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A Pulmonary Rehabilitation Shared Decision Making Intervention (PReSent)

NHS Trust logo

NHS Trust

Status

Completed

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Behavioral: Shared Decision Making Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04990180
EDGE: 137907

Details and patient eligibility

About

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.

Full 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.

Enrollment

144 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

144 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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