JMIR Publications

ABSTRACT

Background:

Structured distress management, comprised of a two-stage screening and referral model, can direct limited supportive care resources towards individuals who are most likely to benefit. This structured approach has yet to be trialled in Australian telephone-based services such as Cancer Council New South Wales and Victoria Cancer Information and Support (CIS) 13 11 20 lines who remotely provide a comprehensive suite of services to a large community of cancer patients and caregivers.

Objective:

The overall trial objective is to evaluate the effectiveness of telephone-based structured screening and referral in increasing the proportion of distressed CIS callers who accept supportive care referrals and reducing distress levels at 6 months follow-up.

Methods:

In this stepped-wedge trial, Cancer Council NSW and Victoria CIS consultants will be randomised to deliver structured care during inbound 13 11 20 calls in accordance with three intervention periods. Eligible callers are: patients or caregivers who score 4 or more on the Distress Thermometer; New South Wales or Victorian residents; 18 years of age or older; and, English proficient. Outcome data will be collected via computer-assisted telephone interviews (CATIs) at 3- and 6-months follow-up and Client Record Management record audit. CATIs include demographic and service use items, the General Health Questionnaire (GHQ-28) to assess distress, and the Health Education and Impact Questionnaire (HeiQ). An economic analysis of the structured care model will be completed.

Results:

The structured care model was developed by review of existing guidelines and identification of service characteristics to guide mapping decisions; place-card methodology to arrange services by distress levels; and, application of clinical vignettes with think-aloud methodology to confirm referral appropriateness. The model includes an additional screening tool (Patient Health Questionnaire-4) and a referral model with 16-20 CIS services. Descriptive statistics will be used to assess referral uptake rates. Differences between GHQ-28 scores for the structured and usual care groups will be tested using a Generalised Linear Mixed Model with fixed effects for intervention and each time period after baseline. Based on 8 consultants participating, the trial aims to recruit a total of 1512 callers across the three periods. The sample size will provide the study with approximately 80% power to detect a difference of 0.3 standard deviations in the mean score of the GHQ-28 at an alpha level of 0.05 and assuming an intra-cluster correlation of 0.04. A random sample of recorded calls will be reviewed to assess intervention fidelity.

Conclusions:

This trial is amongst the first to rigorously test the outcomes of a telephone-based structured approach to distress management. The model is evidence–informed, practice-ready and will be trialled in a real world setting. The outcomes of this trial will advance understanding of distress management internationally. Clinical Trial: ACTRN12617000352303