TITLE: Mixed-methods study to validate and refine the &#39;Strategic Healthcare Implementation Framework for Task Shifting, Sharing and Resource Enhancement&#39; (SHIFT-SHARE)
AUTHORS: Shukanto Das, Liz Grant, David Weller

[DESCRIPTION]
Background: In healthcare, task shifting and task sharing (TS/S) are mechanisms that rationally transfer services from providers with more skills or qualifications to workforces with shorter training or fewer qualifications. Global guidelines on task shifting by the World Health Organization recommended countries to expand on TS/S via production of policy and implementation frameworks. However, implementation-specific frameworks for TS/S are lacking. The authors have conceptualised a framework specific to TS/S, called the ‘Strategic Healthcare Implementation Framework for Task Shifting, Sharing and Resource Enhancement’ (SHIFT-SHARE). Its building blocks are based on popular change management theories, implementation models and program assessment tools. SHIFT-SHARE has six stages laid down in a cycle, each offering stepwise direction on how to operationalise TS/S. The following protocol will now be used to evaluate real-world validity, applicability and utility of SHIFT-SHARE. The protocol can be adopted and used by researchers attempting to evaluate similar aspects of other implementation frameworks or service delivery models. 
 
Objectives: The current protocol describes how data on stakeholder experiences with TS/S in context of health services in India will be collected and how their viewpoints on SHIFT-SHARE will be analysed, to further incorporate their recommendations and fine-tune SHIFT-SHARE. Primary objectives of this planned study are (1) to examine whether services adhere to the overarching philosophy of SHIFT-SHARE and (2) to study how organisations incorporate each component of SHIFT-SHARE into implementation processes and assess quality markers at each stage. Secondary objectives are (1) to appraise enablers and barriers to TS/S in context of SHIFT-SHARE, with a focus on power dynamics, sociocultural norms and regulatory policies, (2) to understand whether front-line healthcare providers get opportunities to contribute to or provide feedback at different stages of TS/S and review these in context of SHIFT-SHARE, (3) to appreciate provider and recipient experiences with TS/S and place these in context of SHIFT-SHARE and (4) to investigate whether TS/S has been reversed after being implemented and learn why. 
 
Methodology: The study will be qualitative and mixed-methods. The setting for this planned study is India. Data is to be collected via semi-structured interviews, focus group discussions and non-participative participant observations. Participants will include organisation-based or privately-practicing frontline providers, public health and community health workers and volunteers, who have been part of services that incorporate TS/S, and directors, managers, administrators, trainers, supervisors, auditors or support staff of such services. Subject experts, academicians, policy makers and decision-makers on matters of health systems, health and social care will be enrolled. Patients who have received interventions from services that use TS/S to deliver care will also be included. Collected data will be coded and analysed using a hybrid deductive-inductive approach.
 
Results: Finings from this analysis are expected to provide insights on care access, care quality and safety of TS/S-based services as perceived by stakeholders. The study will reveal whether stakeholders endorse TS/S and are prepared to employ it as prescribed by SHIFT-SHARE, and will help identify enablers and barriers to its implementation. The analysis will offer user-feedback on SHIFT-SHARE, particularly on its relevance, readability, clarity and applicability. Deeper understanding of the framework’s merits and demits will be obtained. These information will be useful to strengthen the framework before disseminating it. 

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SECTION: Seeking of consent
4. The consent process will ensure that participants have clear understanding of the study and voluntarily provide consent to participate. Once participants are identified, the Investigator will send them a participation information sheet (PIS), which will contain explanation of the study's purpose, procedures and nature of participant involvement. The participants will have sufficient time to go through the PIS at their own pace. They will be encouraged to seek clarification on any aspects of the study before making a decision. The Investigator will address participant queries and concerns, and provide additional information as required.

The Investigator will request participants to fill in and sign a Consent Form (CF). CFs will seek their agreement to voluntarily participate in the study and also to the study's terms and conditions. Participants will retain their copy of the PIS for future reference, and they will be given a signed copy of their CF as evidence of their consent and participation in the study.
 
Only participants who give their consent, will be invited for the respective SSIs, FGDs and POs at a time and location convenient to them. Participants will be free to withdraw from the study at any point without any questions asked. However, data collected before the consent withdrawal will be processed in the study. If withdrawal occurs, the primary reason for withdrawal will be documented.
SECTION: Recruitment strategy
3. Recruitment for this study will commence from September 2023 continue through the next 10 months. As explained previously, the Investigator will identify and enrol particpants using connivence sampling. Broadly, three strategies will be used to recruit participants:

With support of Lifeline Foundation: Lifeline Foundation (www.emsindia.in) is a non-profit based out of Vadodara, India. It works across areas of emergency medical services (EMS), industrial EMS, disaster preparedness, road safety and cardiovascular health and relies on TS/S-based models to train bystanders and healthcare providers, including doctors, nurses, paramedics and community health workers in pre-hospital trauma care. Lifeline has volunteered its programs that use TS/S for the study, as well as has offered the investigator to connect with its networks of collaborators in pre-hospital care, mother and child care, mental health and other areas, for the Investigator to approach, propose and potentially enrol them in the study separately.

Through personal and professional networks of the Investigator: The Investigator has worked for several organisations in India as well as on reports for the Ministry of Health and Family Welfare, Government of India. The Investigator plans on engaging these networks of system stakeholders in India to make approaches to potential participants for the study.

Snowballing: The Investigator will use a network-based approach to expand sample size. The Investigator will request initially identified participants to refer to and nominate their other colleagues as potential participants for the study.
SECTION: Study design and setting
1. The planned study is mixed-methods. Data will be collected via semi-structured interviews (SSIs), focus group discussions (FGDs) and non-participative participant observations (POs). These methods are suitable for exploratory research. The open-ended nature of questions and cues of SSIs and FGDs allow respondents to give direction to the interaction and share in-depth opinion about the subject. SSIs and FGDs will provide the Investigator opportunities to probe responses, understand reasoning and context, capture multiple perspectives and inapparent observations. POs facilitate the examination of participants in their own environment. The non-participative nature indicates that the Investigator will not interrupt or interfere in any processes they observe. Such ethnographic studies can offer thick descriptions of what is being witnessed, whereby the Investigator will be able to place observations in the broader socio-cultural, political, historical or normative context and extract meanings from these complex structures.

Primary data will be collected from healthcare providers and other system stakeholders based in India. Participants are expected to be based out of the states of Gujarat, Telangana, Rajasthan, Maharashtra, Karnataka, Kerala and Delhi. Snowballing may lead to other states as well. The author of this protocol will collect and analyse data, as the Investigator.
SECTION: Data collection
5. Data collection is anticipated to start in November 2023 and will continue through June 2024. As explained above, there will be three different modalities through which data will be collected, namely SSIs, FGDs and POs. Some participants enrolled for SSIs will also be recruited for POs and FGDs; others will be unique recruits. The procedures of each are explained as under:

SSI: The Investigator will contact a participant and schedule an interview at a time suitable for them. The interview will be conducted in-person at a location convenient to them. If the participant prefers, the interview can be held online. The participant will not be required to carry out any pre-reading or preparation for the interview. The interview will last for an hour. The Investigator will ask participants open-ended questions, including about their understanding, current practices and experiences with TS/S. The participant will have the freedom to refuse to answer any question they wish.

 FGDs: The Investigator will contact participants within an identified healthcare organisation or domain of work. The Investigator will form a suitable group for the FGD and schedule the session at a time which works best for the group. FGD will be held in-person and at a venue convenient and safe for all, for e.g., in a meeting room in their organisation. In preparation for the session, participants will be provided with with a document containing a brief overview of SHIFT-SHARE. Participants will be encouraged to review this document before attending the FGD. The session will run for approximately 1-1.5 hours. In the session, the Investigator will ask the group open-ended questions and moderate discussions on its thoughts and feedback on the SHIFT-SHARE. Participants will have the freedom to refuse to answer any question they wish.

 POs: If a participant is providing service or supervising a task that is characteristically shifted or shared from one cadre to the other, the Investigator will contact them and request to accompany them at point of care or delivery. A session or episode of PO should last for an hour or the duration of the task, whichever is more feasible. The Investigator will accompany the participant in the capacity of a passive or non-participative observer and not interfere in any process or task the participant is involved with. All local procedural protocols and norms will be respected. The Investigator will make observations by taking written notes. The PO can be paused or stopped at any moment the participant wishes.

Topic guides to support and direct the SSIs and FGDs have been developed. These contain key themes and questions to help set up interviews and focus groups, and give conversations a general flow. Topic guides are attached with the submitted protocol.

For sessions held in-person, a hand-held audio recording device will be used to record. For sessions where participants prefer to not be recorded, Investigator will take written notes. For sessions held online, in-built recording feature of the app will be used to record the session. Audio recordings will be transcribed manually by the Investigator. This will also help in the process of data familiarisation.

Data generated via the study will respect guidelines of the UK General Data Protection Regulation.
SECTION: Data analysis
6. Data analysis will span from November 2023 to July 2024. Transcription and analysis will begin alongside data collection. The Investigator will become familiar with raw data, begin coding and thematic data analysis using a hybrid deductive-inductive approach.

Data coding and analysis will be done using NVivo.

Themes generated from data collected via SSIs and POs may include:
Stakeholder experiences on care access, quality and safety
Role perception and characterisation of TS/S by providers
Adherence to the SHIFT-SHARE philosophy
Enablers and barriers in TS/S
How stakeholders feedback into TS/S
Provider experiences with regards to TS/S 
Reversibility of TS/S
Perceived benefits and risks of TS/S
Support towards TS/S

Themes generated from data collected via FGDs may include:
Readability and clarity of SHIFT-SHARE
Relevance and applicability of SHIFT-SHARE
Underpinning features of SHIFT-SHARE
Mechanisms to implement SHIFT-SHARE 
Enablers and barriers to implementation
Perceived merits and impact of SHIFT-SHARE
Demerits of and concerns towards SHIFT-SHARE
SECTION: Ethical considerations
8. The study will follow the ‘UK Policy Framework for Health and Social Care Research’ as developed by the Health Research Authority and health departments in Scotland, Wales and Northern Ireland. The following considerations are made:
Participant enrolment will be voluntary. 
The PIS and CF will inform participants about the nature of their involvement.
Participants will be required to spend a total of 1-2 hours in the study, which may cause a one-off interruption to their routine. However, data collection will be scheduled to best suit their convenience. There are no other disadvantages of participating in this study. 
All local procedural protocols and norms will be respected when collecting data.
Participant consent will be obtained before commencing data collection.
Participants will have freedom to opt out of the study at any given point without any further questions. However, data generated prior to withdrawals will be processed in the study.
Participant responses will be kept confidential.
All findings will be reported without distortion or misrepresentation.
Study is purely observational and does not alter treatment or care protocols.
Data collection will be conducted in a professional and respectful manner. 
Themes of research do not cover any sensitive issues, hence potential emotional impact on participants is not anticipated. If participants, while sharing anecdotes or talking about their experiences, feel distressed, the Investigator will handle these conversations with dignity, actively listening to and respecting their views and opinions.
SECTION: Reporting of results
7. The study is an integral part of the first author's doctoral research project at the Usher Institute, University of Edinburgh, and it will be included in their doctoral thesis. Study findings may also be disseminated through publications in scientific journals and reports, and presentations at national and international conferences under authorship of the study team. The published results will not contain identifiable information about individual participants, ensuring confidentiality and privacy.
SECTION: Sampling and participant profile
2. The study will entail conducting SSIs of 30 participants, performing 10 episodes of POs and running 4 FGDs, with each group having 5 participants. Some individuals who participate in the SSIs will also be recruited for POs and FGDs; others will be unique recruits. This sample size to up to 50 participants has been determined on the assumption that it will generate enough data to reach data saturation, and ensure a comprehensive coverage of the research question. The Investigator will recruit particpants using connivence sampling. The following Tables 1-3 show recruitment estimates. Participants will be enrolled in the study if they identify with one or more of the participant profiles listed in respective tables.

Table 1: Participant profile for semi-structured interviews 
 

Table 2: Participant profile for participant observations
 

Table 3: Participant profile for focus group discussions