The PERFORM trial

Work packages

Work Package 1 : Identifying people with multiple Long Term Conditions (LTCs) likely to benefit from rehabilitation (study ongoing)

Work package leads

Staff

  • Professor Rod Taylor
  • Professor Emma McIntosh
  • Dr Lewis Steell
  • Dr Stefanie Krauth
  • Dr Grace Dibben
  • Dr Sayem Ahmed

Aim

To identify those people with multiple LTCs likely to benefit from rehabilitation.

Overview

WP1 has three strands which utilise data science approaches (WP1a); systematic review (WP1b); and health economic approaches (WP1c). and are complementary and will help us understand the patient characteristics and accompanying clusters of LTCs that are associated with poor health related quality of life (HRQoL), the worst health care outcomes, highest healthcare costs, and have the greatest potential to benefit from rehabilitation. This WP will inform the intervention development in real time as new data becomes available allowing us to adapt the intervention to accommodate people with different characteristics and clusters of LTCs with greatest need, highest healthcare costs and clear evidence of benefits from rehabilitation in at least one of the candidate LTCs.

All work will be undertaken in collaboration with our Patient Advisory Group (PAG), we will seek their expert input on our planned analyses and work and share results in real time with them. We plan to incorporate the PAG insights and comments iteratively throughout this WP and  ensure they have the opportunity to comment on our proposed outputs.

Deliverables

  • Identification, through data science methods applied to three high quality UK datasets, of ‘high-risk’ multiple LTC profiles. These profiles include information on clusters or numbers of LTCs and patient characteristics associated with the highest risk of negative impacts on health outcomes (mortality, hospitalisations, and quality of life). Thus, highlighting people with the greatest potential to benefit from rehabilitation (WP1a).
  • A meta-review of the literature which identifies LTCs with evidence of benefits of exercise rehabilitation that are not currently routinely offered access to such rehabilitation. (WP1b).
  • Identification of the multiple LTC profiles associated with the greatest healthcare costs in terms of relationship with healthcare resource use (in primary/secondary care) and Health related quality of life (HRQoL). (WP1c)
  • Identification of the ‘target’ patient population for PERFORM intervention development and testing who belong to ‘high-risk’ multiple LTC profiles with at least one LTC having evidence of benefit from exercise rehabilitation (WP1a, b and c) 

Work Package 2: Intervention development (study ongoing)

Work package lead

Aim

The aim of work package 2 is to develop a programme of Personalised Exercise-based Rehabilitation FOR people with Multiple long-term conditions (PERFORM) to help to improve the patients’ health-related quality of life. Specifically, the aims of the project are to:

  1. Work with stakeholders to adapt and transform existing rehabilitation programmes (e.g., cardiac rehabilitation, pulmonary rehabilitation) into a novel integrated rehabilitation programme (the ‘PERFORM intervention’) to treat a wide range of people with multiple long-term conditions.
  2. Develop a training package to support delivery of the PERFORM intervention.

In Work Package 2, we will conduct workshops involving key stakeholders - that is people with long-term conditions, their caregivers (family and friends who support their care), relevant service providers (e.g. rehabilitation nurses, physiotherapists), and service commissioners and policy makers. The stakeholder workshops will help to prioritise key issues for self-care, such as managing symptoms, exercise and managing stress/anxiety as well as identifying the best ways to support these key self-care actions. As well as working with these key stakeholders, we will use the latest evidence and theories and techniques from behavioural science to ensure that the PERFORM programme is optimised for effectiveness, as well as for patient engagement /usability and practical to deliver within NHS rehabilitation settings.

Work Package 3: Feasibility trial with embedded process and economic evaluation (study not started)

Work package lead

Work package co-lead

CTU staff

  • Amy Branson
  • Hannah Gilbert

Aim

The aim of this work package is to:

  1. assess the feasibility and acceptability of the intervention and evaluation methods, and
  2. assess whether key progression criteria (related to recruitment, retention and intervention adherence) are achieved and a full randomised controlled trial is warranted.

During the feasibility trial we will also further refine the intervention and programme theory.

The PERFORM intervention will be implemented across three sites and we will recruit 60 patients in total. We will randomise 40 to the intervention arm and 20 to the control arm and collect a range of participant outcomes at baseline and 3 month follow-up to assess the feasibility of the different measures. The economic evaluation component will identify, and measure key cost drivers including health care resource use, social care and broader societal resource use (personal expenditure) and identify suitable outcome measures to inform the full trial. In the process evaluation we will collect fidelity data and also interview patients (n~30) and staff (n~12) about their experiences of being part of the trial and their views of the intervention, as well as suggested improvements to the intervention and trial methods. Interviews and analysis will be guided by the programme theory and normalisation process theory.

Work Package 4: Multicentre randomised controlled trial and prospective cohort study (seeking expression of interest)

Work package co-leads

Aim

The overarching aim of this work package assess to assess the clinical and cost-effectiveness of PERFORM in people with multiple LTCs. Specific objectives are to:

  1. To assess the clinical effectiveness and cost-effectiveness of PERFORM to compared to usual in people with multiple LTCs not eligible for referral to a standard cardiac or pulmonary rehabilitation programme in a randomised clinical trial;
  2. To assess the clinical effectiveness and cost-effectiveness of the addition PERFORM to usual care compared to standard cardiac or pulmonary rehabilitation in people with multiple LTCs in a prospective cohort study;
  3. To refine programme theory and identify barriers and facilitators to future wide scale implementation and develop an implementation toolkit.

The study will use a comprehensive cohort study with concurrent multicentre superiority randomised RCT and prospective cohort study with embedded process and economic evaluations and internal pilot phase.

The study will be conducted at 12 NHS sites across the UK. Site selection will take into consideration the geographical variation in the prevalence of multiple LTCs and ethnicity and socioeconomic groups. Within sites, patients will be recruited using both primary and secondary care pathways. A sample size of 604 (302 per arm) participants provides 90% power to detect a minimum clinical important difference (MCID) in the primary outcome (EQ-5D-3L) of 0.05 at the 5% significance level.

Expressions of interest

We are seeking expressions of interest from 12 NHS sites across the UK for full-scale randomised trial in people with multiple LTCs in being contacted by the research team regarding participation in Work Package 4.

Please provide details below so that we can add your hospital to our expression of interest database:

  • Hospital organisation's name
  • Principal Investigator name (e.g. member of the Research and Development department) for your organisation who will organise distribution of study materials to relevant stakeholders
  • Principal Investigator email
  • Appropriate member of your Research and Development (R&D) department team member email

For any questions or queries, please contact PERFORM programme manager Zahira Ahmed at za4@leicester.ac.uk

Work Package 5: Role of Social Media (SoMe) networks are widespread in the course of daily life, some shown to foster positive health behaviour

Work package lead

Aim

To examine the use of Social Media (SoMe) to reduce trial attrition within the RCT described in WP4, using a study within a trial (SWAT), alongside an embedded qualitative enquiry of patient engagement in research.

Overview

WP4 RCT participant will undergo a further 1:1 random allocation to join a SoMe online community (‘SoMe intervention group’) or not (‘SoMe control group’). To mitigate the risk of contamination with the WP4 question of the impact of multimorbid intervention, we will ensure that participants allocated to the SoMe intervention are members of SoMe group that comprises either all PERFORM intervention participants or all PERFORM control participants (and not a mix of the two). We therefore believe that this SWAT has a low threat to the validity of our PERFORM effectiveness question addressed by WP4.

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