A Pulmonary Rehabilitation Shared Decision Making Intervention
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Behavioral: Shared Decision Making Intervention
- Registration Number
- NCT04990180
- Lead Sponsor
- University Hospitals, Leicester
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 144
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Shared Decision Making Intervention Shared Decision Making Intervention The intervention is a shared decision making consultation supported by a patient decision aid and decision coaching for healthcare professionals.
- Primary Outcome Measures
Name Time Method Feasibility of data collection/outcome measures assessed by rate of participant attrition 1 year (end of study) Data completeness
Intervention fidelity assessed by the Observer OPTION 5 Scale 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 Baseline only Presence of bias between stimuli
Feasibility of recruitment assessed by rate of recruitment to time and target Through study completion, an average of 1 year Recruitment to time (proposed study end date) and target (proposed sample size)
- Secondary Outcome Measures
Name Time Method Patient activation as measured by the Patient Activation Measure Baseline & immediately post intervention The Patient Activation Measure is a self-reported, 13 item questionnaire with a 5 point Likert Scale. Raw scores are transformed to a scaled score between of 0-100 with 100 indicating the highest activation in self-management.
Health professionals attitudes/experiences assessed through qualitative interviews with study participants 1 year (end of study) Health professional attitudes/experiences of delivering the intervention
COPD Prem 9 Baseline & immediately post intervention The COPD Prem 9 is a self-reported, 9 item questionnaire with a 6 point Likert scale. Scores range from 0-45 with lower scores indicating better health-related quality of life.
Rate of attendance assessed by the proportion of participants who complete the intervention Baseline & immediately post intervention Intervention completion is termed as the number of participants who attend the shared decision making consultation.
Decisional conflict measured using the Decisional Conflict Scale Baseline & immediately post intervention The Decisional Conflict Scale is a self-reported, 16 item questionnaire with a 5 point Likert Scale with scores ranging from 0-64. The lower the score indicates lower decisional conflict.
COPD Assessment Test Baseline & immediately post intervention The COPD Assessment Test is a self-reported, 8 item questionnaire with a 6 point Likert Scale with scores ranging from 0-40. Higher scores indicate lower health-related quality of life.
Chronic Respiratory Questionnaire Baseline & immediately post intervention The Chronic Respiratory Questionnaire is a self-reported 20 item questionnaire using a 7 point Likert Scale. Scores range from 7-140 with higher scores indicating greater health-related quality of life.
Endurance Shuttle Walking Test Baseline & immediately post intervention Maximal exercise capacity test
Patient satisfaction with Pulmonary Rehabilitation assessed by internal hospital satisfaction questionnaire Baseline & immediately post intervention This is a 6 item open ended questionnaire exploring patient satisfaction with Pulmonary Rehabilitation. The text is analysed using qualitative research methods.
Incremental Shuttle Walking Test Baseline & immediately post intervention Maximal exercise capacity test
Patient attitudes/experiences of the study assessed through qualitative interviews with study participants 1 year (end of study) Patient attitudes/experiences of receiving the intervention
Uptake and adherence to Pulmonary Rehabilitation assessed by the proportion of participants who begin and complete Pulmonary Rehabilitation Baseline & immediately post intervention Completion is termed as participants who complete at least 8 of the available 12 sessions (75%).
Bristol COPD Knowledge Questionnaire Baseline & immediately post intervention The Bristol COPD Knowledge questionnaire is a multiple choice, 65 item self-reported questionnaire. Scores range from 0-65 with higher scores indicating greater knowledge of COPD.
Hospital Anxiety and Depression Scale Baseline & immediately post intervention The Hospital Anxiety and Depression Scale is a multiple choice, 14 item questionnaire using a 4 point Likert scale. Scores range from 0-42 with higher scores indicating greater levels of anxiety and/or depression.
Medical Research Council Dyspnoea Scale Baseline & immediately post intervention The Medical Research Council Dyspnoea Scale is a self-reported, 1 item questionnaire using a 5 point Likert Scale. Scores range from 1-5 with higher scores indicating greater perceived breathlessness.
Trial Locations
- Locations (1)
University Hospitals of Leicester NHS Trust
🇬🇧Leicester, Leicestershire, United Kingdom