Heart FailurePhase 1/2TSM-CHFNCT01812512
Telehealth Self Management for CHF
A Phase 1/2 study testing Teaching for Interactive Patient Self-Management (TIPS) for Heart Failure (HF in people with Heart Failure, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
People with heart failure (HF) are hospitalized over a million times a year in the US at a cost over $39 billion dollars. About half of the patients are readmitted within 30 days. Despite a number of institutional reforms, cost and readmissions remain high in the VA. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Teaching for Interactive Patient Self-Management (TIPS) for Heart Failure (HF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2014to Oct 2015
- Phase
- Phase 1/2
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of chronic heart failure (CHF)
- enrollment in VA Home Telehealth (HT) program for at least 6 months
- Veteran who did not participate in the previous HT study
Who cannot join
- Veteran who is unable to communicate by telephone
- Veteran who does not pass the Clock Drawing Test for screening neurological problems at the initial visit
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ralph H Johnson VA Medical Center
Charleston, South Carolina, 29401-5799
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
Columbia, South Carolina, 29209
About this study
Official title: Communication Skills Training for Heart Failure Self-Management in Telehealth
People with heart failure (HF) are hospitalized over a million times a year in the US at a cost over $39 billion dollars. About half of the patients are readmitted within 30 days. Despite a number of institutional reforms, cost and readmissions remain high in the VA. The VA Home Telehealth (HT) monitoring program decreases preventable readmissions, but HF readmissions remain increased in the VA. Despite an active and effective HT program, the Charleston VAMC has the highest HF readmission rate in VISN 7. Though the HT program introduces communication, self-management, and shared decision-making in initial training, previous QUERI RRP evaluation identified lower than expected levels of specific communication practices associated with the promotion of HF self-management and shared decision-making, mediated by the requirements of the technology.
Read the detailed description
Clinical goals of the VA CHF QUERI identify best practices to empower Veterans and their caregivers for HF self-management. Recommendations of the American College of Cardiology/American Heart Association emphasize shared decision-making. In the previous preliminary study, coding of actual recordings of Veterans speaking with HT nurse care coordinators provided evidence of best practices and areas for improvement for intervention development. The effect of the HT technology as a mediator of Veteran-nurse communication requires particular re-framing in communication skills training to promote shared decision-making and self-management as recommended. This quasi-experimental study proposes the development of an evidence-based intervention to enhance HT training tailored for more effective communication for HF self-management and related outcomes.
Goals:
Phase 1 To conduct a pilot study as a quasi-experimental trial at two VAMC HT sites to determine acceptability, actual use, implementation, practicality, integration, potential for expansion, effect sizes and limited efficacy for an HT-specific communication skills intervention for HF Specific Aim 1.1a Development: Adapt components from the Rochester Participatory Decision-Making Scale (RPAD) and recent advances in communication skills training for chronic disease to develop a valid and reliable intervention specific to HT shared decision-making and telehealth communication using established best-practices and Veteran input; Specific Aim 1.1b Training/Implementation: Implement the developed intervention at two VAMCs; Specific Aim 1.2Booster: Introduce an audit and feedback loop of HF self-management outcomes for telehealth nurse practice as a booster to reinforce communication skills training.
Phase 2 To compare changes in Veteran outcomes after a telehealth communication skills intervention with documented previous practice for differences in: a) shared decision-making; b) Veteran perception of communication, education and self-management for HF, c) quality of life, and d) health service utilization and related costs before and after intervention Specific Aim 2.1: Formative Evaluation: Nurses: Conduct anonymous surveys of knowledge of HF and self-management strategies before and after training, qualitative interviews of reactions to the training course, and nurse care coordinator focus groups about the value of audit and feedback sessions after training.
Specific Aim 2.2: Formative Evaluation: Veterans - Phone record 25 Veterans with HF at two HT sites, for a total of 50 Veterans, speaking with nurse care coordinators before and after communication skills training followed by communication coding and discourse analysis.
Specific Aim 2.3: Summative Evaluation: Compare shared decision-making scores (SDM) measured by the RPAD, communication scores measured by the Four Habits Coding Scheme (FHCS), quality of life (Minnesota Living with Heart Failure Questionnaire), communication, education and self-management in HF as measured by the Improving Chronic Illness Care Evaluation (ICICE) scale, and patient HF hospitalization use (admissions and emergency) and with pre-training averages and with the post training averages at 1 and 3 months Rationale The technology of HT monitoring of Veterans with HF can inadvertently decrease participative communication consistent with shared decision-making and HF self-management. Application of communication skills training using evidence-based coach role competencies promises to improve Veteran engagement and participation in the VA Home Telehealth service with increased self-management and potential improvement in HF health service utilization. Improving engagement and participation in self-management should result in a quantifiably better Veteran quality of life, a reduction in hospital and ED admissions, and thus, a decrease in health care utilization costs for the VA.
- Conditions
- Heart Failure
- Being tested
- Teaching for Interactive Patient Self-Management (TIPS) for Heart Failure (HF
- Keywords
- Heart Failure, Communication, Telemedicine, Veterans, Nurse-patient relations
- Medical subject headings
- Heart Failure, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teaching for Interactive Patient Self-Management (TIPS) for Heart Failure (HFBehavioural
The curriculum plan adapts components from the Rochester Participatory Decision-Making Scale (RPAD) and recent advances in communication skills training for chronic disease to develop a valid and reliable intervention specific to Home Telehealth (HT) shared decision making, effective telehealth communication, and patient self-management for heart failure (HF), using established best-practices and Veteran input. Veteran volunteers will participate in video recorded simulations to promote nurse care coordinator (NCC) active participation and problem-solving during the course. Scenarios are taken from transcribed actual HT interactions from the first exploratory RRP study of HT. The course is set up as one live session, one online module, and a final live session for more difficult conversations.
| Study group | Role | What they receive |
|---|---|---|
| TIPS for HF Intervention HT Training-Charleston-Pre/Post | Other | Group 1 (Charleston): In the proposed intervention, called Teaching for Interactive Patient Self-Management (TIPS) for Heart Failure (HF) , the observations from the previous RRP are used along with best practices from other studies of patient-centered communication in the VA , telephone coaching for chronic disease , problem-solving and counseling skills for telehealth nurse care managers , difficulties identified by patients working with the Health Buddy for telemonitoring , participation in provider-patient communication , essentials of patient education in heart failure process and content, and teach to goal theory to improve HF self-management for patients with low health literacy . Rather than an experimental trial, this implementation quasi-experimental pilot study examines pre- and post-training nurse practices and Veteran outcomes before and after communication skills training. The same intervention will then be delivered to Group 2 HT nurse care coordinators. Receives: Behavioral: Teaching for Interactive Patient Self-Management (TIPS) for Heart Failure (HF |
| TIPS for HF Intervention HT Training-Columbia-Pre/Post | Other | Group 2 (Columbia VAMC): To test the TIPS for HF educational intervention sufficiently in a sample not previously exposed to the information, the HT program at Dorn VA Medical Center in Columbia, South Carolina has volunteered to participate as a second study site. There are six nurse care coordinators who will be recruited; the larger number supports recruitment of a comparable number with 25 Veterans with HF to be recruited in the second site for a total of 50 Veterans. Both groups will use a purposeful sampling plan, beginning with an IRB-approved flyer for recruitment. The demographic make-up of the Charleston VAMC group is comparable Columbia HT group in age, race, and NYHA HF class. Also, consistent with an implementation quasi-experimental pilot study, the second site will examine pre-training and post-training nurse care coordinator communication practices and Veteran outcomes before and after communication skills training. Receives: Behavioral: Teaching for Interactive Patient Self-Management (TIPS) for Heart Failure (HF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rochester Participatory Decision Making (RPAD)
9 item scale that assess how the clinical issue was explained, discussion of uncertainties, clarification of agreement, identification of barriers, patients asked questions, medical language, physician validates open ended questions, checks for understanding
Measured: pre and post (1 - 3 months)
Secondary outcomes (1)
Minnesota Living with Heart Failure Questionnaire
To measure the effects of symptoms, functional limitations, psychological distress on an individual's quality of life, the MLHF questionnaire asks each person to indicate using a 6-point, zero to five, Likert scale how much each of 21 facets prevented them from living as they desired
Measured: pre and post (1 - 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startNov 2014
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Why it stopped: Never funded.
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.
- 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 1/2
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- William Jennings Bryan Dorn VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Charlene A Pope, PhD MPH BSN, Principal investigator, Ralph H. Johnson VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812512
- Sponsor's protocol ID
- RRP 12-230
- Acronym
- TSM-CHF
- Status last verified
- Nov 2014
- First submitted
- 12 Sep 2012
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication Skills Training for Heart Failure Self-Management in Telehealth
- ClinicalTrials.gov ID
- NCT01812512
- Acronym / sponsor ID
- TSM-CHF / RRP 12-230
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Communication, Telemedicine, Veterans, Nurse-patient relations
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- William Jennings Bryan Dorn VA Medical Center
- Study start
- Nov 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 18 Mar 2013 (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.
People with heart failure (HF) are hospitalized over a million times a year in the US at a cost over $39 billion dollars. About half of the patients are readmitted within 30 days. Despite a number of institutional reforms, cost and readmissions remain high in the VA. The VA Home Telehealth (HT) monitoring program decreases preventable readmissions, but HF readmissions remain increased in the VA. Despite an active and effective HT program, the Charleston VAMC has the highest HF readmission rate in VISN 7. Though the HT program introduces communication, self-management, and shared decision-making in initial training, previous QUERI RRP evaluation identified lower than expected levels of specific communication practices associated with the promotion of HF self-management and shared decision-making, mediated by the requirements of the technology.
Detailed description
Clinical goals of the VA CHF QUERI identify best practices to empower Veterans and their caregivers for HF self-management. Recommendations of the American College of Cardiology/American Heart Association emphasize shared decision-making. In the previous preliminary study, coding of actual recordings of Veterans speaking with HT nurse care coordinators provided evidence of best practices and areas for improvement for intervention development. The effect of the HT technology as a mediator of Veteran-nurse communication requires particular re-framing in communication skills training to promote shared decision-making and self-management as recommended. This quasi-experimental study proposes the development of an evidence-based intervention to enhance HT training tailored for more effective communication for HF self-management and related outcomes.
Goals:
Phase 1 To conduct a pilot study as a quasi-experimental trial at two VAMC HT sites to determine acceptability, actual use, implementation, practicality, integration, potential for expansion, effect sizes and limited efficacy for an HT-specific communication skills intervention for HF Specific Aim 1.1a Development: Adapt components from the Rochester Participatory Decision-Making Scale (RPAD) and recent advances in communication skills training for chronic disease to develop a valid and reliable intervention specific to HT shared decision-making and telehealth communication using established best-practices and Veteran input; Specific Aim 1.1b Training/Implementation: Implement the developed intervention at two VAMCs; Specific Aim 1.2Booster: Introduce an audit and feedback loop of HF self-management outcomes for telehealth nurse practice as a booster to reinforce communication skills training.
Phase 2 To compare changes in Veteran outcomes after a telehealth communication skills intervention with documented previous practice for differences in: a) shared decision-making; b) Veteran perception of communication, education and self-management for HF, c) quality of life, and d) health service utilization and related costs before and after intervention Specific Aim 2.1: Formative Evaluation: Nurses: Conduct anonymous surveys of knowledge of HF and self-management strategies before and after training, qualitative interviews of reactions to the training course, and nurse care coordinator focus groups about the value of audit and feedback sessions after training.
Specific Aim 2.2: Formative Evaluation: Veterans - Phone record 25 Veterans with HF at two HT sites, for a total of 50 Veterans, speaking with nurse care coordinators before and after communication skills training followed by communication coding and discourse analysis.
Specific Aim 2.3: Summative Evaluation: Compare shared decision-making scores (SDM) measured by the RPAD, communication scores measured by the Four Habits Coding Scheme (FHCS), quality of life (Minnesota Living with Heart Failure Questionnaire), communication, education and self-management in HF as measured by the Improving Chronic Illness Care Evaluation (ICICE) scale, and patient HF hospitalization use (admissions and emergency) and with pre-training averages and with the post training averages at 1 and 3 months Rationale The technology of HT monitoring of Veterans with HF can inadvertently decrease participative communication consistent with shared decision-making and HF self-management. Application of communication skills training using evidence-based coach role competencies promises to improve Veteran engagement and participation in the VA Home Telehealth service with increased self-management and potential improvement in HF health service utilization. Improving engagement and participation in self-management should result in a quantifiably better Veteran quality of life, a reduction in hospital and ED admissions, and thus, a decrease in health care utilization costs for the VA.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIPS for HF Intervention HT Training-Charleston-Pre/Post | Other | Behavioral: Teaching for Interactive Patient Self-Management (TIPS) for Heart Failure (HFGroup 1 (Charleston): In the proposed intervention, called Teaching for Interactive Patient Self-Management (TIPS) for Heart Failure (HF) , the observations from the previous RRP are used along with best practices from other studies of patient-centered communication in the VA , telephone coaching for chronic disease , problem-solving and counseling skills for telehealth nurse care managers , difficulties identified by patients working with the Health Buddy for telemonitoring , participation in provider-patient communication , essentials of patient education in heart failure process and content, and teach to goal theory to improve HF self-management for patients with low health literacy . Rather than an experimental trial, this implementation quasi-experimental pilot study examines pre- and post-training nurse practices and Veteran outcomes before and after communication skills training. The same intervention will then be delivered to Group 2 HT nurse care coordinators. |
| TIPS for HF Intervention HT Training-Columbia-Pre/Post | Other | Behavioral: Teaching for Interactive Patient Self-Management (TIPS) for Heart Failure (HFGroup 2 (Columbia VAMC): To test the TIPS for HF educational intervention sufficiently in a sample not previously exposed to the information, the HT program at Dorn VA Medical Center in Columbia, South Carolina has volunteered to participate as a second study site. There are six nurse care coordinators who will be recruited; the larger number supports recruitment of a comparable number with 25 Veterans with HF to be recruited in the second site for a total of 50 Veterans. Both groups will use a purposeful sampling plan, beginning with an IRB-approved flyer for recruitment. The demographic make-up of the Charleston VAMC group is comparable Columbia HT group in age, race, and NYHA HF class. Also, consistent with an implementation quasi-experimental pilot study, the second site will examine pre-training and post-training nurse care coordinator communication practices and Veteran outcomes before and after communication skills training. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of chronic heart failure (CHF)
- enrollment in VA Home Telehealth (HT) program for at least 6 months
- Veteran who did not participate in the previous HT study
Key exclusion criteria (2 listed)
- Veteran who is unable to communicate by telephone
- Veteran who does not pass the Clock Drawing Test for screening neurological problems at the initial visit
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 |
|---|---|---|
| Teaching for Interactive Patient Self-Management (TIPS) for Heart Failure (HFThe curriculum plan adapts components from the Rochester Participatory Decision-Making Scale (RPAD) and recent advances in communication skills training for chronic disease to develop a valid and reliable intervention specific to Home Telehealth (HT) shared decision making, effective telehealth communication, and patient self-management for heart failure (HF), using established best-practices and Veteran input. Veteran volunteers will participate in video recorded simulations to promote nurse care coordinator (NCC) active participation and problem-solving during the course. Scenarios are taken from transcribed actual HT interactions from the first exploratory RRP study of HT. The course is set up as one live session, one online module, and a final live session for more difficult conversations. | Behavioural | TIPS for HF Intervention HT Training-Charleston-Pre/Post, TIPS for HF Intervention HT Training-Columbia-Pre/Post |
Primary outcome
Rochester Participatory Decision Making (RPAD)
Time frame: pre and post (1 - 3 months)
9 item scale that assess how the clinical issue was explained, discussion of uncertainties, clarification of agreement, identification of barriers, patients asked questions, medical language, physician validates open ended questions, checks for understanding
1 secondary outcome
Minnesota Living with Heart Failure Questionnaire
Time frame: pre and post (1 - 3 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
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Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
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Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
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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.
Charlene A Pope, PhD MPH BSN principal investigator
Ralph H. Johnson VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Teaching for Interactive Patient Self-Management (TIPS) for Heart Failure (HF in people with Heart Failure, run by US Department of Veterans Affairs at 2 sites in United States.
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 2 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: withdrawn, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rochester Participatory Decision Making (RPAD) (time frame: pre and post (1 - 3 months)). 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 2 Dec 2014.