- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01311583
Evaluating Teach Back as a Method for Improving Self-Care Behaviours in Heart Failure Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5B 1W8
- St. Michael's
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: usual care plus Teach Back intervention
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
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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
|
|
No Intervention: usual care
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
self-care behaviour score
Time Frame: change from baseline in self-care behaviour score at one week.
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mailed questionaire
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change from baseline in self-care behaviour score at one week.
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self-care behaviour score
Time Frame: change from baseline in self-care behaviour score at one month
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mailed questionaire
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change from baseline in self-care behaviour score at one month
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self-care behaviour score
Time Frame: change from baseline in self-care behaviour score at three months
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mailed questionaire
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change from baseline in self-care behaviour score at three months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
patient visits to ER or admission to hospital
Time Frame: one week since discharge
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mailed questionaire
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one week since discharge
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patient visits to ER or admission to hospital
Time Frame: at one month since discharge
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questionaire
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at one month since discharge
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patient ER visits or admission to hospital
Time Frame: three months since discharge
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questionaire
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three months since discharge
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impact on nurses' workload
Time Frame: up to 12 weeks from the last enrolled patient
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focus group
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up to 12 weeks from the last enrolled patient
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satisfaction with the training for the nurses' to provide teach back
Time Frame: up to 12 weeks from the last enrolled patient
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focus group
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up to 12 weeks from the last enrolled patient
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nurses' conviction and confidence related to Teach Back
Time Frame: up to 12 weeks from the last enrolled patient
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focus group
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up to 12 weeks from the last enrolled patient
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ada Andrade, MN, St. Michael's
- Study Chair: Vimy Barnard-Roberts, MN, St. Michael's
- Study Chair: Haytham Sharar, MN, St. Michael's
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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