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An Italian Model of Home-Based Care of Elderly with Acute Decompensated CHF Was Feasible And Efficacious Compared To Traditional Inpatient Hospital Care.

An Italian Model of Home-Based Care of Elderly with Acute Decompensated CHF Was Feasible And Efficacious Compared To Traditional Inpatient Hospital Care.

Critique date: Tue, 12/01/2009 - 3:47pm
Institution: 
Mount Sinai School of Medicine
   
Article Citation
Citation: 
Tibaldi V, et al. Hospital at home for elderly patients with acute decompensation of chronic heart failure: a prospective randomized controlled trial. Arch Intern Med. 2009 Sep 28;169(17):1569-75.
   
Clinical Bottom Lines
  1. Patients in the home-based group had 6-month mortality rate similar to the inpatient group (15%)
  2. Patients in the home-based group had 6 month re-admission rate similar to the inpatient group,
    but the home-based group had a longer mean time to the next admission compared to the inpatient group (84 days vs. 69 days) .
   
Methods
Study Design: 
Randomized, controlled clinical trial
Follow-up Period: 
6 months
Setting: 
ER
Patient Population: 

101 patients with mean age 81 that presented to the ER of a large, urban university teaching and tertiary care hospital in Torino, Italy.

  • ≥75yo
  • Prior Dx CHF with marked functional impairment (NYHA class III or IV)
    • At least 1 previous admission for acute CHF
  • Current ER Dx acute decompensation of CHF (i.e. rapid & significant worsening of CHF signs & symptoms caused by abnormal cardiac function and supported by tests)
    • Need for IV drug infusion
  • Lives in the hospital-at-home catchment area
  • Has care supervision at home
  • Has telephone
  • Informed consent
Significant Exclusions: 
  • Lacks family/social support
  • New-onset heart failure
  • Needs vent, dialysis, or intensive monitoring
  • Severe dementia (MMSE<14), terminal cancer, GFR <20, hepatic failure, Hb <9
  • Planned cardiac surgery
Intervention/Exposure: 

ED patients with acute decompensation of CHF underwent a clinical evaluation, and those sick enough to be admitted were randomized to either the home-based intervention group or the inpatient usual care group.   Patients in the intervention group were transferred from the ER to their home via ambulance for further care by a multidisciplinary team that consisted of 4 geriatricians, 13 nurses, 3 physical therapists, 1 social worker, 1 counselor and 7 cars.  In the first days after admission to home-based care, each patient was visited at home on a daily basis by physicians and nurses. In the following days the patients were seen every 2-3 days or less;  physicians and nurses of the home-based program were available at all times for urgent home visits.  Consultation with cardiologists or other hospital specialists was possible at the home if needed. Treatments available at home included blood tests, pulse oximetry, spirometry, electrocardiography, echocardiography, oral and IV medication administration, oxygen, tranfusion, central venous access, surgical treatment of pressure sores, PT, OT & counseling.  The home-based patients and families received health education about monitoring weight, smoking cessation, physical activity, diet, med compliance, and early recognition of symptoms indicative of worsening heart failure.

The patients were re-evaluated 6-months after discharge.

Correspondence with the authors Vittoria Tibaldi and Nicoletta Aimonino  <tibaldi.vittoria@libero.it> :

Q:  Were the criteria for discharge the same in both groups?

A:  “Both groups of patients were discharge by GHW and GHHS respectively following the hospital guidelines for acute heart failure patients: after at least 48 hours of infusion therapy dismission and when their vital parameters were stable with oral therapy. Moreover, patients were discharged when they were able to walk without dyspnea or vertigo. This clinical evaluation was the same for both groups of patients and we can assume that all patients involved in the study were discharged as soon as their clinical conditions were stable, without difference between two groups.”

Outcome Measures: 

Primary Outcome:  mortality at 6 months

Secondary Outcomes:  morbidity during hospitalization (infection, delirium, bed sores, DVT, falls), admission to nursing home, subsequent hospital admissions for any cause

Other Outcomes:  ADL, IADL, depression, cognition, nutrition, quality of life, caregiver stress

Participant Follow-up: 
97 of 101 patients
   
Conclusion
Results: 

Data was analyzed on an intent-to-treat basis. (4 home-based patients were transferred to the inpatient hospital, and 2 hospitalized patients were transferred from the general medical ward to the ICU.)

Per article’s authors:

  • 8 (16%) from the inpatient group were transferred to LTC facilities after discharge, whereas all the home-based patients remained at home. 
  • Results of treatment morbidity are not mentioned in detail.

From Table 4. Mortality and Subsequent Hospital Admissions at 6-Month Follow-up

 

Home-based
(n = 48)

Inpatient
(n = 53)

 P value
Mortality, No. (%) 7 (15) 8 (15) .83
Subsequent admission to hospital, No. (%) 8 (17) 18 (34) .19
No. of days between discharge and first additional hospital admission 84.3 69.8 .02

 

Correspondence with the authors Vittoria Tibaldi and Nicoletta Aimonino  <tibaldi.vittoria@libero.it> :

Q:  Does the number of readmissions include re-admissions to the home-based program, or does that figure only include re-admissions to traditional inpatient hospital ward?
A:  The number of readmissions includes readmission to both hospital at home and traditional wards.

From Table 3: Change in Clinical Outcome Scores at 6-Month Follow-up
(Plus and minus signs refer to changes in scores)

 

Home-based
(n = 48)

 Inpatient
(n = 53)		  P value
 Geriatric Depression Scale
(0-30, higher score is worse)		  +1.48  +0.12  .02
 Mini Nutritional Assessment
(0-30, lower score is worse)		  -0.86  -0.27  .05
 Nottingham Health Profile
(0-38, lower score is better QOL)		  +1.09  +0.18  .046

 

Correspondence with the authors Vittoria Tibaldi and Nicoletta Aimonino  <tibaldi.vittoria@libero.it>: 

Q:  The article described the GHHS patients experienced improvements in depression and quality-of-life scores.  However, the numbers in Table 3 suggests that the GHHS group's were worse/increased after 6 months?
A:  “the numbers + 1.48 and + 1.09 have to be considered as difference between baseline and follow-up results. The higher (worse) baseline GDS result minus the lower (better) follow-up GDS result gives a positive difference (+1.48). The same is for the NHP results.  Numbers precede by "+" have not to be intended as an increase of the scale results, but as a positive difference between the two evaluations performed.”

Concerns Regarding Methodology, Applicability to Older Adults, etc.: 

Factors that may weaken their conclusions:

  • This pilot study with a small sample size showed many interesting trends that lacked statistical significance.  For example, Table 4 shows the home-based care group tended to have less re-admissions, but the finding was not statistically significant.
  • Table 2 suggests that at baseline the home-based care group was less sick than the inpatient group (e.g. less dyspnea, less exam findings, lower APACHE II score)
  • The home-based care group may also have been less sick because none required transfer to ICU (in the control group 2 inpatients in the general ward were transferred to the ICU).
  • The data was analyzed by intention-to-treat, however 4 (of 48) patients in the home-based program required transfer to the inpatient hospital, so those patient’s outcomes may actually reflect the care they received in the hospital and not the care they received at home (crossover contamination).

Correspondence with the authors Vittoria Tibaldi and Nicoletta Aimonino  <tibaldi.vittoria@libero.it> :

A: We did not perform the sensitivity analysis excluding the 4 patients transferred to hospital.

  • The extensive health education that the home-based patients and families received may be a confounding factor, i.e. the good outcome could be a result of education and not the care at home per se.

Barriers to generalizability:

  • The study was conducted in the context of a well-established multidisciplinary care team that has been in operation for more than 20 years.  It may be difficult for a newer or smaller home-care group to achieve the same results (start up costs, establishing work-flow protocols,  gaining experience, etc.)
  • Italy’s length of stay was 11 days (inpatient) and 20 days (home-based), which is very different from the approximately 5-day length of stay in the U.S.
  • Inclusion criteria for the study only included patients who have adequate support at home.

Promising future:

  • This study is one of many that demonstrate that home-based multidisciplinary teams can provide efficacious medical care to acutely ill frail elderly and is an example of how such a program is structured.
  • Future larger studies are needed to confirm trends seen in this pilot study and to allow sub-group analysis.
Funding Source and Role: 
None
Created By: 
Wen Dombrowski MD
This is a review of the validity of a single study; the ‘bottom lines’ do not reflect comparison with the rest of the literature on this subject.