Back to resultsA Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
Primary Purpose
Breast Neoplasms, Medication Adherence
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
OPTIMUM e-health tool
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Neoplasms focused on measuring Administrative Claims, Healthcare, Aromatase Inhibitors, Breast Neoplasms, Health Services for the Aged, Medical Informatics Applications, Medication Adherence, Outcome and Process Assessment (Health Care), Selective Estrogen Receptor Modulators, Telemedicine
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
male gender
Sites / Locations
- McGill University Health Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Site
Control Site
Arm Description
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: An electronic alert of increased Adjuvant Endocrine Therapy discontinuation risk. An adherence to Adjuvant Endocrine Therapy monitor. An electronic discontinuation occurrence alert
The hospital that will be the control site will not have access to the OPTIMUM e-health tool. The cancer care team will continue to deliver care according to standard processes.
Outcomes
Primary Outcome Measures
Proportion of patients discontinuing adjuvant endocrine therapy treatment
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
Primary Non-adherence
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.
Proportion of patients re-initiating after a discontinuation of adjuvant endocrine therapy treatment
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.
Mean time to adjuvant endocrine therapy treatment re-initiation.
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).
Medical Possession Ratio ≥80%
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 - perform telephone follow-up with patient
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
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).
Cancer Care Team Actions in the intervention arm - arrange for return to clinic with doctor
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 - arrange for return to clinic with nurse
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 - referral to doctor for closer follow-up
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.
Cancer Care Team Actions in the intervention arm - referral to cancer nurse for closer follow-up
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).
Cancer Care Team Actions in the intervention arm - ignore the alert
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 - no changes in usual treatment despite new information provided
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
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.
Full Information
NCT ID
NCT02876848
First Posted
August 16, 2016
Last Updated
August 18, 2016
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
1. Study Identification
Unique Protocol Identification Number
NCT02876848
Brief Title
A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
Official Title
Adjuvant Endocrine Therapy in Breast Therapy in Breast Cancer: A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Medication Adherence
Keywords
Administrative Claims, Healthcare, Aromatase Inhibitors, Breast Neoplasms, Health Services for the Aged, Medical Informatics Applications, Medication Adherence, Outcome and Process Assessment (Health Care), Selective Estrogen Receptor Modulators, Telemedicine
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Site
Arm Type
Experimental
Arm Description
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:
An electronic alert of increased Adjuvant Endocrine Therapy discontinuation risk.
An adherence to Adjuvant Endocrine Therapy monitor.
An electronic discontinuation occurrence alert
Arm Title
Control Site
Arm Type
No Intervention
Arm Description
The hospital that will be the control site will not have access to the OPTIMUM e-health tool. The cancer care team will continue to deliver care according to standard processes.
Intervention Type
Other
Intervention Name(s)
OPTIMUM e-health tool
Intervention Description
If you are treated in a hospital that is using the OPTIMUM e-health tool ("intervention" group), once your care team receives any alerts, they may choose to:
Contact you over the phone or in person to provide medical advice on how to better take your pills,
Contact your pharmacist(s) and other doctors about your anti-cancer treatment.
Primary Outcome Measure Information:
Title
Proportion of patients discontinuing adjuvant endocrine therapy treatment
Description
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.
Time Frame
1.5 years
Secondary Outcome Measure Information:
Title
Primary Non-adherence
Description
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.
Time Frame
1.5 years
Title
Proportion of patients re-initiating after a discontinuation of adjuvant endocrine therapy treatment
Description
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.
Time Frame
1.5 years
Title
Mean time to adjuvant endocrine therapy treatment re-initiation.
Description
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).
Time Frame
1.5 years
Title
Medical Possession Ratio ≥80%
Description
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%.
Time Frame
1.5 years
Title
Cancer Care Team Actions in the intervention arm - perform telephone follow-up with patient
Description
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).
Time Frame
1.5 years
Title
Cancer Care Team Actions in the intervention arm - perform telephone follow-up with community pharmacist
Description
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).
Time Frame
1.5 years
Title
Cancer Care Team Actions in the intervention arm - arrange for return to clinic with doctor
Description
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).
Time Frame
1.5 years
Title
Cancer Care Team Actions in the intervention arm - arrange for return to clinic with nurse
Description
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).
Time Frame
1.5 years
Title
Cancer Care Team Actions in the intervention arm - referral to doctor for closer follow-up
Description
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.
Time Frame
1.5 years
Title
Cancer Care Team Actions in the intervention arm - referral to cancer nurse for closer follow-up
Description
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).
Time Frame
1.5 years
Title
Cancer Care Team Actions in the intervention arm - ignore the alert
Description
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.
Time Frame
1.5 years
Title
Cancer Care Team Actions in the intervention arm - no changes in usual treatment despite new information provided
Description
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).
Time Frame
1.5 years
Title
Cancer Care Team Actions in the intervention arm - Other
Description
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.
Time Frame
1.5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
male gender
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ari N Meguerditchian, MD
Phone
(514) 934-1934
Ext
32999
Email
ari.meguerditchian@mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ari N Meguerditchian, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liane Feldman, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Study Director
Facility Information:
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ari N Meguerditchian, MD
Phone
(514) 934-1934
Ext
32999
Email
ari.meguerditchian@mcgill.ca
12. IPD Sharing Statement
Learn more about this trial
A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
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