A Pulmonary Rehabilitation Shared Decision Making Intervention

NCT ID: NCT04990180

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-14
• Study Completion Date: 2023-02-28

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Shared Decision Making Intervention

The intervention is a shared decision making consultation supported by a patient decision aid and decision coaching for healthcare professionals.

Group Type: EXPERIMENTAL

Shared Decision Making Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

Shared Decision Making Intervention

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.

Intervention Type: BEHAVIORAL

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

• 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

• 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

• 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:-

• 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:-

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals, Leicester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, United Kingdom

Countries

United Kingdom

References

Barradell AC, Doe G, Bekker HL, Houchen-Wolloff L, Robertson N, Singh SJ. A shared decision-making intervention for individuals living with chronic obstructive pulmonary disease who are considering the menu of pulmonary rehabilitation treatment options; a feasibility study. Chron Respir Dis. 2024 Jan-Dec;21:14799731241238428. doi: 10.1177/14799731241238428.

Reference Type: DERIVED

PMID: 39254860 (View on PubMed)

Other Identifiers

EDGE: 137907

Identifier Type: -

Identifier Source: org_study_id