Telehealth Self Management for CHF

NCT01812512 | Withdrawn Phase 1

• 1 other identifier: RRP 12-230
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Heart Failure

Keywords

Heart Failure; Communication; Telemedicine; Veterans; Nurse-patient relations

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Minnesota Living with Heart Failure Questionnaire

  pre and post (1 - 3 months)

Study Arms (2)

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.

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.

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

Interventions

Teaching for Interactive Patient Self-Management (TIPS) for Heart Failure (HF BEHAVIORAL

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.

TIPS for HF Intervention HT Training-Charleston-Pre/Post; TIPS for HF Intervention HT Training-Columbia-Pre/Post

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• William Jennings Bryan Dorn VA Medical Center: collaborator

Study Sites (2)

Ralph H Johnson VA Medical Center

Charleston, South Carolina, 29401-5799, United States

Location

Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

Columbia, South Carolina, 29209, United States

Location

MeSH Terms

Conditions

Heart Failure; Communication

Interventions

Educational Status; Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Study Officials

• Charlene A Pope, PhD MPH BSN

  Ralph H. Johnson VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: March 18, 2013
• Study Start: November 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

US (2)