Adjuvant Endocrine Therapy in Breast Cancer: A Novel e-Health Approach in Optimizing Treatment for Seniors (OPTIMUM): A Two-Group Controlled Comparison Pilot Study

Background In women with hormone receptor positive breast cancer, adjuvant endocrine therapy (AET) is associated with a significant survival advantage. Nonadherence is a particular challenge in older women, even though they stand to benefit the most from AET. Therefore, a novel eHealth tool (OPTIMUM) that integrates real-time analysis of health administrative claims data was developed to provide point-of-care decision support for clinicians. Objectives The objectives of the study are to determine the effectiveness of a patient-specific, real-time eHealth alert delivered at point-of-care in reducing rates of AET discontinuation and to understand patient-level factors related to AET discontinuation as well as to assess integration of eHealth alerts regarding deviations from best practices in administration of AET by cancer care teams. Methods A prospective, 2-group controlled comparison pilot study will be conducted at 2 urban, McGill University–affiliated hospitals, the Royal Victoria Hospital and St. Mary’s Hospital. A minimum of 43 patients per study arm will be enrolled through site-level allocation. Follow-up is 1.5 years. Health care professionals at the intervention site will have access to the eHealth tool, which will report to them in real-time medical events with known associations to AET discontinuation, an AET adherence monitor, and a discontinuation alert. Cox proportional hazard ratios with 95% confidence intervals will estimate risks of AET discontinuation. Tests for significance will be 2-sided with a significance level of P<.05. Results This protocol has been approved and funded by the Canadian Institutes of Health Research. The study will evaluate site-level differences between AET discontinuation and AET adherence and assess care team actions at the intervention site. Participant enrollment into this project is expected to start September 2016 with primary data ready to present by June 2018. Conclusion This study will offer an opportunity to verify the feasibility of integrating an eHealth tool that aims to improve the long-term management of breast cancer in a high-risk population by allowing more timely intervention to prevent or rapidly address AET discontinuation.

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Research Approach
The background makes a very good case for studying older women who start AET for breast cancer after surgery, as the therapy has been shown in meta-analysis to decrease recurrence and death.
Although the project is described as a randomized trial, there are only two sites (two clusters) involved, therefore the inherent advantages of randomization are not realized.
The intervention builds on the previous work of MOXXI, an e-health program which is now described as an e-health tool providing patient-specific decision support using real-time processing of health service claims.
The level of integration with the hospital EHRs is not described.For this study, the AET adherence monitoring tool is to a) calculate 5-year treatment discontinuation risk score, b) provide an electronic alert when discontinuation risk passes and unspecified threshold, c) adherence monitoring of AET, and d) alert for presumed discontinuation.
The clinical structure, environment, current work flow, expected fit and actual personnel targets of the intervention, are not described.
The primary outcome of interest is AET discontinuation rate in the two groups with secondary outcomes examining actions taken by the intervention team, influence on workflow and costs of implementation.The secondary outcomes are very scantily described and do not include important clinical outcomes.
The authors calculate a samples size of only 86 women to detect a 40% decrease in discontinuations.Follow-up is to be 1.5 years; when taking into account recruitment, this will be at least a 2-year grant while catalyst grants are meant to be 12 months.This seems to be a problem which is not serious feasibility discussed.

Originality
The integration of provincial pharmacy administrative data with notification and decision support algorithms for clinicians, is novel.

End-user Requirements or Preferences Incorporated?
Not described.

Budget
Budget totals $265,000 with approximately $83,000 requested from CIHR.The total budget seems very large for such a small, confined project and should be reviewed.If the development budget is this large, it creates anxiety around whether timelines can be met.Budget justification is very detailed but again suggests a larger project than is actually described.For example, why is both a part-time research assistant and a study coordinator required?

Applicants
The NPA is a breast cancer surgeon with research training who has been mentored within McGill University's excellent health informatics research group.His first author publication list for someone approaching Associate Professor status, is modest but grants and academic activities are good.There are 5 other collaborators but their CVs are not included.This is a serious oversight.

Impact of the Research -potential to augment, integrate, evaluate e-health approaches; add value to existing service delivery; improve quality, equity, cost-effectiveness
This is a significant deficit in the grant, as important clinical outcomes are not being measured as part of this grant.Since this is a catalyst grant, the authors should have described the future large study that is planned to follow-up this pilot study.

Environment for Research
Appears to be excellent.Access to large secure databases is required, provided by McGill health informatics group.The applicants propose the use of admin claims as a method of determining adjuvant endocrine therapy (AET) on older women with breast cancer.AET has been shown to be effective, but suffers from adherence issues.A risk assessment will be generated by the system, as well as on-going monitoring and alerting of AET adherence.A trial is proposed is to evaluate the system focusing on the clinical response to the system output.

Alignment with Funding Opportunity
This is an excellent proposal with a novel, practical approach to determine adherence with a simple data collection method.Other methods tried have failed due to the complexity and resource intensiveness.
The applicants make a strong case for the need of such adherence support in this population; the long duration, the age of the patients, co-morbidity, the likelihood of treatment of interruption, etc.The effectiveness of AET in the population given the more limited treatment options also supports its importance.
The use of the data collection method through the MOXXI tool has been supported in other applications such as cardiovascular medications and psychoactive medications.This de-risks this proposal knowing that its been used effectively previously.
No issues with the trial methodology, research team, or budget.The trial has a significant in-kind contributions to refine the system for this application.
In summary, an excellent proposal for a novel, practical application. Assessment/Évaluation:

MEGUERDITCHIAN
This proposal uses a novel, practical approach to study medication adherence.The study may not examine the entire follow up period.The inherent advantages of randomization may not be realized with a cluster design.EHR integration with each hospital is not described.Some clinically important outcomes are not included in the grant.The team has done related work with this type of intervention.Commercialization opportunities may be limited.
success in the recent Canadian Institutes of Health Research funding competition.

Grant Title: # 316814. Electronic Health Information Tools: An Opportunity to provide Better Care to Older Breast Cancer Patients 1. Brief Synopsis of Proposal This
proposal describes a two-site comparison of an electronic adherence risk measurement, monitoring and notification program for adjuvant endrocrine therapy (AET) for HR positive breast cancer in older women in two Montreal hospitals, versus usual care over 1.5 years of follow-up.
-15 Catalyst Grant: e-Health Innovations: Supporting More Efficient Population and Individualized Healthcare/Subvention catalyseur : Innovations en cybersanté : soutenir l'amélioration des soins de santé axés sur les individus et les populations Committee/Comité: e-Health Innovations/Innovations en cybersanté Title/Titre: Adjuvant Endocrine Therapy in Breast Cancer: A Novel E-health Approach in Optimizing Treatment Adherence in Seniors