The Development and Feasibility Testing of a Pulmonary Rehabilitation Shared Decision Making Intervention for Patients With Chronic Obstructive Pulmonary Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- University Hospitals, Leicester
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Feasibility of data collection/outcome measures assessed by rate of participant attrition
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •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%
Outcomes
Primary Outcomes
Feasibility of data collection/outcome measures assessed by rate of participant attrition
Time Frame: 1 year (end of study)
Data completeness
Intervention fidelity assessed by the Observer OPTION 5 Scale
Time Frame: 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
Time Frame: Baseline only
Presence of bias between stimuli
Feasibility of recruitment assessed by rate of recruitment to time and target
Time Frame: Through study completion, an average of 1 year
Recruitment to time (proposed study end date) and target (proposed sample size)
Secondary Outcomes
- 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)