Nucifora 2006 (Continued)
However, QoL data at 6 months only avail- able from 74/98 in intervention group and 75/98 in control group
Selective reporting (reporting bias) Low risk All stated outcomes reported
Other bias Unclear risk More participants in the intervention
group were in sinus rhythm compared to control group (73% vs 52%, P = 0.06) . More participants in control group had previous CABG compared to intervention group (13% vs 5%, P = 0.059)
Ong 2016
Methods Multicentre RCT (6 centres)
Recruiting: October 2011-September 2013 Duration of follow-up: 6 months
Intervention category: case management Person delivering intervention: nurse
Participants Country: USA
Participants: randomised N = 1437 (intervention N = 715; control N = 722) Median (IQR) age: intervention 73 (62-84); control 74 (63-82)
Male sex: intervention 53.4%; control 52.9% Ethnicity:
• intervention: African American 21.5 (18.5-24.5); Hispanic/Latino 12.0; white 54.7; Asian/Pacific Islander or other 11.8
• control: African American 22.7; Hispanic/Latino 10.9; white 54.3; Asian/Pacific Islander or other 12.1
Actual severity of HF in study participants at recruitment: LVEF (%) intervention 42.7; control 43
NYHA class (mean (95% CI) %):
• intervention: class I, 0.2 (0.0-0.5); class II, 23.4 (20.0-26.9); class III, 65.6 (61.8- 69.4); class IV, 10.8 (8.3-13.3);
• control: class I, 0.7 (0.0-1.4); class II, 25.8 (22.2-29.4); class III, 63.9 (59.9-67. 8); class IV, 9.6 (7.2-12.0)
diabetes: intervention 44.8%; control 47.6% Inclusion criteria:
• Individuals admitted as hospital inpatients or on observation status; • ≥50 years
• receiving active treatment for decompensated HF • expected to be discharged to their home
• capable of providing written informed consent in English, Spanish, Farsi, or Russian
”Enrollment criteria were expanded in January 2012 to include all patients being actively treated for HF instead of just those having a principal diagnosis of HF. This change was made because patients deemed prospectively as not having a principal diagnosis of 143 Disease management interventions for heart failure (Review)
Ong 2016 (Continued)
HF were being coded as patients with HF after their discharge because of patients with multiple active problems.“
Exclusion criteria:
• transplant recipient/being evaluated/on a waiting list for a transplant • enrolled or enrolling in hospice
• expected to expire shortly after discharge • dementia
• being admitted from or expected to be discharged to a skilled nursing facility (SNF)
• lack of phone line/reliable cell service • chronic dialysis
• inability to identify a usual source of care (free clinic acceptable) and who will not be assigned a provider upon discharge.
• Also ”patients with the following cardiovascular conditions: patients with valvular disorders requiring surgical intervention (except for those with incidental valvular disease, who will be included), acute myocardial infarction (except for those with demand ischemia, who will be included); patients who are unable to use the intervention equipment (e.g., unable to stand on the weight scale), or who are otherwise unable to comply with the intervention
Interventions intervention: 3 components conducted by registered nurses:
• predischarge HF education by a study nurse, not part of usual care team. Used a booklet and the ‘teach-back’ method to ensure understanding. Also included demonstration of telemonitoring equipment and the important of monitoring physiological variables
• regularly scheduled telephone coaching - 9 calls scheduled over 6 months, usually the same call centre nurse. 1st contact within 2-3 days of discharge to reinforce pre- discharge education, then weekly for the first month. After first month, calls were made monthly until the end of the 6-month study period. Calls were designed to reinforce predischarge education materials
• home telemonitoring of weight, blood pressure, heart rate, and symptoms. Results monitored by call centre nurses.
Comparator: usual care
• “Usual care at the sites included robust pre-discharge education and often a post- discharge follow-up telephone call. No additional surveillance was provided to control patients beyond whatever may have been requested as part of routine clinical practice, and the intervention did not substitute for usual care surveillance. Patients were not precluded from exposure to other readmission reduction or chronic NRs implemented by hospitals, physician groups, or health plans, such as education about HF, pharmacist consultation, and post discharge telephone calls.”
Outcomes • All-cause mortality
• All-cause readmissions • HRQoL (MLHFQ)
Notes Funding: “This study was supported by the Agency for Healthcare Research and Quality; the National Heart, Lung, and Blood Institute (NHLBI); the National Center for Ad- vancing Translational Science, Clinical and Translational Science Institute; the Robert 144 Disease management interventions for heart failure (Review)
Ong 2016 (Continued)
Wood Johnson Foundation; the Sierra Health Foundation; the University of California Center for Health Quality and Innovation; and by the participating institutions. The funders had no role in the design and conduct of the study; collection, management, anal- ysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.”
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias)
Low risk Quote: “Block randomization was con- ducted within each site using random blocks of 4 to 8 individuals via a web-based, computerized, random number generator. ”
Allocation concealment (selection bias) Low risk Web-based implies centralised, and block size was random 4-8
Blinding of participants and personnel (performance bias)
High risk Not possible due to nature of intervention
Blinding of outcome assessment (detection bias)
Objective outcomes
Low risk States that survey interviews were con- ducted “by staff at the coordinating center who were unaware of the treatment ran- domizations”
Blinding of outcome assessment (detection bias)
Subjective outcomes
High risk Self-reported QoL
Incomplete outcome data (attrition bias) All outcomes
Unclear risk There was an unbalanced dropout rate (15% and 26% for intervention and con- trol, respectively, although all randomised participants were included in primary anal- ysis. Hazard models censored data on date of withdrawal for people who had fully withdrawn consent. QoL data only re- ported for those participants who com- pleted follow-up questionnaire (53.6% and 57.2% for intervention and control, respec- tively).
Selective reporting (reporting bias) Low risk Outcomes match those on clinical trials. gov, posted before trial started
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