Trial Outcomes & Findings for Anticoagulation With Enhanced Gastrointestinal Safety (NCT NCT05563714)
NCT ID: NCT05563714
Last Updated: 2024-04-30
Results Overview
The percent of patients reporting medication optimization is defined as the number of patients who either discontinue all antiplatelet medications (none in the past 7 days) or initiate and adhere to a proton pump inhibitor (PPI) (use for at least 5 of the prior 7 days) based on self-report at week 7-10 divided by the total number of patients in that randomization arm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
341 participants
Primary outcome timeframe
Up to 10 weeks
Results posted on
2024-04-30
Participant Flow
Participant milestones
| Measure |
Patient Arm - Clinician Notification With Nurse Facilitation (CNNF)
Clinician Notification with Nurse Facilitation (CNNF): An anticoagulation clinic nurse sends a templated message to the patient's target clinician that identifies the patient as high risk for upper GI bleeding, summarizes guidelines on appropriate antiplatelet medication use and PPI gastroprotection, and recommends that the clinician consider either discontinuing the patient's antiplatelet medication(s) or initiating a PPI for gastroprotection. The nurse will also offer to pend the order for a PPI if the clinician wants to initiate a PPI and will provide education to the patient on any medication changes recommended by the clinician.
|
Patient Arm - Wait List Control (Usual Care)
Wait list control: The anticoagulation clinic will not send the clinician notification letter or other project-specific materials to the clinician or patient, and the patient will be included on a list of patients who will receive the intervention at the conclusion of the trial.
|
Clinician Arm - Clinician Notification With Nurse Facilitation (CNNF)
Clinician Notification with Nurse Facilitation (CNNF): An anticoagulation clinic nurse sends a templated message to the patient's target clinician that identifies the patient as high risk for upper GI bleeding, summarizes guidelines on appropriate antiplatelet medication use and PPI gastroprotection, and recommends that the clinician consider either discontinuing the patient's antiplatelet medication(s) or initiating a PPI for gastroprotection. The nurse will also offer to pend the order for a PPI if the clinician wants to initiate a PPI and will provide education to the patient on any medication changes recommended by the clinician.
|
Clinician Arm - Wait List Control (Usual Care)
Wait list control: The anticoagulation clinic will not send the clinician notification letter or other project-specific materials to the clinician or patient, and the patient will be included on a list of patients who will receive the intervention at the conclusion of the trial.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
110
|
110
|
61
|
60
|
|
Overall Study
COMPLETED
|
81
|
83
|
61
|
60
|
|
Overall Study
NOT COMPLETED
|
29
|
27
|
0
|
0
|
Reasons for withdrawal
| Measure |
Patient Arm - Clinician Notification With Nurse Facilitation (CNNF)
Clinician Notification with Nurse Facilitation (CNNF): An anticoagulation clinic nurse sends a templated message to the patient's target clinician that identifies the patient as high risk for upper GI bleeding, summarizes guidelines on appropriate antiplatelet medication use and PPI gastroprotection, and recommends that the clinician consider either discontinuing the patient's antiplatelet medication(s) or initiating a PPI for gastroprotection. The nurse will also offer to pend the order for a PPI if the clinician wants to initiate a PPI and will provide education to the patient on any medication changes recommended by the clinician.
|
Patient Arm - Wait List Control (Usual Care)
Wait list control: The anticoagulation clinic will not send the clinician notification letter or other project-specific materials to the clinician or patient, and the patient will be included on a list of patients who will receive the intervention at the conclusion of the trial.
|
Clinician Arm - Clinician Notification With Nurse Facilitation (CNNF)
Clinician Notification with Nurse Facilitation (CNNF): An anticoagulation clinic nurse sends a templated message to the patient's target clinician that identifies the patient as high risk for upper GI bleeding, summarizes guidelines on appropriate antiplatelet medication use and PPI gastroprotection, and recommends that the clinician consider either discontinuing the patient's antiplatelet medication(s) or initiating a PPI for gastroprotection. The nurse will also offer to pend the order for a PPI if the clinician wants to initiate a PPI and will provide education to the patient on any medication changes recommended by the clinician.
|
Clinician Arm - Wait List Control (Usual Care)
Wait list control: The anticoagulation clinic will not send the clinician notification letter or other project-specific materials to the clinician or patient, and the patient will be included on a list of patients who will receive the intervention at the conclusion of the trial.
|
|---|---|---|---|---|
|
Overall Study
Death
|
2
|
2
|
0
|
0
|
|
Overall Study
Patient unenrollment from Anticoagulation Monitoring Service prior to primary outcome assessment
|
4
|
3
|
0
|
0
|
|
Overall Study
Patient medication change - warfarin discontinuation, switch to DOAC therapy
|
1
|
2
|
0
|
0
|
|
Overall Study
Patient hospitalized for entirety of primary outcome assessment timeframe
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
22
|
19
|
0
|
0
|
Baseline Characteristics
This data was not collected for clinician participants.
Baseline characteristics by cohort
| Measure |
Patient Arm - Clinician Notification With Nurse Facilitation (CNNF)
n=110 Participants
Clinician Notification with Nurse Facilitation (CNNF): An anticoagulation clinic nurse sends a templated message to the patient's target clinician that identifies the patient as high risk for upper GI bleeding, summarizes guidelines on appropriate antiplatelet medication use and PPI gastroprotection, and recommends that the clinician consider either discontinuing the patient's antiplatelet medication(s) or initiating a PPI for gastroprotection. The nurse will also offer to pend the order for a PPI if the clinician wants to initiate a PPI and will provide education to the patient on any medication changes recommended by the clinician.
|
Patient Arm - Wait List Control (Usual Care)
n=110 Participants
Wait list control: The anticoagulation clinic will not send the clinician notification letter or other project-specific materials to the clinician or patient, and the patient will be included on a list of patients who will receive the intervention at the conclusion of the trial.
|
Clinician Arm - Clinician Notification With Nurse Facilitation (CNNF)
n=61 Participants
Clinician Notification with Nurse Facilitation (CNNF): An anticoagulation clinic nurse sends a templated message to the patient's target clinician that identifies the patient as high risk for upper GI bleeding, summarizes guidelines on appropriate antiplatelet medication use and PPI gastroprotection, and recommends that the clinician consider either discontinuing the patient's antiplatelet medication(s) or initiating a PPI for gastroprotection. The nurse will also offer to pend the order for a PPI if the clinician wants to initiate a PPI and will provide education to the patient on any medication changes recommended by the clinician.
|
Clinician Arm - Wait List Control (Usual Care)
n=60 Participants
Wait list control: The anticoagulation clinic will not send the clinician notification letter or other project-specific materials to the clinician or patient, and the patient will be included on a list of patients who will receive the intervention at the conclusion of the trial.
|
Total
n=341 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Concomitant Medications
Aldosterone Antagonist Use
|
22 Participants
n=110 Participants • This data was not collected for clinician participants.
|
17 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
39 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Medical History
Atrial Fibrillation
|
46 Participants
n=110 Participants • This data was not collected for clinician participants.
|
40 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
86 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Medical History
Venous Thromboembolism
|
34 Participants
n=110 Participants • This data was not collected for clinician participants.
|
28 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
62 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Medical History
Valve Replacement
|
46 Participants
n=110 Participants • This data was not collected for clinician participants.
|
52 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
98 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Age, Customized
Patient Characteristics - Age
|
64 years
n=110 Participants • This data was not collected for clinician participants.
|
65 years
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
64 years
n=220 Participants • This data was not collected for clinician participants.
|
|
Sex: Female, Male
Patient Characteristics - Sex · Female
|
43 Participants
n=110 Participants • Patient and clinician data are reported separately.
|
36 Participants
n=110 Participants • Patient and clinician data are reported separately.
|
—
|
—
|
79 Participants
n=220 Participants • Patient and clinician data are reported separately.
|
|
Sex: Female, Male
Patient Characteristics - Sex · Male
|
67 Participants
n=110 Participants • Patient and clinician data are reported separately.
|
74 Participants
n=110 Participants • Patient and clinician data are reported separately.
|
—
|
—
|
141 Participants
n=220 Participants • Patient and clinician data are reported separately.
|
|
Sex: Female, Male
Clinician Characteristics - Sex · Female
|
—
|
—
|
26 Participants
n=61 Participants • Patient and clinician data are reported separately.
|
23 Participants
n=60 Participants • Patient and clinician data are reported separately.
|
49 Participants
n=121 Participants • Patient and clinician data are reported separately.
|
|
Sex: Female, Male
Clinician Characteristics - Sex · Male
|
—
|
—
|
35 Participants
n=61 Participants • Patient and clinician data are reported separately.
|
37 Participants
n=60 Participants • Patient and clinician data are reported separately.
|
72 Participants
n=121 Participants • Patient and clinician data are reported separately.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=110 Participants • This data was not collected for clinician participants.
|
1 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
2 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
108 Participants
n=110 Participants • This data was not collected for clinician participants.
|
104 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
212 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=110 Participants • This data was not collected for clinician participants.
|
5 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
6 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=110 Participants • This data was not collected for clinician participants.
|
0 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
1 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=110 Participants • This data was not collected for clinician participants.
|
1 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
5 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=110 Participants • This data was not collected for clinician participants.
|
0 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
0 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=110 Participants • This data was not collected for clinician participants.
|
6 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
21 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Race (NIH/OMB)
White
|
86 Participants
n=110 Participants • This data was not collected for clinician participants.
|
99 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
185 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=110 Participants • This data was not collected for clinician participants.
|
0 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
0 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=110 Participants • This data was not collected for clinician participants.
|
4 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
8 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Region of Enrollment
United States
|
110 participants
n=110 Participants
|
110 participants
n=110 Participants
|
61 participants
n=61 Participants
|
60 participants
n=60 Participants
|
341 participants
n=341 Participants
|
|
Antiplatelet Therapy
Aspirin
|
105 Participants
n=110 Participants • This data was not collected for clinician participants.
|
96 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
201 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Antiplatelet Therapy
Clopidogrel
|
4 Participants
n=110 Participants • This data was not collected for clinician participants.
|
12 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
16 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Antiplatelet Therapy
Dual Antiplatelet Therapy
|
1 Participants
n=110 Participants • This data was not collected for clinician participants.
|
2 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
3 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Concomitant Medications
H2 Receptor Antagonist Use
|
11 Participants
n=110 Participants • This data was not collected for clinician participants.
|
5 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
16 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Concomitant Medications
Oral Non-Steroidal Anti-Inflammatory Drug (NSAID) Use
|
2 Participants
n=110 Participants • This data was not collected for clinician participants.
|
2 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
4 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Concomitant Medications
Selective Serotonin Reuptake Inhibitor (SSRI) Use
|
17 Participants
n=110 Participants • This data was not collected for clinician participants.
|
11 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
28 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Concomitant Medications
Oral Glucocorticoid Use
|
5 Participants
n=110 Participants • This data was not collected for clinician participants.
|
5 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
10 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Medical History
Coronary Artery Disease
|
43 Participants
n=110 Participants • This data was not collected for clinician participants.
|
48 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
91 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Medical History
Antiphospholipid Syndrome
|
11 Participants
n=110 Participants • This data was not collected for clinician participants.
|
4 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
15 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Medical History
Peripheral Artery Disease
|
20 Participants
n=110 Participants • This data was not collected for clinician participants.
|
17 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
37 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Medical History
Cerebrovascular Disease
|
27 Participants
n=110 Participants • This data was not collected for clinician participants.
|
19 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
46 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Medical History
GI Bleeding or Peptic Ulcer Disease
|
6 Participants
n=110 Participants • This data was not collected for clinician participants.
|
2 Participants
n=110 Participants • This data was not collected for clinician participants.
|
—
|
—
|
8 Participants
n=220 Participants • This data was not collected for clinician participants.
|
|
Clinician Specialty
Patient Characteristics - Clinician Specialty · Cardiology
|
54 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
56 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
—
|
—
|
110 Participants
n=220 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
|
Clinician Specialty
Patient Characteristics - Clinician Specialty · Electrophysiology
|
2 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
2 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
—
|
—
|
4 Participants
n=220 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
|
Clinician Specialty
Patient Characteristics - Clinician Specialty · Hematology
|
3 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
3 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
—
|
—
|
6 Participants
n=220 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
|
Clinician Specialty
Patient Characteristics - Clinician Specialty · Hepatology
|
0 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
1 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
—
|
—
|
1 Participants
n=220 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
|
Clinician Specialty
Patient Characteristics - Clinician Specialty · Primary Care
|
33 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
28 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
—
|
—
|
61 Participants
n=220 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
|
Clinician Specialty
Patient Characteristics - Clinician Specialty · Pulmonology
|
0 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
1 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
—
|
—
|
1 Participants
n=220 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
|
Clinician Specialty
Patient Characteristics - Clinician Specialty · Radiology
|
4 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
1 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
—
|
—
|
5 Participants
n=220 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
|
Clinician Specialty
Patient Characteristics - Clinician Specialty · Rheumatology
|
4 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
0 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
—
|
—
|
4 Participants
n=220 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
|
Clinician Specialty
Patient Characteristics - Clinician Specialty · Thoracic Surgery
|
8 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
8 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
—
|
—
|
16 Participants
n=220 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
|
Clinician Specialty
Patient Characteristics - Clinician Specialty · Vascular Surgery
|
2 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
10 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
—
|
—
|
12 Participants
n=220 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
|
Clinician Specialty
Clinician Characteristics - Clinician Specialty · Cardiology
|
—
|
—
|
23 Participants
n=61 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
22 Participants
n=60 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
45 Participants
n=121 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
|
Clinician Specialty
Clinician Characteristics - Clinician Specialty · Electrophysiology
|
—
|
—
|
1 Participants
n=61 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
1 Participants
n=60 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
2 Participants
n=121 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
|
Clinician Specialty
Clinician Characteristics - Clinician Specialty · Hematology
|
—
|
—
|
2 Participants
n=61 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
2 Participants
n=60 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
4 Participants
n=121 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
|
Clinician Specialty
Clinician Characteristics - Clinician Specialty · Hepatology
|
—
|
—
|
0 Participants
n=61 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
1 Participants
n=60 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
1 Participants
n=121 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
|
Clinician Specialty
Clinician Characteristics - Clinician Specialty · Primary Care
|
—
|
—
|
27 Participants
n=61 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
25 Participants
n=60 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
52 Participants
n=121 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
|
Clinician Specialty
Clinician Characteristics - Clinician Specialty · Pulmonology
|
—
|
—
|
0 Participants
n=61 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
1 Participants
n=60 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
1 Participants
n=121 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
|
Clinician Specialty
Clinician Characteristics - Clinician Specialty · Radiology
|
—
|
—
|
2 Participants
n=61 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
1 Participants
n=60 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
3 Participants
n=121 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
|
Clinician Specialty
Clinician Characteristics - Clinician Specialty · Rheumatology
|
—
|
—
|
1 Participants
n=61 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
0 Participants
n=60 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
1 Participants
n=121 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
|
Clinician Specialty
Clinician Characteristics - Clinician Specialty · Thoracic Surgery
|
—
|
—
|
4 Participants
n=61 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
4 Participants
n=60 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
8 Participants
n=121 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
|
Clinician Specialty
Clinician Characteristics - Clinician Specialty · Vascular Surgery
|
—
|
—
|
1 Participants
n=61 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
3 Participants
n=60 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
4 Participants
n=121 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
|
|
Clinician Proceduralist Status
Patient Characteristics - Clinician Proceduralist Status · Proceduralist
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16 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
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21 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
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—
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—
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37 Participants
n=220 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
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Clinician Proceduralist Status
Patient Characteristics - Clinician Proceduralist Status · Non-Proceduralist
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94 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
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89 Participants
n=110 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
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—
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—
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183 Participants
n=220 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
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Clinician Proceduralist Status
Clinician Characteristics - Clinician Proceduralist Status · Proceduralist
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—
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—
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8 Participants
n=61 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
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9 Participants
n=60 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
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17 Participants
n=121 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
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Clinician Proceduralist Status
Clinician Characteristics - Clinician Proceduralist Status · Non-Proceduralist
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—
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—
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53 Participants
n=61 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
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51 Participants
n=60 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
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104 Participants
n=121 Participants • As up to 4 patients were assigned to each clinician cluster, this data is reported separately for patient and clinician participants.
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Years Since Medical School Completed
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—
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—
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22 years
n=61 Participants • This measure applies only to clinician participants and data was not collected for patient participants.
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22 years
n=60 Participants • This measure applies only to clinician participants and data was not collected for patient participants.
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22 years
n=121 Participants • This measure applies only to clinician participants and data was not collected for patient participants.
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PRIMARY outcome
Timeframe: Up to 10 weeksPopulation: All patients who entered the study were included in this intention-to-treat analysis. Multiple imputation was used to account for missing data for patients lost to follow-up, including patients who were closed to the anticoagulation service, discontinued warfarin therapy, died or were hospitalized throughout the data collection window, were unreachable by phone, declined to participate in the phone survey, or self-reported non-use of antiplatelet therapy or use of PPIs at baseline.
The percent of patients reporting medication optimization is defined as the number of patients who either discontinue all antiplatelet medications (none in the past 7 days) or initiate and adhere to a proton pump inhibitor (PPI) (use for at least 5 of the prior 7 days) based on self-report at week 7-10 divided by the total number of patients in that randomization arm.
Outcome measures
| Measure |
Patient Arm - Clinician Notification With Nurse Facilitation (CNNF)
n=110 Participants
Clinician Notification with Nurse Facilitation (CNNF): An anticoagulation clinic nurse sends a templated message to the patient's target clinician that identifies the patient as high risk for upper GI bleeding, summarizes guidelines on appropriate antiplatelet medication use and PPI gastroprotection, and recommends that the clinician consider either discontinuing the patient's antiplatelet medication(s) or initiating a PPI for gastroprotection. The nurse will also offer to pend the order for a PPI if the clinician wants to initiate a PPI and will provide education to the patient on any medication changes recommended by the clinician.
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Patient Arm - Wait List Control (Usual Care)
n=110 Participants
Wait list control: The anticoagulation clinic will not send the clinician notification letter or other project-specific materials to the clinician or patient, and the patient will be included on a list of patients who will receive the intervention at the conclusion of the trial.
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|---|---|---|
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ITT Analysis - Percent of Patients Reporting Medication Optimization
Reached by phone & achieved medication optimization
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30 Participants
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2 Participants
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ITT Analysis - Percent of Patients Reporting Medication Optimization
Reached by phone & did not achieve medication optimization
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29 Participants
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65 Participants
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ITT Analysis - Percent of Patients Reporting Medication Optimization
Data Imputed - Reached by phone but reported non-use of antiplatelet therapy at baseline
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15 Participants
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10 Participants
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ITT Analysis - Percent of Patients Reporting Medication Optimization
Data Imputed - Reached by phone but reported use of or uncertain use of PPIs at baseline
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8 Participants
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6 Participants
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ITT Analysis - Percent of Patients Reporting Medication Optimization
Data Imputed - Patients lost to follow-up due to death or hospitalization
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2 Participants
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3 Participants
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ITT Analysis - Percent of Patients Reporting Medication Optimization
Data Imputed - Patients closed to the anticoagulation service or who discontinued warfarin therapy
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5 Participants
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5 Participants
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ITT Analysis - Percent of Patients Reporting Medication Optimization
Data Imputed - Patients unable to be reached by phone or who declined to participate in the survey
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21 Participants
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19 Participants
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PRIMARY outcome
Timeframe: Up to 10 weeksPopulation: Patients who self-reported either not using antiplatelet therapy or using a PPI at the start of the trial during the week 7-10 phone survey, and those who were lost to follow up were excluded from the modified completer analysis (n=94).
The percent of patients reporting medication optimization is defined as the number of patients who either discontinue all antiplatelet medications (none in the past 7 days) or initiate and adhere to a proton pump inhibitor (PPI) (use for at least 5 of the prior 7 days) based on self-report at week 7-10 divided by the total number of patients in that randomization arm.
Outcome measures
| Measure |
Patient Arm - Clinician Notification With Nurse Facilitation (CNNF)
n=59 Participants
Clinician Notification with Nurse Facilitation (CNNF): An anticoagulation clinic nurse sends a templated message to the patient's target clinician that identifies the patient as high risk for upper GI bleeding, summarizes guidelines on appropriate antiplatelet medication use and PPI gastroprotection, and recommends that the clinician consider either discontinuing the patient's antiplatelet medication(s) or initiating a PPI for gastroprotection. The nurse will also offer to pend the order for a PPI if the clinician wants to initiate a PPI and will provide education to the patient on any medication changes recommended by the clinician.
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Patient Arm - Wait List Control (Usual Care)
n=67 Participants
Wait list control: The anticoagulation clinic will not send the clinician notification letter or other project-specific materials to the clinician or patient, and the patient will be included on a list of patients who will receive the intervention at the conclusion of the trial.
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|---|---|---|
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Modified Completer Analysis - Percent of Patients Reporting Medication Optimization
All patients who reported non-use of antiplatelet therapy or use of PPI gastroprotection
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30 Participants
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2 Participants
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Modified Completer Analysis - Percent of Patients Reporting Medication Optimization
Stopped antiplatelet therapy
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17 Participants
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1 Participants
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Modified Completer Analysis - Percent of Patients Reporting Medication Optimization
Started a PPI
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11 Participants
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1 Participants
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Modified Completer Analysis - Percent of Patients Reporting Medication Optimization
Stopped antiplatelet therapy and started a PPI
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2 Participants
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0 Participants
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SECONDARY outcome
Timeframe: Up to 10 weeksThe number of patients who have a recommendation from a Michigan Medicine clinician to either discontinue all antiplatelet medications or initiate a PPI divided by the total number of patients in that randomization arm.
Outcome measures
| Measure |
Patient Arm - Clinician Notification With Nurse Facilitation (CNNF)
n=110 Participants
Clinician Notification with Nurse Facilitation (CNNF): An anticoagulation clinic nurse sends a templated message to the patient's target clinician that identifies the patient as high risk for upper GI bleeding, summarizes guidelines on appropriate antiplatelet medication use and PPI gastroprotection, and recommends that the clinician consider either discontinuing the patient's antiplatelet medication(s) or initiating a PPI for gastroprotection. The nurse will also offer to pend the order for a PPI if the clinician wants to initiate a PPI and will provide education to the patient on any medication changes recommended by the clinician.
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Patient Arm - Wait List Control (Usual Care)
n=110 Participants
Wait list control: The anticoagulation clinic will not send the clinician notification letter or other project-specific materials to the clinician or patient, and the patient will be included on a list of patients who will receive the intervention at the conclusion of the trial.
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|---|---|---|
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ITT Analysis - Percent of Patients With Documented Recommendation Regarding Antiplatelet Therapy Cessation or PPI Initiation
Received a recommendation for medication optimization
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75 Participants
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1 Participants
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ITT Analysis - Percent of Patients With Documented Recommendation Regarding Antiplatelet Therapy Cessation or PPI Initiation
Received a recommendation to discontinue antiplatelet therapy
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32 Participants
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1 Participants
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ITT Analysis - Percent of Patients With Documented Recommendation Regarding Antiplatelet Therapy Cessation or PPI Initiation
Received a recommendation to initiate a PPI
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38 Participants
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0 Participants
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ITT Analysis - Percent of Patients With Documented Recommendation Regarding Antiplatelet Therapy Cessation or PPI Initiation
Received a recommendation to discontinue antiplatelet therapy and to initiate a PPI
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5 Participants
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0 Participants
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Adverse Events
Patient Arm - Clinician Notification With Nurse Facilitation (CNNF)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Patient Arm - Wait List Control (Usual Care)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Clinician Arm - Clinician Notification With Nurse Facilitation (CNNF)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinician Arm - Wait List Control (Usual Care)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place