A Pulmonary Rehabilitation Shared Decision Making Intervention

NCT04990180 | Completed DMC

• 1 other identifier: EDGE: 137907
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Rehabilitation; Shared Decision Making; Patient Decision Aid; Decision Coaching; Implicit Association Test; Implicit Bias

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (15)

• Decisional conflict measured using the Decisional Conflict Scale

  Baseline & immediately post intervention

• Patient activation as measured by the Patient Activation Measure

  Baseline & immediately post intervention

• Rate of attendance assessed by the proportion of participants who complete the intervention

  Baseline & immediately post intervention

• Patient attitudes/experiences of the study assessed through qualitative interviews with study participants

  1 year (end of study)

• Health professionals attitudes/experiences assessed through qualitative interviews with study participants

  1 year (end of study)

Study Arms (1)

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.

Behavioral: Shared Decision Making Intervention

Interventions

Shared Decision Making Intervention 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.

Shared Decision Making Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:-
• 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
• 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

Sponsors & Collaborators

• University Hospitals, Leicester: lead

Study Sites (1)

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39254860 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bias, Implicit

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Prejudice; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mixed methods observational and feasibility study

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 4, 2021
• Study Start: June 14, 2021
• Primary Completion: February 23, 2023
• Study Completion: February 28, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)