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Effect of Pharmacist Provided Drug Information Services After Hospital Discharge

2019년 6월 4일 업데이트: Tim Emil Vejborg, Region Hovedstadens Apotek

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.

연구 개요

상태

완전한

상세 설명

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.

연구 유형

중재적

등록 (실제)

250

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • København NV
      • Copenhagen, København NV, 덴마크, 2400
        • Capital Regions Hospital Pharmacy

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Control group
Participants in the control group received the normal care following the Danish standard procedure.
활성 비교기: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Sense of security regarding drug treatment and satisfaction with drug counseling.
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Number of medications by admission.
기간: Within one week after discharge.
Number of medications will be read in admission report.
Within one week after discharge.
Number of medications by discharge.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: Within one week after discharge.
The patient's journal will be searched for cause of hospitalization.
Within one week after discharge.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Tim E Vejborg, M.Sc.Pharm, Region Hovedstadens Apotek

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2018년 7월 12일

기본 완료 (실제)

2019년 6월 3일

연구 완료 (실제)

2019년 6월 3일

연구 등록 날짜

최초 제출

2019년 1월 22일

QC 기준을 충족하는 최초 제출

2019년 2월 1일

처음 게시됨 (실제)

2019년 2월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 6월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 6월 4일

마지막으로 확인됨

2019년 6월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • H-18003889

약물 및 장치 정보, 연구 문서

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미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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