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Telehealth Self Management for CHF (TSM-CHF)

Primary Purpose

Heart Failure

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Teaching for Interactive Patient Self-Management (TIPS) for Heart Failure (HF
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring Heart Failure, Communication, Telemedicine, Veterans, Nurse-patient relations

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ralph H Johnson VA Medical Center
  • Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

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

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2012
Last Updated
November 25, 2014
Sponsor
US Department of Veterans Affairs
Collaborators
William Jennings Bryan Dorn VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01812512
Brief Title
Telehealth Self Management for CHF
Acronym
TSM-CHF
Official Title
Communication Skills Training for Heart Failure Self-Management in Telehealth
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Never funded.
Study Start Date
November 2014 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
William Jennings Bryan Dorn VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Communication, Telemedicine, Veterans, Nurse-patient relations

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TIPS for HF Intervention HT Training-Charleston-Pre/Post
Arm Type
Other
Arm Description
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.
Arm Title
TIPS for HF Intervention HT Training-Columbia-Pre/Post
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Teaching for Interactive Patient Self-Management (TIPS) for Heart Failure (HF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rochester Participatory Decision Making (RPAD)
Description
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
Time Frame
pre and post (1 - 3 months)
Secondary Outcome Measure Information:
Title
Minnesota Living with Heart Failure Questionnaire
Description
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
Time Frame
pre and post (1 - 3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlene A Pope, PhD MPH BSN
Organizational Affiliation
Ralph H. Johnson VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ralph H Johnson VA Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5799
Country
United States
Facility Name
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29209
Country
United States

12. IPD Sharing Statement

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Telehealth Self Management for CHF

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