Clinical trial NCT05956912: Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Official title: Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anxiety
Depression
Cardiac Rehabilitation
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Greater Manchester Mental Health NHS Foundation Trust
name: University of York
name: National Institute for Health Research, United Kingdom
First posted: 2023-07-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac rehabilitation staff trained in delivering Group-MCT, wider cardiac rehabilitation staff and managers, and healthcare professionals from local clinical commissioning groups.

All CR patients attending cardiac rehabilitation.

Brief summary: Background: Cardiac rehabilitation (CR) services aim to improve heart disease patients' health and quality of life and reduce the risk of further cardiac events. Depression and anxiety are common among CR patients, and current psychological treatments for cardiac patients have minor effects. However, the NIHR-funded PATHWAY trial found that group Metacognitive Therapy (MCT) was associated with improvements in anxiety and depression when added to CR and was more effective than usual CR alone. Group MCT was also associated with preventing anxiety and depression. The next steps will establish beacon sites for delivering MCT and pilot-test additions to the national audit of cardiac rehabilitation (NACR) data capture mechanism to include an MCT data field. Such steps will support a quantitative and qualitative evaluation of implementation.

Methods: The investigators aim to address questions concerning the quality of patient data recorded, level of adoption at sites, the characteristics of patients attending MCT, the impact of adding MCT to CR on mental health outcomes, and patient, healthcare staff and commissioner views of barriers/enablers to implementation. The investigators will deliver training in group MCT to CR staff from CR services across England. The investigators will conduct semi-structured qualitative interviews with CR staff trained in group MCT to assess views on the training programme, including successes and barriers to implementation of training and delivery. The investigators will interview 8-10 CR stakeholders to identify any barriers to implementation and how these might be resolved.

Discussion: The study will support development of an NHS roll-out strategy and systematic data collection that can be used to evaluate wide-scale implementation. The study can benefit service users by improving patients' mental health outcomes and CR practitioners' clinical skills. Results will be disseminated via peer-reviewed journals, national and international conferences and service user/voluntary sector organisations and networks.


Eligibility criteria: Qualitative Inclusion Criteria:

All CR staff must meet the following inclusion criteria to be eligible:

1. Be a healthcare professional working with cardiac rehabilitation services being trained to deliver group-MCT
2. Be a healthcare professional working with cardiac rehabilitation or be a professional working at the commissioner level
3. Minimum of 18 years old
4. Competent level of English Language skills (able to read, understand and complete interviews in English).

Exclusion Criteria:

1. Below 18 years of age
2. Not a healthcare professional or professional working at the commissioner level
3. Does not have a competent level of English language skills

Audit inclusion criteria:

All patients attending CR who meet the NICE recommendations for acute coronary syndrome (NG185) and heart failure (NG106) will be offered group MCT as part of routine CR.

Primary outcomes:
measure: Adoption of group MCT
timeFrame: Within the 6 months that MCT is being delivered in CR services
Secondary outcomes:
measure: Dartmouth Coop
timeFrame: Initial Cardiac Rehabilitation Assessment (Baseline) & Within 6 months of attending cardiac rehabilitation (Discharge)
measure: Semi-structured interviews will explore the views and opinions of group-MCT in CR (CR staff trained in group-MCT)
timeFrame: 1 month prior to training in MCT
measure: Semi-structured interviews will explore the views and opinions of group-MCT in CR (CR staff trained in group-MCT)
timeFrame: Within 1 month of delivering the pilot group of MCT
measure: Semi-structured interviews will explore the views and opinions of group-MCT in CR (CR staff trained in group-MCT)
timeFrame: Upon completion of delivering group-MCT, approximately 5 months after starting the delivery of MCT in CR
measure: Semi-structured interviews will explore the views and opinions of group-MCT in CR (CCG and other management stakeholders)
timeFrame: Through implementation of MCT in CR services, approximately 7 months.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Initial Cardiac Rehabilitation Assessment (Baseline) & Within 6 months of attending cardiac rehabilitation (Discharge)
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
affiliation: University of Manchester
name: Adrian Wells, PhD
role: PRINCIPAL_INVESTIGATOR
References: