| TITLE OF THE STUDY Effectiveness of a “Transitional Care Program” on Hospital Re-admissions and Self-Efficacy among heart failure patients at a tertiary care hospital.
AIM – To develop “Transitional Care Program” for heart failure patients
OBJECTIVES - PRIMARY OBJECTIVES: 1. To assess effectiveness of “Transitional Care Program” on self- efficacy and hospital Readmissions among heart failure patients. SECONDARY OBJECTIVES: 2. To find out association between heart failure knowledge scores and Self-Efficacy among heart failure patients. 3. To find association between selected demographic variables and Self-Efficacy among heart failure patients. 4. To find out correlation between Self-Efficacy and quality of life scores among heart failure patients.
HYPOTHESIS - H1 – There will be significant reduction in hospital readmission among heart failure patients receiving “Transitional Care Program” as compared to control group at P value < 0.05 as measure by self-structured heart failure rehospitalisation tool. H2- There will be significant improvement in self- efficacy among heart failure patients receiving TCP as compared to control group at P value < 0.05 as measured by self-care of heart failure index. H3- There will be significant correlation between Self-Efficacy scores and quality of life among heart failure patients receiving TCP as compared to control group at P value < 0.05.
ASSUMPTIONS 1. The Transitional Care Program (TCP) may improves self-efficacy and effectively reduce hospital readmissions. 2. The intervention will may be implemented promptly after hospital discharge.
OPERATIONAL DEFINITIONS Transitional Care Program (TCP): A structured and coordinated set of healthcare interventions designed to facilitate the safe and effective transition from the hospital to home or another care setting of heart failure patients due to any cause, delivered at the time of discharge. It includes patient education, medication adherence, follow-up appointments and telephonic follow up. The program aims to ensure continuity of care and reduce gaps in post-discharge management.30 minutes will be given twice (total 60 minutes). 1 st time- When patient achieves hemodynamic stability and discharge planning starts. 2 nd time – On the day of discharge TCP will be delivered 2nd time. Hospital Readmissions: The occurrence of a heart failure patient being readmitted to the hospital for any cause within 15 days of discharge. Telephonic follow up will be done 3rd day and 14th day to assess for any hospital any readmission. Self-Efficacy in Disease Management: The confidence of heart failure patients in their ability to effectively manage their condition, including adherence to medication, dietary restrictions, symptom monitoring, and seeking timely medical help. It will be measured by SCHFI version 0.8. Heart Failure Patients: Those patients admitted in cardiology ICU and wards of LARI, Department of Cardiology, KGMU with the diagnosis of Heart failure, (NYHA II and III) with any cause (CMPs, ACS, etc).
RESEARCH METHODOLOGY Research Approach – Quantitative approach Research Design – Randomized Controlled Trial (RCT)
RESEARCH VARIABLES Independent variable – 1. Transitional Care Program Dependent Variable – 1. Hospital Readmissions 2. Self-Efficacy in Disease Management
SETTING Intensive Care Unit and wards, Department of Cardiology, LARI, KGMU, Lucknow POPULATION Heart Failure patients with any cause from Cardiology Department ICU and wards. Target Population – Patients with heart failure due to any cause admitted in Intensive Care Unit and wards, Department of Cardiology, LARI, who meets the set of inclusion criteria at KGMU, Lucknow. Accessible Population – Patients with heart failure due to any cause in NYHA Classification II and III who meets the set of inclusion criteria and are hemo-dynamically stable admitted in Intensive Care Unit / wards, Department of Cardiology, LARI, at KGMU, Lucknow.
SAMPLE SIZE - Total Participants = 98 49 participants per group
INCLUSION AND EXCLUSION CRITERIA Inclusion Criteria: 1. Hemodynamically stable patients aged 18-75 years with a confirmed diagnosis of Heart Failure [(both HFrEF and HFpEF) and BNP level > 100 pg/ml] due to any cause, admitted in Cardiology Lari, ICU and wards, KGMU, Lucknow. 2. Possessing a functional mobile phone or access to communication technology for program interaction. 3. Willing to participate in the study and is Capable of providing informed consent and understanding instructions related to the care program.
Exclusion Criteria: 1. Patients with severe cognitive impairments or psychiatric conditions that hinder program participation. 2. Diagnosed with a terminal illness or advanced co-morbid conditions (Chronic Kidney Disease (CKD), Diabetes Mellitus (DM), Atrial Fibrillation (AF), Chronic Obstructive Pulmonary Disease (COPD), Anemia and Iron Deficiency, Depression, Cognitive Impairment, Obesity, Hypertension) limiting survival to less than 6 months. 3. Already participating in another clinical trial or disease management program.
DESCRIPTION OF TOOLS SELF-STRUCTURED TOOL- This is self-structured tool prepared by PI for the purpose of study. It consists of Tool -1 and Tool -2 Tool 1 - Demographic Profile- This tool consists of self- structured 9 items. The content and face validity of the tool will be established by the experts. Tool 2- Clinical Profile- This tool consists of self- structured 13 items. The content and the face validity of the tool will be established by the experts. Tool 3- Heart Failure Rehospitalisation Tool - This tool consists of self- structured 3 items. The content and the face validity of the tool will be established by the experts.
STANDARDIZED TOOLS – TOOL 4- KCCQ -12- The Kansas City Cardiomyopathy Questionnaire (KCCQ) is an international standard, based on its psychometric properties, for quantifying the diseasespecific health status of patients with heart failure. (29) TOOL 5- SCHFI Version 0.8 - Assesses self-care in heart failure patients across three domains: maintenance, management, and confidence. Number of Items: 23 items. Scoring: Each item is scored on a Likert scale (1 to 5). Scores for each domain is standardized to a range of 0 to 100, with higher scores reflecting better self-care. TOOL 6- Heart Failure Patients’ Knowledge of Their Disease- the questionnaire about HF patients’ knowledge of their disease comprised three steps with three different procedures: theoretical, empirical and analytical. It consists of 19 items. TOOL 7- NYHA Classification Assessment -NYHA Classification - The Stages of Heart failure
DATA COLLECTION PROCEDURE - Participant Recruitment - Identify eligible heart failure patients using inclusion and exclusion criteria. Inform patients about the study purpose, procedures, and confidentiality, obtaining written informed consent. Randomization-Assign participants to either the intervention group (TCP) or the control group by simple random sampling technique using concealed envelop generated by research randomizer software.
- Baseline Data Collection- Collect demographic data (e.g., age, gender, socioeconomic status).
- Intervention Implementation (for the TCP group) - Conduct individualized educational sessions on Transitional Care Program and disease understanding. Provide structured discharge planning and follow-up schedules. Ensure regular follow-up through phone calls, or clinic appointments. Routine Care (for the Control group) - Provide the standard discharge care as per the hospital’s protocol.
- Follow-up Data Collection - Monitor participants for a specific period of 2 weeks. Record hospital readmissions through patient interviews and hospital records. Assess patient satisfaction using validated satisfaction scales.Evaluate Self-Efficacy using tools like the SelfCare of Heart Failure Index (SCHFI).
- Data Recording- Maintain a secure and organized database for all collected data. Ensure accuracy and consistency in data entry.
- Quality Assurance- Regularly review and cross-check collected data to avoid errors. Address missing data or inconsistencies promptly.
PLAN FOR DATA ANALYSIS • Data will be collected, and raw data will be entered in the master data sheet. • Analysis of data will be with the help of Descriptive and Inferential statistics. |