Pulmonary Disease, Chronic ObstructivePReSentNCT04990180
A Pulmonary Rehabilitation Shared Decision Making Intervention
A study testing Shared Decision Making Intervention in people with Pulmonary Disease, Chronic Obstructive, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Shared Decision Making Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jun 2021to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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:-
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE3 9QP
About this study
Official title: 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.
Read the 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
- Being tested
- Shared Decision Making Intervention
- Keywords
- Pulmonary Rehabilitation, Shared Decision Making, Patient Decision Aid, Decision Coaching, Implicit Association Test, Implicit Bias
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bias, Implicit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Decision Making InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Shared Decision Making Intervention | Experimental | The intervention is a shared decision making consultation supported by a patient decision aid and decision coaching for healthcare professionals. Receives: Behavioral: Shared Decision Making Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response latency
Presence of bias between stimuli
Measured: 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)
Measured: Through study completion, an average of 1 year
Feasibility of data collection/outcome measures assessed by rate of participant attrition
Data completeness
Measured: 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.
Measured: 1 year (end of study)
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: Baseline & immediately post intervention
Patient attitudes/experiences of the study assessed through qualitative interviews with study participants
Patient attitudes/experiences of receiving the intervention
Measured: 1 year (end of study)
Health professionals attitudes/experiences assessed through qualitative interviews with study participants
Health professional attitudes/experiences of delivering the intervention
Measured: 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%).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline & immediately post intervention
Incremental Shuttle Walking Test
Maximal exercise capacity test
Measured: Baseline & immediately post intervention
Endurance Shuttle Walking Test
Maximal exercise capacity test
Measured: 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.
Measured: Baseline & immediately post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start14 Jun 2021
- Primary completion23 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mixed methods observational and feasibility study
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990180
- Sponsor's protocol ID
- EDGE: 137907
- Acronym
- PReSent
- Status last verified
- May 2023
- First submitted
- 14 Jul 2021
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 39254860
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Feasibility Testing of a Pulmonary Rehabilitation Shared Decision Making Intervention for Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04990180
- Acronym / sponsor ID
- PReSent / EDGE: 137907
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Rehabilitation, Shared Decision Making, Patient Decision Aid, Decision Coaching, Implicit Association Test, Implicit Bias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mixed methods observational and feasibility study
| Arm | Type | Receives |
|---|---|---|
| Shared Decision Making Intervention | Experimental | Behavioral: Shared Decision Making InterventionThe intervention is a shared decision making consultation supported by a patient decision aid and decision coaching for healthcare professionals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared Decision Making InterventionDecision 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. | Behavioural | Shared Decision Making Intervention |
Primary outcome
Response latency
Time frame: Baseline only
Presence of bias between stimuli
Feasibility of recruitment assessed by rate of recruitment to time and target
Time frame: Through study completion, an average of 1 year
Recruitment to time (proposed study end date) and target (proposed sample size)
Feasibility of data collection/outcome measures assessed by rate of participant attrition
Time frame: 1 year (end of study)
Data completeness
Intervention fidelity assessed by the Observer OPTION 5 Scale
Time frame: 1 year (end of study)
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.
15 secondary outcomes
Decisional conflict measured using the Decisional Conflict Scale
Time frame: Baseline & immediately post intervention
Patient activation as measured by the Patient Activation Measure
Time frame: Baseline & immediately post intervention
Rate of attendance assessed by the proportion of participants who complete the intervention
Time frame: Baseline & immediately post intervention
Patient attitudes/experiences of the study assessed through qualitative interviews with study participants
Time frame: 1 year (end of study)
Health professionals attitudes/experiences assessed through qualitative interviews with study participants
Time frame: 1 year (end of study)
Uptake and adherence to Pulmonary Rehabilitation assessed by the proportion of participants who begin and complete Pulmonary Rehabilitation
Time frame: Baseline & immediately post intervention
COPD Assessment Test
Time frame: Baseline & immediately post intervention
Bristol COPD Knowledge Questionnaire
Time frame: Baseline & immediately post intervention
Chronic Respiratory Questionnaire
Time frame: Baseline & immediately post intervention
Hospital Anxiety and Depression Scale
Time frame: Baseline & immediately post intervention
COPD Prem 9
Time frame: Baseline & immediately post intervention
Medical Research Council Dyspnoea Scale
Time frame: Baseline & immediately post intervention
Incremental Shuttle Walking Test
Time frame: Baseline & immediately post intervention
Endurance Shuttle Walking Test
Time frame: Baseline & immediately post intervention
Patient satisfaction with Pulmonary Rehabilitation assessed by internal hospital satisfaction questionnaire
Time frame: Baseline & immediately post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Derived from this study: PubMed 39254860Barradell 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Decision Making Intervention in people with Pulmonary Disease, Chronic Obstructive, run by University Hospitals, Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response latency (time frame: Baseline only). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04990180, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.