Patient EngagementNCT05280171
Impact of Teach Back of Discharge Information in Term of Patient Recall of Information and Patient Engagement
A study testing Teach back in people with Patient Engagement, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Patient Engagement
- What is being tested?
- Teach back
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2021to 5 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic liver disease -
- Admitted in general ward of ILBS New, Delhi
- Within the age group 18-65 year
- Willing to participate.
- Can understand Hindi or English.
Who cannot join
- Patients with chronic liver disease -
- Diagnosis of altered mental status.
- On hospice care
- On leaving against medical advice.
Trial locations and contacts
1 site in 1 country.
India1 site
Sheetal Chhikara
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: 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
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
Read more
- To evaluate the impact of teach back on patient recall of discharge information among Chronic Liver Disease patients.
- To evaluate the impact of teach back on engagement in self care among Chronic Liver Disease patients.
Secondary objectives
- To find the association of health literacy with patient recall in experimental group after discharge information.
- To find the association of health literacy with patient engagement in experimental group after discharge information.
- To find the association of patient recall with selected demographic and clinical variable in experimental group after discharge information.
- 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
- It is assumed that the patients health information need to be focused on individual needs to improve their health literacy (Yen\&Leasure,2019).
- It is assumed that teach back method will improve patient's immediate and short term recall of discharge information(Mahajan et al,2020).
- It is assumed that teach back will support self management and promote health outcome(Yen \& Leasure, 2019).
Read the detailed 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
- It is assumed that the patients health information need to be focused on individual needs to improve their health literacy (Yen\&Leasure,2019).
- It is assumed that teach back method will improve patient's immediate and short term recall of discharge information(Mahajan et al,2020).
- 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)
- Conditions
- Patient Engagement
- Being tested
- Teach back, Standard of care
- Keywords
- Teach Back, Recall of Discharge Information, Patient Engagement in self care, Health Literacy, Chronic Liver Disease
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teach backOther
Discharge information was explained by the principal investigator. On the day of discharge, pictographs teach back regarding medication, exercise, diet and follow-up was given and they were asked teach back.
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.
Standard of careOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Teach back | Experimental | Discharge information was explained by the principal investigator. It includes pictographs teach back regarding medication, exercise, diet and follow-up was given and they were asked teach back. Receives: Other: Teach back |
| Standard of Care | Active comparator | Discharge information as per the standard existing routine. Than assessed the recall and patient engagement of CLD patients in general ward regarding discharge instructions by structure questionnaires for patients recall, and PAM for patient's Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of teach back on patient engagement in self care
Patient engagement in self-care was assessed by the patient activation measure scale of the chronic liver disease patient. It consists of 22 items with minimum 0 and maximum 22 score and whether higher scores mean a better outcome.
Measured: up to 5 weeks
Impact of teach back on patient recall of the discharge information
Assessment using recall inventory consist of 28 items with minimum 0 and maximum 28 score and higher scores mean a better outcome and was assessed by the recall of discharge information that includes medication, diet, exercise and follow-up of chronic liver disease patient.
Measured: up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start1 Nov 2021
- Primary completion14 Nov 2021
- Study completion5 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient EngagementStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheetal Ms Chhikara, Nursing, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280171
- Sponsor's protocol ID
- ILBS-TBDIRPE-101
- Status last verified
- Jan 2022
- First submitted
- 29 Dec 2021
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05280171
- Acronym / sponsor ID
- ILBS-TBDIRPE-101
- Conditions
- Patient Engagement
- Keywords
- Teach Back, Recall of Discharge Information, Patient Engagement in self care, Health Literacy, Chronic Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 14 Nov 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To evaluate the impact of teach back on patient recall of discharge information among Chronic Liver Disease patients.
- To evaluate the impact of teach back on engagement in self care among Chronic Liver Disease patients.
Secondary objectives
- To find the association of health literacy with patient recall in experimental group after discharge information.
- To find the association of health literacy with patient engagement in experimental group after discharge information.
- To find the association of patient recall with selected demographic and clinical variable in experimental group after discharge information.
- 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
- It is assumed that the patients health information need to be focused on individual needs to improve their health literacy (Yen\&Leasure,2019).
- It is assumed that teach back method will improve patient's immediate and short term recall of discharge information(Mahajan et al,2020).
- It is assumed that teach back will support self management and promote health outcome(Yen \& Leasure, 2019).
Detailed 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
- It is assumed that the patients health information need to be focused on individual needs to improve their health literacy (Yen\&Leasure,2019).
- It is assumed that teach back method will improve patient's immediate and short term recall of discharge information(Mahajan et al,2020).
- 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)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teach back | Experimental | Other: Teach backDischarge information was explained by the principal investigator. It includes pictographs teach back regarding medication, exercise, diet and follow-up was given and they were asked teach back. |
| Standard of Care | Active comparator | Other: Standard of careDischarge information as per the standard existing routine. Than assessed the recall and patient engagement of CLD patients in general ward regarding discharge instructions by structure questionnaires for patients recall, and PAM for patient's |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with chronic liver disease -
Key exclusion criteria (4 listed)
- Patients with chronic liver disease -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teach backDischarge information was explained by the principal investigator. On the day of discharge, pictographs teach back regarding medication, exercise, diet and follow-up was given and they were asked teach back. 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. | Other | Teach back |
| Standard of careStandard of care | Other | Standard of Care |
Primary outcome
Impact of teach back on patient engagement in self care
Time frame: up to 5 weeks
Patient engagement in self-care was assessed by the patient activation measure scale of the chronic liver disease patient. It consists of 22 items with minimum 0 and maximum 22 score and whether higher scores mean a better outcome.
Impact of teach back on patient recall of the discharge information
Time frame: up to 5 weeks
Assessment using recall inventory consist of 28 items with minimum 0 and maximum 28 score and higher scores mean a better outcome and was assessed by the recall of discharge information that includes medication, diet, exercise and follow-up of chronic liver disease patient.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheetal Ms Chhikara, Nursing principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teach back in people with Patient Engagement, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of teach back on patient engagement in self care (time frame: up to 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.