Trial Outcomes & Findings for Engaging Patients to Promote Deprescribing (NCT NCT04294901)

Last Updated: 2025-05-18

Results Overview

Non-refill of the medication in the 6 months following the primary care appointment (i.e., cessation) or any reduction in the total daily dose (i.e., de-escalation). There is an exception to the de-escalation rule for insulin, where only complete cessation will qualify since dose changes are less likely to be reflected in the order compared to oral medications.

Recruitment status

COMPLETED

Study phase

Target enrollment

5946 participants

Primary outcome timeframe

6 months post-index date

Results posted on

2025-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Group Patients who received an EMPOWER brochure two weeks before their primary care appointment. Direct to patient medication brochure: An EMPOWER medication brochure, adapted to the VA, designed to educate and activate patients. These brochures provide detailed medication information, allow self-testing of indications for use, prompt reflection of experiences with potential side effects, discuss alternative therapies (medication and non-pharmacologic options), and provide a vignette of a patient who successfully stopped the medicine. They were designed for a 6th grade reading level and were based upon theories of patient activation, adult learning, and cognitive dissonance. The visually appealing brochure repeatedly emphasizes that patients should not make any medication changes without first consulting their health care providers.	Historical Control Group The historical control cohort were seen by the same PCPs at the same sites as our intervention cohort from October 2019 to April 2020 (eighteen months to one year before the intervention timeframe). The PPI group included adult patients of any age with an active prescription for any PPI with at least 90 consecutive days on the medication in the prior year, excluding diagnoses for which PPI continuation would be appropriate (e.g., Barrett's esophagus, or those prescribed chronic anti-inflammatory drugs associated with peptic ulcers). The Gabapentin group included adult patients of any age with an active prescription of gabapentin \>1800mg/day with at least 90 consecutive days on the medication in the prior year, excluding patients with potential indications for use, including neuropathic pain, seizure disorders, and cancer-related pain. The hypoglycemia-risk group included patients with diabetes based upon ICD-10-CM diagnosis codes, most recent HbA1c \<7%, as well as one or more of the following criteria: 1) age 65 years or older, 2) renal insufficiency defined as creatinine \>2 mg/dL, and/or 3) a diagnosis of cognitive impairment or prescription for an acetylcholinesterase inhibitor (e.g., donepezil). Patients in the hypoglycemia-risk group had an active prescription for insulin or sulfonylurea with at least 90 consecutive days on the medication in the prior year.
Overall Study STARTED	3206	2740
Overall Study PPI	2064	2000
Overall Study DM-Hypoglycemia Risk	378	427
Overall Study Gabapentin	97	105
Overall Study COMPLETED	2539	2532
Overall Study NOT COMPLETED	667	208

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Group Patients who received an EMPOWER brochure two weeks before their primary care appointment. Direct to patient medication brochure: An EMPOWER medication brochure, adapted to the VA, designed to educate and activate patients. These brochures provide detailed medication information, allow self-testing of indications for use, prompt reflection of experiences with potential side effects, discuss alternative therapies (medication and non-pharmacologic options), and provide a vignette of a patient who successfully stopped the medicine. They were designed for a 6th grade reading level and were based upon theories of patient activation, adult learning, and cognitive dissonance. The visually appealing brochure repeatedly emphasizes that patients should not make any medication changes without first consulting their health care providers.	Historical Control Group The historical control cohort were seen by the same PCPs at the same sites as our intervention cohort from October 2019 to April 2020 (eighteen months to one year before the intervention timeframe). The PPI group included adult patients of any age with an active prescription for any PPI with at least 90 consecutive days on the medication in the prior year, excluding diagnoses for which PPI continuation would be appropriate (e.g., Barrett's esophagus, or those prescribed chronic anti-inflammatory drugs associated with peptic ulcers). The Gabapentin group included adult patients of any age with an active prescription of gabapentin \>1800mg/day with at least 90 consecutive days on the medication in the prior year, excluding patients with potential indications for use, including neuropathic pain, seizure disorders, and cancer-related pain. The hypoglycemia-risk group included patients with diabetes based upon ICD-10-CM diagnosis codes, most recent HbA1c \<7%, as well as one or more of the following criteria: 1) age 65 years or older, 2) renal insufficiency defined as creatinine \>2 mg/dL, and/or 3) a diagnosis of cognitive impairment or prescription for an acetylcholinesterase inhibitor (e.g., donepezil). Patients in the hypoglycemia-risk group had an active prescription for insulin or sulfonylurea with at least 90 consecutive days on the medication in the prior year.
Overall Study Death	86	110
Overall Study Provider did not have historical control patients	581	0
Overall Study Provider did not have intervention patients	0	98

Baseline Characteristics

Engaging Patients to Promote Deprescribing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=3206 Participants Patients who received an EMPOWER brochure two weeks before their primary care appointment. Direct to patient medication brochure: An EMPOWER medication brochure, adapted to the VA, designed to educate and activate patients. These brochures provide detailed medication information, allow self-testing of indications for use, prompt reflection of experiences with potential side effects, discuss alternative therapies (medication and non-pharmacologic options), and provide a vignette of a patient who successfully stopped the medicine. They were designed for a 6th grade reading level and were based upon theories of patient activation, adult learning, and cognitive dissonance. The visually appealing brochure repeatedly emphasizes that patients should not make any medication changes without first consulting their health care providers.	Historical Control Group n=2740 Participants The historical control cohort were seen by the same PCPs at the same sites as our intervention cohort from October 2019 to April 2020 (eighteen months to one year before the intervention timeframe). The PPI group included adult patients of any age with an active prescription for any PPI with at least 90 consecutive days on the medication in the prior year, excluding diagnoses for which PPI continuation would be appropriate (e.g., Barrett's esophagus, or those prescribed chronic anti-inflammatory drugs associated with peptic ulcers). The Gabapentin group included adult patients of any age with an active prescription of gabapentin \>1800mg/day with at least 90 consecutive days on the medication in the prior year, excluding patients with potential indications for use, including neuropathic pain, seizure disorders, and cancer-related pain. The hypoglycemia-risk group included patients with diabetes based upon ICD-10-CM diagnosis codes, most recent HbA1c \<7%, as well as one or more of the following criteria: 1) age 65 years or older, 2) renal insufficiency defined as creatinine \>2 mg/dL, and/or 3) a diagnosis of cognitive impairment or prescription for an acetylcholinesterase inhibitor (e.g., donepezil). Patients in the hypoglycemia-risk group had an active prescription for insulin or sulfonylurea with at least 90 consecutive days on the medication in the prior year.	Total n=5946 Participants Total of all reporting groups
Age, Continuous	71.15 years STANDARD_DEVIATION 12.03 • n=93 Participants	70.61 years STANDARD_DEVIATION 12.59 • n=4 Participants	70.68 years STANDARD_DEVIATION 12.30 • n=27 Participants
Sex: Female, Male Female	195 Participants n=93 Participants	141 Participants n=4 Participants	336 Participants n=27 Participants
Sex: Female, Male Male	3011 Participants n=93 Participants	2599 Participants n=4 Participants	5610 Participants n=27 Participants
Race/Ethnicity, Customized White	2287 Participants n=93 Participants	2029 Participants n=4 Participants	4316 Participants n=27 Participants
Race/Ethnicity, Customized Black	459 Participants n=93 Participants	297 Participants n=4 Participants	756 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	42 Participants n=93 Participants	36 Participants n=4 Participants	78 Participants n=27 Participants
Race/Ethnicity, Customized Asian	36 Participants n=93 Participants	53 Participants n=4 Participants	89 Participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	27 Participants n=93 Participants	33 Participants n=4 Participants	60 Participants n=27 Participants
Race/Ethnicity, Customized Missing	355 Participants n=93 Participants	292 Participants n=4 Participants	647 Participants n=27 Participants
Medication Group Proton Pump Inhibitor	2624 Participants n=93 Participants	2157 Participants n=4 Participants	4781 Participants n=27 Participants
Medication Group Gabapentin	121 Participants n=93 Participants	112 Participants n=4 Participants	233 Participants n=27 Participants
Medication Group Hypoglycemic	461 Participants n=93 Participants	471 Participants n=4 Participants	932 Participants n=27 Participants

PRIMARY outcome

Timeframe: 6 months post-index date

Population: It is pre-specified in the Study Protocol and Statistical Analysis Plan to assess all medication groups combined within the Intervention and Control Arms/Groups

Outcome measures

Outcome measures
Measure	Intervention Group n=2539 Participants Patients who received an EMPOWER brochure two weeks before scheduled primary care appointments. Direct to patient medication brochure: An EMPOWER medication brochure, adapted to the VA, designed to educate and activate patients. These brochures provide detailed medication information, allow self-testing of indications for use, prompt reflection of experiences with potential side effects, discuss alternative therapies (medication and non-pharmacologic options), and provide a vignette of a patient who successfully stopped the medicine. They were designed for a 6th grade reading level and were based upon theories of patient activation, adult learning, and cognitive dissonance. The visually appealing brochure repeatedly emphasizes that patients should not make any medication changes without first consulting their health care providers.	Historical Control Group n=2532 Participants The historical control cohort were seen by the same PCPs at the same sites as our intervention cohort from October 2019 to April 2020 (eighteen months to one year before the intervention timeframe). The PPI group included adult patients of any age with an active prescription for any PPI with at least 90 consecutive days on the medication in the prior year, excluding diagnoses for which PPI continuation would be appropriate (e.g., Barrett's esophagus, or those prescribed chronic anti-inflammatory drugs associated with peptic ulcers). The Gabapentin group included adult patients of any age with an active prescription of gabapentin \>1800mg/day with at least 90 consecutive days on the medication in the prior year, excluding patients with potential indications for use, including neuropathic pain, seizure disorders, and cancer-related pain. The hypoglycemia-risk group included patients with diabetes based upon ICD-10-CM diagnosis codes, most recent HbA1c \<7%, as well as one or more of the following criteria: 1) age 65 years or older, 2) renal insufficiency defined as creatinine \>2 mg/dL, and/or 3) a diagnosis of cognitive impairment or prescription for an acetylcholinesterase inhibitor (e.g., donepezil). Patients in the hypoglycemia-risk group had an active prescription for insulin or sulfonylurea with at least 90 consecutive days on the medication in the prior year.	Proton Pump Inhibitor (PPI) Patients prescribed a PPI meeting inclusion/exclusion criteria who have a primary care appointment with a provider in the PPI cohort Direct to patient medication brochure: An EMPOWER medication brochure, adapted to the VA, designed to educate and activate patients. These brochures provide detailed medication information, allow self-testing of indications for use, prompt reflection of experiences with potential side effects, discuss alternative therapies (medication and non-pharmacologic options), and provide a vignette of a patient who successfully stopped the medicine. They were designed for a 6th grade reading level and were based upon theories of patient activation, adult learning, and cognitive dissonance. The visually appealing brochure repeatedly emphasizes that patients should not make any medication changes without first consulting their health care providers.
Deprescribing	748 Participants	653 Participants	—

SECONDARY outcome

Timeframe: Index visit until survey completion (up to 8 weeks post-index visit)

Population: Note that this Outcome Measure was only assessed in a subsample of the "Intervention Group" Arm/Group participants who responded to the survey. It was not assessed at all in the "Historical Control Group" Arm/Group subjects.

Patient report of a conversation about deprescribing during the index primary care visit. Note that this Outcome Measure was only assessed in a subsample of the "Intervention Group" Arm/Group participants and not at all in the "Historical Control Group" Arm/Group subjects.

Outcome measures

Outcome measures
Measure	Intervention Group n=40 Participants Patients who received an EMPOWER brochure two weeks before scheduled primary care appointments. Direct to patient medication brochure: An EMPOWER medication brochure, adapted to the VA, designed to educate and activate patients. These brochures provide detailed medication information, allow self-testing of indications for use, prompt reflection of experiences with potential side effects, discuss alternative therapies (medication and non-pharmacologic options), and provide a vignette of a patient who successfully stopped the medicine. They were designed for a 6th grade reading level and were based upon theories of patient activation, adult learning, and cognitive dissonance. The visually appealing brochure repeatedly emphasizes that patients should not make any medication changes without first consulting their health care providers.	Historical Control Group n=226 Participants The historical control cohort were seen by the same PCPs at the same sites as our intervention cohort from October 2019 to April 2020 (eighteen months to one year before the intervention timeframe). The PPI group included adult patients of any age with an active prescription for any PPI with at least 90 consecutive days on the medication in the prior year, excluding diagnoses for which PPI continuation would be appropriate (e.g., Barrett's esophagus, or those prescribed chronic anti-inflammatory drugs associated with peptic ulcers). The Gabapentin group included adult patients of any age with an active prescription of gabapentin \>1800mg/day with at least 90 consecutive days on the medication in the prior year, excluding patients with potential indications for use, including neuropathic pain, seizure disorders, and cancer-related pain. The hypoglycemia-risk group included patients with diabetes based upon ICD-10-CM diagnosis codes, most recent HbA1c \<7%, as well as one or more of the following criteria: 1) age 65 years or older, 2) renal insufficiency defined as creatinine \>2 mg/dL, and/or 3) a diagnosis of cognitive impairment or prescription for an acetylcholinesterase inhibitor (e.g., donepezil). Patients in the hypoglycemia-risk group had an active prescription for insulin or sulfonylurea with at least 90 consecutive days on the medication in the prior year.	Proton Pump Inhibitor (PPI) n=1116 Participants Patients prescribed a PPI meeting inclusion/exclusion criteria who have a primary care appointment with a provider in the PPI cohort Direct to patient medication brochure: An EMPOWER medication brochure, adapted to the VA, designed to educate and activate patients. These brochures provide detailed medication information, allow self-testing of indications for use, prompt reflection of experiences with potential side effects, discuss alternative therapies (medication and non-pharmacologic options), and provide a vignette of a patient who successfully stopped the medicine. They were designed for a 6th grade reading level and were based upon theories of patient activation, adult learning, and cognitive dissonance. The visually appealing brochure repeatedly emphasizes that patients should not make any medication changes without first consulting their health care providers.
Deprescribing Conversations	12 Participants	37 Participants	353 Participants

Adverse Events

Intervention Group

Serious events: 25 serious events

Other events: 0 other events

Deaths: 86 deaths

Historical Control Group

Serious events: 26 serious events

Other events: 0 other events

Deaths: 110 deaths

Serious adverse events

Serious adverse events
Measure	Intervention Group n=2539 participants at risk Patients who received an EMPOWER brochure two weeks before their primary care appointment. Direct to patient medication brochure: An EMPOWER medication brochure, adapted to the VA, designed to educate and activate patients. These brochures provide detailed medication information, allow self-testing of indications for use, prompt reflection of experiences with potential side effects, discuss alternative therapies (medication and non-pharmacologic options), and provide a vignette of a patient who successfully stopped the medicine. They were designed for a 6th grade reading level and were based upon theories of patient activation, adult learning, and cognitive dissonance. The visually appealing brochure repeatedly emphasizes that patients should not make any medication changes without first consulting their health care providers.	Historical Control Group n=2532 participants at risk The historical control cohort were seen by the same PCPs at the same sites as our intervention cohort from October 2019 to April 2020 (eighteen months to one year before the intervention timeframe). The PPI group included adult patients of any age with an active prescription for any PPI with at least 90 consecutive days on the medication in the prior year, excluding diagnoses for which PPI continuation would be appropriate (e.g., Barrett's esophagus, or those prescribed chronic anti-inflammatory drugs associated with peptic ulcers). The Gabapentin group included adult patients of any age with an active prescription of gabapentin \>1800mg/day with at least 90 consecutive days on the medication in the prior year, excluding patients with potential indications for use, including neuropathic pain, seizure disorders, and cancer-related pain. The hypoglycemia-risk group included patients with diabetes based upon ICD-10-CM diagnosis codes, most recent HbA1c \<7%, as well as one or more of the following criteria: 1) age 65 years or older, 2) renal insufficiency defined as creatinine \>2 mg/dL, and/or 3) a diagnosis of cognitive impairment or prescription for an acetylcholinesterase inhibitor (e.g., donepezil). Patients in the hypoglycemia-risk group had an active prescription for insulin or sulfonylurea with at least 90 consecutive days on the medication in the prior year.
General disorders Potential adverse drug withdrawal event	0.98% 25/2539 • Number of events 25 • Potential medication-specific adverse drug withdrawal events (ADWEs) within 12 months after index date. All participants that started the study were assessed for All-Cause Mortality. Only the Safety Analysis Population was assessed for Serious and Other Adverse Events ADWEs - a priori specified serious adverse drug withdrawal events: upper gastrointestinal bleed for PPIs, diabetic ketoacidosis or hyperosmolar hyperglycemic state for insulin and sulfonylureas, and seizure for gabapentin. It was pre-specified to combine all medication groups within the Intervention and Control Arms/Groups.	1.0% 26/2532 • Number of events 26 • Potential medication-specific adverse drug withdrawal events (ADWEs) within 12 months after index date. All participants that started the study were assessed for All-Cause Mortality. Only the Safety Analysis Population was assessed for Serious and Other Adverse Events ADWEs - a priori specified serious adverse drug withdrawal events: upper gastrointestinal bleed for PPIs, diabetic ketoacidosis or hyperosmolar hyperglycemic state for insulin and sulfonylureas, and seizure for gabapentin. It was pre-specified to combine all medication groups within the Intervention and Control Arms/Groups.

Other adverse events

Adverse event data not reported

Additional Information

Amy Linsky, MD, MSc

VA Boston Healthcare System

Phone: 857-364-2760

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place