A Pulmonary Rehabilitation Shared Decision Making Intervention (PReSent)

The Development and Feasibility Testing of a Pulmonary Rehabilitation Shared Decision Making Intervention for Patients With Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Behavioral: Shared Decision Making Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE3 9QP
      • University Hospitals of Leicester NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Shared Decision Making Intervention; The intervention is a shared decision making consultation supported by a patient decision aid and decision coaching for healthcare professionals.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response latency	Presence of bias between stimuli	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)	Through study completion, an average of 1 year
Feasibility of data collection/outcome measures assessed by rate of participant attrition	Data completeness	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.	1 year (end of study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline & immediately post intervention
Rate of attendance assessed by the proportion of participants who complete the intervention	Intervention completion is termed as the number of participants who attend the shared decision making consultation.	Baseline & immediately post intervention
Patient attitudes/experiences of the study assessed through qualitative interviews with study participants	Patient attitudes/experiences of receiving the intervention	1 year (end of study)
Health professionals attitudes/experiences assessed through qualitative interviews with study participants	Health professional attitudes/experiences of delivering the intervention	1 year (end of study)
Uptake and adherence to Pulmonary Rehabilitation assessed by the proportion of participants who begin and complete Pulmonary Rehabilitation	Completion is termed as participants who complete at least 8 of the available 12 sessions (75%).	Baseline & immediately post intervention
COPD Assessment Test	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.	Baseline & immediately post intervention
Bristol COPD Knowledge Questionnaire	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.	Baseline & immediately post intervention
Chronic Respiratory Questionnaire	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.	Baseline & immediately post intervention
Hospital Anxiety and Depression Scale	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.	Baseline & immediately post intervention
COPD Prem 9	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.	Baseline & immediately post intervention
Medical Research Council Dyspnoea Scale	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.	Baseline & immediately post intervention
Incremental Shuttle Walking Test	Maximal exercise capacity test	Baseline & immediately post intervention
Endurance Shuttle Walking Test	Maximal exercise capacity test	Baseline & immediately post intervention
Patient satisfaction with Pulmonary Rehabilitation assessed by internal hospital satisfaction questionnaire	This is a 6 item open ended questionnaire exploring patient satisfaction with Pulmonary Rehabilitation. The text is analysed using qualitative research methods.	Baseline & immediately post intervention

Collaborators and Investigators

• Sponsor: University Hospitals, Leicester

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Actual): February 23, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Pulmonary Rehabilitation; Shared Decision Making; Patient Decision Aid; Implicit Bias; Implicit Association Test; Decision Coaching
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: EDGE: 137907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Direct access will be granted to authorised representatives from the Sponsor, host institution and the regulatory authorities to permit trial-related monitoring, audits and inspections- in line with participant consent.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No