Heart FailureNCT01311583
Evaluating Teach Back as a Method for Improving Self-Care Behaviours in Heart Failure Patients
A study testing Teach Back method of patient discharge teaching in people with Heart Failure, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Patient education using Teach Back has the potential to increase self-care behaviour in heart failure (HF) patients and reduce adverse clinical outcomes. Teach back is an interactive teaching method that uses plain language, focuses on key points, and asks the patient to verbally recall information just discussed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Teach Back method of patient discharge teaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to Feb 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the in-patient cardiology (7CCS) or Coronary Care Unit (CCU), with documentation of HF as the most responsible diagnosis
- Prescribed a diuretic such as Lasix plus or minus Metolazone
- New or established diagnosis of HF
Who cannot join
- Cognitive impairment
- Suffer from a co-existing, severe, chronic debilitating disease
- Require hemo or peritoneal dialysis, have planned surgical intervention that will impact the etiology or manifestation of HF symptoms
- Life expectancy of less than three months
- Unable to receive discharge teaching, or are unable to communicate on the telephone
- Already enrolled in a patient education study
Trial locations and contacts
1 site in 1 country.
About this study
Patient education using Teach Back has the potential to increase self-care behaviour in heart failure (HF) patients and reduce adverse clinical outcomes. Teach back is an interactive teaching method that uses plain language, focuses on key points, and asks the patient to verbally recall information just discussed. Questions are asked to confirm patient understanding of the information delivered.
This pilot study will be conducted to evaluate the effectiveness of teach back on self-care (as measured by the European Heart Failure Self-Care Behaviour Scale- EHFScBS) and determine if teach back affects the number of ER visits and re-admissions post discharge. The study will also assess if teach back technique is a feasible, acceptable and sustainable method of discharge teaching for hospitalized HF patients at St Michael's.
Read the detailed description
Background: Heart Failure (HF) is a common and debilitating disease associated with frequent hospitalizations, decreased quality of life, and requires complex health care regimen. Heart failure management programs promote self-care by teaching patients how to recognize signs and symptoms, how to respond to these symptoms and who to contact for advice. Teaching interventions aimed at self-care have been shown to improve patient outcomes, however, the optimal method of delivering the education is unknown.
Patient education using Teach Back has the potential to increase self-care behaviour in HF patients and reduce adverse clinical outcomes by using plain language, focusing on key points, and asking the patient to verbally recall information just discussed, in an interactive manner. Research has shown Teach Back to be an effective strategy to improve patient comprehension in chronic conditions such as HF and diabetes.
The RNAO Best Practice Guidelines for Self-Management in Chronic Conditions (2010) recommends a nursing communication technique of "Closing the Loop" also known as "Teach Back" to assess patient understanding of information. The level of evidence for this technique is level III (from well designed, non-experimental descriptive studies, such as comparative studies, correlation studies, and case studies). This study will provide additional evidence in a randomized experimental design.
The objectives of this study are to evaluate the effectiveness of Teach Back on self-care (as measured by the European Heart Failure Self-Care Behaviour Scale) and determine if Teach Back affects the number of ER visits and re-admissions post discharge. A secondary objective is to assess if Teach Back technique is a feasible, accepted and sustainable method of discharge teaching for hospitalized HF patients at St. Michael's.
- Research Question: Does discharge teaching using the Teach Back method from trained nurses improve self-care behaviour in HF patients as measured by the EHFScBS scale as compared to standard care discharge teaching? Hypothesis: Patients who receive teach back discharge teaching will have improved self-care (achieve lower scores on EHFScBS).
- Research Question: Are there fewer ER visits and hospital admissions post discharge in patients who receive instruction with teach back method? Hypothesis: Patients who receive discharge teaching with Teach Back will have less ER visits and hospital admissions in the 3 months following hospital discharge.
- Research Question: What is the feasibility and acceptability of adapting Teach Back as standard practice of discharge teaching for heart failure patients in the in-patient cardiac care units at St. Michael's?
Hypothesis: Teach Back is an accepted and sustainable method of discharge teaching in HF patients in the in-patient cardiac care units at St. Michael's as evidenced by participants' feedback (patient questionnaires and nursing focus groups).
- Conditions
- Heart Failure
- Being tested
- Teach Back method of patient discharge teaching
- Keywords
- Self-care, Teach Back
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teach Back method of patient discharge teachingBehavioural
Trained nurses will provide Teach Back to the intervention group. Appendix D lists the four questions that will be used in this study to confirm the patient's understanding. The nurses' training will focus on the concepts of Teach Back, provide coaching and guidance on how to use it as well as review the principles of conducting research. Role play will be a feature in the education sessions to improve the nurses' comfort level
| Study group | Role | What they receive |
|---|---|---|
| usual care plus Teach Back intervention | Active comparator | Trained nurses will provide Teach Back to the intervention group. The nurses' training will focus on the concepts of Teach Back, provide coaching and guidance on how to use it as well as review the principles of conducting research. Role play will be a feature in the education sessions to improve the nurses' comfort level Receives: Behavioral: Teach Back method of patient discharge teaching |
| usual care | No intervention | All participants will experience the current practice of discharge teaching: daily interaction with the interdisciplinary team members via rounds, counseling on diet and medications with a dietician and pharmacist when referred, view the Heart Failure Discharge Video, and receive a Congestive Heart Failure education package which includes the Heart and Stroke "Managing Congestive Heart Failure" booklet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-care behaviour score
mailed questionaire
Measured: change from baseline in self-care behaviour score at one week.
self-care behaviour score
mailed questionaire
Measured: change from baseline in self-care behaviour score at one month
self-care behaviour score
mailed questionaire
Measured: change from baseline in self-care behaviour score at three months
Secondary outcomes (6)
patient visits to ER or admission to hospital
mailed questionaire
Measured: one week since discharge
patient visits to ER or admission to hospital
questionaire
Measured: at one month since discharge
patient ER visits or admission to hospital
questionaire
Measured: three months since discharge
impact on nurses' workload
focus group
Measured: up to 12 weeks from the last enrolled patient
satisfaction with the training for the nurses' to provide teach back
focus group
Measured: up to 12 weeks from the last enrolled patient
nurses' conviction and confidence related to Teach Back
focus group
Measured: up to 12 weeks from the last enrolled patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ada Andrade, MN, Principal investigator, St. Michael'sVimy Barnard-Roberts, MN, Study chair, St. Michael'sHaytham Sharar, MN, Study chair, St. Michael's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311583
- Sponsor's protocol ID
- 11-010
- Status last verified
- Jan 2016
- First submitted
- 22 Feb 2011
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Teach Back as a Method for Improving Self-Care Behaviours in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT01311583
- Acronym / sponsor ID
- 11-010
- Conditions
- Heart Failure
- Keywords
- Self-care, Teach Back
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 9 Mar 2011 (estimated)
- 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.
Patient education using Teach Back has the potential to increase self-care behaviour in heart failure (HF) patients and reduce adverse clinical outcomes. Teach back is an interactive teaching method that uses plain language, focuses on key points, and asks the patient to verbally recall information just discussed. Questions are asked to confirm patient understanding of the information delivered.
This pilot study will be conducted to evaluate the effectiveness of teach back on self-care (as measured by the European Heart Failure Self-Care Behaviour Scale- EHFScBS) and determine if teach back affects the number of ER visits and re-admissions post discharge. The study will also assess if teach back technique is a feasible, acceptable and sustainable method of discharge teaching for hospitalized HF patients at St Michael's.
Detailed description
Background: Heart Failure (HF) is a common and debilitating disease associated with frequent hospitalizations, decreased quality of life, and requires complex health care regimen. Heart failure management programs promote self-care by teaching patients how to recognize signs and symptoms, how to respond to these symptoms and who to contact for advice. Teaching interventions aimed at self-care have been shown to improve patient outcomes, however, the optimal method of delivering the education is unknown.
Patient education using Teach Back has the potential to increase self-care behaviour in HF patients and reduce adverse clinical outcomes by using plain language, focusing on key points, and asking the patient to verbally recall information just discussed, in an interactive manner. Research has shown Teach Back to be an effective strategy to improve patient comprehension in chronic conditions such as HF and diabetes.
The RNAO Best Practice Guidelines for Self-Management in Chronic Conditions (2010) recommends a nursing communication technique of "Closing the Loop" also known as "Teach Back" to assess patient understanding of information. The level of evidence for this technique is level III (from well designed, non-experimental descriptive studies, such as comparative studies, correlation studies, and case studies). This study will provide additional evidence in a randomized experimental design.
The objectives of this study are to evaluate the effectiveness of Teach Back on self-care (as measured by the European Heart Failure Self-Care Behaviour Scale) and determine if Teach Back affects the number of ER visits and re-admissions post discharge. A secondary objective is to assess if Teach Back technique is a feasible, accepted and sustainable method of discharge teaching for hospitalized HF patients at St. Michael's.
- Research Question: Does discharge teaching using the Teach Back method from trained nurses improve self-care behaviour in HF patients as measured by the EHFScBS scale as compared to standard care discharge teaching? Hypothesis: Patients who receive teach back discharge teaching will have improved self-care (achieve lower scores on EHFScBS).
- Research Question: Are there fewer ER visits and hospital admissions post discharge in patients who receive instruction with teach back method? Hypothesis: Patients who receive discharge teaching with Teach Back will have less ER visits and hospital admissions in the 3 months following hospital discharge.
- Research Question: What is the feasibility and acceptability of adapting Teach Back as standard practice of discharge teaching for heart failure patients in the in-patient cardiac care units at St. Michael's?
Hypothesis: Teach Back is an accepted and sustainable method of discharge teaching in HF patients in the in-patient cardiac care units at St. Michael's as evidenced by participants' feedback (patient questionnaires and nursing focus groups).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual care plus Teach Back intervention | Active comparator | Behavioral: Teach Back method of patient discharge teachingTrained nurses will provide Teach Back to the intervention group. The nurses' training will focus on the concepts of Teach Back, provide coaching and guidance on how to use it as well as review the principles of conducting research. Role play will be a feature in the education sessions to improve the nurses' comfort level |
| usual care | No intervention | –All participants will experience the current practice of discharge teaching: daily interaction with the interdisciplinary team members via rounds, counseling on diet and medications with a dietician and pharmacist when referred, view the Heart Failure Discharge Video, and receive a Congestive Heart Failure education package which includes the Heart and Stroke "Managing Congestive Heart Failure" booklet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted to the in-patient cardiology (7CCS) or Coronary Care Unit (CCU), with documentation of HF as the most responsible diagnosis
- Prescribed a diuretic such as Lasix plus or minus Metolazone
- New or established diagnosis of HF
Key exclusion criteria (6 listed)
- Cognitive impairment
- Suffer from a co-existing, severe, chronic debilitating disease
- Require hemo or peritoneal dialysis, have planned surgical intervention that will impact the etiology or manifestation of HF symptoms
- Life expectancy of less than three months
- Unable to receive discharge teaching, or are unable to communicate on the telephone
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 Back method of patient discharge teachingTrained nurses will provide Teach Back to the intervention group. Appendix D lists the four questions that will be used in this study to confirm the patient's understanding. The nurses' training will focus on the concepts of Teach Back, provide coaching and guidance on how to use it as well as review the principles of conducting research. Role play will be a feature in the education sessions to improve the nurses' comfort level | Behavioural | usual care plus Teach Back intervention |
Primary outcome
self-care behaviour score
Time frame: change from baseline in self-care behaviour score at one week.
mailed questionaire
self-care behaviour score
Time frame: change from baseline in self-care behaviour score at one month
mailed questionaire
self-care behaviour score
Time frame: change from baseline in self-care behaviour score at three months
mailed questionaire
6 secondary outcomes
patient visits to ER or admission to hospital
Time frame: one week since discharge
patient visits to ER or admission to hospital
Time frame: at one month since discharge
patient ER visits or admission to hospital
Time frame: three months since discharge
impact on nurses' workload
Time frame: up to 12 weeks from the last enrolled patient
satisfaction with the training for the nurses' to provide teach back
Time frame: up to 12 weeks from the last enrolled patient
nurses' conviction and confidence related to Teach Back
Time frame: up to 12 weeks from the last enrolled 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 8 Jan 2016.
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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.
Ada Andrade, MN principal investigator
St. Michael's
Vimy Barnard-Roberts, MN study chair
St. Michael's
Haytham Sharar, MN study chair
St. Michael's
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 method of patient discharge teaching in people with Heart Failure, run by Unity Health Toronto at 1 site in Canada.
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 3 inclusion and 6 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 8 Jan 2016. 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 Canada. 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?
self-care behaviour score (time frame: change from baseline in self-care behaviour score at one week.). The study lists 3 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 8 Jan 2016.