Evaluation of Home Telehealth Following Hospitalization for Heart Failure:  A Randomized Trial 

Funded by VA HSR&D NRI 99-345-1 & HSR&D Career Development Award 99-311-1 

Bonnie Wakefield, PhD, RN

Harry S Truman Memorial Veterans Hospital

Sinclair School of Nursing & School of Medicine, University of Missouri

Objectives
        - Provide an overview of telehealth care 
        - Compare two forms of telehealth vs. usual care for veterans with heart failure
        - Compare nurse-patient communication patterns in two modes of telehealth care

Telehealth Background
        - Care moving from hospital  clinic  home
        - Increasing rates of chronic illness
        - Unique challenges for rural health care 
        - Elderly
        - Remote from health care centers
        - Lack formal support services
        - Traditional home care limited by distance
        - Advances in computing and telecommunications technologies

Telemedicine
        - The use of audio, video, and other telecommunications and electronic information processing technologies to provide health services or assist health care personnel at distant sites (IOM, 1996)
        - Other terms: telehealth, remote monitoring, smart devices

Candidates for Telehealth Home Care
        - Non compliant with treatment plan, medications, diet, or self-monitoring of key indicators
        - High risk for frequent changes in condition
        - Newly diagnosed
        - Lack of caregiver support
        - Frequent use of health care services
        - Isolated or distant from provider (rural & urban, transportation issues)

VA Care Coordination Home Telehealth (CCHT) Program
        - VA 2nd largest provider of telehealth services (DoD first) 
        - physician visits, teleretinal imaging, store and forward radiology
        - VA Office of Care Coordination is implementing home telehealth & remote monitoring nation wide
        - 30,000+ veterans enrolled

Evidence Base for Telehealth

Review (Hersh et al. 2006)
        - 44 studies
        - Studies limited by small samples &/or lack of control group (what is usual care?)
        - Conclusions
        - may enhance communication with health providers & provide closer monitoring
        - required additional resources & dedicated staff, i.e., not integrated into routine care 
        - gaps in the evidence base in telehealth

Heart Failure Study Team

Investigators:
        - PI: Bonnie Wakefield, PhD, RN
        - Marcia Ward, PhD
        - Michael Kienzle, MD
        - Trudy Burns, PhD
        - Gary Rosenthal, MD

Study staff:
        - John Holman, MA, Project Director
        - Annette Ray, RN
        - Melody Sherubel, RN

Iowa City VA Medical Center

VA HSR&D Center for Implementation of Innovative Strategies in Practice (CRIISP)

University of Iowa College of Public Health & College of Medicine

PURPOSE
        - To compare the effectiveness of telehealth to usual care in recently discharged outpatients with heart failure (HF):
        - readmission rates
        - urgent care visits
        - mortality
        - Secondary outcomes
        - quality of life
        - self-efficacy
        - medication adherence

BACKGROUND
        - Heart failure is one of the most common reasons for hospitalization in older patients
        - Frequent admissions common
        - Telehealth technologies may facilitate detection of early signs of decompensation  prevent hospitalization
        - Few empirical studies have compared telehealth to traditional outpatient care
        - One previous study compared the effectiveness of alternative telehealth applications (Jerant et al. 2001)

DESIGN
        - Randomized controlled clinical trial
        - Compared usual care to a nurse managed intervention delivered by either telephone or videophone
        - Veterans following discharge from the hospital
        - Treatment group subjects (telephone or videophone) received the intervention for 90 days following discharge from the hospital
        - Subjects in the usual care group received traditional outpatient care 

Inclusion Criteria
        - Hospital admission with HF exacerbation
        - Telephone line in home
        - No hearing, visual, or communication impairments
        - Cognitively intact

INTERVENTION
        - Provided an electronic blood pressure monitor & scale instructed to measure daily vital signs and weights; tape measure for ankles
        - Mutually agreed upon scheduled “appointment” times 
        - Symptom Review Checklist to assist patients
        - Nurses reinforced positive behaviors, teaching, & recommendations as needed
        - If the patient reports deterioration or if the nurse notes problems over the phone, e.g., worsening shortness of breath, she provided guidance and/or consulted with the appropriate provider (e.g., physician, dietitian, pharmacist). 

Video Phone

Video Phone

SAMPLE
        - Enrolled n=148 over 3 years
        - 19 deaths (12.2% 6-month mortality)
        - 20 lost to follow up (13 drop-outs; 4 quit participating; 3 moved)
        - 109 with complete data
        - Three groups 
        - 33 (52) videophone (63% completed)
        - n=19 (9 died; 6 drop outs; 2 stopped participating; 2 relocated)
        - 34 (47) telephone (73% completed)
        - n=13 (5 died; 6 drop outs; 1 stopped participating; 1 relocated)
        - 42 (49) usual care (85% completed)
        - n=7 (5 died; 1 drop out; 1 stopped participating)

SAMPLE
        - 99% male 
        - 94% Caucasian
        - Average age at enrollment 69.3 years
        - 33% less than 12 years education
        - No significant differences across three groups at enrollment for severity of illness measures:
        - New York Heart Association (NYHA) classification
        - index admission length of stay
        - left ventricle ejection fraction (LVEF)*
        - prior revascularization
        - length of time with HF diagnosis*

Intervention Dose
| TelephoneAll subjects (N=47)    | Telephonecompleters (N=34) | VideophoneAll subjects(N=52) | Videophone completers(N=33) |
|---------------------------------|----------------------------|------------------------------|-----------------------------|
| Mean # intervention visits      | 11.4 (3.9)                 | 13.2 (1.4)                   | 10.5 (5.4)                  | 13.4 (0.9) |
| Mean length of visits (minutes) | 33.5 (11.7)                | 36.5 (12.4)                  |

Intervention

Usual Care

SAS Proc Lifetest

Log-Rank p=.02

Survival Analysis: Time to First Readmission (365 days)

Cox Proportional Hazards Models: Intervention vs Control Time to First Readmission and Death
| First AdmissionModel Fit p=0.14 | DeathModel Fit p=0.08 |
|---------------------------------|-----------------------|
| Covariate                       | Hazard Ratio(95% CI)  | p= | Hazard Ratio(95% CI) | p= |
| Intervention                    | 0.54 (0.33-0.90)      | 0.02 | 1.04 (0.49-2.24) | 0.91 |
| LVEF                            | 1.01 (0.99-1.02)      | 0.37 | 0.98 (0.96-0.99) | 0.04 |
| NYHA Classification             | 1.38 (0.85-2.24)      | 0.19 | 1.15 (0.61-2.17) | 0.67 |
| Age at Admission                | 0.99 (0.97-1.03)      | 0.81 | 1.00 (0.97-1.04) | 0.77 |
| MLHF*                           | 1.00 (0.99-1.01)      | 0.77 | 1.02 (0.99-1.03) | 0.07 |

Secondary Outcomes
        - Medication changes at 90 days (p=0.04)
        - 29% control
        - 48% telephone
        - 59% videophone
        - Medication adherence – no difference 

Secondary Outcomes
        - Quality of life – improved for all groups; no significant differences
        - Self-efficacy – no differences
        - Satisfaction – no differences

SUMMARY
        - Intervention was effective in reducing time to first readmission during the active intervention period
        - Effect was not sustained at 6 months
        - No differences in Urgent Care visits or mortality
        - Usual care group had access to Primary Care nurse case manager & Cardiology nurse case managers

Summary
        - Telehealth-facilitated care has the potential to enable earlier detection of key clinical symptoms, triggering early intervention and thus reducing the need for hospitalization
        - The VA Office of Care Coordination is implementing home telehealth nation wide
        - Currently published studies are mixed re: efficacy of care management in HF
        - Further work is needed to determine which technologies work for specific patient populations, and to determine the effective intervention dose

INTERVENTION ANALYSIS
        - Qualitative analyses
        - Roter Interaction Analysis System
        - Instrumental/task oriented
        - gathering data, information giving
        - Affective/socioemotional
        - building a relationship, activating and partnership building
        - 36 sub-categories

INTERVENTION ANALYSIS
        - Compared 14 video sessions and 14 telephone sessions over 90 day intervention period
        - Nurses were more likely to use open-ended questions, back-channel responses, friendly jokes, and checks for understanding on the telephone compared to videophone 
        - Patients were more likely to give lifestyle information and approval comments on the telephone, and used more closed-ended questions on the videophone 

FUTURE RESEARCH

Targeting - matching appropriate technology to the patient (disease severity, literacy, age)
        - Intervention dose and timing (frequency, duration, post-discharge transitions)
        - Comparison of low-cost low-tech & higher cost more complex telehealth interventions (telephone vs web based interventions)
        - Caregivers