A Pulmonary Rehabilitation Shared Decision Making Intervention

University Hospitals, Leicester144 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Shared Decision Making InterventionBEHAVIORAL

Decision coaching will be provided to the Pulmonary Rehabilitation Specialists to provide the skills needed to facilitate shared decision making between themselves and patients (and carers). The patient decision aid will be an informational booklet which describes the available Pulmonary Rehabilitation options at the University Hospitals of Leicester. It will detail the risks and benefits of each option and provide interactive sections to engage patients with the content, guide them through it, encourage them to attribute personal meaning and preference to each one so they can make an informed and values-based decision about PR.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, United Kingdom

Outcomes

Primary Outcomes

Response latency

Presence of bias between stimuli

Time frame: Baseline only

Feasibility of recruitment assessed by rate of recruitment to time and target

Recruitment to time (proposed study end date) and target (proposed sample size)

Time frame: Through study completion, an average of 1 year

Feasibility of data collection/outcome measures assessed by rate of participant attrition

Data completeness

Time frame: 1 year (end of study)

Intervention fidelity assessed by the Observer OPTION 5 Scale

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.

Time frame: 1 year (end of study)

Secondary Outcomes

Decisional conflict measured using the Decisional Conflict Scale

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.

Time frame: Baseline & immediately post intervention

Patient activation as measured by the Patient Activation Measure

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.

Time frame: Baseline & immediately post intervention

Data from ClinicalTrials.gov

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