How cAN we grow research in community-baseD NHS and SociaL CarE Services (HANDLE)?

Rationale

In view of the above, there is a clear need to explore barriers and facilitators to engaging and delivering research in community-based NHS and social care services. By understanding these barriers and facilitators, recommendations can be made to address them. This will support the delivery of research in the community and increase research capacity and capability across local NHS trusts.

Research questions/aim(s)

This study aims to understand how we can build research in community-based NHS and Social Care Services.

Objectives and outcomes

Objectives

To use semi-structured interviews and develop a qualitative framework to explore the perspectives and experiences of research staff and practitioners (with or without research experience) on barriers and facilitators of community-based research, and how we can build research in community-based NHS and Social Care services.

Outcomes

Study design, data collection and data analysis

Study design

Handle study is a qualitative study where members of research staff and other practitioners (with or without research experience) from community-based NHS and social care services will be invited to participate in a single semi-structured interview. The interviews will be conducted either face-to-face, via telephone, or using platforms such as MS Teams. The interviews will aim to explore the viewpoints and experiences of staff in engaging with research, which will help us understand the barriers and facilitators to building research in community-based NHS and social care services.

The sample

The sample will consist of research staff and practitioners with or without experience in research. People can be identified in several ways.

Inclusion criteria

Exclusion criteria

Sample size

Based on similar research projects and the study team’s experiences, the predicted sample size is up to 25 staff members, including research staff and practitioners, or until data saturation is reached.

Consent

To recruit participants for this study, professional networks and social media will be used. Potential participants expressing interest will be asked to contact the Research Associate (RA) if they would like to participate in the study. The RA will share the study documents, including the Participant Information sheets and consent form, with them via email. Participants will be given the time to read the study documents and the opportunity to ask questions. An interview will then be organised either face-to-face or telephone/MS teams, as preferred by each participant. Informed consent will be obtained from each participant by the RA before the interviews. The participants will be given an opportunity to discuss any concerns with the RA before signing a written consent form and sharing it with the RA via email (if the interview is conducted virtually) or in person (if the interview is conducted face-to-face). The RA will countersign these forms prior to the interviews. Two copies of the consent forms will be completed: one to be retained by the research team and one for the participant.

Data collection

A topic guide for interviews will be developed by the research team with reference to the literature, and input from the stakeholders and will change iteratively depending on ongoing data collection and analysis. The topic guide has been informed by results from a scoping review (conducted by the PI and Dr. Louise Warburton from the study team) looking at barriers to research in community-based NHS and social care services.

With the participants’ consent, the interviews will be audio-recorded and transcribed for analysis.

Data analysis

The interviews will be transcribed verbatim and anonymized. Qualitative framework analysis^6,7 will be undertaken by the RA (GT) with support from other members of the research team. Framework analysis, which is well-suited for applied qualitative research and deductively moves from pre-specified aims and objectives, will be utilised to organize and understand the interviews by forming an analytical framework and then charting this data into a framework matrix.^8,9

The initial analysis will be presented to and discussed with patient and public involvement and engagement (PPIE) members and key stakeholders to gain additional perspectives. The findings from this qualitative study will inform recommendations made to clinicians, practitioners, policymakers (local and national), and funding organizations on how to build research in community-based NHS and social care services.

Patient and public involvement and engagement (PPIE)

Dissemination

Upon completion of HANDLE, a Final Study Report will be written for the funders in the form of an academic publication. This paper will be available online in Open Access. The funding body will be acknowledged according to the standard NIHR criteria. Anonymised data will be made available upon formal request.

If participants desire, they can consent to being notified about the outcome of the study by providing their e-mail address on the consent form. E-mail addresses for this purpose will be stored for up to 2 years to allow time for the research to be completed. At this point, a lay summary report will be written and sent to consenting participants alongside the publication.

This research will be used to create recommendations to address the barriers and facilitators of conducting research in community-based NHS and social services. Findings and conclusions will also be shared at appropriate conferences (e.g., Health Services Research UK and Society for Academic Primary Care).

Full ethics statement

Approval committee: College of Health and Life Sciences, College Research Ethics Committee (CREC), Aston University.

Approval number: #HLS21115

Approval date: 1^st August 2023

HANDLE involves human participants, and we will adhere to the Declaration of Helsinki at all times.

Ethical considerations

Ethical and regulatory considerations

Study management

This study is led by Professor Ian Maidment. Members of the study team will meet fortnightly in Study Management Group meetings to oversee the study’s progress.

Research Ethics Committee (REC) and other Regulatory Review & Reports

As data collection does not include the recruitment of NHS patients, ethical approval was sought from the College of Health and Life Sciences College Research Ethics Committee (CREC) at Aston University.

Any subsequent amendments to the study design and/or process will be submitted via CREC procedures. Routine reporting will take place in line with the Aston University CREC and

Amendments

For any amendment to the study, the Chief Investigator in agreement with the sponsor will submit information to the appropriate body for them to issue approval for the amendment. Any amendments required for the study will be submitted to the College of Health and Life Sciences Research Ethics Committee, Aston University, for review.

The PI and RA will be responsible for the decision to amend the protocol.

If substantive changes are required, the funding body and R&D at each participating site will be notified in writing. Any amendments approved by the College of Health and Life Sciences Research Ethics Committee of Aston University will be added to an updated version of the research protocol.

Assessment and management of risk

HANDLE is a non-interventional study that is associated with a very low risk. There is a slight possibility that the interviews might cause distress to the participants; however, this is not an emotive subject. The study team recognises that sparing time to participate in interview/travel may cause minor discomfort. To minimise the discomfort the participants will be given a choice to take part in a remote meeting interview. Also, prior to the interview, the researcher will make it clear to the participants that there are no right, or wrong answers and they have the right to ‘not answer’ any question if they wish; pause/stop the interview or withdraw from the study altogether at any point during the interview. The RA has received appropriate training, as required, to conduct the interviews and ongoing support and supervision from the PI and other members of the team throughout the project will also be provided. The safety of the RA will be protected by adhering to Aston University’s Lone Working Guidance. The NIHR Safeguarding policy will always be followed.

Participants may feel that their participation will have an impact on their work lives. To address this issue, all participants will be fully briefed about the study procedures to maintain confidentiality before participating in the study. There is also the possibility that a participant may raise concerns or safeguard issues. If this occurs, the issue will be discussed with the person making the disclosure, and if appropriate, the RA will discuss the issue with the PI and report the matter to the relevant bodies. Ensuring the safety, well-being, and confidence of participants in the research is a prime concern.

Regulatory compliance

The study will be conducted in accordance with the principles of Good Clinical Practice (GCP) in research studies and the UK Policy Framework for Health and Social Care Research. Aston University as the Sponsor, has a quality management system in place containing standard operating procedures that will be adhered to in the conduct of the study. Studies may be subject to an audit by Aston University as the Sponsor for quality assurance.

Any potential noncompliance event affecting the research will be promptly reported to the PI as soon as any member of the research team becomes aware of the event. The PI (or delegate), in discussion with the study management group/committee (SMG), will gather information to assess whether the event is a true noncompliance event with escalation and reporting, as outlined in the applicable HSCR standard operating procedure (SOP).

The SMG will monitor protocol compliance and recruitment during the conduct of this study, which will be discussed at fortnight meetings. Technical deviations from the protocol that do not result in harm to the study participants, do not compromise data integrity, or significantly affect the scientific value of the reported results of the study will be documented, and appropriate corrective and preventative actions will be taken by the research team with the PI responsible for these with agreement from the SMG.

A “serious breach” is defined as a breach of the protocol or of the conditions or principles of GCP, which is likely to significantly affect the safety or physical or mental integrity of the study subjects, or the scientific value of the research. In the event of doubt or for further information or guidance, the investigator should contact the PI. All protocol deviations and breaches of the GCP will be recorded and reported to the Sponsor and REC according to the applicable HSCR SOP.

Data protection and patient confidentiality

Standard data protection procedures at Aston University will be employed to protect confidentiality and anonymity. The interviews will be audio-recorded with the permission of the participants. RA ensures that the audio files do not contain any personally identifiable information. To do so, the RA will ensure that the participants do not discuss personal information about themselves, their workplace, or any other identifying information after the recording has started. The participants will be made aware of this before starting the interview recording and will be reminded during the interview if a need arises. After the recording has started, the RA will ensure that the participants are not referred using their real name during the interview. The interview recordings will be securely transferred electronically to an Aston University-approved transcription service for transcribing.

After receiving the transcripts, the RA will go through each transcript to check for accuracy and again ensure that there were no names or other identifiable information recorded/included in the transcription. At this stage, each participant’s transcript will be replaced with a unique participant identifier, following the procedure described by Aston University. Only the PI and RA will have access to personal information and data. The agreement with the external transcription service covers confidentiality, data transfer, and destruction (files will be deleted once the transcription is completed). At all times, the transcriber will comply with the Data Protection Act of 1998. At the end of the study, database anonymization and locking will be performed in accordance with the SOPs.

Aston University has robust data security systems and procedures that are regularly reviewed, and it achieves the legal obligations set by the Data Protection Act (2018) and the General Data Protection Regulation (GDPR),¹⁰ followed by the GMC Caldicott Guardian and British Computer Society standards and guidelines.¹¹

Data collected from the interviews will be stored in Aston University’s secure Box, accessed by a password-protected laptop. The storage and access to the data will be in accordance with the SOPs. Data used for analysis will be kept separate from the consent forms containing participant-identifiable information. All confidentiality arrangements will adhere to relevant regulations and guidelines, and the PI has responsibility for ensuring the integrity of the data and that all confidentiality procedures are followed.

All investigators and study site staff must comply with the requirements of the Data Protection Act 2018 with regard to the collection, storage, processing, and disclosure of personal information and will uphold the Act’s core principles.

Indemnity

Insurance and/or indemnity to meet the potential legal liability of the sponsor for harm to participants arising from the management of the research will be covered by the Aston University insurance.

Insurance and/or indemnity to meet the potential legal liability of the sponsor or employer for harm to participants arising from the design of the research will be covered by Aston University insurance.

No equipment will be provided to NHS sites for the purposes of this study.

Access to the final study dataset

Only members of the Project Management Team will have access to the fully anonymized dataset. The consent form will include permission to use the interview data for appropriate analysis within the overall scope of the project.