A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
- Conditions
- Breast NeoplasmsMedication Adherence
- Interventions
- Other: OPTIMUM e-health tool
- Registration Number
- NCT02876848
- Lead Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Brief Summary
Background: In women with hormone receptor positive (HR+) 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 e-health tool (OPTIMUM) that integrates real-time analysis of health administrative claims data was developed to provide point-of-care decision support for clinicians.
- Detailed Description
Objectives: 1) To determine the effectiveness of a patient-specific, real-time e-health alerts delivered at point-of-care in reducing rates of AET discontinuation and to understand patient-level factors related to AET discontinuation. 2) To assess integration of e-health alerts regarding deviations from best practices in administration of AET by cancer care teams.
Methods: A prospective, two group controlled comparison pilot study will be conducted at two 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. Healthcare professionals at the intervention site will have access to the e-health tool which will report to them in real-time: medical events with known associations to AET discontinuation, AET adherence monitor, and a discontinuation alert.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 120
- Must be ≥ 65 years old,
- Have been diagnosed with incident (non-metastatic) breast cancer,
- Have a histologically-confirmed breast adenocarcinoma,
- Have undergone breast surgery for stages I-III disease,
- Have medical insurance with the Régie de l'Assurance Maladie du Québec (RAMQ) for at least 1 year prior to surgery,
- Have HR positive disease,
- Have no history of AET use prior to the diagnosis of breast cancer,
- Expected to initiate AET or have only recently initiated AET (<6 months) but are free of previous discontinuation events,
- Have the ability to consent for herself.
male gender
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Site OPTIMUM e-health tool The hospital that will be the intervention site will have access to the OPTIMUM e-health tool. The intervention site cancer care team will receive the following OPTIMUM e-health alerts: 1. An electronic alert of increased Adjuvant Endocrine Therapy discontinuation risk. 2. An adherence to Adjuvant Endocrine Therapy monitor. 3. An electronic discontinuation occurrence alert
- Primary Outcome Measures
Name Time Method Proportion of patients discontinuing adjuvant endocrine therapy treatment 1.5 years In each trial arm, the proportion of patients discontinuing AET treatment will be calculated as the number of patients discontinuing AET treatment divided by the total number of patients in that trial arm.
- Secondary Outcome Measures
Name Time Method Cancer Care Team Actions in the intervention arm - arrange for return to clinic with doctor 1.5 years Upon alert receipt that a patient is at risk of discontinuing adjuvant endocrine therapy treatment or has discontinued AET treatment, for that patient, if a member of the cancer care team arranged for the patient to return to the clinic to see the doctor will be assessed qualitatively (yes/no) and quantitatively (if yes, time in number of days before the cancer care team arranged a return to clinic with doctor).
Cancer Care Team Actions in the intervention arm - referral to doctor for closer follow-up 1.5 years Upon alert receipt that a patient is at risk of discontinuing adjuvant endocrine therapy treatment or has discontinued AET treatment, for that patient, if a member of the cancer care team referred the patient to a doctor will be assessed qualitatively (yes/no) and quantitatively (if yes, time in number of days before the cancer care team referred the patient to a doctor). Note that this action is different than the outcome "arrange for return to clinic with doctor" because this outcome occurs when a nurse directly schedules a patient to see a specific doctor without discussing with a doctor first.
Primary Non-adherence 1.5 years In each trial arm, the proportion of patients who are prescribed AET treatment but do not fill any prescriptions will be calculated as the number of patients with primary non-adherence divided by the total number of patients in that trial arm.
Medical Possession Ratio ≥80% 1.5 years In each trial arm, the proportion of patients that maintain a Medical Possession Ratio ≥80% will be calculated as the proportion patients whose proportion of number of days covered by medication supply in the treatment period is ≥80%.
Cancer Care Team Actions in the intervention arm - no changes in usual treatment despite new information provided 1.5 years Upon alert receipt that a patient is at risk of discontinuing adjuvant endocrine therapy treatment or has discontinued AET treatment, for that patient, if no changes by the cancer care team were taken will be assessed qualitatively (yes/no) and quantitatively (how many alerts per patient were ignored). Note that this "no changes" is an explicit option that care teams can specify. They will be trained to understand that the "no changes" option represents that the patient requires other considerations beyond adhering to AET such as is stopping AET for upcoming surgery or no longer is indicated for AET based on disease progression (for e.g., brain metastases).
Cancer Care Team Actions in the intervention arm - Other 1.5 years Any care team action that cannot be described by the predefined actions will be described by the care team in a free-text field for subsequent qualitative analysis. An overall theme or logical grouping of these qualitative outcomes will be explored and reported upon.
Mean time to adjuvant endocrine therapy treatment re-initiation. 1.5 years In each trial arm, mean time to AET treatment re-initiation will be calculated as the average number of days for a patient who has stopped taking AET treatment to start again, among those who start again (re-initiate).
Cancer Care Team Actions in the intervention arm - perform telephone follow-up with patient 1.5 years Upon alert receipt that a patient is at risk of discontinuing adjuvant endocrine therapy treatment or has discontinued AET treatment, for that patient, if a member of the cancer care team called the patient will be assessed qualitatively (yes/no) and quantitatively (if yes, time in number of days before the patient was called).
Cancer Care Team Actions in the intervention arm - perform telephone follow-up with community pharmacist 1.5 years Upon alert receipt that a patient is at risk of discontinuing adjuvant endocrine therapy treatment or has discontinued AET treatment, for that patient, if a member of the cancer care team called the patient's pharmacist will be assessed qualitatively (yes/no) and quantitatively (if yes, time in number of days before the patient's pharmacist was called).
Proportion of patients re-initiating after a discontinuation of adjuvant endocrine therapy treatment 1.5 years In each trial arm, the proportion of patients re-initiating after a discontinuation of AET treatment will be calculated as the number of patients who start taking AET after a period of stopping divided by the total number of patients that discontinued in that trial arm.
Cancer Care Team Actions in the intervention arm - arrange for return to clinic with nurse 1.5 years Upon alert receipt that a patient is at risk of discontinuing adjuvant endocrine therapy treatment or has discontinued AET treatment, for that patient, if a member of the cancer care team arranged for the patient to return to the clinic to see the nurse will be assessed qualitatively (yes/no) and quantitatively (if yes, time in number of days before the cancer care team arranged a return to clinic with nurse).
Cancer Care Team Actions in the intervention arm - ignore the alert 1.5 years Upon alert receipt that a patient is at risk of discontinuing adjuvant endocrine therapy treatment, for that patient, if no action by the cancer care team was taken will be assessed qualitatively (yes/no) and quantitatively (how many alerts per patient were ignored). Note that "ignore the alert" is an explicit option that care teams can specify. They will be trained to understand that the "ignore the alert" option represents that the patient has not discontinued AET treatment and that they are of the opinion that the patient is not at risk of discontinuing AET treatment despite reading the alert.
Cancer Care Team Actions in the intervention arm - referral to cancer nurse for closer follow-up 1.5 years Upon alert receipt that a patient is at risk of discontinuing adjuvant endocrine therapy treatment or has discontinued AET treatment, for that patient, if a member of the cancer care team referred the patient to a cancer nurse will be assessed qualitatively (yes/no) and quantitatively (if yes, time in number of days before the cancer care team referred the patient to a cancer nurse).
Trial Locations
- Locations (1)
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada