Telehealth Self Management for CHF

Heart Failure Clinical Trial

— TSM-CHF  

Official title:

Communication Skills Training for Heart Failure Self-Management in Telehealth

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01812512
• Other study ID #: RRP 12-230
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: September 12, 2012
• Last updated: November 25, 2014
• Start date: November 2014
• Est. completion date: October 2015

Study information

• Verified date: November 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Teaching for Interactive Patient Self-Management (TIPS) for Heart Failure (HF
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.

Locations

Country	Name	City	State
United States	Ralph H Johnson VA Medical Center	Charleston	South Carolina
United States	Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	William Jennings Bryan Dorn VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	pre and post (1 - 3 months)	No
Secondary	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	pre and post (1 - 3 months)	No

External Links

•   The VA Office of Home Telehealth Services provides a comprehensive description of the health service being studied.