- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01793220
Economic and Clinical Outcomes of Attendance in Psychosis Services Using SMS. (ECO APSS)
2013년 2월 14일 업데이트: Daniel Hayes, King's College London
Economic and Clinical Outcomes of Attendance in Psychosis Services Using SMS: The ECO APSS Randomized Controlled Trial
The aim of this research is to find out if mobile phone text message reminders of appointments can help to address missed appointments in Psychosis Community Services.
Another aim is to examine if fewer missed appointments result in clinical benefits for service users and in lower costs for Psychosis Community Services over a period of 6 months.
600 users from 2 London Psychosis Community Services will take part in this research.
Each participant will be put into one of two groups, as s/he joins the study: In the first (experimental) group, each participant will receive appointment reminders for 6 months (7 and 1 day/s before each appointment), starting with the first available opportunity upon joining the study.
In the second (control) group, each participant will not receive appointment reminders for 6 months.
The choice of group for each individual will be made at random by a computer.
Clinical information will be collected for 6 months from the time each participant joins the study, using, with his or her consent, their anonymised electronic medical records.
The following clinical information will be compared between the experimental and control groups: Attendance of appointments, number of inpatient admissions, number of days in inpatient care, number of inpatient admissions under the mental health treatment act, number of referrals to a home treatment team, number of times patient has changed medication, health and social functioning.
Service use, service costs and the cost-effectiveness of the reminder system will also be examined.
Towards the end of their participation, service users, as well as mental health professionals, will be invited to express their views, concerns and suggestions in relation to the reminder service by completing a brief anonymised (service users) or anonymous (staff) questionnaire
연구 개요
연구 유형
중재적
등록 (예상)
600
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Greater London
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London, Greater London, 영국, BR3 3BX
- South London and Maudsley NHS Foundation Trust
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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
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Be a user of Psychosis Community Services
- Manifest at least a basic level of comprehension of the study (including its nature, purpose, procedures and implications) prior to enrollment, and adequate capacity to consent, as assessed by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) scale.
- Own a mobile phone.
- Be willing to receive SMS reminders of appointments with the Psychosis Community Service.
- Provide written informed consent to participate in the study.
Exclusion Criteria:
- Is not a user of Psychosis Community Services.
- Cannot manifest at least a basic level of comprehension of the study (including its nature, purpose, procedures and implications) prior to enrollment, and/or adequate capacity to consent, as assessed by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) scale.
- Does not own a mobile phone.
- Is under 18 years of age.
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 |
|---|---|
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실험적: SMS Reminder
A text message reminder service will be sent 7 and 1 days(s) prior to the patients appointment at their Psychosis Community Service.
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A text message reminder service will be sent 7 and 1 days(s) prior to the patients appointment at their Psychosis Community Service.
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간섭 없음: No SMS Reminders
The service user will not be sent text message reminders prior to each appointment at their Psychosis Community Service
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Outcome of appointment (attended, missed, cancelled by the participant, cancelled by the service)
기간: From baseline to end of intervention (6 months)
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To assess differences in appointment attendance using online patient records in those who receive the SMS appointment reminders and those that do not
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From baseline to end of intervention (6 months)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Economic outcome: Use of Psychosis Services and impact on cost
기간: From baseline to end of intervention (6 months)
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Data on the use of services over the follow-up period will be combined with appropriate unit cost information (Curtis, 2011; Department of health, 2012).
Service costs will be compared between the experimental (SMS intervention) and control (No SMS intervention)groups.
Cost data often follow a skewed distribution and so bootstrap methods will be employed
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From baseline to end of intervention (6 months)
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Clinical outcome: Number of inpatient admissions
기간: From baseline to end of intervention (6 months)
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To assess differences in the number of inpatient admissions using online patient records in those who receive the SMS appointment reminders and those that do not
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From baseline to end of intervention (6 months)
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Clinical outcome: Number of days in inpatient care
기간: From baseline to end of intervention (6 months)
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To assess differences in number of days in inpatient care using online patient records in those who receive the SMS appointment reminders and those that do not
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From baseline to end of intervention (6 months)
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Clinical outcome: Number of inpatient admissions under the mental health treatment act
기간: From baseline to end of intervention (6 months)
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To assess differences in number of inpatient admissions under the mental health act using online patient records in those who receive the SMS appointment reminders and those that do not
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From baseline to end of intervention (6 months)
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Clinical outcome: Number of referrals to a home treatment team
기간: From baseline to end of intervention (6 months)
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To assess differences in the number of times a patient has been referred to a home treatment team, using online patient records (a crisis team who further support those with declining mental health) in those who receive the SMS appointment reminders and those that do not
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From baseline to end of intervention (6 months)
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Clinical outcome: Number of times patient has had changes to their medication
기간: From baseline to end of intervention (6 months)
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To assess differences in the number of times patient has had changes to their medication using online patient records in those who receive the SMS appointment reminders and those that do not
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From baseline to end of intervention (6 months)
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Clinical outcome: Level of health and social functioning, as reflected in the patient's score on the Health of the Nation Outcome Scales (HoNOS)
기간: Baseline and 6 months
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To assess differences in levels of health and social functioning in those who receive the SMS appointment reminders and those that do not
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Baseline and 6 months
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Economic outcome: cost effectiveness of the SMS intervention
기간: 1 year after baseline
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The cost of the actual intervention will be negligible given the extent of general SMS use.
However, there could be an impact on service costs and this will be estimated.
Data on the use of services over the follow-up period (see below for details) will be combined with appropriate unit cost information (Curtis, 2011; Department of health, 2012).
Cost-effectiveness will be assessed by combining the cost data with HoNOS scores using an incremental cost-effectiveness ratio.
Uncertainty around the cost-effectiveness estimates will be explored using cost-effectiveness planes and cost-effectiveness acceptability curves.
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1 year after baseline
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Views and suggestions of services users in relation to the SMS reminders
기간: 6 months (end of study participation)
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At the end of their participation, service users will be invited to complete an optional brief questionnaire (designed for the purposes of the study by the research team), to express their views, concerns and suggestions in relation to the SMS service.
This information will be collected in an anonymised format.
The questionnaires will be posted to the study participants, or alternatively, administered to them over the telephone or in person (whichever they prefer) by a research worker.
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6 months (end of study participation)
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Views and suggestions of mental health professionals in relation to the SMS reminders
기간: After the study has ended (1 year after 1st recruitment)
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At the end of ths study, staff from participating services will be invited to complete an optional brief questionnaire (designed for the purposes of the study by the research team), to express their views, concerns and suggestions in relation to the SMS service.
This information will be collected in an anonymous format.
The questionnaires will be given to staff and posted back to the researcher.
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After the study has ended (1 year after 1st recruitment)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Daniel P Hayes, MSc, King's College London
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
2013년 3월 1일
기본 완료 (예상)
2015년 3월 1일
연구 완료 (예상)
2015년 3월 1일
연구 등록 날짜
최초 제출
2013년 2월 14일
QC 기준을 충족하는 최초 제출
2013년 2월 14일
처음 게시됨 (추정)
2013년 2월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2013년 2월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2013년 2월 14일
마지막으로 확인됨
2013년 2월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ECOAPSS1
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