries and additionally five questions on a five-point scale, four closed-ended and one open-ended question. A total of 27 items.
The effect of the drug counseling regarding patient safety was evaluated by a pharmaceutical assessment in which it was assessed whether the drug counseling had potentially prevented a drug-related problem.
Quantitative data from the phone interviews will be analyzed in Microsoft excel with descriptive statistics and simple parametric statistics. An analysis will determine whether there is a difference in the primary outcome measures.
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
-
-
København NV
-
Copenhagen、København NV、デンマーク、2400
- Capital Regions Hospital Pharmacy
-
-
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:
- Patients discharged from the acute medical ward and department of respiratory medicine at Bispebjerg Hospital.
- Patients discharged to own home.
- Can speak the danish language.
- ≥18 years old.
- Can be contacted by phone.
Exclusion Criteria:
- Cognitive and communicative problems (e.g. dementia, aphasia, suicidal) or other barriers that unable the participant to use the intervention service.
- Patient does not answer phone within five attempts on five different days, when trying to conduct patient interview.
- Cognitive and communicative problems that unable the participant to answer questions in the patient interview.
- Deceased or readmitted before patient interview.
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）
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
Participants in the control group received the normal care following the Danish standard procedure.
|
|
|
アクティブコンパレータ：Intervention group
Participants in the intervention group received the normal care following the Danish stadard procedure.
Additionally the participants was also offered the possibility to contact a hospital pharmacy department by phone or mail for drug counseling.
|
Participants can contact a hospital pharmacy department by phone or mail and ask questions regarding drug-related issues.
|
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 |
|---|---|---|
|
Sense of security regarding drug treatment and satisfaction with drug counseling.
時間枠：2-4 weeks after discharge.
|
The questionnaire comprised closed-ended questions, open-ended questions and questions or statements where the respondents were asked to rate the questions or statements on a five-point scale.
The scale used is a attitude measurement scale that assess attitudes by presenting respondents with sentences that state beliefs about the particular attitude being measured.
The respondents then decide to what extent he or she agrees with the statement.
The responses are divided numerically into a series of ordered responses.
Ratings: 1 = not at all, 2 = to a small extent, 3 = to some extent, 4 = to a great extent, 5 = to a very great extent.
|
2-4 weeks after discharge.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of medications by admission.
時間枠：Within one week after discharge.
|
Number of medications will be read in admission report.
|
Within one week after discharge.
|
|
Number of medications by discharge.
時間枠：Within one week after discharge.
|
Number of medications will be read in discharge report..
|
Within one week after discharge.
|
|
Number of patients that received medication review by pharmacist during admission.
時間枠：Within one week after discharge.
|
The patient's journal will be searched for a medication review.
|
Within one week after discharge.
|
|
Number of patients that received help with medication at home after discharge.
時間枠：Within one week after discharge.
|
The patient's journal will be searched for information regarding help with medication at home.
|
Within one week after discharge.
|
|
Number of enquiries.
時間枠：Directly after the patient received drug counseling.
|
Patient enquiries will be classified to one of the predefined categories: adverse effects, choice of therapy, dosage and administration, interactions, product information, storage and handling, indication or other.
|
Directly after the patient received drug counseling.
|
|
Number of potentially prevented drug-related problems.
時間枠：Directly after the patient received drug counseling.
|
The pharmacist that performed the drug counseling assessed whether the drug counseling had potentially prevented a drug-related problem.
|
Directly after the patient received drug counseling.
|
|
Cause of hospitalization.
時間枠：Within one week after discharge.
|
The patient's journal will be searched for cause of hospitalization.
|
Within one week after discharge.
|
協力者と研究者
捜査官
- 主任研究者：Tim E Vejborg, M.Sc.Pharm、Region Hovedstadens Apotek
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
その他の研究ID番号
- H-18003889
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。