A feasibility hybrid II randomised controlled trial of volunteer ‘Health Champions’ supporting people with serious mental illness manage their physical health: study protocol

Williams, Julie; Fairbairn, Elliann; McGrath, Ray; Bakolis, Ioannis; Akpan, Ubong; Mdudu, Isabel; Gaughran, Fiona; Sadler, Euan; Khadjesari, Zarnie; Lillywhite, Kate; Sevdalis, Nick

doi:10.1186/s40814-021-00854-8

Cited by 5 publications

(3 citation statements)

References 24 publications

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“…The inclusion of cost data is not study-design specific and spans a wide range of designs from N of 1 to cluster randomized studies. 185 – 187 …”

Section: Resultsmentioning

confidence: 99%

Expert Perspectives on Pilot and Feasibility Studies: A Delphi Study and Consolidation of Considerations for Behavioral Interventions

Pfledderer,

von Klinggraeff,

Burkart

et al. 2023

Preprint

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Background In the behavioral sciences, conducting pilot and/or feasibility studies (PFS) is a key step that provides essential information used to inform the design, conduct, and implementation of a larger-scale trial. There are more than 160 published guidelines, reporting checklists, frameworks, and recommendations related to PFS. All of these publications offer some form of guidance on PFS, but many focus on one or a few topics. This makes it difficult for researchers wanting to gain a broader understanding of all the relevant and important aspects of PFS and requires them to seek out multiple sources of information, which increases the risk of missing key considerations to incorporate into their PFS. The purpose of this study was to develop a consolidated set of considerations for the design, conduct, implementation, and reporting of PFS for interventions conducted in the behavioral sciences. Methods To develop this consolidation, we undertook a review of the published guidance on PFS in combination with expert consensus (via a Delphi study) from the authors who wrote such guidance to inform the identified considerations. A total of 161 PFS-related guidelines, checklists, frameworks, and recommendations were identified via a review of recently published behavioral intervention PFS and backward/forward citation tracking of well-know PFS literature (e.g., CONSORT Ext. for PFS). Authors of all 161 PFS publications were invited to complete a three-round Delphi survey, which was used to guide the creation of a consolidated list of considerations to guide the design, conduct, and reporting of PFS conducted by researchers in the behavioral sciences. Results A total of 496 authors were invited to take part in the Delphi survey, 50 (10.1%) of which completed all three rounds, representing 60 (37.3%) of the 161 identified PFS-related guidelines, checklists, frameworks, and recommendations. A set of twenty considerations, broadly categorized into six themes (Intervention Design, Study Design, Conduct of Trial, Implementation of Intervention, Statistical Analysis and Reporting) were generated from a review of the 161 PFS-related publications as well as a synthesis of feedback from the three-round Delphi process. These 20 considerations are presented alongside a supporting narrative for each consideration as well as a crosswalk of all 161 publications aligned with each consideration for further reading. Conclusion We leveraged expert opinion from researchers who have published PFS-related guidelines, checklists, frameworks, and recommendations on a wide range of topics and distilled this knowledge into a valuable and universal resource for researchers conducting PFS. Researchers may use these considerations alongside the previously published literature to guide decisions about all aspects of PFS, with the hope of creating and disseminating interventions with broad public health impact.

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“…The inclusion of cost data is not study-design specific and spans a wide range of designs from N of 1 to cluster randomized studies. 185 – 187 …”

Section: Resultsmentioning

confidence: 99%

Expert Perspectives on Pilot and Feasibility Studies: A Delphi Study and Consolidation of Considerations for Behavioral Interventions

Pfledderer,

von Klinggraeff,

Burkart

et al. 2023

Preprint

View full text Add to dashboard Cite

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“…Peer-led programmes for self-management of comorbid general medical conditions are effective for improving the health status of patients with an SMI (e.g., physical health-related quality of life, medication adherence) and the utilisation of healthcare services by these patients (50,51). An ongoing randomised controlled trial is investigating the feasibility of a novel intervention involving training volunteers to be 'Health Champions' to support people with SMI using mental health services to manage and improve their physical health (52). Follow-up after discharge from psychiatric hospital is another necessity.…”

Section: Discussionmentioning

confidence: 99%

Barriers to Somatic Health Care for Persons With Severe Mental Illness in Belgium: A Qualitative Study of Patients' and Healthcare Professionals' Perspectives

et al. 2022

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BackgroundA huge and still growing mortality gap between people with severe mental illness (SMI) and the general population exists. Physical illnesses, mainly cardiovascular diseases, substantially contribute to the high mortality rates in patients with SMI. Disparities in somatic health care access, utilisation, and provision contribute to these poor physical health outcomes.MethodsA qualitative study, using semi-structured interviews, was set up to explore SMI patients' and healthcare professionals' perspectives on somatic health care in different psychiatric settings of the three Belgian regions (Flanders, Brussels, Wallonia). Interviews were digitally recorded and transcribed prior to qualitative inductive thematic analysis, using Nvivo software. The COnsolidated criteria for REporting Qualitative research (COREQ) were used for reporting methods and findings.ResultsCollaboration and information flows between psychiatric healthcare professionals, non-psychiatric healthcare professionals, and persons with SMI were troublesome. This seemed to be mainly due to stigma and prejudice and challenging communication and data transfer. Lack of sufficient training and experience to identify and treat somatic health problems in people with SMI (for psychiatrists and psychiatric nurses) and lack of psychiatric knowledge and feeling or sensitivity for psychiatric patients (for non-psychiatric healthcare professionals) further complicated adequate somatic health care. Finally, optimal somatic follow-up of patients with SMI was hampered by organisational problems (unavailability of equipment, unadapted infrastructure, understaffing, hospital pharmacy issues, and insufficient health promotion/lifestyle interventions), patient-related issues (unawareness of physical problems, non-adherence, need for accompaniment) and financial barriers.ConclusionThere is an urgent need for integrated somatic and mental healthcare systems and a cultural change. Psychiatrists and primary care providers continue to consider the mental and physical health of their patients as mutually exclusive responsibilities due to a lack of sufficient training and experience, poor or absent liaison links, time constraints and organisational and financial barriers. Modifying these aspects will improve the quality of somatic health care for these vulnerable patients.

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“…Costs can be separated into the costs associated with the initial design/development, set up of the intervention, training of staff to deliver, and the costs associated with intervention delivery. The inclusion of cost data is not study-design specific and spans a wide range of designs from Nof 1 to cluster randomized studies [185][186][187].…”

Section: Considerationsmentioning

confidence: 99%

Consolidated guidance for behavioral intervention pilot and feasibility studies

Pfledderer,

von Klinggraeff,

Burkart

et al. 2024

Pilot Feasibility Stud

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Background In the behavioral sciences, conducting pilot and/or feasibility studies (PFS) is a key step that provides essential information used to inform the design, conduct, and implementation of a larger-scale trial. There are more than 160 published guidelines, reporting checklists, frameworks, and recommendations related to PFS. All of these publications offer some form of guidance on PFS, but many focus on one or a few topics. This makes it difficult for researchers wanting to gain a broader understanding of all the relevant and important aspects of PFS and requires them to seek out multiple sources of information, which increases the risk of missing key considerations to incorporate into their PFS. The purpose of this study was to develop a consolidated set of considerations for the design, conduct, implementation, and reporting of PFS for interventions conducted in the behavioral sciences. Methods To develop this consolidation, we undertook a review of the published guidance on PFS in combination with expert consensus (via a Delphi study) from the authors who wrote such guidance to inform the identified considerations. A total of 161 PFS-related guidelines, checklists, frameworks, and recommendations were identified via a review of recently published behavioral intervention PFS and backward/forward citation tracking of a well-known PFS literature (e.g., CONSORT Ext. for PFS). Authors of all 161 PFS publications were invited to complete a three-round Delphi survey, which was used to guide the creation of a consolidated list of considerations to guide the design, conduct, and reporting of PFS conducted by researchers in the behavioral sciences. Results A total of 496 authors were invited to take part in the three-round Delphi survey (round 1, N = 46; round 2, N = 24; round 3, N = 22). A set of twenty considerations, broadly categorized into six themes (intervention design, study design, conduct of trial, implementation of intervention, statistical analysis, and reporting) were generated from a review of the 161 PFS-related publications as well as a synthesis of feedback from the three-round Delphi process. These 20 considerations are presented alongside a supporting narrative for each consideration as well as a crosswalk of all 161 publications aligned with each consideration for further reading. Conclusion We leveraged expert opinion from researchers who have published PFS-related guidelines, checklists, frameworks, and recommendations on a wide range of topics and distilled this knowledge into a valuable and universal resource for researchers conducting PFS. Researchers may use these considerations alongside the previously published literature to guide decisions about all aspects of PFS, with the hope of creating and disseminating interventions with broad public health impact.

show abstract

A feasibility hybrid II randomised controlled trial of volunteer ‘Health Champions’ supporting people with serious mental illness manage their physical health: study protocol

Cited by 5 publications

References 24 publications

Expert Perspectives on Pilot and Feasibility Studies: A Delphi Study and Consolidation of Considerations for Behavioral Interventions

Expert Perspectives on Pilot and Feasibility Studies: A Delphi Study and Consolidation of Considerations for Behavioral Interventions

Barriers to Somatic Health Care for Persons With Severe Mental Illness in Belgium: A Qualitative Study of Patients' and Healthcare Professionals' Perspectives

Consolidated guidance for behavioral intervention pilot and feasibility studies

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