Trial Outcomes & Findings for Pharmacy Home Adherence Reporting and Monitoring Outcomes Study (NCT NCT02306122)

Results Overview

Patients who were more than 10 days late refilling a chronic medication prescription were in the analytic sample frame and were targeted for intervention according to how they were randomized. This outcome is the rate at which these patients have filled a prescription by 30 days. Outcome is 1 if the patient fills the prescription by 30 days (considered resolution of nonadherence); otherwise it is 0. Outcome measures reported are the means of the per-person proportions of nonadherence (NAE) events resolved within 30 days across all patients in each particular arm.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2697 participants

Primary outcome timeframe

Outcome measure examines fills within 30 days of a nonadherence event. Participants were followed over a total of 6 months.

Results posted on

2022-01-11

Participant Flow

Physician recruitment with signed consent forms was in-person. 91 physicians were consented and enrolled at launch. All eligible patients were automatically enrolled, and mailed an opt-out card to be returned if participation was refused.

Both patients and doctors were enrolled in the study. Separate Periods represent the sequential nature of the study design: Period 1 includes physicians only. Only those patients with a nonadherence event were randomized to a control or intervention arm, so the number consented at launch (2,606) is higher than the number included in the study results (1,474). Patients were removed if insurance coverage expired or if their enrolled physician withdrew.

Participant milestones

Participant milestones
Measure	Default Patient Default Doctor Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call	Information Patient Default Doctor Patient nonadherence information sent to physician	Control Patient Default Doctor Control - no intervention	Choice Patient Choice Doctor Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call	Information Patient Choice Doctor Patient nonadherence information sent to physician	Control Patient Choice Doctor Control - no intervention	Information Patient Information Doctor Patient nonadherence information sent to physician	Control Patient Information Doctor Control - no intervention	Information Doctor Physician randomized to Information Only arm	Default Doctor Physician randomized to Default arm	Choice Doctor Physician randomized to Choice arm
Initial Physician Randomization STARTED	0	0	0	0	0	0	0	0	29	31	31
Initial Physician Randomization COMPLETED	0	0	0	0	0	0	0	0	28	31	31
Initial Physician Randomization NOT COMPLETED	0	0	0	0	0	0	0	0	1	0	0
Post Nonadherence Subgroup Randomization STARTED	244	123	121	274	134	137	220	221	28	31	31
Post Nonadherence Subgroup Randomization COMPLETED	244	123	121	274	134	137	220	221	28	31	31
Post Nonadherence Subgroup Randomization NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Default Patient Default Doctor Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call	Information Patient Default Doctor Patient nonadherence information sent to physician	Control Patient Default Doctor Control - no intervention	Choice Patient Choice Doctor Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call	Information Patient Choice Doctor Patient nonadherence information sent to physician	Control Patient Choice Doctor Control - no intervention	Information Patient Information Doctor Patient nonadherence information sent to physician	Control Patient Information Doctor Control - no intervention	Information Doctor Physician randomized to Information Only arm	Default Doctor Physician randomized to Default arm	Choice Doctor Physician randomized to Choice arm
Initial Physician Randomization Physician Decision	0	0	0	0	0	0	0	0	1	0	0

Baseline Characteristics

Pharmacy Home Adherence Reporting and Monitoring Outcomes Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Default Patient n=244 Participants Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call	Information Patient n=477 Participants Patient nonadherence information sent to physician	Control Patient n=479 Participants Control - no intervention	Choice Patient n=274 Participants Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call	Information Doctor n=29 Participants Physician randomized to information only arm	Choice Doctor n=31 Participants Physician randomized to choice arm	Default Doctor n=31 Participants Physician randomized to default arm	Total n=1565 Participants Total of all reporting groups
Age, Continuous	56.80 years STANDARD_DEVIATION 0.49 • n=5 Participants	55.99 years STANDARD_DEVIATION 0.51 • n=7 Participants	56.58 years STANDARD_DEVIATION 0.47 • n=5 Participants	56.29 years STANDARD_DEVIATION 0.68 • n=4 Participants	53.86 years STANDARD_DEVIATION 1.67 • n=21 Participants	56.87 years STANDARD_DEVIATION 1.53 • n=8 Participants	56.16 years STANDARD_DEVIATION 1.78 • n=8 Participants	56.33 years STANDARD_DEVIATION 0.45 • n=24 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	167 Participants n=7 Participants	163 Participants n=5 Participants	107 Participants n=4 Participants	16 Participants n=21 Participants	11 Participants n=8 Participants	12 Participants n=8 Participants	554 Participants n=24 Participants
Sex: Female, Male Male	166 Participants n=5 Participants	310 Participants n=7 Participants	316 Participants n=5 Participants	167 Participants n=4 Participants	13 Participants n=21 Participants	20 Participants n=8 Participants	19 Participants n=8 Participants	1011 Participants n=24 Participants
Region of Enrollment United States	244 participants n=5 Participants	477 participants n=7 Participants	479 participants n=5 Participants	274 participants n=4 Participants	29 participants n=21 Participants	31 participants n=8 Participants	31 participants n=8 Participants	1565 participants n=24 Participants

PRIMARY outcome

Timeframe: Outcome measure examines fills within 30 days of a nonadherence event. Participants were followed over a total of 6 months.

Population: All Information Only patients are grouped together in these results (regardless of physician arm), because the treatment for all Information Only patients is identical across all physician arms.

Patients who were more than 10 days late refilling a chronic medication prescription were in the analytic sample frame and were targeted for intervention according to how they were randomized. This outcome is the rate at which these patients have filled a prescription by 30 days. Outcome is 1 if the patient fills the prescription by 30 days (considered resolution of nonadherence); otherwise it is 0. Outcome measures reported are the means of the per-person proportions of nonadherence (NAE) events resolved within 30 days across all patients in each particular arm.

Outcome measures

Outcome measures
Measure	Default Patient n=244 Participants Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call	Choice Patient n=274 Participants Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call	Information Patient n=477 Participants Patient nonadherence information sent to physician	Control Patient n=479 Participants No information sent to physician, no opportunity for pharmacist intervention
Probability of Resolution of Nonadherence Within 30 Days	.4286 Proportion of resolved NAEs within 30 Standard Deviation .4953	.4290 Proportion of resolved NAEs within 30 Standard Deviation .4953	.4554 Proportion of resolved NAEs within 30 Standard Deviation .4982	.4437 Proportion of resolved NAEs within 30 Standard Deviation .4971

PRIMARY outcome

Timeframe: Participants were followed over a total of 6 months

Population: All Information Only patients are grouped together in these results (regardless of physician arm), because the treatment for all Information Only patients is identical across all physician arms.

Patients who were more than 10 days late refilling a chronic medication prescription were in the analytic sample frame and were targeted for intervention according to how they were randomized. This outcome is the duration of nonadherence event (the length of time the patient took to refill a prescription if the refill had been late), in days.

Outcome measures

Outcome measures
Measure	Default Patient n=244 Participants Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call	Choice Patient n=274 Participants Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call	Information Patient n=477 Participants Patient nonadherence information sent to physician	Control Patient n=479 Participants No information sent to physician, no opportunity for pharmacist intervention
Duration of Nonadherence Event	40.91 Days Standard Deviation 37.89	39.46 Days Standard Deviation 35.02	41.35 Days Standard Deviation 43.51	41.04 Days Standard Deviation 41.80

SECONDARY outcome

Timeframe: Participants were followed over a total of 6 months

Population: We excluded the Control group because we considered only claims where physicians assigned to a treatment arm would have been notified by email of nonadherence.

Patients who were more than 10 days late refilling a chronic medication prescription were in the analytic sample frame and were targeted for intervention according to how they were randomized. This outcome is the rate at which physicians viewed nonadherence event information. Outcome measures reported are the means of the per-person proportions of NAE event notices viewed by the physician across all patients in each particular arm.

Outcome measures

Outcome measures
Measure	Default Patient n=244 Participants Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call	Choice Patient n=274 Participants Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call	Information Patient n=477 Participants Patient nonadherence information sent to physician	Control Patient No information sent to physician, no opportunity for pharmacist intervention
Probability of Physician Viewing Nonadherence Event Information	0.2822 Proportion of NAEs viewed Standard Deviation 0.4505	0.3856 Proportion of NAEs viewed Standard Deviation 0.4872	0.3257 Proportion of NAEs viewed Standard Deviation 0.4688	—

SECONDARY outcome

Timeframe: Participants were followed over a total of 6 months

Population: We considered only claims for patients who had been randomly assigned to intervention arms where the pharmacist was available - Default and Choice.

Patients who were more than 10 days late refilling a chronic medication prescription were in the analytic sample frame and were targeted for intervention according to how they were randomized. This outcome is the rate at which pharmacist action was triggered to resolve nonadherence. Outcome measures reported are the means of the per-person proportions of NAE events which triggered pharmacist action across all patients in each particular arm.

Outcome measures

Outcome measures
Measure	Default Patient n=244 Participants Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call	Choice Patient n=274 Participants Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call	Information Patient Patient nonadherence information sent to physician	Control Patient No information sent to physician, no opportunity for pharmacist intervention
Probability of Pharmacist Action Triggered	0.6102 Proportion with pharmacist calls Standard Deviation 0.4881	0.1903 Proportion with pharmacist calls Standard Deviation 0.3929	—	—

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joanne Michaud

Brown University

Phone: 401-863-9317

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place