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Enhanced integration of primary and secondary health systems and patient empowerment through improved continuity of patient care and clinical handover – Development Phase I

PROJECT PROTOCOL

Joint-Funding Agencies:UK Medical Research Council

Department for International DevelopmentEconomic and Social Research Council

Wellcome Trust

Version 2.0 Updated 17/02/18

Executive Summary:

Effective integration of care between community (primary) and hospital care (secondary) health services is essential for a patient whose needs extend beyond the initial episode, and more care is required by the next level of health provider. This may include referral to a hospital if a primary care doctor cannot manage the condition or the continuation of medication and check-ups in primary care after a hospital admission. The crucial stage is communication of patient-specific information from one caregiver to another or to the patient and family, for the purpose of ensuring continuity of patient care and safety, termed clinical handover.

A review of evidence in the high-income countries showed that the consequences of ineffective handover include: incorrect treatment, delays in medical diagnosis, life-threatening adverse events, patient complaints, increased health care expenditure, increased length of hospital stay, increased re-admissions, and other detrimental health systems impacts. Although we have not been able to find similar data for low and middle-income countries (LMICs), experience and discussions with partners and experts indicate that the rate of adverse events and other unwanted outcomes due to poor handover are even greater in these nations due to notable gaps in health provider integration. Therefore, it is likely that considerable scope exists to improve handover practices in a way that is cost-effective. Interventions may be adapted from methods that have been successfully implemented in high-income countries (e.g. check-lists, patient held records).

There is a global focus from the World Health Organisation (WHO) on health systems development, critical for a better response to challenges of emergencies and both infectious and non-communicable diseases. The rise in elderly populations and deteriorating lifestyle behaviours (e.g. smoking rates) in LMICs has led to an increased burden of cardiovascular disease, diabetes and other long term conditions. Due to their need for on-going care, these are particularly adversely affected by poor integration between primary and secondary care.

Therefore, the main drivers for our proposal are evidence for the following:

-Clinical handover processes are at the core of patient safety and consequences of inadequate clinical handover result in poor patient outcomes and high costs to health systems.

- Clinical handover is a global priority identified by the WHO Patient Safety Programme. There is great need and interest in many LMICs to improve integration between differing levels of health care, but little evidence is currently available to guide local decision makers on how to identify and overcome barriers to improved practice.

- Initial interventions can be culturally and politically acceptable, affordable and sustainable, but such interventions have not yet been systematically explored, tested or implemented.

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Technical abstract

Design: Observational prospective study using mixed-methodology; Setting: Three hospitals, two primary health centres and one community health centre across Kerala and Himachal Pradesh states, India.

Objectives:

1. Situation analysis of policies, training, activities, and professional culture for clinical handover between primary and secondary care during referrals and discharge

2. Identification of barriers and facilitators (health care system and patient-related) to clinical handover and improving practices

3. Exploration of the relationship between handover practices during discharge and post-discharge patient health outcomes

4. Exploration of patient-related intervention options for complex health systems to improve clinical handover

5. Development of pilot data collection tools for future handover intervention evaluation

6. Building health systems research capacity in order to enable further research and progress in integrating health systems, with the aim of developing and implementing a future cluster-RCT assessing the effectiveness of chosen interventions

Methods: These will be achieved via utilisation of mixed-methodology research, to include:

a) Semi-structured interviews with patients and healthcare providers: Views will be elicited on barriers, facilitators, potential interventions and identifying training/education needs regarding clinical handover

b) Expert groups with health care academics, policy makers, managers, providers in primary and secondary care and patients: Views will be elicited on barriers, facilitators, potential interventions and identifying training needs regarding clinical handover

c) Patient-held medical document content review

d) Health care provider surveys

e) Patient and case note surveys for outpatients on admission and discharge, and for inpatients on admission, discharge, 5 weeks and 4 months post-discharge. Patients will have one (or more) of the following chronic, non-communicable diseases (NCDs) requiring follow-up: cardio vascular disease, diabetes mellitus, chronic obstructive pulmonary disease, stroke, and/or elderly patients (>65 years old) with multiple co morbidities

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A range of analytical frameworks will triangulate the findings, together with evidence of best practice, to identify opportunities for improvement and options for intervention/s. The findings will be used by local policy makers, managers and practitioners to start addressing low-cost barriers and solutions, while a systematic application of the results will be used to develop a complex-health systems intervention programme for a future cluster trial.

Background and literature review:

This Project, conceived jointly with our Indian partners, is designed to enhance the quality of health care in low- and middle-income countries (LMIC) by addressing the inadequacies of clinical handover processes, as a show-case in 2 states of India using tracer conditions. Clinical handover is the cornerstone for continuity of health care between providers. This is the first Project in a LMIC rigorously describing the current situation, barriers and facilitators for improvement with respect to clinical handover between primary-secondary care services, defining relevant transferable and sustainable interventions.

Effective integration of care between community (primary) and hospital care (secondary) services is essential for patients whose needs extend beyond the care episode. This may include referral to a hospital if a primary care doctor cannot manage the condition or the continuation of medication and check-ups in primary care after a hospital admission. At a basic level, ‘integrated or continuity of health care’ consists of communication and coordinated care across different services and levels of care putting patients at the centre. This begins with the crucial stage of information exchange between providers about the patient’s current medical condition(s) and required care within an institution (e.g. shifts in a hospital) or between institutions or levels of care (e.g. discharge from hospital to primary care), termed ‘clinical handover’.

In Europe, 19-35% of admissions may suffer adverse events after discharge,1 including premature preventable death - a third attributable to poor handover originating within the hospital. A review by the Australian Commission on Safety and Quality in Healthcare (ACSQH)) 2 3 found that ineffective handover led to delays in diagnosis, incorrect treatment, , life-threatening adverse events, patient complaints, health costs, increased length of stay, and increased re-admissions. Experience and discussions with our partners and experts indicate that the adverse events and other unwanted outcomes due to poor handover are even greater in LMIC. This is maybe in parts due to care being provided by diverse providers that are not regulated centrally and do not fall within defined health systems that relate to each other in a systematic and defined way. Hospital to primary care handover is often omitted entirely under these circumstances.4 Furthermore, the rise in elderly populations and deteriorating lifestyle behaviours (e.g. smoking rates) has increased the burden of non-communicable diseases. The care for these is particularly adversely affected by poor integration between primary and secondary care.

WHO Collaborating Centre for Patient Safety Solutions5 offer some suggestions for action, but evidence is sorely lacking. One action is targeted on improving communication failures during patient handovers to prevent harm.6 These set an agenda and some LMIC have begun

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projects that incorporate improvements in handover, mainly aimed at the within-hospital shift-change handovers.

WHO and ACSQH reviews concluded that clinical handover is not well-researched, and that there are substantial gaps in policy and research throughout the world.2 3 A recently concluded FP7 programme in which the applicants were partners provides an additional updated review of effective clinical handover interventions.7 LMICs hardly featured in any of these reviews. As a preparation for this proposal, we are concluding a systematic literature review on clinical handover targeted specifically at LMIC. The key finding is that there is a dearth of published literature on handover, or interventions to improve it, from LMIC: 11 studies from Asia (two from India8 9) and 18 in total from other continents. In Asia, the publications covered patient records, discharge planning and community service support for patients with heart disease, use of emails for referral and information exchange and mobile phone messages to provide advice to patients about drugs. The studies were mostly descriptive or of ad-hoc quasi-experimental evaluation of one intervention and were excluded from the aforementioned reviews. Nevertheless, insights can be gained from these publications with regards to LMIC. The shortage of published evidence is not due to a lack of interest in LMIC. Our partners in India initiated projects in 2010 (with WHO India office), looking into the effects of training packages for staff and improvement of in-hospital communication and clinical handover.

Theories on implementation of innovations in health care emphasise that an analysis of the barriers and facilitators to change of practice is a prerequisite for development of effective interventions. Taxonomy of categorising barriers and facilitators has identified 3 domains:2 3 7

1) System factors (handover within the context of policies and procedures, operating systems, work systems and routines, supervision and legislation. Operating system variables included support for information tools and systems such as computer based reports, written notes, checklists and tape-recording processes as well as a range of other methods of communication);

2) Organisational factors (communication between and amongst health professional groups that impacts on patient care; and interpersonal relationships influencing communication ability and willingness to share information);

3) Individual factors (individual staff variables relating to their knowledge, skills and attitudes that describe an individual’s ability to perform their role and transfer appropriate information to another person. This includes the impact of fatigue, clinical decision-making and organisational skills in the process of knowledge transfer. Types of human errors that can be classified according to misperception, mistaken priorities, attention lapses, mistaken actions, or violations or sabotage).

The role of patients cannot be underestimated, being at the core of guidance from WHO patient safety policy.2 5 6 The evidence from high-income countries for barriers, facilitators and interventions could inform the development of a LMIC programme to improve clinical handover, because anecdotal evidence and the limited literature suggests that, in principle, the

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issues are similar where some level of primary or secondary care provision exist. We believe that considerable improvement could be achieved by means of cost-effective low cost interventions addressing the 3 domains or patient involvement, e.g. yielding savings for the government or charity based health systems or out of pocket payments for patients due to the reduction of adverse events, readmissions and years of healthy life lost. Examples of potentially cost-effective intervention are the use of simple applications for mobile phones, check-lists, or patient-held records. However, in order to develop locally applicable interventions which are owned and adopted by health system planners and providers, we need to engage them, and understand and describe at a high level of granularity the process of clinical handover between primary and secondary care. Multi-disciplinary studies to provide this information form the basis of this development grant proposal.

Beyond this in a follow-on step wedge cluster RCT,10 we plan to provide new evidence for effective interventions in these settings through the development and testing of a multi-component complex package of interventions that incorporate elements to be implemented in the primary care, hospitals and including patients/carers (see impact section). Thus the importance of our current proposal at this time, focussing mainly on clinical handover in the interface of primary and secondary care, are highlighted by the main drivers for the study which are:

1) Evidence indicating that handover processes are at the core of patient safety and consequences of their inadequacies result in poor patient outcome and high cost to the health system;

2) Evidence that there is interest in many LMIC (especially in India) to improve integration between-levels of health care, but little evidence to guide local decision makers/managers in how to identify and overcome barriers to improved practice;

3) Wealth of evidence from high-income countries and some publications from LMIC that initial interventions can be culturally and politically acceptable, affordable and sustainable, but that such interventions have not been systematically explored, tested or implemented;

4) Increasing elderly and rates of non-communicable diseases in LMIC demand better continuity of care and clinical handover.

5) Clinical handover is a global priority identified by the WHO Patient Safety Programme. Interventions to strengthen health system are crucially needed in LMIC for better outcomes in communicable and non-communicable diseases and reduced spending on health care.

Rationale:

This project is directed at India, a large country with challenging and complex health systems. This project is timely for India, given the stage of development of their health care systems, the emergence of primary care systems, and increasing interest in the topic of clinical handover. The rapidly aging population of India, as with many other Asian countries,

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is leading to a growing burden of chronic NCDs. These incurable and degenerative conditions require better integration between primary and hospital care services because NCD patients have health needs surpassing that which can be managed by individual services alone.

Objectives:

This project and a follow-up step wedge cluster randomised controlled trial (cRCT) aims to enhance the quality of health care in India as an example of a LMIC by addressing the inadequacies of clinical handover processes. Clinical handover is the cornerstone for continuity of health care between providers and has barely been explored in the context of LMICs. There are inherent challenges for clinical handover in many LMICs since there is often no single health system that delivers both primary and secondary care, with primary care often being highly fragmented. Additionally, the problem of integration between levels of health care has become prominent given the rising prevalence of NCDs (in particular cardiovascular disease) in LMICs. The need for further research in this area has been highlighted by global reviews and the WHO Patient Safety programme. This project will be the first to describe the current situation, whilst also outlining barriers and facilitators for change with respect to optimal clinical handover between primary and secondary care services in a LMIC. It will also be one of the first of its kind in an LMIC to explore the relationship between discharge-related handover practices and post-discharge patient health outcomes.

This will facilitate the definition of relevant transferable and low-cost interventions, which can then be tested to establish evidence determining the possibilities for sustainable implementation. We will undertake a situation analysis project documenting the state of clinical handover between primary and secondary care in India for patients with the following NCDs: cardiovascular disease, diabetes mellitus, chronic obstructive pulmonary disease, stroke, or elderly patients (>65 years old) with multiple co morbidities. This will be achieved through the following specific objectives:

1. To undertake situation analysis with regards to policies, training, activities, and professional culture for clinical handover between primary and secondary care during referral and discharge

2. To identify health care system and patient-related barriers and facilitators to clinical handover and improving handover practices

3. To explore the relationship between current handover practices during discharge and post-discharge patient health outcomes

4. To develop options for clinical handover interventions between primary and secondary care

5. To develop pilot data collection tools for a future cluster RCT of handover interventions

6. To build health systems research capacity and collaboration between India and the UK

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Work leading to this proposal

The team have worked in a range of aspects of patient safety, and particularly clinical handover, in both high and low/middle-income countries, and are pioneering in the field of clinical handover in LMICs. The team were part of a large consortium funded by the European Union from 2007 until 2011 under the Framework 7 of research funding to develop a large agenda on clinical handover across Europe, including middle-income European countries. This study included numerous systematic reviews, qualitative studies, quantitative surveys and the development of an online training intervention. Since then the team have begun work with WHO Headquarters in Geneva to look at the gap with respect to this topic in LMICs. A systematic review of the literature focussing on publications from LMICs is almost complete, and very few published studies were found. A pilot survey of senior experts/practitioners in LMICs has begun to understand the priorities, protocols, barriers and facilitators related to clinical handover in LMICs. Also, an outpatient cardiovascular disease study has been conducted in Nigeria in a medium-sized hospital to understand handover practices there (submitted as a Masters project and awaiting publication in peer review journals). This MRC proposal is an attempt to forward this agenda systematically in one LMIC.

Methods/ detail of research plan:

We will undertake a situation analysis project documenting the state of clinical handover practise between primary and secondary care in India for chronic NCDs. A mixed method situation analysis will be used, describing practices, barriers and facilitators for handover and integration between primary and secondary care services, as well as exploring patient and carer experiences through the triangulation of qualitative and quantitative data.

It will assess:

a) System design factors,

b) Organisational and cultural factors, and

c) Individual factors (patients/carers/healthcare providers).

The micro-systems at the primary care/hospital interface will be assessed in relation to the tracer medical conditions (cardio vascular disease, diabetes, chronic obstructive pulmonary disorder, stroke, elderly patients (>65 years old) with multiple co morbidities). Tools will be refined using learning from high-income countries and consultation with Indian co-investigators and experts. Three hospitals, two primary health centres and one community health centre across Kerala and Himachal Pradesh states have been chosen for the situation analysis.

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Diversity of health systems between each state/region of India will mean that we will not be able to capture the totality of this diversity. Rather inferences will be made and generic recommendations considered in National Expert Group meetings allowing transferability of principles to the other states/regions. Inclusion of stakeholders working at the national level will ensure that diversity is kept within the agenda. Intervention options will be detailed based on these conclusions and cross-referenced with the literature review.

Study participants:

INCLUSIONARY CRITERIA:

(1) Inpatients - admitted for particular health conditions requiring follow-up: cardio vascular disease, diabetes, chronic obstructive pulmonary disorder, stroke, and/or elderly patients (>65 years old) with multiple co morbidities, within 24 hours of admission.

(2) Outpatients - patients waiting for their outpatient clinic appointment with one (or more) of the aforementioned tracer conditions.

(3) Health Care Providers: All staff (doctors, nurses and allied professionals) working in the relevant healthcare facilities and with at least 12 months experience of healthcare work will be eligible. In the community, frontline health workers (junior public health nurse, health inspectors, health visitors, Anganwadi workers, and Accredited Social Health Activist (ASHA) workers will be eligible.

(4) Consultative experts for qualitative work: a range of policy makers, academics, managers, clinicians (primary and secondary level, nurses, doctors and health workers) and community leaders, with working knowledge or experience of handover, health systems development (primary or secondary care) or patient safety will be listed within the national and regional scenes of our study sites in India and invited to participate in interviews/experts meetings.

EXCLUSIONARY CRITERIA:

(5) Patients: No consent given to participate in study, too unwell or terminally ill. If inpatient lives outside the catchment area where study-trained ASHAs exist.

(6) Staff: Consent not given.

Sampling and recruitment:

Setting: Solan Government District Hospital, Himachal Pradesh, India

Primary Health Centre, Himachal Pradesh, India

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Community Health Centre, Himachal Pradesh, India

Solan Regional Hospital, Himachal Pradesh, India

Taluk Hospital, Kerala, India

General Hospital Ernakulam, Kerala, India

Primary Health Centre, Kerala, India

Quantitative studies:

In-Patients: 450 patient cases will be surveyed, 150 in each of the 3 hospitals. For each patient data will be collected at 4 contact points (admission, discharge, 5 weeks after and 4 months after discharge in the community during visits at home). Sampling for patient surveys will be 150 per hospital admitted for at least 24 hours with a tracer condition.

These will be recruited on a daily basis by hospital researchers going to the relevant wards per hospital every morning, identifying eligible patients admitted in the last 24 hours, and visiting them for consent (starting with the ones admitted first and meeting the criteria).

A sample size calculation is difficult given no prior work has been done in this field. However, these numbers will provide enough precision to allow an estimate of the practice of important steps in clinical handover. Due to a need to follow patients, patient identifier information will be collected in the inpatient surveys.

Out-patients: 150 in each of the 3 hospitals will be recruited based on the provision of enough precision to allow an estimate of the practice of important steps in clinical handover. Two hospital researchers will go to the appropriate outpatient clinics. There, while patients are waiting to be seen, they will identify patients meeting the recruitment criteria, gather consent and interview them. Then as patients come out of their outpatient clinic appointments, they will be interviewed again before going home. For outpatient questionnaires, personal identifiers will not be collected (as they will not be followed in the community).

Health Care Providers: For staff/provider surveys we will use a random sampling of up to 100 doctors, nurses or other providers per hospital and 50 in the primary care catchment area of each hospital. The Hospital and Community Researchers associated with each hospital will be interviewing them or giving them the questionnaires to fill (as appropriate).

Qualitative studies:

Patients and their carers in the hospital and community (not involved in the quantitative study component) will be recruited at each site to take part in the qualitative study. They will be recruited by the hospital/community researchers and interviewed by the qualitative researcher during their visit to each hospital and associated catchment area.

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Health Care Providers from the hospitals will be recruited by the hospital/community researchers and will be interviewed by the qualitative researcher during their visit to each hospital and associated catchment area. In this case some of the staff already in the quantitative study may have to be recruited due to the lack of senior staff.

Data methods, collection and tools:

Qualitative studies:

Data will be collected by trained Indian qualitative researchers and then transcribed, translated, coded and analysed guided by/in consultation with researchers at the University of Birmingham (UoB) and national experts. The below methods will be used in each of the hospital sites and their catchment areas:

a) Non-participant and participant (wherever possible) observation and narratives to follow the patient’s journey in each hospital: This will entail observing how clinics and inpatient admission or discharge procedures occur in the hospital and some community providers in order to find out the issues that need exploring.

b) Semi-structured interviews (SSI)/ in-depth interviews: We will elicit data and pointers and not become a victim of methods at the cost of validity and depth in data. This is because the terrain is variable, with few structures in place and doctors under the high pressure of time and performance, and patients too may be constrained as they may come from distant locations with poor resources. These methods will be adopted at each hospital and associated community care service will be conducted until theoretical saturation is reached using same schedule for all 3 hospital sites, and analysed thematically. The participants will be health providers and patients/carers recruited as described above.

c) Expert groups: Although SSIs will cover a range of issues per topic, consensus methods can be used in order to derive specific issue-related consensus within a topic, e.g. consultative prioritisation of barriers or facilitators and of possible interventions. ‘Experts’ can be in any category, including patients who are experienced in the topic of discussion. See recruitment above.

e) Document content review: Using policy and guideline documents (at organisational, national or regional level), training manuals, course materials, management or meeting records involving any aspect of record keeping, referral and discharge, and communication of patient records will be assessed by the study senior researchers in Delhi and Cochin centres using qualitative methods on a thematic basis.

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Quantitative studies:

a) Healthcare provider questionnaire surveys: Will investigate handover culture, practice, knowledge and attitude including barriers to communication within the teams in hospitals and primary care units (where they exist). Components of WHO’s Hospital Survey on Patient Safety will be used, supplemented with additional questions: This survey has been translated, cross-culturally validated and used in India. Double entry of survey questionnaires will be in an Access database with in-built validation checks to reduce data entry errors.

b) Inpatient questionnaire survey: See patient recruitment above. In short, hospital researchers will recruit the patients, consent and interview them. They will be trained and supervised by the study manager. Patients will be asked to consent to a visit from ASHAs in their locality at home 5 weeks and 4 months after discharge. There they will receive a basic check-up (pulse, blood pressure and general advice) and complete a questionnaire via interviews. They may receive a mobile phone text 2 days before the visit date to remind them to expect this visit. For each hospital, 20 community ASHAs recruited from each catchment area of the hospital will be trained to do this work. They will be supervised by the community researcher in each area. If an ASHA or researcher leaves their post, another will be trained. Piloted questionnaires have been developed for use for each survey point of the recruited patients. This data collection will also serve as a test for the tools to be used for assessments in the follow-on cRCT study. Double entry of survey questionnaires will be in an Access database with in-built validation checks to reduce data entry errors.

c) Outpatients survey: see under recruitment above. In short, 2 trained hospital researchers, supervised by the project manager, will conduct this survey on appropriate clinic days until the sample size is achieved. Piloted questionnaires will be used to interview patients. Double entry of survey questionnaires will be in an Access database with in-built validation checks to reduce data entry errors.

d) Cognitive artefact analysis: study any notes, letter, emails, scraps of paper, board notes or other materials used in the daily workflow of patient care with a particular attention to those pertinent to communication between secondary and primary care providers for the 150 random patients selected for the survey above. This will be mostly done by hospital researchers through the use of structured checklists.

Consultative methods:

A network of local, national and international stakeholders will be developed through co-investigators (Co-Is) drawing up a list. At the local level and for the hospital case review, Co-

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Is will purposively shortlist a range of policy makers, academics, managers, clinicians (primary and secondary level, nurses, doctors and health workers) and community leaders, as stakeholders as well as patients and carers (with tracer conditions, see above). Subgroups of providers will be those working in private, charity and public primary or secondary care. Nationally and internationally two virtual panels of 7 to 10 policy makers (including WHO HQ), manager, academics, and patient representative groups will become members of the expert Group. This expert group will advise the project.

Qualitative work with these experts (analysis of meeting outcomes and semi-structured interviews with a sample of them) will also allow for their input into the situation analysis in a systematic way.

Specific Objective Approaches to address thisTo undertake situation analysis with regards to policies, training, activities, and culture for clinical handover between primary and secondary care during referral and discharge

Mixed method situational analysis

To identify health care system and patient-related barriers and facilitators to clinical handover and improving practices

Inpatient and Outpatient surveys; combination of qualitative methods (narrative and semi-structured/ in-depth interviews )

To explore the relationship between current handover practices during discharge and post-discharge patient health outcomes

Inpatient surveys; multivariate analysis exploring the relationship between handover practices (verbal and/or documented) during discharge and post-discharge patient health outcomes (i.e. death / hospital readmission / deterioration of NCD/s)

To develop options for clinical handover interventions between primary and secondary care

Semi-structured interviews with experts; healthcare provider questionnaires

To pilot data collection tools for a future cRCT of handover interventions

Pilot in 3 hospitals and their catchment community

To build health systems research capacity and collaboration between India and UK

UoB UK team collaborating with the Public Health Foundation India (PHFI) team to work on health systems research that is relevant to clinical handover in LMICs, through expert input and training, methodology development and joint publications.

A mixed method situation analysis will be used. That is quantitative and qualitative data will be analysed separately and then triangulated to answer the primary study questions around describing the current situation, exploring possible routes of intervention, barriers and facilitators to improving services. The analysis will be primarily done in India by the senior study qualitative researcher and statistician, but guided by UoB and associated UK collaborators.

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The quantitative analysis will be mainly descriptive with some multivariate analysis to investigate associations between variables, such as:

Handover practices for vulnerable patient groups

Handover practices and patient health outcomes

Healthcare qualifications/staff positions and perceived barriers to handover

Summary data will be appropriate to the nature of the data (i.e. continuous/ nominal/ binary).

The qualitative work and its analysis will be reiterative in that information from one part will feed into the next part of the data collection using the aforementioned range of techniques and analysis. This will be necessary since there a lack of existing data in this field from India or any similar LMIC and thus information gathered in one qualitative method can inform and develop the tools used for the next. These will in turn feed into refining the quantitative tools.

Then the following complex analytical methods will be applied to the totality or specific sections of the data collected:

a) Case study and cross-case comparison: of each hospital site, collating them to compare and look for similarities, differences and range of themes;

b) Policies and guideline analysis: exploring the extent to which the issue of clinical handover has reached the level of national, regional or institutional policy, their extent of implementation, facilitators and barriers to this.

c) Patient Journey and Care Pathway analysis: exploring typical patients experience of health systems.

d) Inventory of best practice: including the identification of “product champions” (i.e. positive deviants) who can powerfully influence other centres and help propagate best practices.

e) Process analysis and process mapping: applying quality improvement science to organisations. When breaking down multiple steps in the process of clinical handover, it is possible to define current processes and how these processes are viewed by each ‘actor’ in the chain, construct cause and effect models (such as the Ishikawa or fish bone model)14 exploring the role of place, procedures, people and policies as barriers or facilitators to effective communication.

f) Resource and current structure analysis: to identify a list of suggested resources and tools that would facilitate handover practices.

g) Knowledge, Attitudes and Skills Analysis and Patient safety culture analysis: to identify how much providers and patients understand the principles of safety science and the role of handover and communication.

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g) Training needs analysis: to identify the in-service and pre-service training gaps for healthcare providers.

Health Economic data:

A model, based on our previous work,15 16 will be planned to enable us to justify whether our proposed generic intervention would add sufficient value to justify the costs. We will collect data to estimate the cost for best options of interventions that would overcome the obstacles to good handover identified in the study. In the full trial, this will enable the calculation of the minimal effectiveness necessary for interventions of different intensity (cost) to be cost effective, at different levels of national per capital wealth (and hence threshold levels at which a society should be willing to bear the opportunity cost of the intervention). As above, we will also document the clinical and process outcomes on which proposed interventions have a potential effect, and the pathways through which this could impact key health system goals such as health gain, equity and responsiveness. This will provide data on the plausibility of achieving the minimal effectiveness required to justify the proposed interventions, and help in the design of the follow-on trial.

Data needed for this economic analysis will be collected by the researchers in each site and Indian PIs guided by UK experts.

Management structures:

The Centre for Chronic Disease Control (CCDC) in New Delhi is the lead collaborator in this project. A senior researcher from CCDC will act as the Indian Principal Investigator. There will be senior researchers as project managers in Delhi and Cochin. Together, they will coordinate the study in Cochin and Solan. A senior qualitative expert affiliated to the CCDC will oversee all qualitative work. The overall complementation of the project will be guided by expert opinion from senior investigators at University of Birmingham.

Confidentiality:

The confidentiality of patients and staff will be kept anonymized using ID numbers and their respective consent forms will be filed away separately. The study researchers and statistician at CCDC in India will be responsible for data curation and other quality assurance of data on a day to day basis during the study. The PI will be overall responsible for the data storage and management after the initial analysis.

Requests to use the data will be granted to external investigators with a well-designed proposal. As required by the funders, anonymised data will be available for sharing in a timely and responsible manner ensuring that potential studies will meet the high standards of all

Subject Rights:

Participants will be given information about the study for them to read and then ask questions. Consent will be taken from them (or their carer if appropriate) only when they

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understand clearly what is expected. Patients will be free to withdraw from the study without giving any reason at any time, and their level of care will not be affected in any way.

Ethics/research governance:

The main ethical issues are patient confidentiality, ensuring that participation does not lead to inferior care or employment discrimination. The study will be conducted in compliance with MRC Good Clinical Practice Guidelines and ICMR Good Clinical Practice Guidelines and ethical/research governance approval sought via the appropriate committees in India and UK.

Benefits of study/ Expected outcomes:

The impact of the development phase will be realised by many different groups in the short and long term, both directly and indirectly; internationally, academic impact will be felt as new methods of research and knowledge are shared through publications and presentations, setting new agenda for research. Local researchers will learn from the experience of the mixed methodology employed in this project, and local service providers will begin to meaningfully consider service integration and optimal clinical handover. Our findings of barriers, facilitators and intervention options for optimal clinical handover will empower policy makers and managers with evidence in order to begin to improve the system. A local process of better cohesion will develop amongst practitioners through multi-disciplinary research and expert groups consulted on the research questions.

Patients will also benefit through helping to design services for their community, which can be a positive, empowering and enjoyable experience. However, the full impact will be achieved through the implementation of the follow-on trial; they will have wider impact at the local, national and international levels: This will test out a package of complex, but affordable and cost-effective health service design interventions. Patients will benefit from the impact of the study in the short term through the provision of safer, improved and integrated health care, and in the longer term from generic knowledge about the science and art of service improvement.

Front line staff will gain in knowledge and experience through acquiring generic skills in service innovation to improve the quality and safety of care, and will benefit from the inclusive ideology of the proposed methods. Any lacunae in technical knowledge will be remedied, and they will have a practical introduction to systems thinking and the principles of safety and implementation of effective care. They will also have experience of working on cognitively demanding tasks in teams involving doctors, nurses and mangers, as well as service users.

Managers and policy makers will benefit through the experience of state-of-the-art techniques of service redesign and quality improvement and involvement in a program that has aspects of action research embedded in it. The national and international experts and policy makers

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will benefit through their involvement at the start of the program and at regular intervals thereafter as findings emerge and theories develop and they can explore emerging themes that can be applied more generically to other LMIC settings.

Local academics will benefit as they learn through application of new methods of health systems situation analysis, development of complex service design improvement interventions, evaluation of interventions through a large cluster randomised controlled trial, and the development of pre-service and in-service training courses to sustain and embed knowledge and attitudes within the system.

Economic impact will be felt by individual patients as their out-of-pocket expenditures are reduced through improved and safer services, and society as the whole will benefit as the members thereof become healthier, productive and better-off economically. The health services spend less on unnecessary adverse events and litigation (emerging in middle-income countries), and retain their staff through motivation, training and integration.

Dissemination of Results:

Communication and dissemination to stakeholders and partners, internal and external to the project, are integral to the success of the study and multi-sectoral engagement central to the methodology of the study. Communication plan will adhere to MRC's Communication Policy. It will include an evolving list of national (India) and international stakeholders at the level of policy and academia who will form our dissemination network. From these, a selected group will form the International and another will form the Indian Expert Advisory Groups. These will continue into the follow-on trial and will help prioritise and customise intervention options to LMICs, and assist in dissemination and application nationally and globally. WHO Headquarters will be a member of this group.

Dissemination to the research community: The investigators foresee that due to the novelty of this project and its importance to LMICs and WHO, it will be published in a significant peer journal. Findings will be presented at national (India and UK) and international conferences. Funding will be sought to present at the International Forum for Quality and Safety in Healthcare. Networks established through the EC funded FP7(2008-11) programme will be disseminated too. In India, throughout the study there will be feedback and communication with academic stakeholders for dissemination, but also to seek their views on development and integration of handover training in pre- and in-service courses.

Dissemination to Policy makers and senior managers, national and international: The Indian and International Expert Advisory Groups will constitute the Ministry of Health, WHO, World Bank and other health systems policy and planning institutions. Their (and other policy stakeholders on our network list) reflection upon the findings and input into the Expert Group prioritisation exercises will be critical to understanding barriers and drivers, as well as to derive at emerging intervention strategies, e.g. training, tools. Early consultation will secure buy-in to the packages of interventions that will be tested.) WHO Headquarters have indicated a keen interest in our findings and offered technical input into the follow-on RCT. An opportunity for funding will be sought in order to present the findings at WHO

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Headquarters. We will include both private and government run institutions in our consultations, since in LMICs frequently both are regular providers of health care, and lessons can be learnt from both.

Dissemination to clinicians: The national professional bodies, such as the National Accreditation of Hospitals and Healthcare providers in India, will be members of our Indian Expert Group. Six monthly meetings publicised and open to all local clinicians in our target hospitals and communities will enable regular communication and dissemination.

Dissemination to Charities/Non-Governmental Organisations (NGOs): Partners have been keenly involved with the work of NGOs, delivering health care and inputting into policy in LMICs. WHO's Patients for Patient Safety Network board members will be a part of the Expert Group.

Dissemination to the public/patients: There is an overlap with some NGOs, but additionally information (leaflets, local groups and media) will be available to patients and families and user group representatives. Members will be a part of the Expert Group where they could interact and be able to hear the findings and consult in a multi-disciplinary manner about their relevance and application. A website will provide public access to the progress and achievements of the study.

In short, our communication plan will mean the dissemination of our results at local, national and international level through a systematically developed network of clinical and policy institutions, voluntary/charitable organizations, media (including ethnic media) as well as through national/international.

Timeline:

Timeline: Task / dates Jul 2014-Aug 2015 1 2 3 4 5 6 7 8 9 10 11 12 13Ethics/local permissions/hospital set up (6wks) Expert grp, Staff recruitment, and training Finalising/field testing of tools UK investigators to India Patient hospital survey (2.5 months per hospital) follow-up of patients in community (4 month each) Qualitative work in each hospital and community Data cleaning; transcription & analysis Publication and dissemination; planning of next phase Core management mtg wkly/Virtual steering grp mtgs mthly X X X X X X X X X X X X X

Virtual Expert Group meetings - national and international X X

PIs and Collaborators:

Role India UK

Principal Investigator Dr Jeemon Panniyammakal1 Dr Semira Manaseki-Holland3

31Centre for Chronic Disease Control2AMRITA Institute of Medical Sciences

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Co-Investigators

Dr Sanjeev Singh2 Dr Paramjit Gill3

Dr D. Prabhakaran1 Professor Richard Lilford3

Dr Shifalika Goenka1 Dr Sheila Greenfield3

Dr Jonathon Shapiro3

Budget in GB£

UK Delhi CochinTotal Salary 30413 22535 15960Travel budget (Local in India)

1000 8985 7200

Travel budget (international) 3500 0 0Recurring contingencies 0 600 800Non-recurring contingencies 0 3334 3326

Total (INR) 34913 35454 27286

References

1. Forster AJ MH, Peterson JF, et al. The incidence and severity of adverse events affecting patients following discharge from the hospital Ann Intern Med 2003;138:161-7.

2. World Health Organization. High 5s Project - Action on Patient Safety In: Safety WWAfP, editor. High 5s Project Geneva: WHO World Alliance for Patient Safety 2010.

3. Australian Council for Safety and Quality in Health Care. Clinical Handover and Patient Safety -Literature review report In: Safety and Quality Council, editor, 2005:1-31.

4. Philibert I, Leach DC. Re-framing continuity of care for this century. Quality & Safety in Health Care 2005;14(6):394-6.

5. World Health Organization. Communication During Patient Hand-Overs In: Solutions. WCCfPS, editor. Geneva World Health Organization 2007 1-4

6. World Health Organization. Summary of the evidence on patient safety: Implicarions for research World Alliance for Patient Safety Geneva World Health Organization 2008:1- 136.

7. Hesselink G, Schoonhoven L, Barach P, Spijker A, Gademan P, Kalkman C, et al. Improving patient handovers from hospital to primary care: a systematic review. Ann Intern Med 2012; 157(6):417-28.

8. Deodhar J. Telemedicine by email--experience in neonatal care at a primary care facility in rural India. J Telemed Telecare 2002; 8 Suppl 2:20-1.

9. Nagendra NDV, Rajavelu P, Rajagopalan A. Pre-formatted written discharge summary-a step towards quality assurance in the emergency department. Int J Emerg Med. 2008; 1(4):321-5. Epub 2008 Nov 18.

3University of Birmingham

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10. Hemming K, Girling AJ, Sitch AJ, Marsh J, Lilford RJ. Sample size calculations for cluster randomised controlled trials with a fixed number of clusters. BMC Medical Research Methodology 2011;11:102.

11. Jones J, Hunter, D. Consensus methods for medical and health services research. British Medical Journal 1995(311):376 - 80.

12. Sorra J, Nieva V. Hospital Survey on Patient Safety Culture Rockville, MD: Agency for Healthcare Research and Quality 2004.

13. Tetali SK, NK. Rao, M. Assessment of patient safety culture in hospitals of Hyderabad, India. Inj Prev 2010;16:288-89.

14. Shima K UY. Operational Experiment of Seamless Handover of a Mobile Router using Multiple Care-of Address Registration. Journal of Networks 2006;1(3):23-30.

15. Lilford RJ, Chilton PJ, Hemming K, Girling AJ, Taylor CA, Barach P. Evaluating policy and service interventions: framework to guide selection and interpretation of study end points. BMJ 2010;341:c4413.

16. Yao GL, Novielli N, Manaseki-Holland S, Chen YF, van der Klink M, Barach P, et al. Evaluation of a predevelopment service delivery intervention: an application to improve clinical handovers. BMJ Quality & Safety 2012;21 Suppl 1:i29-38.

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