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. 2012 Jul 11;2012(7):CD007672. doi: 10.1002/14651858.CD007672.pub2

Hughes 1992.

Methods RCT; Unit of allocation: Patient; Stratified by: N/A
Participants Terminal ill patients admitted to medicine, surgery, and neurology,  and their primary informal caregivers.
Setting / country: Department of Edward Hines, Jr. Veteran affairs (VA) Hospital, Illinois / USA
Type of cancer: Not mentioned
Phase of care: Palliative care
Sample size at randomisation: 175 patients and their primary informal caregivers
Interventions Hospital‐based home care program (HBHC): this home based palliative care program encompass an interdisciplinary team that is led by a physician and includes nurses, a social worker, a physical therapist, a dietitian, and health technicians. The Hines HBHC program develops goal‐oriented, interdisciplinary patient care plans at team meetings, and schedules visits according to individual patient needs. The HBHC physician is also able to manage HBHC patients both in and out of the hospital. The HBHC model of care emphasizes the provision of care to high‐risk patients, the provision of comprehensive services based on need, the importance of timely communication about patients across team members, and the instruction and involvement of informal caregivers in patient care to the maximum extent possible. To improve subject recall, patients were provided with a healthcare diary and were asked to record in the diary all home healthcare visits, clinic visits, and admissions to healthcare facilities for the six‐month period of their participation in the study.
Control: Customary care within or outside the VA (i.e. in community home care or in Hospice care) with the exception of access to HBHC.
Outcomes Patient: Survival, patient emotional adjustment, satisfaction, cognitive functioning, functional status
Informal carer: Emotional adjustment, caregiver satisfaction
Process: Use of hospital and community services, use of non VA‐services, length of hospital stay, place of death
Notes Length of follow‐up: 6 months
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "This study used a randomised pretest‐multiple posttest experimental design."
Quote: "Prior to the patient's discharge, the patient was randomised to treatment or control group status."
Allocation concealment (selection bias) Unclear risk See quote first item.
Blinding (performance bias and detection bias) 
 Functional status High risk Quote "If a patient died between baseline and the one‐month follow‐up, only the one‐month interview was conducted with the caregiver."
Blinding (performance bias and detection bias) 
 Psychological status High risk Quote "If a patient died between baseline and the one‐month follow‐up, only the one‐month interview was conducted with the caregiver."
Blinding (performance bias and detection bias) 
 Satisfaction High risk Quote "If a patient died between baseline and the one‐month follow‐up, only the one‐month interview was conducted with the caregiver."
Blinding (performance bias and detection bias) 
 Use of services Low risk Quote: "VA services were tracked through existing records, files, and computer data bases. Use of healthcare services outside the VA was monitored by participants. To improve subject recall, patients were provided with a healthcare diary and were asked to record in the diary all home healthcare visits, clinic visits, and admissions to healthcare facilities for the six‐month period of their participation in the 
 study. Patients were contacted monthly by research staff to retrieve the diary information, and diaries were also examined by research staff in patients' homes during the one‐month and six‐month interviews." 
 
 Comment: Such information is objective in nature so there is no need for the assessor to be blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "The major reason for attrition from posttest measurement was mortality, at 79 percent in the HBHC group and 78 percent in the control group. An examination of survival days indicated no group differences: 76.2 days, s.d. = 67.1 in the HBHC group versus 83.1 days, s.d. = 68.1, (n.s.) in the control group for all study subjects and 48.0 days, s.d. = 43.3 versus 54.5 days, s.d. = 47.7 days for decedents."
Comment: Similar proportion of missing data in the 2 study groups.
Selective reporting (reporting bias) Low risk All outcomes in the methods section are reported in the results section.
Other bias Low risk No evidence of other bias.
Baseline outcomes similar? Low risk Quote: "Baseline functional and cognitive status, morale, and satisfaction with care scores for control and HBHC groups (also shown in Table 1) indicate that the study groups were very similar to each other at the time of randomisation"
Baseline characteristics similar? Low risk Quote: "Baseline characteristics of HBHC and control group patients displayed in Table 1 indicate that the HBHC group was slightly older (P < 0.10) and the mean age for retirement was also slightly higher in the HBHC group versus for the control sample (P < 0.10)."
Comment: This difference is unlikely to lead to bias.
Protected against contamination? Unclear risk The home care intervention program encompass an interdisciplinary team and an informal caregiver. There are no evidence that the same healthcare providers are accessible to intervention and control group participants. The HBHC is a program in the VA Hospital. Control group patients were able to access customary care within or outside the VA with the exception of access to Hines HBHC.