Systematic development and feasibility testing of a multibehavioural digital prehabilitation intervention for patients approaching major surgery (iPREPWELL): A study protocol

Improving outcomes for people undergoing major surgery, specifically reducing perioperative morbidity and mortality remains a global health challenge. Prehabilitation involves the active preparation of patients prior to surgery, including support to tackle risk behaviours that mediate and undermine physical and mental health and wellbeing. The majority of prehabilitation interventions are delivered in person, however many patients express a preference for remotely-delivered interventions that provide them with tailored support and the flexibility. Digital prehabilitation interventions offer scalability and have the potential to benefit perioperative healthcare systems, however there is a lack of robustly developed and evaluated digital programmes for use in routine clinical care. We aim to systematically develop and test the feasibility of an evidence and theory-informed multibehavioural digital prehabilitation intervention iPREPWELL designed to prepare patients for major surgery. The intervention will be developed with reference to the Behaviour Change Wheel, COM-B model, and the Theoretical Domains Framework. Codesign methodology will be used to develop a patient intervention and accompanying training intervention for healthcare professionals. Training will be designed to enable healthcare professionals to promote, support and facilitate delivery of the intervention as part of routine clinical care. Patients preparing for major surgery and healthcare professionals involved with their clinical care from two UK National Health Service centres will be recruited to stage 1 (systematic development) and stage 2 (feasibility testing of the intervention). Participants recruited at stage 1 will be asked to complete a COM-B questionnaire and to take part in a qualitative interview study and co-design workshops. Participants recruited at stage 2 (up to twenty healthcare professionals and forty participants) will be asked to take part in a single group intervention study where the primary outcomes will include feasibility, acceptability, and fidelity of intervention delivery, receipt, and enactment. Healthcare professionals will be trained to promote and support use of the intervention by patients, and the training intervention will be evaluated qualitatively and quantitatively. The multifaceted and systematically developed intervention will be the first of its kind and will provide a foundation for further refinement prior to formal efficacy testing.

169 Additional objectives are to generate estimates of variability for behavioural outcomes (e.g., 170 physical activity) and outcomes (e.g., quality of life) to inform a sample size calculation for a 171 randomised controlled trial (should the intervention demonstrate acceptability and 172 feasibility), and to undertake a preliminary cost evaluation of the intervention.

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is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint The copyright holder for this this version posted October 22, 2022.   [36], an interim analysis will be conducted following data collection from the 239 10 th patient and the 10 th HCP participants. If new ideas and themes continue to emerge, . CC-BY 4.0 International license It is made available under a perpetuity.
is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint The copyright holder for this this version posted October 22, 2022. ; https://doi.org/10.1101/2022.10.21.22281380 doi: medRxiv preprint 240 recruitment will continue, and sample size will be increased in increments of three. This will 241 be followed by a further interim analysis, up to a maximum of 20 patients and 20 HCPs. Where 242 possible, these participants will also be invited to participate in co-design workshops.

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244 Recruitment of participants to co-design workshops will be guided by individual session 245 requirements. The aim is for patient and HCP participants to attend workshops together, with 246 no more than 12 participants present at each session. Patient or HCP specific sessions may be 247 required depending on progress of the co-design process and/or preferences of each participant 248 group. 269 will be sent by post or email to each participant, with a follow-up call within seven days to 270 confirm receipt and determine interest in participation. Those wishing to take part in the study 271 will be asked to provide informed consent prior to data collection through completion of a 272 study consent form. Patients declining participation will continue to receive usual perioperative 273 care and a reason for non-participation will be recorded. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint The copyright holder for this this version posted October 22, 2022. ; https://doi.org/10.1101/2022.10.21.22281380 doi: medRxiv preprint 275 We anticipate that patient participants may wish to involve a partner, friend, or family member 276 during their interview or at workshops, and we acknowledge the valuable contribution these 277 companions can make to the co-design process. As such, we will ask companions to complete 278 a consent form to enable their contributions to be recorded, analysed and findings used to 279 contribute to the intervention development process. 294 Additional recruitment will be undertaken to offset drop-out between stage 1 components. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint The copyright holder for this this version posted October 22, 2022. ; https://doi.org/10.1101/2022.10.21.22281380 doi: medRxiv preprint 13 373 Co-design workshops 374 Audio recordings of workshops will be transcribed verbatim. Transcripts will be reviewed 375 alongside facilitator notes to capture all key information and decisions. This will enable an 376 audit trail and reporting of when, how, and why key development decisions were made.
377 Following the conduct of each co-design workshop, a summary document will be prepared to 378 enable Hark 2 to iteratively develop an intervention prototype ahead of usability testing. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint 418 Patients listed for major surgery will be screened for eligibility by perioperative teams utilising 419 electronic hospital records. Potential participants will be approached by telephone to explore 420 interest. Those interested will be given a patient PIS sent by post or email. Interested patients 421 will receive a follow-up telephone call by a team member within 7 days allowing time to 422 receive, read and understand the study information and consider participation. Those who 423 would like to participate will be invited to undertake a screening and baseline assessment (visit 424 1) where they will be given an opportunity to ask questions and complete a consent form with 425 a study team member. Patients who decline participation at that stage will undergo routine 426 preoperative care and their reason for non-participation will be recorded if they elect to provide 427 one. 428 429 HCP participants 430 Perioperative team members at each site will be contacted by email inviting them to take part 431 in the study with a follow-up after 7 days providing time to consider participation. The email 432 will provide a HCP PIS and those who are interested in taking part will complete a consent 433 form with a study team member and be invited to begin the intervention HCP training package. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint 555 Visit 2 will be scheduled prior to surgery to assess changes in health behaviours (e.g., physical 556 activity) following platform usage. The visit will be conducted at the hospital site by at least 557 two research team members. Data collected will mirror visit 1 (supplementary document [S4]). is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint The copyright holder for this this version posted October 22, 2022. ; https://doi.org/10.1101/2022.10.21.22281380 doi: medRxiv preprint 570 571 Quantitative data collection 572 Data will be collected, where possible, as an electronic case-record form (e-CRF) within the 573 online intervention. Completion of these will be scheduled as part of intervention utilisation 574 e.g., the registration process will include e-CRF 1. Data will be entered by patient participants, 575 with additional data input by HCP participants and study team members, where appropriate. 576 577 Additional data will be collected on intervention utilisation, e.g., number of logins, duration of 578 session, completion of individual intervention components, and information entered by 579 participants during intervention usage. The integrated physical activity wearable device will 580 collect data that will be uploaded into the intervention platform, stored, and made available to 581 participants, e.g., daily recorded step counts. 582 583 Qualitative data collection 584 Up to 40 patient participants and all participating HCPs will be invited to take part in a semi-585 structured interview with a research team member. This component of the study is optional 586 (i.e., patient participants can take part in the intervention study and refuse participation in the 587 qualitative study). In keeping with stage 1, companions will also be included if patient 588 participants wish and will complete a stage 2 consent form to allow their interview 589 contributions to be included in the analysis. All interviews will be audio recorded and 590 transcribed verbatim. 591 592 To facilitate an early health economic analysis, HCP participants will be asked to complete a 593 diary of activity in terms of support provided to patient participants. 594 595 Stage 2 Data analysis 596 597 Quantitative data 598 Data will be summarised descriptively using mean and SD or median and IQR for continuous 599 variables, and count and percentage for categorical variables. As this is a feasibility study, the 600 level of missing data will be documented but no imputation undertaken. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint The copyright holder for this this version posted October 22, 2022. ; https://doi.org/10.1101/2022.10.21.22281380 doi: medRxiv preprint 602 delivery to inform design of a future efficacy study.
603 An initial exploratory analysis of pseudo anonymised perioperative wearable data will be 604 undertaken utilising machine learning techniques supported by Telstra Health UK.
605 Qualitative data 606 Qualitative data will be thematically analysed using the TDF. Two members of the research 607 team will independently code and analyse interview transcripts. The same procedure will be 608 undertaken as described during stage 1 to develop a coding strategy.  is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint 677 If a participant wishes to withdraw or is discontinued from the study, the following 678 procedures will be observed: 679 680  Participants will be offered the chance to take part in a semi-structured interview to 681 provide their reasons for withdrawal from the process to allow learning. Participants 682 will be free to decline this interview without providing a reason.
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is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint The copyright holder for this this version posted October 22, 2022. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint The copyright holder for this this version posted October 22, 2022. ; https://doi.org/10.1101/2022.10.21.22281380 doi: medRxiv preprint https://www.cpoc.org.uk/sites/cpoc/files/documents/2021-09/CPOC-Perioperative-

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is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint The copyright holder for this this version posted October 22, 2022. ; https://doi.org/10.1101/2022.10.21.22281380 doi: medRxiv preprint