The Development and Feasibility Testing of a Pulmonary Rehabilitation Shared Decision Making Intervention for Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Feasibility of data collection/outcome measures assessed by rate of participant attrition
研究概览
简要总结
The PReSent study seeks to clarify the need, develop and test the feasibility and acceptability of a shared decision making intervention to support patients with Chronic Obstructive Pulmonary Disease make decisions about Pulmonary Rehabilitation. The study is split into two parts; (1) an observational study of healthcare professionals implicit attitudes, and (2) a feasibility and acceptability study assessing the value of the newly developed shared decision making intervention including a patient decision aid and decision coaching.
详细描述
Whilst Pulmonary Rehabilitation (PR) is an evidence-based intervention for patients with Chronic Obstructive Pulmonary Disease (COPD), the service suffers poor referral and uptake. One identified barrier to accessing PR at the University Hospitals of Leicester is healthcare professionals beliefs about patient motivation (e.g. believing patients to be unmotivated reduces their desire to offer PR). This shows healthcare professionals have conscious (explicit) bias but little is known about whether they also have unconscious (implicit) bias. It is important to measure this as it can also shape individuals attitudes and therefore referral behaviour.
The first objective of this study is to measure healthcare professionals implicit bias. Healthcare professionals from the United Kingdom who refer patients to PR will be invited to complete a one-off computerised Implicit Association Test, adapted to measure their bias towards the behaviours of patients living with COPD (i.e. smoking, exercising).
The second objective of this study is to test the feasibility and acceptability of a shared decision making intervention (a patient decision aid and decision coaching for PR specialists). Patients with COPD will receive the decision aid upon referral to PR and encouraged to use it to support their PR decision making. At their PR assessment they will engage in a shared decision making consultation with their trained PR specialist to decide on their preferred PR programme.
Following completion/drop out from PR, patients and trained PR specialists will be invited to take part in either a focus group (patients) or interview (PR specialist) to discuss the acceptability of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phase 1: Measuring Healthcare Professionals attitudes towards patients with COPD
- •Inclusion Criteria:
- •Willing and able to provide informed consent for participation in the research
- •A United Kingdom healthcare professional
- •A healthcare professional who has the capability to refer patients with COPD to Pulmonary Rehabilitation services
- •Male or female, aged 18+ years
- •Able to communicate in written and spoken English
排除标准
- •Unable to provide valid informed consent
- •Healthcare professionals practising outside of the United Kingdom
- •A healthcare professional who does not refer patients with COPD to Pulmonary Rehabilitation services
- •Aged <18 years
- •Unable to understand written English as the Implicit Association Test is currently only available in English
- •Phase 2: A Pulmonary Rehabilitation shared decision making intervention Patients:-
- •Inclusion Criteria:
- •Willing and able to give informed consent for participation in the research
- •Male or female, aged 40+years
- •A confirmed diagnosis of COPD, post bronchodilator Forced Expiratory Volume 1/Full Vital Capacity ratio <70%
- •Eligible for attendance at a University Hospitals of Leicester Pulmonary Rehabilitation assessment
- •Able to communicate in written and spoken English
- •Exclusion Criteria:
- •Unable to provide valid informed consent
- •Aged <40years
- •Primary diagnosis is another chronic respiratory condition.
- •Ineligible for attendance at a University Hospitals of Leicester PR assessment (e.g. significant comorbidity which limits exercise training
- •Unable to understand written English as the research information and shared decision making intervention is currently only available in English
- •Healthcare professionals:-
- •Inclusion Criteria:
- •A participant who is willing and able to give informed consent for participation in the research
- •A healthcare professional directly involved in the provision of the shared decision making intervention (e.g. a Pulmonary Rehabilitation specialist)
- •Male or female, aged 18+ years
- •Exclusion criteria:-
- •A participant who is unable to provide valid informed consent
- •A healthcare professional not directly involved in the provision of the shared decision making intervention
- •Aged <18 years
结局指标
主要结局
Feasibility of data collection/outcome measures assessed by rate of participant attrition
时间窗: 1 year (end of study)
Data completeness
Intervention fidelity assessed by the Observer OPTION 5 Scale
时间窗: 1 year (end of study)
This questionnaire is completed by the researcher when listening back to the shared decision making consultation audio recordings. It measures adherence to the principles of shared decision making. It is a 5 item questionnaire with a 4 point Likert Scale with scores ranging from 0-20. The higher the score the greater the adherence to the principles of shared decision making.
Response latency
时间窗: Baseline only
Presence of bias between stimuli
Feasibility of recruitment assessed by rate of recruitment to time and target
时间窗: Through study completion, an average of 1 year
Recruitment to time (proposed study end date) and target (proposed sample size)
次要结局
- Patient activation as measured by the Patient Activation Measure(Baseline & immediately post intervention)
- Health professionals attitudes/experiences assessed through qualitative interviews with study participants(1 year (end of study))
- COPD Prem 9(Baseline & immediately post intervention)
- Rate of attendance assessed by the proportion of participants who complete the intervention(Baseline & immediately post intervention)
- Chronic Respiratory Questionnaire(Baseline & immediately post intervention)
- Decisional conflict measured using the Decisional Conflict Scale(Baseline & immediately post intervention)
- COPD Assessment Test(Baseline & immediately post intervention)
- Endurance Shuttle Walking Test(Baseline & immediately post intervention)
- Patient satisfaction with Pulmonary Rehabilitation assessed by internal hospital satisfaction questionnaire(Baseline & immediately post intervention)
- Incremental Shuttle Walking Test(Baseline & immediately post intervention)
- Patient attitudes/experiences of the study assessed through qualitative interviews with study participants(1 year (end of study))
- Uptake and adherence to Pulmonary Rehabilitation assessed by the proportion of participants who begin and complete Pulmonary Rehabilitation(Baseline & immediately post intervention)
- Bristol COPD Knowledge Questionnaire(Baseline & immediately post intervention)
- Hospital Anxiety and Depression Scale(Baseline & immediately post intervention)
- Medical Research Council Dyspnoea Scale(Baseline & immediately post intervention)