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A Pulmonary Rehabilitation Shared Decision Making Intervention (PReSent)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Shared Decision Making Intervention
Sponsored by
University Hospitals, Leicester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Rehabilitation, Shared Decision Making, Patient Decision Aid, Decision Coaching, Implicit Association Test, Implicit Bias

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals of Leicester NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Shared Decision Making Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Response latency
Presence of bias between stimuli
Feasibility of recruitment assessed by rate of recruitment to time and target
Recruitment to time (proposed study end date) and target (proposed sample size)
Feasibility of data collection/outcome measures assessed by rate of participant attrition
Data completeness
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.

Secondary Outcome Measures

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.
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.
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.
Patient attitudes/experiences of the study assessed through qualitative interviews with study participants
Patient attitudes/experiences of receiving the intervention
Health professionals attitudes/experiences assessed through qualitative interviews with study participants
Health professional attitudes/experiences of delivering the intervention
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%).
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.
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.
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.
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.
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.
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.
Incremental Shuttle Walking Test
Maximal exercise capacity test
Endurance Shuttle Walking Test
Maximal exercise capacity test
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.

Full Information

First Posted
July 14, 2021
Last Updated
May 11, 2023
Sponsor
University Hospitals, Leicester
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1. Study Identification

Unique Protocol Identification Number
NCT04990180
Brief Title
A Pulmonary Rehabilitation Shared Decision Making Intervention
Acronym
PReSent
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
February 23, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals, Leicester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Pulmonary Rehabilitation, Shared Decision Making, Patient Decision Aid, Decision Coaching, Implicit Association Test, Implicit Bias

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Mixed methods observational and feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shared Decision Making Intervention
Arm Type
Experimental
Arm Description
The intervention is a shared decision making consultation supported by a patient decision aid and decision coaching for healthcare professionals.
Intervention Type
Behavioral
Intervention Name(s)
Shared Decision Making Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response latency
Description
Presence of bias between stimuli
Time Frame
Baseline only
Title
Feasibility of recruitment assessed by rate of recruitment to time and target
Description
Recruitment to time (proposed study end date) and target (proposed sample size)
Time Frame
Through study completion, an average of 1 year
Title
Feasibility of data collection/outcome measures assessed by rate of participant attrition
Description
Data completeness
Time Frame
1 year (end of study)
Title
Intervention fidelity assessed by the Observer OPTION 5 Scale
Description
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 Outcome Measure Information:
Title
Decisional conflict measured using the Decisional Conflict Scale
Description
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
Title
Patient activation as measured by the Patient Activation Measure
Description
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
Title
Rate of attendance assessed by the proportion of participants who complete the intervention
Description
Intervention completion is termed as the number of participants who attend the shared decision making consultation.
Time Frame
Baseline & immediately post intervention
Title
Patient attitudes/experiences of the study assessed through qualitative interviews with study participants
Description
Patient attitudes/experiences of receiving the intervention
Time Frame
1 year (end of study)
Title
Health professionals attitudes/experiences assessed through qualitative interviews with study participants
Description
Health professional attitudes/experiences of delivering the intervention
Time Frame
1 year (end of study)
Title
Uptake and adherence to Pulmonary Rehabilitation assessed by the proportion of participants who begin and complete Pulmonary Rehabilitation
Description
Completion is termed as participants who complete at least 8 of the available 12 sessions (75%).
Time Frame
Baseline & immediately post intervention
Title
COPD Assessment Test
Description
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.
Time Frame
Baseline & immediately post intervention
Title
Bristol COPD Knowledge Questionnaire
Description
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.
Time Frame
Baseline & immediately post intervention
Title
Chronic Respiratory Questionnaire
Description
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.
Time Frame
Baseline & immediately post intervention
Title
Hospital Anxiety and Depression Scale
Description
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.
Time Frame
Baseline & immediately post intervention
Title
COPD Prem 9
Description
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.
Time Frame
Baseline & immediately post intervention
Title
Medical Research Council Dyspnoea Scale
Description
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.
Time Frame
Baseline & immediately post intervention
Title
Incremental Shuttle Walking Test
Description
Maximal exercise capacity test
Time Frame
Baseline & immediately post intervention
Title
Endurance Shuttle Walking Test
Description
Maximal exercise capacity test
Time Frame
Baseline & immediately post intervention
Title
Patient satisfaction with Pulmonary Rehabilitation assessed by internal hospital satisfaction questionnaire
Description
This is a 6 item open ended questionnaire exploring patient satisfaction with Pulmonary Rehabilitation. The text is analysed using qualitative research methods.
Time Frame
Baseline & immediately post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University Hospitals of Leicester NHS Trust
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE3 9QP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

A Pulmonary Rehabilitation Shared Decision Making Intervention

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