Multi-level Intervention for the Improvement of Medication Use in Patients with Stage 0-III Breast Cancer, The IMPACT Trial

PRIMARY OBJECTIVE:

I. To determine the efficacy of a multicomponent adherence intervention that targets digital and pharmacoequity versus minimally enhanced usual care among patients with early-stage breast cancer (or ductal carcinoma in situ [DCIS]) with at least some nonadherence to endocrine therapy and/or at one oral cardiovascular disease (CVD) medication (either blood pressure or statin medication or metformin) on concurrent adherence to endocrine therapy and to CVD medication at 28 weeks assessed by a combination of self-report using the Voils Domains Of Subjective Extent (DOSE) Nonadherence measure and pharmacy fill data using Surescripts pharmacy dispensing records available in the electronic health record (EHR).

SECONDARY OBJECTIVES:

I. To compare the effect of the intervention between intervention and minimally-enhanced usual care groups on:

Ia. Concurrent adherence to endocrine therapy (ET) and to CVD medications at 52 weeks assessed by a combination of self-report and pharmacy fill data;

Ib. Adherence to ET and CVD medications, separately, at 28 weeks and 52 weeks, using the Voils DOSE Nonadherence measure;

Ic. Adherence to ET and CVD medications, separately, at 28 weeks and 52 weeks, using pharmacy fill data from the EHR;

Id. Office blood pressure at 52 weeks;

Ie. Low-density lipoprotein (LDL) cholesterol at 52 weeks;

If. Self-efficacy with their medication regimens, as measured by the Medical Adherence Self-Efficacy Scale (MASES-R) at 28 weeks, and 52 weeks;

Ig. Medication regimen complexity (total number of medications, number of doses per day) at 28 weeks and 52 weeks as per EHR records;

Ih. Number of and intensity of reasons for nonadherence using the Voils DOSE Nonadherence measure (note: reasons include side-effects and perceived need for medications);

Ii. Use of medication reminder apps, alarms, pill organizing systems, or other actions to make it easier to remember to take daily medications;

Ij. Use of 90-day medication fills, synchronization of medication fills, home delivery services to make it easier to keep up with medication refills;

Ik. Use of patient portal to communicate with treating clinicians;

Il. Use of discount pharmacy, coupons, switch to lower cost medication to help lower out-of-pocket cost of medications;

Im. Healthcare related quality of life (HRQOL), measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 28 weeks.

II. To evaluate acceptability, appropriateness, and feasibility of the multicomponent adherence intervention using the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) as well as the Net Promoter Scale. (Intervention group)

III. To evaluate intrusive and avoidant thoughts about participant’s underlying breast cancer diagnosis at baseline using the PCL-5. (Intervention group)

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients participate in a one-time meeting with a pharmacist to review medications. Patients also download and use the MyConnect and Medisafe smartphone applications (apps) for 24 weeks, undergo monthly review of prescription medications that have been filled, and if needed, undergo monthly community healthcare worker-led coaching on reducing barriers to taking medications.

GROUP II: Patients undergo usual care with the exception that treating doctors are notified if patients don’t always take medications as prescribed.

After completion of study intervention, patients are followed for up to 1 year from time of study enrollment.