Protocol (Description of the Project)

1.   Title of the project: Exploring the association between Patient Involvement and Patient Experience – a Cross-sectional Study at a tertiary care hospital.

2.  Type of Study: Prospective study- cross sectional study

3.  Aims & objectives (hypotheses if applicable):

Aims: To assess patient/attendant’s perception in relation to patient participation while in care provision.

Objectives:

a)     To understand patient perception on their engagement during care provision.

b)    To assess the effect of patient engagement on patient experience.

4.  Justification for study (whether of national significance with rationale):

Patient participation is an essential component of patient-centered care. Healthcare practitioners can better satisfy patients’ needs and preferences by understanding their perceptions on engagement in their own care and safety. Patients who are engaged are more likely to stick to treatment programmes, adhere to safety standards, and speak openly with their healthcare providers. This can lead to better health outcomes and fewer medical errors, which will benefit both patients and the healthcare system in the long run. Evaluating patient perceptions of engagement can provide insights into healthcare organisations’ safety cultures. Patients who feel empowered and appreciated as partners in their care may indicate that the organisation places a high focus on safety and open communication.

5.  Departments involved: Critical Care Unit and Surgical oncology.

6.  Study period: November 2023- February 2024.

7.  Sample size:

Sample size in the study aimed for is 124 which has been calculated taken the p value as 0.92 based on a study conducted using the same tool at a tertiary care treatment centre in North India (Namrata Makkar, 2019)

Sample Size =    z ²x p (1-p)/ e ²

e = Margin of error z = z score

p = Standard deviation

n = 1.96 ² * 0.92 (1 - 0.92)/ 0.05 ²

n = 124

8.  Materials and methods:

a)  Inclusion and exclusion criteria:

Inclusion: Critical care unit and Department of Surgical Oncology. (In-patient / Patient attendant above 18 years of age).

Exclusion: All the other Departments.

b)  Biological materials required (type - blood, tissue etc and quantity): Yes ☐ No �’

i)  Biological material: Nil.

ii)  Biosafety Measures: Nil.

c)  Statistical methods: Descriptive statistical analysis and Inferential Statistical analysis

d)  Tools used: Picker Patient Experience (PPE-15) questionnaire.

9.  Detailed description of procedure / processes:

For eliciting patient service experience, the study will be using Picker Patient Experience questionnaire (PPE- 15). This is a 15-item questionnaire with high internal consistency, reliability and promising evidence of both face and criterion validity; it is available online as supplemental file. It has been used internationally for measuring patient’s hospital experience for the purpose of bench- marking care quality. The PPE-15 assesses 8 key aspects of the care: (1) information and education, (2) coordination of care, (3) physical comfort, (4) emotional support, (5) respect for patient preference, (6) involvement of family and friends, (7) continuity and transition, and (8) overall impression. Both the objectives of the study intended to be achieved using this questionnaire. Questions are posed with a variety of possible responses, which are then converted into a binary conclusion reflecting the presence or absence of an issue within the questioned domain. For each question, the proportion of patients with or without a problem was computed based on these binary responses. This instrument has the advantage of not being disease-specific and can be utilised in a variety of scenarios. A Kannada translation of the questionnaire will be done as majority of the participants are conversant with Kannada Language and translation deemed adequate.

As the study is intended to collect the responses from the patients or the attendants, the researcher will be seeking approval from IEC to consult the research ethics and consent (translated in Kannada) from the individual respondent will be obtained before administering the questionnaire.

10.  Outcome measures:

While evaluating Patient’s perception on patient engagement for ensuring patient safety there are several outcome measure that can be among them a few are –

I.          Assessing patients’ perception of their ability to actively participate in healthcare decision-making processes and to determine whether they feel empowered to ask questions, voice concerns, and make informed choices about their care.

II.          Another outcome measure can be understanding the awareness and knowledge of the patients regarding patient safety.

III.          The third outcome measure can be the evaluation of patient safety culture.

All these outcome measures will help in establishing a safer health care delivery system with more empowered patients.

11.  Potential risks and benefits: Minimal risk of confidentiality on their personal information and no harm to their privacy. However, the Primary Investigator ensures that the data will not be shared with any third   parties. Personal information will not be taken other than the demographic details of age, gender, and educational qualification.   The questionnaire (PPE- 15) neither invokes nor intends to take the participants through any emotional trauma.  The PPE- 15 provides a basic set of questions that should be applicable to all  hospitals and relevant to all patients ( (Crispin Jenkinson, 2002). As this is a survey, no other specific anticipated risks exist.

Benefits of the study include-

I.          Understanding patient’s perspective on Patient Safety.

II.          Giving Patient centered care.

III.          Improving communication between health care providers and patients during their care provision.

IV.          This study will help in better care transition from hospital to home care.

12.  Ethical considerations and methods to address issues:

As it is a survey that includes individual responses from the patients or their attendants therefore clearance to be taken from Institutional Ethics Committee. No data regarding patient name, Hospital registration no. and medical records will be collected. Further to ensure safety and privacy of patients Participant Information Sheet translated in vernacular language will be given.

13.  Budget (give details) and proposed funding source:

This study is self-funded.

14.  Review of literature (within 1000 words):

Research databases like Scopus, google scholar were searched with the key words like, ‘patient engagement’, ‘patient safety’, ‘shared decision making’, ‘patient empowerment’. The Picker/Commonwealth Programme for Patient-Centered Care (now the Picker Institute) originated the term "patient-centered care" in 1988 to highlight the need for doctors, employees, and health care systems to shift their focus away from diseases and towards the patient and family. The word was intended to emphasize the significance of better understanding the sickness experience and meeting patients’ demands within an increasingly complicated and fragmented health care delivery system. The process by which the best decision for a patient at a critical health juncture is known as shared decision making, and it involves, at minimum, a clinician and the patient, though other members of the health care team, as well as friends and family members, may be invited to participate. Both parties communicate information in shared decision making: the clinician presents options and outlines their risks and advantages, while the patient expresses his or her preferences and values. Each member is thus better informed about the relevant factors and shares responsibility for the decision on how to proceed. (Michael J. Barry, 2012).

Traditionally, initiatives to increase safety have centered on solutions including institutional or professional measures, such as improving incident reporting systems, modifying care systems, and professional behavior. However, there is a growing interest in integrating patients and their representatives in safety measures. Several international safety programmes have emphasized the necessity of patient engagement in patient safety. Patients, families, and community engagement were selected as one of six initial patient safety goals by the World Health Organization (WHO) in 2004, and it remains a fundamental priority of the WHO patient safety strategy. It is commonly acknowledged that a successful strategy to understanding and eliminating medical errors requires account for all individuals involved in system activities. Recent evidence suggests that patients can contribute significantly to their own safety by preventing errors and bad outcomes. They can play an important role in establishing an accurate diagnosis, deciding on appropriate therapy, selecting providers, ensuring that treatment is provided as intended, and detecting and preventing occurrences. Patient involvement in patient safety aims to raise patient awareness and participation in error-prevention initiatives. However, many factors hinder patient participation, including acceptance of the new role of the patients by caregivers,

unwillingness of patients, cultural barriers, and lack of system-level efforts supporting patient and family engagement (Samaneh Sarkhosh, 2022) .

The engaging of a patient in their care is a complex process, and there is no single agreed definition of patient engagement. Carman et al. defines “patient and family engagement” as the active partnership between patients, their families, representatives, and health- care professionals (HCPs) across different levels of the healthcare systems, including direct care, organizational design and governance and health policy creation, with the overall aim to improve the health of the patient and healthcare systems. There are many ways patients can engage in their direct care to enhance their safety. Patients can provide information and ask questions to influence safety (Zahra Chegini, 2021).

Thus, there is clearly a need to understand barriers and challenges of patient involvement in patient safety. The involvement of patients and attendants, who are most directly affected by patient safety issues, has been emphasized in recent years. Patients and family members, for example, should ensure that their medication is the correct prescription to take and that they understand what it is and its side effects. Indeed, past research has demonstrated that patient interaction is effective in minimizing prescription errors and undesirable drug effects. (Hyeon-Jeong Lee, 2021).

15.  References:

I.         Michael J. Barry, M. a.-L. (2012). Shared Decision Making — The Pinnacle of Patient-Centered Care. The New England Journal of Medicine, 780-781.

II.          Hyeon-Jeong Lee, S. G.-I. (2021, November 21). Assessment of Public Perception Regarding Patient Engagement for Patient Safety in Korea. Journal of Patient Safety, 17, 44-50.

III.          Samaneh Sarkhosh, Z. A. (2022). Engaging patients in patient safety: a qualitative study examining healthcare managers and providers’ perspectives. BMC Nursing.

IV.          Zahra Chegini, M. A.-Z. (2021). Barriers and facilitators to patient engagement in patient safety from patients and healthcare professionals’ perspectives: A systematic review and meta-synthesis . Nursing Forum, 938-950.

V.         Subhrojyoti Bhowmick, S. B. (2022). Awareness and understanding among patients about patient safety in India: A cross-sectional questionnaire-based study. Journal of Patient Safety and Risk Management, 21, 21-25.

VI.          Namrata Makkar, K. J. (2019). Patient Involvement in Decision-Making: An Important Parameter for Better Patient Experience—An Observational Study (STROBE Compliant). North India: Journal of Patient Experience.