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MISSION COPD - Modern Innovative SolutionS in Improving Outcomes iN COPD (MISSION-COPD)

2016年9月26日更新者：Portsmouth Hospitals NHS Trust

MISSION COPD - Modern Innovative SolutionS in Improving Outcomes iN - COPD - A Comparison of Clinical Outcomes Before and After the MISSION Clinic.

MISSION is a new and novel way of delivering highly specialised Chronic Obstructive Pulmonary Disease (COPD) care and has the potential to change the way COPD care across the UK is delivered as well as services for other long term health conditions. The MISSION model has been piloted in asthma which is the subject of an ongoing research study. This is the first model of this type in COPD and the current research study aims to evaluate the outcomes of the project. This will be done in several different ways. The study is a mixed methods evaluation of the new service comparing outcomes before and after the clinic using retrospective data analysis and prospective qualitative interview. The study will be conducted at Portsmouth Hospitals NHS Trust and will recruit patients who attend MISSION COPD clinics as well as staff who attended MISSION clinics in a professional capacity.

調査の概要

状態

完了

条件

肺疾患、慢性閉塞性疾患

詳細な説明

The purpose of the study is to evaluate in detail the clinical and health economic outcomes from the MISSION COPD project. MISSION COPD is a quality improvement project funded by the Health Foundation, Foundation with additional funding from Pfizer, to trial an innovative way of finding and assessing patients with COPD and also case finding new diagnoses of COPD.

MISSION-COPD will allow swift early specialist multi-disciplinary interventions in primary care to diagnose and treat those at greatest risk, consistent with the NHS England '5-year Forward View' calling for removal of traditional primary and secondary care barriers. MISSION COPD will target COPD patients with risk factors for exacerbations and deteriorating lung function as well potential new diagnoses of COPD.

The aim of the study is to review the MISSION clinic model outcomes as well as performing qualitative interviews with patients who attended and staff who took part in the project.

Up to 150 patients who attend the MISSION COPD clinic will be recruited along with approximately 20 health care professionals. The number of patients has been decided as the number that can be seen for the project in the MISSION COPD project time and budget.

Participants will be either:

Patients who attend MISSION COPD clinics - identified as having uncontrolled or potentially severe COPD or unrecognised COPD from GP records by the MISSION clinical team
Health care professionals who attend the clinic in a clinical capacity.

Retrospective quantitative analysis of the data collected during the MISSION clinics will be analysed looking for COPD phenotypes and contributing co-morbidities. The data collected at the initial visit and 3 and 6 month follow up questionnaires will be analysed looking for improvement in COPD control and quality of life following the patients' attendance at MISSION clinics.

A self completion questionnaire will be filled in after the clinic by participants in the research study to assess their views on the clinic and where they would like changes to be made. A questionnaire will also be given to health care professionals to seek their views on the clinic.

Qualitative interviews will be conducted with a sample of participants, willing to take part, to explore the experiences and acceptability of the participants and health care professionals. The interviews with health care professionals will explore their thoughts on MISSION and its strengths and weaknesses as well as any suggestions for improvement.

This research is important as it will provide evidence to support the use of the MISSION clinic model for patients with COPD. It will also give us more information on the patient with COPD and any medical conditions related to their COPD so we can adapt our service to meet their needs.

The telephone and group interviews will help us understand what we are doing right and what we are doing wrong with COPD care.

研究の種類

観察的

入学 (実際)

114

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

イギリス
- Hampshire
  - Portsmouth、Hampshire、イギリス、PO6 3LY
    - Portsmouth Hospitals NHS Trust, Queen Alexandra 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

はい

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Participants will be patients who attend MISSION COPD clinics, identified as having uncontrolled or potentially severe COPD or unrecognised COPD from GP records by the MISSION clinical team or health care professionals who attend the clinic in a clinical capacity.

説明

Inclusion Criteria - Patients:

Male of Female, aged 18 years or above.
Attended the MISSION clinic as a patient.
Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria - Patients:

- The patient is unable or unwilling to give consent

Inclusion criteria - Health Care Professionals

Male or Female, aged 18 or above.
Attended the MISSION clinic as a health care professional
Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria - Health Care Professionals

- The health care professional is unable or unwilling to give consent

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

グループ/コホートの数

コホートと介入

グループ/コホート
Patients who attended the MISSION COPD clinics COPD patients who attended the MISSION COPD clinics, identified as having uncontrolled or potentially severe COPD or unrecognised COPD from GP records by the MISSION clinical team
Health Care Professionals Health Care Professionals who attended the MISSION COPD clinics in a professional/ clinical capacity.

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
COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days 時間枠：6 months previous	To assess whether the number COPD exacerbations (prednisolone or equivalent ≥30 mg for >3 days or antibiotics for >3 days) improves in MISSION patients in the 6 months after the clinic compared with the 6 months before.	6 months previous
COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days 時間枠：6 months	To assess whether the number COPD exacerbations (prednisolone or equivalent ≥30 mg for >3 days or antibiotics for >3 days) improves in MISSION patients in the 6 months after the clinic compared with the 6 months before.	6 months
Number of exacerbations of COPD that require hospital admission and treatment 時間枠：6 months previous	Number of exacerbations of COPD that require admission to hospital for treatment to assess whether hospital admissions change in the 6 months after the MISSION clinic	6 months previous
Number of exacerbations of COPD that require hospital admission and treatment 時間枠：6 months	Number of exacerbations of COPD that require admission to hospital for treatment to assess whether hospital admissions change in the 6 months after the MISSION clinic	6 months

二次結果の測定

結果測定	メジャーの説明	時間枠
COPD Assessment Test (CAT) Score 時間枠：baseline	patients will complete the CAT questionnaire to assess COPD control	baseline
COPD Assessment Test (CAT) Score 時間枠：3 months	patients will complete the CAT questionnaire to assess COPD control	3 months
COPD Assessment Test (CAT) Score 時間枠：6 months	patients will complete the CAT questionnaire to assess COPD control	6 months
St George's Respiratory Questionnaire (SGRQ) 時間枠：baseline		baseline
St George's Respiratory Questionnaire (SGRQ) 時間枠：3 months		3 months
St George's Respiratory Questionnaire (SGRQ) 時間枠：6 months		6 months
Number of non elective GP visits for COPD 時間枠：6 month previous	Number of non elective GP visits for COPD in the 6 months pre MISSION	6 month previous
Number of non elective GP visits for COPD 時間枠：6 months	Number of non elective GP visits for COPD in the 6 months post MISSION	6 months
Number of hospital admissions for COPD 時間枠：6 month previous	Number of hospital admissions for COPD in the 6 months pre MISSION	6 month previous
Number of hospital admissions for COPD 時間枠：6 months	Number of hospital admissions for COPD in the 6 months post MISSION	6 months
Number of Emergency Department contacts for COPD 時間枠：6 month previous	Number of Emergency Department contacts for COPD in the 6 months pre MISSION	6 month previous
Number of Emergency Department contacts for COPD 時間枠：6 months	Number of Emergency Department contacts for COPD in the 6 months post MISSION	6 months
Number of out of hour (OOH) attendances/contacts for COPD 時間枠：6 month previous	Number of out of hour attendances (OOH) contacts for COPD in the 6 months pre MISSION	6 month previous
Number of out of hour (OOH) attendances/contacts for COPD 時間枠：6 months	Number of out of hour attendances (OOH) contacts for COPD in the 6 months post MISSION	6 months
Global initiative in chronic Obstructive Lung Disease (GOLD) score 時間枠：Baseline	To assess the severity of COPD by GOLD and BTS stage in the MISSION clinics	Baseline
Measurement and variation of lung function. 時間枠：Baseline		Baseline
Assessment of eosinophilic airways inflammation 時間枠：Baseline	Assessment of eosinophilic airways inflammation by Fractional Exhaled Nitric Oxide (FeNO) Assessment.	Baseline
COPD controller medication 時間枠：6 months previous	COPD controller medication in 6 months pre MISSION.	6 months previous
COPD controller medication 時間枠：6 months	COPD controller medication in 6 months post MISSION.	6 months
Number of antibiotic courses without prednisolone for lower respiratory tract infections 時間枠：6 months previous	Number of antibiotic courses without prednisolone for lower respiratory tract infections in 6 months pre MISSION	6 months previous
Number of antibiotic courses without prednisolone for lower respiratory tract infections 時間枠：6 months	Number of antibiotic courses without prednisolone for lower respiratory tract infections in 6 months post MISSION	6 months
Short acting bronchodilator (SABA) use 時間枠：6 months previous	Short acting bronchodilator (SABA) use measured by number of inhalers prescribed in 6 months pre MISSION.	6 months previous
Short acting bronchodilator (SABA) use 時間枠：6 months	Short acting bronchodilator (SABA) use measured by number of inhalers prescribed in 6 months post MISSION.	6 months
Frequency and severity of co-morbidities 時間枠：Baseline	Frequency and severity of co morbidities including anxiety and depression, dysfunctional breathing, gastro oesophageal reflux and obstructive sleep apnoea in all patients.	Baseline
Medication adherence 時間枠：Baseline	Medication adherence will be measured at baseline	Baseline
Medication adherence 時間枠：3 months	Medication adherence will be measured at 3 months	3 months
Medication adherence 時間枠：6 months	Medication adherence will be measured at 6 months	6 months
Patient activation measure 時間枠：Baseline	Patients will complete the patient activation measure questionnaire at Baseline	Baseline
Patient activation measure 時間枠：3 months	Patients will complete the patient activation measure questionnaire at 3 months	3 months
Patient activation measure 時間枠：6 months	Patients will complete the patient activation measure questionnaire at 6 months	6 months
Investigations performed 時間枠：Baseline	Investigations performed at the MISSION COPD clinics (e.g. sputum induction, High-Resolution Computed Tomography (HRCT) chest).	Baseline
Hospital Anxiety and Depression Scale (HADS) score 時間枠：Baseline	HADS scores at baseline for patients attending the MISSION clinics	Baseline
Hospital Anxiety and Depression Scale (HADS) score 時間枠：6 months	HADS scores at 6 months for patients attending the MISSION clinics	6 months
Gastroesophageal Reflux Disease Questionnaire (GERDQ) score 時間枠：baseline	GERDQ scores at baseline for patients attending the Severe COPD Assessment Clinic (SCAC)	baseline
Gastroesophageal Reflux Disease Questionnaire (GERDQ) score 時間枠：6 months	GERDQ scores at 6 months for patients attending the Severe COPD Assessment Clinic (SCAC)	6 months
Assessment of inhaler technique and recommendations for inhaler devices. 時間枠：Baseline		Baseline
Smoking cessation advice 時間枠：Baseline		Baseline
The frequency of non-attendance at clinic 時間枠：Baseline	The frequency of non-attendance at the MISSION clinic	Baseline

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

Portsmouth Hospitals NHS Trust

協力者

Pfizer

捜査官

主任研究者：Professor Anoop J Chauhan、Portsmouth Hospitals NHS Trust

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

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

2015年9月1日

一次修了 (実際)

2016年8月1日

研究の完了 (実際)

2016年8月1日

試験登録日

最初に提出

2015年8月25日

QC基準を満たした最初の提出物

2015年8月25日

最初の投稿 (見積もり)

2015年8月28日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年9月27日

QC基準を満たした最後の更新が送信されました

2016年9月26日

最終確認日

2016年9月1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

PHT/2015/71

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。