Development of a patient centred, structured, individually tailored, multi-component intervention to promote rehabilitation and recovery after critical illness: content, theory, and construction.

Patient and Public involvement

Patient and Public partners had a pivotal role from concept and throughout the design and development stages of this multicomponent intervention. This partnership continues while the intervention is tested during a RCT and its subsequent dissemination¹⁰.

Patients and family members with lived experiences of critical illness indicated that they want access to a rehabilitation program that could support recovery after discharge home. They indicated that they would have attended such an intervention if it had been available to them, and this motivated them to be involved in the development of the iRehab intervention. Patient and Public partners inputted to qualitative research that also underpinned the intervention content. Based on their experiences and views, they identified that key facilitators of the intervention include supervision, tailoring of support and rehabilitation to personal needs, and access to manual/materials that can be referred to. They wanted the intervention to include help with motivation or mental health challenges if these were barriers to someone taking part, and help to modify exercises and activities depending on the stage of recovery. Other examples of active contributions by our Patient and Public partners were input into the content and design of the patent materials, the format for delivery of the intervention, and advice about practical issues such as access to computers. Patient and Public partners have formed our current iRehab Patient Advisory Group (PAG), which supports the implementation of this intervention in the iRehab trial¹⁰. Together, we will plan dissemination to linked communities in formats that are accessible to a wide audience. To support the dissemination of this manuscript, two of our PAG members have co-written the plain language summary (see acknowledgements).

Intervention development

This manuscript adheres to recommended guidance for explicit and comprehensive reporting as per the Template for Intervention Development and Replication (TiDIER)¹¹. The intervention embedded a range of influences to address the core elements (a-f) recommended by the MRC for the development and testing of complex interventions¹². To (a) ‘identify content’ and (b) ‘develop and refine the content, and programme theory’, we included theories and evidence underpinning treatments, existing literature around post ICU outcomes, and patient feedback and experiences. Our key (c) ‘stakeholders’ included multiprofessional staff with experience providing healthcare to post ICU patients and undertaking research, patient partners and a Patient Advisory Group (PAG) with former ICU survivors (including experience of mechanical ventilation), and relatives of ICU survivors and members of the public. Input from our patient partners relating to the lived knowledge of a patient journey following critical illness affirmed the need to have an individualized multicomponent approach to rehabilitation to address the complexities of the recovery process for survivors.

The construction of our intervention focused on (d) ‘identifying key uncertainties’ and (e) ‘refining’ the intervention, and (f) ‘economic considerations’ were made by considering the efficiency of using a core trained team to remotely deliver the intervention online.

Ethics approval was not required for this manuscript which reports intervention development and does not involve research data or participation.

(i) Underpinning theory

Components 1–4: goal setting and weekly action planning

The iRehab intervention was informed by Leventhal’s Common-Sense Model (CSM) of self-regulation^13,14. Leventhal’s CSM describes the process by which individuals respond to a perceived health threat, in this case their critical illness¹³. It models how we think about our health by using common sense to interpret health threats and react to them in ways that may not always seem rational from the outside but have their internal logic. The model emphasizes several mechanisms that are important for adaptation to illness, including knowledge, past experiences, memories, and personal history. The model asserts that when a person is faced with a health problem, “an illness-related memory schema or ‘prototype’ is activated”^13,14. Patients generally act to try to manage their condition or manage their ‘problem’; this is a self-regulation process, and it can evolve over time as illness progresses.

Patients use their perceptions of the illness (cognitive and emotional representations of the illness) to help them develop action and coping plans to manage the illness and find potential solutions (e.g., “I should call my doctor”; “maybe I’ll feel better if I rest”). Then, the ‘successes of these actions are appraised through constant feedback loop e.g.’ Am I less tired now’ ‘Am I better now?’)¹³. Appraisal considers whether the strategy led to improvement, no change, or deterioration in symptoms, resulting in adjustment of the individual’s representation – this is a dynamic process. It has been proposed that clinicians can support and improve management/self-management by communicating with patients, clarifying their illness, supporting treatments, and helping with action plans¹⁵. We incorporated these strategies into the intervention and included goal setting and weekly action planning^16–19.

(ii) Content based on post ICU outcomes, patient experience and evidence

Component 1: Weekly discussion and individual symptoms management

People experience common and varied symptoms after critical care, including dysphagia²⁰, breathlessness²¹, fatigue²², reduced appetite²³, delirium²⁴, and psychological symptoms including anxiety²⁵ and low mood/depression²⁶. Participants in our qualitative research identified the potential benefits of symptom management for recovery^27,28. People wanted communication and guidance from healthcare professionals after critical illness “Encouragement from more people, within the health system” and “getting to know what your symptoms are”²⁹. Views from our PAG about how helpful information sharing and weekly support from health professionals would be, informed the intervention. The iRehab intervention will address commonly occurring symptoms after critical illness, and care pathways will be prescribed based on individual needs²⁹. Evidence-informed treatment strategies have been embedded to help with individual symptom management. For example, breathing techniques for the management of breathlessness³⁰ and dietary advice for the management of poor appetite^31,32.

Component 2: Exercise and physical activity

Physical impairment and deconditioning are common after critical care³³ and patients want advice about exercise and return to usual activities; they have indicated “there are certain physical things I would like to know about”^27,28. Exercise and physical activity programs can aid physical and emotional recovery in people with chronic obstructive pulmonary disease, chronic fatigue, and congestive heart failure^34–37. We previously tested an exercise intervention for people after critical care, which informed the exercise component for iRehab³⁸. We also drew on international experiences of remote multicomponent interventions e.g. pulmonary rehabilitation, liver surgery prehabilitation and cardiac rehabilitation; this informed the platform for remote delivery^8,39–43. Therefore, the inclusion of exercise and physical activity components was based on research and patient feedback.

Component 3: Support for psychological wellbeing

Patients often face a long journey from critical illness to recovery. Patients with lived experiences of critical illness told us about their challenges with their psychological wellbeing “I had terrible dreams when I was in ICU; nobody asked me once I came round about my ICU experience. And I have to say I was quite traumatised by it,” and they wanted advice from someone who understood the sequelae after critical illness²⁸. Integrating an Acceptance and Commitment Therapy (ACT) based approach into a multidisciplinary intervention provides a clear framework for supporting individuals to set their own meaningful goals during that journey⁴⁴. The potential utility of the ACT approach is supported by previous research in related areas of physical health, demonstrating that ACT supports functioning and quality of life in life-limiting conditions, palliative care, chronic pain, and physical and mental health^15–44. Strategies for well-being activities, such as mindfulness or relaxation^45,47–49 as well as psycho-education related to delirium⁵⁰, are included in the iRehab program. The iRehab specialists delivering the intervention utilize resources based on ACT principles and committed action plans are reviewed with participants evolved on a weekly basis.

Component 4: Group based peer support sessions and other information needs

Participants in our qualitative research identified the potential benefit of speaking to others who have experience of recovery following discharge after an admission to ICU “maybe if I could speak to someone who had gone through the same experience as me”²⁸. In an international stakeholder engagement project involving patients, and families (n=66 interviews across the UK, Australia, and the US), the reported benefits of a peer-support intervention were 1) sharing experiences; 2) care debriefing (e.g., care understanding/navigation of health care system, external and internal validation of progress and feelings), and 3) altruism (e.g., a sense of purpose, giving back/helping others)⁵¹. There is some evidence that peer support may reduce psychological morbidity in patients with critical illness⁵². The inclusion of a peer support group in the iRehab intervention is based on this existing research, feedback from patients participating in our previous research on rehabilitation after critical illness, as well as input from our PAG members. Patients said that there was a “lack of information” about what happened in the ICU and what to expect during recovery, and they wanted this information to guide their recovery. Hence, information provision and peer support groups were included in the iRehab intervention.

(iii) Constructing the intervention

The multiprofessional intervention development team (BO’N, JMB, BC, RC, ET, PF, SAD) used an iterative process (embedding the information above) to prepare, meet, obtain feedback, refine, and construct the intervention and its components. Input on a draft of the intervention was then sought from patient partners (n =11 current and past patient partners) and additional team members with relevant experience (DMcA, JB, JC). The content and construction of the iRehab intervention was also presented to an independent review panel of expert clinicians (n=5) (see acknowledgements) with critical care rehabilitation and intervention development expertise for feedback.

Materials were prepared for patients, and these underwent iterative review with specific input sought from the patient partners. The patient materials were assessed using the Drivel Defence Index to optimize the level of plain English⁵³. Our patient partners also provided feedback on video-based materials, such as exercise videos, recordings of treatment strategies, and the approach to providing these to participants. Intervention resources and a detailed intervention manual and training package were developed for use by trained iRehab intervention specialists to deliver key skills related to common problems managed after critical illness.

The intervention was developed to embed progressive intervention strategies capable of being delivered by a trained intervention team from a broad range of backgrounds. A multiprofessional group, each with specific expertise, is expected to support and guide iRehab specialists in the management of patient symptoms and problems as required. iRehab specialists utilize resources which are defined as Level 1, where the content of the resource duplicates that of the patient materials, and Level 2, where the multiprofessional group member(s) provide additional specific guidance to the iRehab specialist to complement the use and implementation of the Level 1 resources. Level 2 could include an additional instruction, skill, or advice to iRehab specialists to facilitate their provision of individualized support to a participant, for example, instructions from the dietician about dietary modifications for a patient wanting to increase their intake of plant-based protein; advice from the physiotherapist about how to modify a specific exercise to change the muscle load or joint lever due to patient reporting tendinitis, neuropathy, or pain; or advice from the clinical psychologist to undertake a brief patient assessment, for example, completion of the generalized anxiety disorder questionnaire (GAD-7) to enable the psychologist to guide escalation of care. NICE (2011) recommends stepped models of care, which are of increasing relevance globally in response to high demand against a background of limited resources⁵⁴.

Key uncertainties were identified during intervention development, and refinements were made. For example, a key uncertainty is the use of remote delivery and our patient panel informed us about practical information to optimise remote delivery and communication with participants such as options to access computers or a phone, use of email and texts, opportunity for technical assistance from family or carers, and it was highlighted that specifically scheduling a weekly appointment slot is an important intervention element. It was also suggested that written intervention materials be provided to participants by post, with help available from the iRehab specialist to go through these printed materials with participants to optimize their understanding and application. Information for the intervention needed to be deliverable via phone/remotely; therefore, sections within the printed manuals were required to be color coded for easy identification of relevant sections during calls with participants.

The iRehab intervention

The iRehab intervention is a patient centered, structured, individually tailored, multicomponent intervention designed to promote rehabilitation and recovery after critical illness. An overview of the rehabilitation intervention delivery format is shown in Table 1. It is intended to include a broad range of information, strategies, and support for people discharged home after mechanical ventilation in the ICU and at an early stage of the dynamic critical care recovery journey.

The intervention is designed to allow for progression according to individual ability, building over six weeks, with weekly online, one-to-one appointments with a trained iRehab specialist, usually lasting up to one hour or more based on individual needs. Participants are required to continue with the agreed individual rehabilitation techniques at home and their progress should be reviewed, and action plans amended at weekly appointments. Participants are encouraged to attend a weekly group-based remote exercise session and a group-based remote peer support session (iRehab Peer Support Café).

The final iRehab intervention includes four core components (See Table 2 for further details).

1. Weekly discussion and guidance regarding symptom management;

2. Exercise and physical activity;

3. Support for psychological wellbeing;

4. Group based peer support and other information.

The intervention includes a range of strategies that can be adapted based on individual patient needs. The iRehab specialist can consult with the relevant expert member(s) of the multiprofessional team to assure their delivery of the ‘Level 1’ resources/intervention or identify an additional ‘Level 2’ intervention strategy. If there is a need for an onward referral, the intervention team can connect with the critical care team at the patient’s hospital site to identify an appropriate pathway or onwards referral or direct the patient to their GP. The intervention strategies provided to individual participants should be appraised at the weekly appointments through a constant feedback loop e.g. has the strategy helped or not, does the goal or treatment strategy need adjusted or the patient’s expectations; this is a dynamic process.

iRehab Intervention team, training, materials, and mode of delivery

Intervention team and training: The iRehab specialists will receive bespoke training, including access to the detailed intervention manual to support delivery, presentations, rehearsals, and interactive problem solving via case studies prior to delivering the intervention. They should be certified to deliver the iRehab intervention and supported with frequent and ongoing mentorship from an expert multiprofessional team, as well as training updates.

Materials: An iRehab specialist’s detailed intervention manual contains instructions and information designed to enable them to support participants over a six-week period to set goals and plan their actions for exercise, physical activity, psychological well-being, and symptom management for the week ahead, along with any other activities in line with the components of the intervention. To minimize performance bias in intervention delivery, the core components in the manual are standardized and incorporate suggested scripts and protocols to guide overarching delivery, while still enabling flexibility in how these are applied to individual participants. The intervention is designed to be used alongside a range of participant materials, either printed copies or accessed via electronic versions for reference during remote rehabilitation sessions, after which supplemental information is provided according to patients’ feedback and individual needs.

Access/Mode of Delivery: The preferred mode of remote delivery (video or telephone) should be agreed with the participant. Guidance and help with troubleshooting the use of technology can be provided and/or an invite to have a relative or caregiver to assist.