Mitchell, G.K., Girgis, A., Jiwa, M., Sibbritt, D., Burridge, L.H., & Senior, H.E. (2013). Providing general practice needs-based care for carers of people with advanced cancer: A randomised controlled trial. The British Journal of General Practice, 63(615), e683–e690.

To test whether a general practice consultation directed by a carer needs checklist would improve meeting the needs of carers

General practitioners of intervention patients were visited, introduced to intervention resources, and invited to participate. Tools provided were a needs assessment tool and a general practice toolkit of paper-based and electronic forms providing evidence-based information, resources, and services that might help address problems. Consultations were provided at baseline and at three months, based on needs assessment results. Patients were randomized, but those whose general practitioner had a previous participant were nonrandomly allocated to the same study group to prevent contamination. Data collection included survey at one, three, and six months by telephone interview. Control group general practitioners were not contacted. General practitioners were educated on the process through academic detailing.

• N = 211 carers
• MEAN AGE = 57.5 years
• MALES: 33.5%, FEMALES: 66.5%
• KEY DISEASE CHARACTERISTICS: Varied prognoses in terms of life expectancy 
• OTHER KEY SAMPLE CHARACTERISTICS: Most carers were spouse or partner and lived with the patient. 32% were employed full-time, and 18.5% were employed part-time. 

• SITE: Multi-site  
• SETTING TYPE: Outpatient  
• LOCATION: Australia

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Palliative care 

• Single-blind RCT

• Supportive care needs survey for partners and carers to measure unmet needs
• Hospital Anxiety and Depression Scale
• SF-12

Twenty-nine percent of intervention group patients and 15% of control group patients dropped out of the study—most said this was because they were too busy to continue after their initial interview. Three of 158 general practitioners refused to conduct the consultations. No between-group differences were seen in change from scores at baseline to scores at any time point. Subgroup analysis showed no change in depression scores. For those who were clinically depressed at baseline, control patients demonstrated significantly worse anxiety at six months, while intervention group scores were essentially stable. Intervention group carers with baseline anxiety or depression reported deterioration in physical scores on the SF-12 (p = .053). In analysis adjusted for baseline anxiety, those in the intervention group had significant worsening of physical function scores (p = .037) and increased psychological and emotional needs from baseline to three months (p = .033). Those caring for less ill individuals had improvement in mental health at three months in SF-12 scores.

The study did not demonstrate improvement in intensity or number of unmet needs or carer outcomes overall.

• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)  
• Unintended interventions or applicable interventions not described that would influence results
• Questionable protocol fidelity 
• Subject withdrawals 10% or greater 
• Other limitations/explanation: Although general practitioner participation was stated, actual completion of expected consultations at the expected timeframes is not discussed or reported—no approach to ensure treatment fidelity in such consultations; high attrition rate; no information about the patient’s type of cancer, severity, or symptoms is provided—these are likely to have an impact on the degree of caregiver burden and associated outcomes; the nature of the general practice consultation is not clearly described, and actions taken to meet assessed needs is not discussed.

Findings did not support the idea of reducing carer unmet needs via an assessment-driven general practice consultation over time. Undergoing assessment of needs possibly increases the degree to which carers identify needs that are not being met. This study focused on provision of tools to general practitioners but does not describe what actions were taken on the basis of the assessment done, so it provides little support for any specific approach to address caregiver needs.