Edited by: Adriana Mihai, University of Medicine and Pharmacy Tg Mures, Romania
Reviewed by: Jana Chihai, State Medical and Pharmacy University Nicolae Testemitanu, Moldova; Costin Roventa, Hospital “Prof. Dr. Al. Obregia”, Romania
Specialty section: This article was submitted to Public Mental Health, a section of the journal Frontiers in Psychiatry
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This review introduces a conceptual framework for understanding stakeholder management (ShM) in the clinical and community-based research environment. In recent years, an evolution in practice has occurred in many applicants for public and non-governmental funding of public health research in hospital settings. Community health research projects are inherently complex, have sought to involve patients and other stakeholders in the center of the research process. Substantial evidence has now been provided that stakeholder involvement is essential for management effectiveness in clinical research. Feedback from stakeholders has critical value for research managers inasmuch as it alerts them to the social, environmental, and ethical implications of research activities. Additionally, those who are directly affected by program development and clinical research, the patients, their families, and others, almost universally have a strong motivation to be involved in the planning and execution of new program changes. The current overview introduces a conceptual framework for ShM in the clinical research environment and offers practical suggestions for fostering meaningful stakeholder engagement. The fifth edition of PMBOK® of the Project Management Institute, has served as basis for many of the suggested guidelines that are put forward in this article.
A true architect is not an artist but an optimistic realist. They take a diverse number of stakeholders, extract needs, concerns, and dreams, and then create a beautiful yet tangible solution that is loved by the users and the community at large. We create vessels in which life happens
In recent years, a revolution in thinking about organizational management and decision making has taken place. Increasingly, programs have been incorporated into organizations, typically private sector corporations or government agencies, which have sought to involve “stakeholders” in management decision making. Stakeholders are the customers, suppliers, the general public, and any other group, which are likely to be affected by the organization’s ultimate decisions. The process of incorporating the ideas and input from these groups has been termed “stakeholder engagement.” It reflects an increasingly accepted attitude that organizations not only have an ethical obligation to involve the participation of stakeholders in their collective activity but also in so doing their overall organizational effectiveness will be enhanced. While certain generalizations in the application of this philosophy are constant, minor variations also exist, which reflect the specific goals that the organization is pursuing. In this review, the application of stakeholder engagement in clinical research settings, particularly in hospitals or university research centers, is considered.
According to the Institute of Medicine (IOM), the purpose of comparative effectiveness research (CER) is, “to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve healthcare at both the individual and population level” (
The key focus in the process of stakeholder engagement is of course the stakeholder. Freeman (
In clinical research, researchers are often faced with questions about the choices that must be made by patients. Research can also be focused on assisting the process of program development. In either instance, the underlying motivation remains the same: to healthcare delivery, to become aware of dysfunctionalities that may exist in healthcare, and to improve the outcomes of proposed changes. It is essential then that research and program processes are assisted by those who are most directly affected by proposals, i.e., the patients themselves. Central to the process of encouraging stakeholder involvement therefore is a basic assumption that patients have the right to make the best decisions about their own health care.
Stakeholder engagement versus stakeholder management (ShM): in recent years, the term “
The obligation to serve all stakeholder interests is often called
A stakeholder analysis is a process, which provides insights into, and understanding of, the interaction between a project and its stakeholders. In other words, the process of listing, classifying, and assessing the influence of these stakeholders in a project is termed a stakeholder analysis. Stakeholder analysis systematically gathers and analyzes both qualitative and quantitative information thereby to determine whose interest should be taken into account throughout the project. One of the first tasks that a clinical project manager must undertake is to identify how stakeholders can make the greatest impact on the research project or program change, which is being contemplated. The function of stakeholder analysis is to produce an awareness of who will be affected by the project and who can contribute to making the project more successful. The stakeholder analysis, which is usually undertaken at an early stage of planning, is an integral part of risk and reward assessment activities.
It is essential for maximal project effectiveness that managers be committed to the basic philosophy of stakeholder involvement. Project managers must communicate and impart what they see as their goals but also seek to encourage participation by stakeholders so that their perspectives are included in decision making.
The process of identifying, engaging stakeholders must begin well in advance so that dialog is seen to play an important part of project implementation; no decisions should be already made before commencing stakeholder engagement on project-related issues.
Well managed projects, although long and complex, create long-term economic gain and social values meaning that proper use of taxpayer’s money. When done correctly, stakeholder engagement provides opportunities to further align clinical research practices with societal needs, values, and expectations, helping to drive long-term sustainability and stakeholder interests.
Stakeholder engagement is intended to help administrators fully realize the benefits of applying community and patient interest in hospital programs, and to ensure that research and program changes benefit those who are most directly affected.
The stakeholder focus group is a communication medium through which the opinions of individuals or groups of individuals who are impacted by the research can be elicited. Focus groups can also serve to clarify each stakeholder’s role and responsibilities, as well as promoting an overall understanding of the project requirements. Such processes also provide stakeholders with an environment in which they can express their opinions and feel that they have been heard.
In a series of related manuals the Patient-Centered Outcomes Research Institute (PCORI) (
It can be seen from one of our case studies (see
Stakeholder management involves the processes of identifying (both internal as well as external) stakeholders; assessing stakeholders’ skills, knowledge, and expertise; determining stakeholders’ requirements; determining stakeholders’ interests and expectations; determining stakeholders’ communication needs; addressing stakeholders’ issues and concerns as they occur; maintaining a positive relationship and communicating with stakeholders throughout the project; identifying stakeholders’ influence-controlling strategies; making sure that stakeholders are involved in the project at the required level throughout the project; and confirming continuous interactions with the stakeholders. In the area of clinical research patients and other stakeholders such as physicians, clinicians, nurses, and others have critical roles to play. Clinical researchers at the outset of research need to ask for patient participation in the development of research questions. Researchers need to find out the exact characteristics of study participants and to define what the nature of the research outcomes should be. In this process, contributions from patients are helpful and often critically important for project success. The process of carrying out research also involves measuring the results of research interventions and monitoring the progress of the research, especially in terms of whether or not it is being directed toward the initial intentions of the research. Finally, patients, who are often very closely connected with the target populations of the research, have a direct perspective on how the targets of the research will respond to the research recommendations, and therefore, can provide useful inputs for insuring its relevancy.
The PMI identifies four key processes that are associated with the stakeholder management knowledge area in initiating, planning, executing, and monitoring and controlling process groups (
Processes | Process groups | Detail | Key outputs |
---|---|---|---|
1. Identify stakeholders | Initiating | This is the process of identifying all people or organizations impacted by the project and documenting relevant information regarding their interests, expectations, involvement, and influence on project success | Stakeholder register |
2. Plan stakeholder management | Planning | This is the process of defining an approach to managing stakeholders throughout the entire project life cycle as per their interest, importance, impact, and influence over the project | Stakeholder management plan |
3. Manage stakeholder engagement | Executing | This is the process of meeting and exceeding the Stakeholder stakeholders’ expectations by continuously communicating with them, clarifying and resolving their issues, addressing their concerns, and improving project performance by implementing their change requests | Issue log Change requests |
4. Control stakeholder engagement | Monitoring and controlling | This is the process of evaluating and monitoring overall stakeholder relationships and ensuring stakeholders’ appropriate engagement in the project by adjusting plans and strategies as required | Work performance information Change requests |
This entails identifying all people or organizations impacted by the project and documenting relevant information regarding their interests, expectations, involvement, and influence on project success. In the hospital setting, the stakeholders are usually the patients, but can also be healthcare professionals and the families of patients. Examples of stakeholders are given in Table
Examples of stakeholders in a clinical research setting |
|
---|---|
External stakeholders | Internal stakeholders |
Board of directors | The project team |
Community | |
Consultants | Consultants co-principal investigators (co-Pls) |
Customers (patients/patient groups) | Clinical research associates (CRAs) |
Government agencies | Clinical research coordinators (CRCs) |
Healthcare stakeholders | Functional manager (FM) |
Industry partners | Medical directors |
Legislators or policy makers | Operation manager (OM) |
Media | Other clinicians involved in the project |
Non-governmental organizations (NGOs) | Portfolio Manager (PfM), Program manager (PM) |
Non-profit organizations (NPOs) | Project manager (PM) |
Other businesses | Project management office (PMO) |
Regulatory agencies | Principal investigators (PIs) |
Research partners | Subject matter experts (SMEs) |
Scientific communities | Consultants |
Sponsors – financial institutions (public and private consultants) | |
Subject matter experts (SMEs) | |
Vendors or suppliers |
Throughout the project the following critical tasks should be carried out.
All internal and external stakeholders should be identified. These will usually be the patients but often will include the patients’ family members, healthcare providers, or program administrators.
Stakeholders’ interests, requirements, and expectations should be identified. Obviously, patients are interested in the effects of proposed program changes or research outcomes on their health and well-being, but may have additional interests such as hoping to improve their employment prospects, or expanding their range of capabilities. Clinical researchers and administrators should be alert to these concerns and take appropriate steps to address them. It has been found, for instance, that stakeholder views at the beginning of a program evaluation process may be provisional or may change as a result of additional information. Additionally, stakeholders’ interests may change over time. In one study, the results of pre-workshop and final workshop voting often differed, suggesting that prioritization efforts relying solely on requests for topics from stakeholder groups without in-person discussion may provide different research priorities (
All stakeholders’ levels of influence should be determined. It is often the case that patients and other beneficiaries of program development have talents and skills that may not be reflected in records of formal education or social standing. Certain personal traits, which patient stakeholders may possess, such as communication skills or life experience, could nevertheless prove invaluable for achieving project goals.
A communication plan for the stakeholders should be determined. Patient stakeholders may not always be familiar with or comfortable in using traditional channels of communication in large organizations. As noted by Lavallee et al. (
Stakeholders’ expectations and influence over the project should be managed. Reality checks are important for balancing patients’ idealistic expectations and the necessity of dealing with the challenges of getting things done through institutions. Program administrators must identify patient stakeholders’ strengths and channel these for optimal organizational impact.
Depending on their complexity, size, and type, most projects have a diverse number of internal and external stakeholders at different levels of the organization with different authority levels.
Stakeholder identification is a dynamic and sometimes difficult process, and the influence of a stakeholder may not become evident until later stages of a project. And, sometimes projects evolve so that solving unseen problems emerges as a critical task. It is essential to identify as many as stakeholders as possible at the beginning of the project and classify them according to their level of interest, influence, importance, and expectations at the earliest stages of the project as much as possible (Table
Stakeholder | Classification | Potential strategies for gaining support or reducing obstacles |
---|---|---|
Stakeholder 1 | Resistor | Notify the sponsor about the potential negative impact of the stakeholder |
Arrange a meeting with this stakeholder and invite the sponsor to discuss project objectives | ||
Explain the benefits of the project to the stakeholder | ||
Try to gain commitment from the stakeholder on the resources and deliverables in the presence of the sponsor | ||
Stakeholder 2 | Neutral | Ask the stakeholder to join the project management team and be an active member of the project |
Stakeholder 3 | Not Supportive | Find out from others who have experience with this stakeholder about how to Work with this person |
Stakeholder 4 | Difficult | Find out from others who have experience with this stakeholder about how to Work with this person |
Identify requirements clearly and get approval | ||
Send regular updates |
As per the PMBOK®, the “
The project charter gives an overall picture of the project as well as describing some of the stakeholders and their interest in the project along with their requirements.
If a project is based on an established contract or the result of a procurement activity, the parties in that contract are key project stakeholders. Other relevant parties such as suppliers, legal parties, and people who will execute the contract should also be considered as part of the project stakeholders list.
Hospital culture and structure, and other factors may influence the identify stakeholders process.
To benefit from previous experience those in charge of developing proposals should carefully review the efforts of earlier projects. The stakeholder register template, lessons learned, and the stakeholder registers from previous projects may influence the identify stakeholders process.
It is not possible to treat all stakeholders equally in the project, and they are given different priorities with respect to their interests, expectations, and influence on the project. Stakeholder analysis is a process of systematically gathering and analyzing all relevant quantitative and qualitative information about the stakeholders in order to prioritize them and determine whose interests should be taken into consideration throughout the project.
As per PMI, stakeholder analysis is performed by the following steps:
Step 1: all potential project stakeholders and their relevant information, such as their roles, interests, knowledge levels, expectations, and influence levels should be identified. Step 2: the potential impact or support each stakeholder can contribute should be identified. As per the PMBOK®, there are several classification models below:
Power/interest grid: this is based on the level of authority or power and the level of concern or interest that a stakeholder has regarding the project outcome (Figure Power/influence grid: this is based on the level of authority or power and active influence a stakeholder has. Influence/impact grid: this groups stakeholders based on their involvement or influence and their ability to affect changes to planning or execution (impact). Salience model: this addresses a stakeholder’s power or ability to impose their will, urgency, or need for immediate attention from the team and legitimate involvement in a project. Step 3: in order to influence the stakeholders to enhance their support and to mitigate potential negative impacts, the way in which key stakeholders are likely to react or respond in various situations should be assessed.
Stakeholders who have greater power or influence and a strong interest in the project should be managed closely and continuously updated. Stakeholders who have significant power but low interest in the project should be kept informed about the project. Stakeholders who have low power and low interest should be monitored, and stakeholders who have low power and high interest should be kept satisfied.
Judgment and expert opinions can be gathered to identify stakeholders, usually from the senior management. These resources can include project team members, project managers from similar projects, subject matter experts, industry groups and consultants, and other units within the hospital or research setting.
Profile analysis meetings with team members and the sponsor will be beneficial for identifying stakeholders and their knowledge, potential roles, importance, impact, interest, and expectations in the project.
This contains all details related to the identified stakeholders including but not limited to
Stakeholder classification: stakeholders can be classified in many different ways. For example, primary (users of the products, services, or results) or secondary (may not be the direct users, but have some influential relationship), Internal/external, neutral/resistor/supporter/hard to hear, and so on. Identification information: name, title, location, organization, role in the project, position, and contact information. Assessment information: key requirements and expectations, potential impact, importance, and influence on the project.
A project manager may publish the stakeholder register with other project documentation or keep it in reserve for personal use only (Table
Stakeholder register |
|||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Project ID # | Project title # | ||||||||||||
ID | Name | Title | Organization | Contact info | Spectrum of stakeholder position (in a scale of 1–5) | Classification | Key expectation | Information needed | Role(s) in project | Action plan (ways to manage expectations – action to maximize support or reaction to minimize disruption) | |||
Knowledge Level | Interest Level | Influence Level | Power Level | ||||||||||
JD101 | Dr. John Doe | Co-investigator | MIT | 617-222-1111 | 1 | 4 | 5 | 4 | External and Supporter | 1. Functional module 2. Reporting tools | 1. Status update 2. Issue logs | Verify proposed budget | |
JD102 | Mrs. Jane Doe | Telephone screener – patient recruitment | NYU | 347-222-3333 | 4 | 5 | 4 | 1 | Neutral | Monthly recruitment target | Weekly reports | Assist with patient recruitment plan | |
Evaluators: | Location. | ||||||||||||
Signature: | Date. | ||||||||||||
Signature: | Date. |
The plan stakeholder management process defines an approach for managing stakeholders throughout the entire project life cycle as per their interest, impact, importance, and influence over the project. It defines the strategies for building close relationships with stakeholders who can benefit the project and for minimizing the influence of stakeholders who may have a negative impact on the project.
This process is iterative and should be reviewed on a regular basis as the required level of engagement of the stakeholders’ changes in the project.
As per the PMBOK®, the Plan Stakeholder Management process has the following inputs, tools and techniques, and outputs:
Components of the project management plan (PMP) such as the human resource management plan, staffing management plan, communications management plan, change management plan, and others are used in developing the stakeholder management plan (SMP).
This contains all details related to the identified stakeholders, including identification information, assessment information, and classification.
All environmental factors within the hospital or clinical research facility, including its culture and history of the organization, are used.
All organizational process assets, especially lessons learned and historical information are used.
Judgment and expert opinions can be gathered from senior management, project team members, identified stakeholders, project managers from similar projects, subject matter experts, industry groups and consultants, other units within the organization, and other people to identify the level of involvement required from each stakeholder at various stages of the project. However, it is possible that expert judgment can be mistaken when possible expert judgment must be balanced with input from the stakeholders themselves.
Meetings with team members and the sponsor will be beneficial for identifying the level of engagement required from each stakeholder.
Various analytical techniques are used for identifying the required level of stakeholder engagement. These techniques take into consideration stakeholder sensitivity to project goals and personal orientations such as being unaware, resistant, neutral, supportive, or providing leadership.
The stakeholder engagement assessment matrix (SEAM) is used to assess the current and desired state of engagement of a stakeholder for the current phase of the project (Table
Project stakeholders | Project stakeholders | Project stakeholders | Project stakeholders | Project stakeholders | Project stakeholders |
---|---|---|---|---|---|
Stakeholder 1 | C | D | |||
Stakeholder 1 | C | D | |||
Stakeholder 1 | C | D | |||
Stakeholder 1 | C, D | ||||
Stakeholder 1 | C | D | |||
Stakeholder 1 | C | D |
The SEAM illustrates that only Stakeholder 4 is engaged in the project at the desired state. The project manager should consider additional communication and further actions to bring all other stakeholders to the supportive and leading states.
Stakeholder engagement is critical to project success; thus, required actions and communication should be planned to minimize the gap between the desired level of engagement and the actual level of engagement.
Stakeholder management plan, which is a subsidiary plan of the PMP that defines the processes, procedures, tools, and techniques to effectively engage stakeholders in project decisions and execution on the analysis of their needs, interests, and potential impact ( information needs of each stakeholder or stakeholder group; stakeholder communication requirements; format, method, time frame, and frequency for the distribution of required information to the stakeholders; person responsible for communicating the information to the stakeholders; methods of refining the SMP; required engagement level of the stakeholders at various stages of the project; stakeholder management strategy that defines an approach to manage stakeholders throughout the entire project life cycle. It defines the strategies to increase the support of the stakeholders who can impact the project positively and minimize the negative impacts or intentions of the stakeholders who can negatively impact the project.
The portion of the plan that contains sensitive information such as stakeholders’ personalities and attitudes, negative impact that stakeholders may cause, or other factors is not usually published and is kept in reserve by the project manager for personal use only.
Project documents such as the project schedule, stakeholder register, and others may be updated.
The Manage Stakeholder Engagement process is focused on meeting and exceeding the stakeholders’ expectations by continuously communicating with them, clarifying and resolving their issues, addressing their concerns, and improving the project performance by implementing their change requests.
As per PMI, the project manager is responsible for managing the stakeholders’ expectations. Meeting the stakeholders’ expectations increases the probability of project success by enabling the stakeholders to be active supporters of the project, drastically reducing unresolved stakeholder issues, and limiting disruptions in the project.
As per the PMBOK®, the Manage Stakeholder Engagement process has the following inputs, tools and techniques, and outputs:
Within the research context, the SMP identifies information needs, communication requirements, required engagement level at various stages of the project, stakeholder management strategy, and other factors to identify and manage stakeholders throughout the entire project life cycle.
The communications management plan is a subsidiary of the PMP. It can be formal, informal, highly detailed, or broadly framed based on the needs of the project. The communications management plan typically describes the following: purpose for communication; Information needs of each stakeholder or stakeholder group; stakeholder communication requirements; format, method, time frame, and frequency for the distribution of required information; person responsible for communicating the information; methods for updating the communications management plan; persons or groups who will receive the information; glossary of common terms; issues/concerns escalation procedures.
A change log is used to document changes that occur during a project. A lot of these changes can impact different stakeholder interests; thus, the change log is reviewed in this process.
Organization communication requirements, issue management procedures, change control procedures, and historical information are used.
According to the needs of the project, the methods of communication identified for each stakeholder in the communications management plan are utilized during the manage stakeholder engagement process.
The project manager applies appropriate interpersonal skills or soft skills to manage stakeholder expectations by building trust and resolving conflict.
Management skills such as presentation skills, negotiation skills, writing skills, and public speaking skills used by the project manager can greatly influence how stakeholders feel about the project.
An issue is an obstacle that threatens project progress and can block the team from achieving its goals. An issue log is a written log document to record issues that require a solution. It helps monitor who is responsible for resolving specific issues by a target date. There should be one owner assigned for each issue reported within the project.
Change requests can include a new change to the product or the project, corrective or preventive actions, and other items.
The SMP portion of the PMP is updated as new stakeholders’ requirements are identified, existing requirements are changed, or as a result of addressing concerns and resolving issues of the stakeholders.
Project documents that may be updated include, but are not limited to, the following:
Issue log: this will be updated as resolutions to the current issues are implemented and new issues are identified. Stakeholder register: this is updated as stakeholders’ statuses change, new stakeholders are identified, registered stakeholders are no longer involved or impacted by the project, and other factors.
Lessons learned from managing stakeholders, feedback from stakeholders, project records, causes of issues, and reasons for corrective actions chosen may be updated.
The control stakeholder engagement is the process of evaluating and monitoring overall stakeholder relationships and ensuring stakeholders’ appropriate engagement in the project by adjusting plans and strategies as required. As the project progresses and its environment changes, this process will maintain or increase the efficiency and effectiveness of stakeholder engagement activities.
As per the PMBOK®, the Control Stakeholder Engagement process has the following inputs, tools and techniques, and outputs:
Components of the PMP such as the human resource management plan, staffing management plan, communications management plan, change management plan, and others are used in controlling stakeholder engagement.
An issue is an obstacle that threatens project progress and can block the team from achieving its goals. An issue log is a written log document to record issues that require a solution. A modified issue log is developed as a result of identifying new issues and resolving current issues.
Work performance data such as resource utilization, deliverables status, schedule progress, percentage of work completed, number of defects, number of change requests, technical performance measures, costs incurred, quality updates, and other factors are used in this process.
Project documents such as issue logs, the stakeholder register, the project schedule, the change log, and others are used in this process.
An information management system is an automated system that can serve as a repository for information, a tool to assist with communication, and a system for tracking documents and deliverables. An information management system also supports the project from beginning to end by collecting and distributing information about cost, schedule, and performance for the stakeholders. Several reporting techniques such as spreadsheet analysis, table reporting, presentations, graphics for visual representations, and others may be consolidated from various systems and communicated to the stakeholders.
Judgment and expert opinions can be gathered from senior management, project team members, identified stakeholders, project managers from similar projects, subject matter experts, industry groups and consultants, other units within the organization, and other people to identify new stakeholders, reassess the current stakeholders, and figure out the level of involvement required from each stakeholder at various stages of the project.
Status review meetings with the team, sponsor, and other stakeholders will be beneficial for reviewing information about stakeholder engagement.
Work performance information such as deliverables status, change request implementation status, and forecasted estimates to completion are distributed through communication processes.
These are recommended corrective actions for bringing the imminent performance of the project as per the expectations in the PMP and recommended preventive actions for reducing the probability, and impact of future negative project performance will generate a lot of change requests.
Most of the components of the PMP may be updated to reflect changes in the stakeholder management strategy and the approach to effectively control stakeholder engagement in the project.
Project documents such as the issue log, the stakeholder register, and others may be updated.
Lessons learned from managing stakeholders, feedback from stakeholders, project records, causes of issues, reasons for corrective actions chosen, project reports, stakeholder notifications, and other items may be updated.
While the burden of disease is growing rampantly and disproportionately, the challenge to global health outreach efforts is to prioritize those illnesses, which require immediate attention. The global health equity sorts to prioritize on improving health care and achieving equity in health of people around the world. In this context, researchers from high income countries often study the existing diseases and/or emerging challenges in low income countries in order to gain expertise on the health care needs (
Although the process of partnering with stakeholders in clinical research settings is still in its nascent stages, it is anticipated that it will increasingly become accepted and implemented by project managers. In tandem with this process, greater efficiency and transparency will develop in working with stakeholders to meet targets (
Stakeholders have unique perspectives and often possess a number of capabilities which they have acquired from life experience. Program developers can derive the maximum benefit from stakeholders if the proper context is established for drawing out this experience. Alternatively, barriers to effective participation by stakeholders can occur if managers remain unaware of stakeholders’ skills, or if they believe that they do not have appropriate knowledge to contribute.
By increasing the acceptability of programs, stakeholders increase the likelihood of their success. Stakeholders play pivotal roles as healthcare advocates or healthcare ambassadors, partners, and/or agents of change. Although stakeholders differ considerably in their expertise and interests, their involvement is pivotal inasmuch as it can facilitate the successful completion of projects. Stakeholder participation can (a) improve relevance; (b) promote visibility and research transparency; (c) accelerate and translate the research findings to real-world challenges; (d) enhance greater project acceptance as confidence derived in the decisions made during the project’s milestone developments. Similarly, the project’s final outcome can only be considered successful when it is acknowledged by its key stakeholders.
Due to the broad range of ways in which stakeholders can influence program development, it is essential that their behavior be closely monitored, and modulated if necessary. One of the advantages of the described system of viewing the management of stakeholder engagement is that it documents many processes that have taken place. Future efforts to manage this type of engagement can therefore benefit from established experience.
In a nutshell, as Wheeler et al. (
A balanced assessment recognizes that certain caveats apply in the establishment of stakeholder engagement and management in clinical and research settings. These relate to the unique nature, demands, resources, and implementation issues which every organization has and how these demands can interact with the unique skills and abilities which stakeholders bring to it.
Many investigators lack clear or a basic understanding and/or training concerning the stakeholder framework as well as terminologies (Figure
Often a reactive approach is favored over a proactive one for dealing with stakeholder issues is favored over a proactive one. As suggested by Greenwood, the “glorified depiction of stakeholder engagement gives way to the murky reality that engagement of stakeholders can mean many things to many people” (
Not every project can require or afford to have a full ShE or ShM system in place as outlined in this review. The main barrier here is that stakeholder involvement, and the fostering of attitudes that encourage this process, require a degree of organizational change (i.e., additional paperwork, more meetings, and more communication), which can be expensive. Hence, the benefits of managing a full program of stakeholder engagement, analysis, and management are only applicable to high impact projects. As Cennamo et al. (
Above all, it is impossible to engage with stakeholders and to do stakeholder management in an authentic and effective way without dealing with the multiplicity of ethical issues that arise. These issues arise, first of all, because the stakeholders’ interests can conflict along key ethical dimensions. Therefore, engaging with them must be sensitive to the rights of the parties involved, as well as to the overall harms and benefits, which accrue from managerial action. Second, it is not always apparent when there may be conflicts of interests or hidden advantages or hidden disadvantages among key stakeholders and decision makers. Obviously, these conflicts must be disclosed, and many organizations have specific procedures for handling such conflicts. However, given the nature of the decisions that are to be made, managers must be willing to accept that effective stakeholder management places them squarely in the realm of ethical decision making.
It is not always possible to anticipate all of the ethical issues and conflicts, which may develop in such a multi-stakeholder environment. Therefore, the traditional method of assigning responsibility for solving these problems to an ethics committee does not always work. Clinical project managers must be willing to make choices based on both good ethics (based on PMI’s code of ethics and professional conduct) and on the overall purpose and values of their institution that is best for all stakeholders (
Assuming that the challenges reviewed above can be overcome, additional “higher order” issues will emerge. These will consist of how to best promote the operational adaptability, viability, and implementation of the changes in an acceptable timeframe. Project managers will need to ask if the benefits of managing a full stakeholder analysis are really greater than the costs associated with it. Efforts will also need to be directed toward retrospective analysis, i.e., did real cases go badly because the stakeholder views were not sought out? The difficulty of these questions varies in different clinical settings but it is essential that they be resolved for maximum project effectiveness.
In summary, the concept of promoting stakeholder engagement and management is a relatively recent one in the clinical research arena; hence, there are many lessons to be learnt in the coming years. As this is an iterative process, although the current efforts from funding agencies such as PCORI are necessary but are insufficient to respond to the above challenges. All indications are that attempts to meet these challenges will nevertheless provide significant benefits for project management effectiveness.
From a clinical standpoint, stakeholder engagement and management is pivotal to the development and deployment of community-oriented national and global health initiatives. The ultimate purpose of such engagement is the efficient use of time, money, and resources thereby positively impact existing and/or emerging healthcare challenges.
For the purpose of our review, we have followed the guidelines of PMBOK® (
This review has drawn on the experience of stakeholder engagement in private organizations and government agencies and has argued that the process is equally viable in hospital program development and in clinical research. It has taken the view that the concept of stakeholder engagement and a proper stakeholder management framework is more than a useful adjunct to pursuing project or program goals and is actually pivotal for enhancing organizational success.
These guidelines have been broken down into a number of component parts. It emphasizes that the stakeholders should first be identified, that their interests and expectations should be understood, and that their level of power and influence should be understood as well. A plan for communicating with stakeholders has been outlined and techniques for encouraging their participation and management have been laid out.
All authors intellectually contributed to the design, analysis, and interpretation of the results and to drafting the critical review of manuscript. All authors reviewed and approved the final version of the manuscript.
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
In one of our landmark study by the author (MN), the South Carolina Department of Mental Health partnered with the University of South Carolina School of Medicine, Department of Health and Human Services and 18 predominantly rural hospitals from the South Carolina Hospital Association to establish the statewide telepsychiatry initiative. In this public-private-academic partnership, the psychiatrists were available via teleconference 16 h a day, 7 days a week, to assess and treat patients with mental health issues at hospital emergency departments.
The clinicians called the psychiatrist on duty whenever they have a patient who needed a mental health assessment and/or counseling and provide relevant medical records and details. Through a secure video link, the psychiatrists were able to assess the patient and makes recommendations about needed treatment and follow-up, including referrals to community-based resources.
The advantage of such program was that, it drastically reduced emergency department wait times, inpatient admissions, as well as costs; increased attendance at follow-up outpatient appointments; and generated higher level of satisfaction among patients and clinicians. Additional evidence includes post-implementation surveys that gauge the satisfaction of patients and clinicians with the program.
In such an innovative approach, the stakeholder (State Department of Mental Health, University of South Carolina, Department of Neuropsychiatry and Behavioral Science, Hospital, Physicians and Nurses from the South Carolina Hospital Association, and Patients) engagement proved to be feasible, necessary, and beneficial in clinical environment.
The program has reduced emergency department (ED) wait times, inpatient admissions, and costs; increased attendance at follow-up outpatient appointments; and generated high levels of satisfaction among patients and clinicians.
Shorter ED Wait Times: From March 2009 through 2014, the average waiting time for patients with mental health problems at the 18 participating EDs fell by roughly 50%. Fewer hospitalizations: during the same timeframe, 11% of ED patients assessed by a psychiatrist were hospitalized, half of the 22% admission rate among similarly cared-for patients in South Carolina EDs not offering this program.
Health care utilization: Telepsychiatry consultations resulted in an estimated $1,400 less per mental health patient compared to patients seen in ED’s that did not have telepsychiatry due primarily to the reductions in hospital admissions.
Greater attendance at follow-up appointments: About 46% of patients served by the program attended an outpatient follow-up appointment within 30ădays of the initial ED visit, well above the 16% attendance rate among similar ED patients cared for in South Carolina hospitals not offering the program. Similarly, 54% of patients served by the program attended a follow-up appointment within 90ădays versus 20% among ED patients in hospitals not offering the program.
High satisfaction among patients and staff: More than 80% of patients served by the program reported being satisfied with the process and services received. In addition, 84% of ED physicians and staff believe that the program has improved patient care; 91% report being satisfied with program-related procedures; and 84% express satisfaction with the technology used.
The authors would like to sincerely thank Professor Philip Kotler, S. C. Johnson & Son Distinguished Professor of International Marketing, Kellogg School of Management, Northwestern University, USA for his time, advice, and his valuable comments on the earlier versions of our manuscript, which enormously improved the quality of the final manuscript. We are also grateful for the comments from the anonymous reviewers. We gratefully acknowledge the National Institutes of Health; National Institute of Mental Health; Duke Endowment; South Carolina Department of Health and Human Services. As of the end of 2012, the Duke Endowment had provided more than $7.25 million in support of the program. Additional funding has come from the South Carolina Department of Health and Human Services, the National Institute of Mental Health (NIMH), and the National Institutes of Health (NIH). NIMH and NIH awarded two grants (one in 2009 and one in 2012) totaling $3.04 million to support evaluation of project outcomes (on quality, economic impact, utilization, and sustainability). In addition to grant funding, user fees and third-party insurance cover some program-related costs; for example, beginning in 2013, BlueCross BlueShield of South Carolina began covering use of telemedicine in mental health. However, the funders had no involvement in study design, data collection, data analysis and interpretation, preparation of the manuscript, or in the decision to submit the manuscript for publication.