Clinical trial NCT04990180: A Pulmonary Rehabilitation Shared Decision Making Intervention
Official title: The Development and Feasibility Testing of a Pulmonary Rehabilitation Shared Decision Making Intervention for Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Rehabilitation
Shared Decision Making
Patient Decision Aid
Decision Coaching
Implicit Association Test
Implicit Bias
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mixed methods observational and feasibility study
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

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%
* 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

Primary outcomes:
measure: Response latency
timeFrame: Baseline only
measure: Feasibility of recruitment assessed by rate of recruitment to time and target
timeFrame: Through study completion, an average of 1 year
measure: Feasibility of data collection/outcome measures assessed by rate of participant attrition
timeFrame: 1 year (end of study)
measure: Intervention fidelity assessed by the Observer OPTION 5 Scale
timeFrame: 1 year (end of study)
Secondary outcomes:
measure: Decisional conflict measured using the Decisional Conflict Scale
timeFrame: Baseline & immediately post intervention
measure: Patient activation as measured by the Patient Activation Measure
timeFrame: Baseline & immediately post intervention
measure: Rate of attendance assessed by the proportion of participants who complete the intervention
timeFrame: Baseline & immediately post intervention
measure: Patient attitudes/experiences of the study assessed through qualitative interviews with study participants
timeFrame: 1 year (end of study)
measure: Health professionals attitudes/experiences assessed through qualitative interviews with study participants
timeFrame: 1 year (end of study)
measure: Uptake and adherence to Pulmonary Rehabilitation assessed by the proportion of participants who begin and complete Pulmonary Rehabilitation
timeFrame: Baseline & immediately post intervention
measure: COPD Assessment Test
timeFrame: Baseline & immediately post intervention
measure: Bristol COPD Knowledge Questionnaire
timeFrame: Baseline & immediately post intervention
measure: Chronic Respiratory Questionnaire
timeFrame: Baseline & immediately post intervention
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline & immediately post intervention
measure: COPD Prem 9
timeFrame: Baseline & immediately post intervention
measure: Medical Research Council Dyspnoea Scale
timeFrame: Baseline & immediately post intervention
measure: Incremental Shuttle Walking Test
timeFrame: Baseline & immediately post intervention
measure: Endurance Shuttle Walking Test
timeFrame: Baseline & immediately post intervention
measure: Patient satisfaction with Pulmonary Rehabilitation assessed by internal hospital satisfaction questionnaire
timeFrame: Baseline & immediately post intervention
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
state: Leicestershire
Study officials:
References: