Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05280171 |
| Other study ID # |
ILBS-TBDIRPE-101 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2021 |
| Est. completion date |
December 5, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Institute of Liver and Biliary Sciences, India |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Impact of Teach Back of Discharge Information in term of patient Recall of Information and
patient Engagement in self-care among Chronic Liver Disease patients admitted in selected
wards of ILBS, New Delhi
Primary objectives
1. To evaluate the impact of teach back on patient recall of discharge information among
Chronic Liver Disease patients.
2. To evaluate the impact of teach back on engagement in self care among Chronic Liver
Disease patients.
Secondary objectives
1. To find the association of health literacy with patient recall in experimental group
after discharge information.
2. To find the association of health literacy with patient engagement in experimental group
after discharge information.
3. To find the association of patient recall with selected demographic and clinical
variable in experimental group after discharge information.
4. To find the association of engagement in self-care with selected demographic and
clinical variable in experimental group after discharge information.
Assumptions The current study is conceptualized on the basis of the following assumptions
1. It is assumed that the patients health information need to be focused on individual
needs to improve their health literacy (Yen&Leasure,2019).
2. It is assumed that teach back method will improve patient's immediate and short term
recall of discharge information(Mahajan et al,2020).
3. It is assumed that teach back will support self management and promote health
outcome(Yen & Leasure, 2019).
Description:
Aim of the study This study is aimed to assess the impact of teach back on Chronic Liver
Disease patients recall of discharge information and patient's engagement.
To evaluate the efficacy of teach-back in improving comprehension and engagement in self care
at the time of discharge.
Problem statement A quasi experimental study to assess the impact of Teach Back of Discharge
Information in terms of patient Recall of information and patient Engagement in self care
among Chronic Liver Disease patients admitted in selected wards of ILBS New Delhi.
Assess
Operational Definitions
It means to evaluate and estimate the nature, ability or quality of something. In this study,
assess refers to evaluate and estimate, the nature or ability of the patient
recall and engagement regarding discharge information among Chronic Liver Disease patients.
Impact The term impact describes all the changes which are expected to happen due to the
implementation and application of a given policy option/intervention.
In this study, impact refers to improved patients recall and engagement in self care with the
use of teach back of discharge information.
Teach Back Teach-back is a method of ensuring that the teaching is effective by asking for
the learner to teach it back in his or her own words.
Teach back is a communication confirmation method used by Researcher to provide information
about their diagnosis ,treatment ,medication, risk of treatment, during discharge, then
patients will be clearly describe the information provided by researcher. The researcher will
clarify the information as needed in Chronic Liver Disease.
Teach back is an evidence based technique to verify not patient recall ,but also their
understanding by asking them to repeat the given discharge information in their own words.
Teach back is an efficient and non time consuming method to improve patients, immediate and
short term recall and comprehension of the discharge information
Recall It means remembrance of what has been learned or experienced. In this study, it refers
to remembrance of discharge information related to treatment, follow up, and self care of
Chronic Liver Disease patients. It is measured by structured recall inventory and each item
categorized in complete comprehension>90%, partial 90-65%,minimal 65-40%, none<40 Patient
Engagement Patient engagement is defined as a concept that combines a patient's Recall,
skills, ability and willingness to manage his/her own health and care with interventions. It
increases patient activation and promote positive patient behavior.
In this study refers to patient's Recall, skill, ability and willingness to manage her/ his
own health include self-care, to increase activation and promote positive patient behavior.
It measured by a 22 item patient activation measure scale and the score are categorized as
level 1:<47 not believing activation is important, level 2: 47-55 a lack of Recall and
confidence to take action, level 3: 55-67 beginning to take action, level 4:>67 taking
action.
Discharge Information Discharge information means documented information relevant to a
patient's medical condition or behavioral health issue provided by a health care institution
to the patient or the patient's representative at the time of the patient's discharge.
In this study it refers to documented information including patient's treatment,(medical and
self care),follow up consultations, and return precautions provided by a health care
institution to the Chronic Liver Disease patients at the time of patient's discharge.
Chronic Liver Disease(CLD) Chronic liver disease is a progressive deterioration of liver
functions for more than six months, which includes synthesis of clotting factors, other
proteins, detoxification of harmful products of metabolism and excretion of bile. Chronic
Liver Disease is a continuous process of inflammation, destruction, and regeneration of liver
parenchyma, which leads to fibrosis and cirrhosis.
In this study, Chronic liver disease is a progressive deterioration due to inflammation,
destruction leading to fibrosis and cirrhosis of liver functions for more than six months.
Chronic Liver Disease is diagnosed by the physician and admitted in the selected ward of ILBS
for treatment.
Variable of the study Assumptions The current study is conceptualized on the basis of the
following assumptions
1. It is assumed that the patients health information need to be focused on individual
needs to improve their health literacy (Yen&Leasure,2019).
2. It is assumed that teach back method will improve patient's immediate and short term
recall of discharge information(Mahajan et al,2020).
3. It is assumed that teach back will support self management and promote health
outcome(Yen &Leasure, 2019).
Conceptual Framework The present study is based on Iowa Model of Evidence-Based Practice
to assess the impact of teach back on patient recall of discharge information and
patient engagement among patients with chronic liver disease admitted at ILBS, New
Delhi.
Delimitation of the study The study is delimitation to;
• The patients with chronic liver disease admitted in general ward of ILBS New Delhi.
Material and Methods Research Approach Quantitative research approach Research Design:
Quasi experimental research design Two group post test only design
The symbols used means: R:Randomization allocation E:Experimental group C:Comparison
group X:Teach back of discharge information, O:Recall and patients' engagement of
discharge patients.
INTERVENTION:
Teach back is a approach which is used in cognitive psychology experiments describing
repeating short sequences of information helps to improve repeat back of information.
This teach back technique is recommended as a universal precaution by the agency for
healthcare research and quality and the national quality forum.
Need of teach back:
Teach back is an important issue for the recommendation , which relates to the time this
may be take relative to standard instruction.
Teach back would likely result in increased nurse time spent in the room at the time of
discharge discussing and answering remaining questions.
Therefore in the current study teach back method is undertaken on the basis of broad
literature review find out that teach back are better advanced as a universal precaution
or in a more a targeted intervention for patient.
Setting of the study The study will be conducted in General Ward of ILBS, New Delhi
Population Target population: Chronic Liver Disease patients Accessible population:
Chronic Liver Disease patients in General Ward of ILBS, New Delhi
Sample Technique Random allocation into experimental and control group.
Sample Size The sample size for the present study was estimated based on previous
research study done on patient 's recall of discharge information regarding chronic
liver disease and patient engagement. For this purpose, the literature was reviewed and
the study by Mahajan et al.,(2020) was chosen. Assuming the baseline values were same,
after the intervention the mean recall of discharge information in experimental group
was3.95 ± 0.15 and in comparison group was 3.72 ± 0.4.based on this study ,the sample
size was calculated with alpha 5% and power 80 percent using the formula.
According a total of 54 patients were required to be included in the study,27 in
experimental group and 27 in comparison group.
In anticipation of sample dropout, it was decided to round up the total to 60 patients
(30 enrolled in each group) from among those who meet the sample selection criteria.
Sampling criteria
Tool for data collection
There are 4 tools used in this study.
There are given below:
Tool-1 Demographic Variables Tool-2 Recall inventory Tool-3Patient Activation Measure
(PEM-22) Tool-4 All aspects of health literacy scale (AAHLS)
Data analysis method Descriptive statistics - Descriptive analysis will be used to
calculate mean, percentage distribution and standard deviation, through tabulation and
graphic presentation.
Inferential statistics- Chi square test, independent t-test will be used to measure the
relationship between two or more variables (demographic and clinical variable)
