Trial Outcomes & Findings for Comparative Effectiveness Trial of Communication Strategies in the Management of Chronic Pain (NCT NCT03301623)

Last Updated: 2021-10-13

Results Overview

PROMIS - Pain Interference instruments assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Pain Interference, a T-score of 60 is one SD higher pain than average. A t-score of 50 represents the mean pain interference reported by a representative US population. We report pre- and post-intervention means. Analysis featured a linear mixed model for repeated measures where the term of interest was an interaction term describing the change in the PEAT group during the post-intervention period.

Recruitment status

COMPLETED

Study phase

Target enrollment

983 participants

Primary outcome timeframe

Assessed at baseline at randomization, monthly up to 20 months after start of intervention (i.e. repeated measures).

Results posted on

2021-10-13

Participant Flow

Participant milestones

Participant milestones
Measure	Clinical Decision Support Patients within the physicians randomized to the Informed Decision Making (IDM) arm will receive the Clinical Decision Support alerts via the Electronic Health Record (EHR) when certain order criteria are triggered appropriately. Clinical Decision Support: The CDS intervention will test the use of existing guideline-based EHR alerts related to the prescription of opioids. CDS alerts employ computer algorithms that account for patient characteristics and diagnoses to deliver reminders of appropriate use when a provider enters an order for a medication.	Patient Education and Activation Tools Patients within the physicians randomized to Shared Decision Making (SDM) will receive the PEAT materials via REDCap two days prior to their Primary Care Physician (PCP) office visit. They will receive these materials every time they have an office visit with their PCP. Patient Education and Activation Tools: The patient education materials selected for this study: "Pain Management: Which Treatment is Right for You," "Preparing for Your Health Care Visit," and a video from the American Chronic Pain Association (ACPA) named "A Car with Four Flat Tires," which helps to give patients a better understanding of how multi-modal treatment can be more effective than relying on one source of treatment (e.g., pain medication).
Overall Study STARTED	462	521
Overall Study COMPLETED	445	506
Overall Study NOT COMPLETED	17	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Clinical Decision Support Patients within the physicians randomized to the Informed Decision Making (IDM) arm will receive the Clinical Decision Support alerts via the Electronic Health Record (EHR) when certain order criteria are triggered appropriately. Clinical Decision Support: The CDS intervention will test the use of existing guideline-based EHR alerts related to the prescription of opioids. CDS alerts employ computer algorithms that account for patient characteristics and diagnoses to deliver reminders of appropriate use when a provider enters an order for a medication.	Patient Education and Activation Tools Patients within the physicians randomized to Shared Decision Making (SDM) will receive the PEAT materials via REDCap two days prior to their Primary Care Physician (PCP) office visit. They will receive these materials every time they have an office visit with their PCP. Patient Education and Activation Tools: The patient education materials selected for this study: "Pain Management: Which Treatment is Right for You," "Preparing for Your Health Care Visit," and a video from the American Chronic Pain Association (ACPA) named "A Car with Four Flat Tires," which helps to give patients a better understanding of how multi-modal treatment can be more effective than relying on one source of treatment (e.g., pain medication).
Overall Study Death	3	1
Overall Study Withdrawal by Subject	11	13
Overall Study Lost to Follow-up	3	1

Baseline Characteristics

Sample limited to survey respondents.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clinical Decision Support n=445 Participants Patients within the physicians randomized to the IDM arm will receive the Clinical Decision Support alerts via the EHR when certain order criteria are triggered appropriately. Clinical Decision Support: The CDS intervention will test the use of existing guideline-based EHR alerts related to the prescription of opioids. CDS alerts employ computer algorithms that account for patient characteristics and diagnoses to deliver reminders of appropriate use when a provider enters an order for a medication.	Patient Education and Activation Tools n=506 Participants Patients within the physicians randomized to SDM will receive the PEAT materials via REDCap two days prior to their PCP office visit. They will receive these materials every time they have an office visit with their PCP. Patient Education and Activation Tools: The patient education materials selected for this study: "Pain Management: Which Treatment is Right for You," "Preparing for Your Health Care Visit," and a video from the American Chronic Pain Association (ACPA) named "A Car with Four Flat Tires," which helps to give patients a better understanding of how multi-modal treatment can be more effective than relying on one source of treatment (e.g., pain medication).	Total n=951 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=445 Participants	0 Participants n=506 Participants	0 Participants n=951 Participants
Age, Categorical Between 18 and 65 years	317 Participants n=445 Participants	380 Participants n=506 Participants	697 Participants n=951 Participants
Age, Categorical >=65 years	128 Participants n=445 Participants	126 Participants n=506 Participants	254 Participants n=951 Participants
Age, Continuous	55.38 years STANDARD_DEVIATION 16.01 • n=445 Participants	53.57 years STANDARD_DEVIATION 16.08 • n=506 Participants	54.42 years STANDARD_DEVIATION 16.07 • n=951 Participants
Sex: Female, Male Female	262 Participants n=445 Participants	290 Participants n=506 Participants	552 Participants n=951 Participants
Sex: Female, Male Male	183 Participants n=445 Participants	216 Participants n=506 Participants	399 Participants n=951 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=445 Participants	2 Participants n=506 Participants	4 Participants n=951 Participants
Race (NIH/OMB) Asian	26 Participants n=445 Participants	29 Participants n=506 Participants	55 Participants n=951 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=445 Participants	3 Participants n=506 Participants	3 Participants n=951 Participants
Race (NIH/OMB) Black or African American	93 Participants n=445 Participants	120 Participants n=506 Participants	213 Participants n=951 Participants
Race (NIH/OMB) White	283 Participants n=445 Participants	313 Participants n=506 Participants	596 Participants n=951 Participants
Race (NIH/OMB) More than one race	0 Participants n=445 Participants	0 Participants n=506 Participants	0 Participants n=951 Participants
Race (NIH/OMB) Unknown or Not Reported	41 Participants n=445 Participants	39 Participants n=506 Participants	80 Participants n=951 Participants
Region of Enrollment United States	445 participants n=445 Participants	506 participants n=506 Participants	951 participants n=951 Participants
PROMIS - Pain Interference Short Form 8a	62.18 t-score STANDARD_DEVIATION 8.54 • n=89 Participants • Sample limited to survey respondents.	62.79 t-score STANDARD_DEVIATION 6.85 • n=73 Participants • Sample limited to survey respondents.	62.46 t-score STANDARD_DEVIATION 7.78 • n=162 Participants • Sample limited to survey respondents.
CAHPS® Clinician & Group Survey (CG-CAHPS) Top Box	108 Responses n=170 Participants • Analysis was limited to survey respondents. CG-CAHPS is an extant measure within the health system. All surveys for PCPs in the study were included in analysis. There was not a requirement for a patient to have balanced data (i.e. responses in both study periods) to be included in analysis.	79 Responses n=187 Participants • Analysis was limited to survey respondents. CG-CAHPS is an extant measure within the health system. All surveys for PCPs in the study were included in analysis. There was not a requirement for a patient to have balanced data (i.e. responses in both study periods) to be included in analysis.	188 Responses n=357 Participants • Analysis was limited to survey respondents. CG-CAHPS is an extant measure within the health system. All surveys for PCPs in the study were included in analysis. There was not a requirement for a patient to have balanced data (i.e. responses in both study periods) to be included in analysis.
CAHPS® Clinician & Group Survey (CG-CAHPS) Not Top Box	14 Responses n=170 Participants • Analysis was limited to survey respondents. CG-CAHPS is an extant measure within the health system. All surveys for PCPs in the study were included in analysis. There was not a requirement for a patient to have balanced data (i.e. responses in both study periods) to be included in analysis.	24 Responses n=187 Participants • Analysis was limited to survey respondents. CG-CAHPS is an extant measure within the health system. All surveys for PCPs in the study were included in analysis. There was not a requirement for a patient to have balanced data (i.e. responses in both study periods) to be included in analysis.	38 Responses n=357 Participants • Analysis was limited to survey respondents. CG-CAHPS is an extant measure within the health system. All surveys for PCPs in the study were included in analysis. There was not a requirement for a patient to have balanced data (i.e. responses in both study periods) to be included in analysis.
PROMIS Physical Function 6b v1.2	38.82 t-score STANDARD_DEVIATION 9.24 • n=88 Participants • Sample limited to survey respondents.	38.32 t-score STANDARD_DEVIATION 7.39 • n=72 Participants • Sample limited to survey respondents.	38.59 t-score STANDARD_DEVIATION 8.41 • n=160 Participants • Sample limited to survey respondents.
Opioid Prescription Over 90 Morphine Milligram Equivalents (MME) (Dichotomous) Rx Over 90	68 prescriptions n=445 Participants • Limited to participants with at least one prescription during the post-intervention period. Multiple prescriptions are possible within patient.	210 prescriptions n=506 Participants • Limited to participants with at least one prescription during the post-intervention period. Multiple prescriptions are possible within patient.	278 prescriptions n=951 Participants • Limited to participants with at least one prescription during the post-intervention period. Multiple prescriptions are possible within patient.
Opioid Prescription Over 90 Morphine Milligram Equivalents (MME) (Dichotomous) Rx Not Over 90	737 prescriptions n=445 Participants • Limited to participants with at least one prescription during the post-intervention period. Multiple prescriptions are possible within patient.	1212 prescriptions n=506 Participants • Limited to participants with at least one prescription during the post-intervention period. Multiple prescriptions are possible within patient.	1949 prescriptions n=951 Participants • Limited to participants with at least one prescription during the post-intervention period. Multiple prescriptions are possible within patient.
Co-prescription of Opioids and Benzodiazepines Co-Prescriptions	40 prescriptions n=445 Participants • Sample limited to participants who had a prescription for benzodiazepines during the study period. There was not a requirement for a patient to have balanced data (i.e. prescriptions in both study periods) to be included in analysis.	30 prescriptions n=506 Participants • Sample limited to participants who had a prescription for benzodiazepines during the study period. There was not a requirement for a patient to have balanced data (i.e. prescriptions in both study periods) to be included in analysis.	70 prescriptions n=951 Participants • Sample limited to participants who had a prescription for benzodiazepines during the study period. There was not a requirement for a patient to have balanced data (i.e. prescriptions in both study periods) to be included in analysis.
Co-prescription of Opioids and Benzodiazepines Not Co-Prescriptions	20 prescriptions n=445 Participants • Sample limited to participants who had a prescription for benzodiazepines during the study period. There was not a requirement for a patient to have balanced data (i.e. prescriptions in both study periods) to be included in analysis.	86 prescriptions n=506 Participants • Sample limited to participants who had a prescription for benzodiazepines during the study period. There was not a requirement for a patient to have balanced data (i.e. prescriptions in both study periods) to be included in analysis.	106 prescriptions n=951 Participants • Sample limited to participants who had a prescription for benzodiazepines during the study period. There was not a requirement for a patient to have balanced data (i.e. prescriptions in both study periods) to be included in analysis.
Patient Health Questionnaire-9 (PHQ-9) None	633 Responses n=445 Participants • Because the instrument can be collected at each appointment, participants could contribute multiple responses.	678 Responses n=506 Participants • Because the instrument can be collected at each appointment, participants could contribute multiple responses.	1311 Responses n=951 Participants • Because the instrument can be collected at each appointment, participants could contribute multiple responses.
Patient Health Questionnaire-9 (PHQ-9) Mild	20 Responses n=445 Participants • Because the instrument can be collected at each appointment, participants could contribute multiple responses.	21 Responses n=506 Participants • Because the instrument can be collected at each appointment, participants could contribute multiple responses.	41 Responses n=951 Participants • Because the instrument can be collected at each appointment, participants could contribute multiple responses.
Patient Health Questionnaire-9 (PHQ-9) Moderate	34 Responses n=445 Participants • Because the instrument can be collected at each appointment, participants could contribute multiple responses.	28 Responses n=506 Participants • Because the instrument can be collected at each appointment, participants could contribute multiple responses.	62 Responses n=951 Participants • Because the instrument can be collected at each appointment, participants could contribute multiple responses.
Patient Health Questionnaire-9 (PHQ-9) Moderately Severe	32 Responses n=445 Participants • Because the instrument can be collected at each appointment, participants could contribute multiple responses.	31 Responses n=506 Participants • Because the instrument can be collected at each appointment, participants could contribute multiple responses.	63 Responses n=951 Participants • Because the instrument can be collected at each appointment, participants could contribute multiple responses.
Patient Health Questionnaire-9 (PHQ-9) Severe	23 Responses n=445 Participants • Because the instrument can be collected at each appointment, participants could contribute multiple responses.	26 Responses n=506 Participants • Because the instrument can be collected at each appointment, participants could contribute multiple responses.	49 Responses n=951 Participants • Because the instrument can be collected at each appointment, participants could contribute multiple responses.

PRIMARY outcome

Timeframe: Assessed at baseline at randomization, monthly up to 20 months after start of intervention (i.e. repeated measures).

Population: Consists of all participants who contributed at least one response to the PROMIS-PI survey.

Outcome measures

Outcome measures
Measure	Clinical Decision Support n=89 Participants Patients within the physicians randomized to the IDM arm will receive the Clinical Decision Support alerts via the EHR when certain order criteria are triggered appropriately. Clinical Decision Support: The CDS intervention will test the use of existing guideline-based EHR alerts related to the prescription of opioids. CDS alerts employ computer algorithms that account for patient characteristics and diagnoses to deliver reminders of appropriate use when a provider enters an order for a medication.	Patient Education and Activation Tools n=73 Participants Patients within the physicians randomized to SDM will receive the PEAT materials via REDCap two days prior to their PCP office visit. They will receive these materials every time they have an office visit with their PCP. Patient Education and Activation Tools: The patient education materials selected for this study: "Pain Management: Which Treatment is Right for You," "Preparing for Your Health Care Visit," and a video from the American Chronic Pain Association (ACPA) named "A Car with Four Flat Tires," which helps to give patients a better understanding of how multi-modal treatment can be more effective than relying on one source of treatment (e.g., pain medication).
PROMIS - Pain Interference Short Form 8a	61.68 score on a scale Standard Deviation 9.22	60.26 score on a scale Standard Deviation 9.51

PRIMARY outcome

Timeframe: 1-year pre-intervention vs. 1-year post-intervention (i.e. repeated measures).

Population: Sample is limited to patients who returned a CG-CAHPS survey following a visit to their PCP.

The Consumer Assessment of Healthcare Providers and System Clinician and Group Survey (CG-CAHPS) is a widely used PRO for collecting and reporting information from patients' about their experiences of care. We used the "How well providers communicate with patients" 6-item composite score. The response scale for these items was "Yes, definitely", "Yes, somewhat", and "No". The composite score was represented as a binary value indicating whether a PCP received all "top-box" scores (represented by "Yes, definitely" responses) on the 6 items. We report the count of "top box" responses in the pre- and post-intervention periods by group. Analysis featured a mixed effects logistic regression model for repeated measures where the term of interest was an interaction term describing the change in the odds of a "top box" score in the PEAT group during the post-intervention period.

Outcome measures

Outcome measures
Measure	Clinical Decision Support n=170 Participants Patients within the physicians randomized to the IDM arm will receive the Clinical Decision Support alerts via the EHR when certain order criteria are triggered appropriately. Clinical Decision Support: The CDS intervention will test the use of existing guideline-based EHR alerts related to the prescription of opioids. CDS alerts employ computer algorithms that account for patient characteristics and diagnoses to deliver reminders of appropriate use when a provider enters an order for a medication.	Patient Education and Activation Tools n=187 Participants Patients within the physicians randomized to SDM will receive the PEAT materials via REDCap two days prior to their PCP office visit. They will receive these materials every time they have an office visit with their PCP. Patient Education and Activation Tools: The patient education materials selected for this study: "Pain Management: Which Treatment is Right for You," "Preparing for Your Health Care Visit," and a video from the American Chronic Pain Association (ACPA) named "A Car with Four Flat Tires," which helps to give patients a better understanding of how multi-modal treatment can be more effective than relying on one source of treatment (e.g., pain medication).
CG-CAHPS Post-intervention : Top Box	188 Responses	194 Responses
CG-CAHPS Post-intervention : Not Top Box	34 Responses	27 Responses

SECONDARY outcome

Timeframe: Assessed at baseline at randomization, monthly up to 20 months after start of intervention (i.e. repeated measures).

Population: Consists of all participants who contributed at least one response to the PROMIS-Physical Function survey.

PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. A single Physical Function capability score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Physical Function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average. We report pre- and post-intervention means. Analysis featured a linear mixed model for repeated measures where the term of interest was an interaction term describing the change in the PEAT group during the post-intervention period.

Outcome measures

Outcome measures
Measure	Clinical Decision Support n=88 Participants Patients within the physicians randomized to the IDM arm will receive the Clinical Decision Support alerts via the EHR when certain order criteria are triggered appropriately. Clinical Decision Support: The CDS intervention will test the use of existing guideline-based EHR alerts related to the prescription of opioids. CDS alerts employ computer algorithms that account for patient characteristics and diagnoses to deliver reminders of appropriate use when a provider enters an order for a medication.	Patient Education and Activation Tools n=72 Participants Patients within the physicians randomized to SDM will receive the PEAT materials via REDCap two days prior to their PCP office visit. They will receive these materials every time they have an office visit with their PCP. Patient Education and Activation Tools: The patient education materials selected for this study: "Pain Management: Which Treatment is Right for You," "Preparing for Your Health Care Visit," and a video from the American Chronic Pain Association (ACPA) named "A Car with Four Flat Tires," which helps to give patients a better understanding of how multi-modal treatment can be more effective than relying on one source of treatment (e.g., pain medication).
PROMIS Physical Function 6b v1.2	38.26 score on a scale Standard Deviation 9.38	39.35 score on a scale Standard Deviation 9.29

SECONDARY outcome

Timeframe: 1-year pre-intervention vs. 1 year post-intervention

Population: Includes patients with at least one Rx for opioids written by PCPs randomized in the study (i.e. does not include patients who had opioids written by physicians not included in the study).

Physicians should avoid increasing dosage to ≥90 MME/day, and this measure compares odds of writing prescriptions over 90mme pre- vs. post-intervention

Outcome measures

Outcome measures
Measure	Clinical Decision Support n=426 Participants Patients within the physicians randomized to the IDM arm will receive the Clinical Decision Support alerts via the EHR when certain order criteria are triggered appropriately. Clinical Decision Support: The CDS intervention will test the use of existing guideline-based EHR alerts related to the prescription of opioids. CDS alerts employ computer algorithms that account for patient characteristics and diagnoses to deliver reminders of appropriate use when a provider enters an order for a medication.	Patient Education and Activation Tools n=483 Participants Patients within the physicians randomized to SDM will receive the PEAT materials via REDCap two days prior to their PCP office visit. They will receive these materials every time they have an office visit with their PCP. Patient Education and Activation Tools: The patient education materials selected for this study: "Pain Management: Which Treatment is Right for You," "Preparing for Your Health Care Visit," and a video from the American Chronic Pain Association (ACPA) named "A Car with Four Flat Tires," which helps to give patients a better understanding of how multi-modal treatment can be more effective than relying on one source of treatment (e.g., pain medication).
Number of Opioid Prescriptions Over 90 MME/Day Written by Physicians Post-intervention Rx Over 90	208 prescriptions	679 prescriptions
Number of Opioid Prescriptions Over 90 MME/Day Written by Physicians Post-intervention Rx Not Over 90	3278 prescriptions	3625 prescriptions

SECONDARY outcome

Timeframe: 1-year pre-intervention vs. 1-year post-intervention

Population: These are patients who had at least one prescription for benzodiazepines as written by their PCP, and where PCP was included in the study.

Physicians should avoid co-prescribing of opioids and benzodiazepines. This binary outcome captures the presence (or lack) of a written prescriptions for opioids within a 24-hour window on either side of a prescription for benzodiazepines.

Outcome measures

Outcome measures
Measure	Clinical Decision Support n=113 Participants Patients within the physicians randomized to the IDM arm will receive the Clinical Decision Support alerts via the EHR when certain order criteria are triggered appropriately. Clinical Decision Support: The CDS intervention will test the use of existing guideline-based EHR alerts related to the prescription of opioids. CDS alerts employ computer algorithms that account for patient characteristics and diagnoses to deliver reminders of appropriate use when a provider enters an order for a medication.	Patient Education and Activation Tools n=144 Participants Patients within the physicians randomized to SDM will receive the PEAT materials via REDCap two days prior to their PCP office visit. They will receive these materials every time they have an office visit with their PCP. Patient Education and Activation Tools: The patient education materials selected for this study: "Pain Management: Which Treatment is Right for You," "Preparing for Your Health Care Visit," and a video from the American Chronic Pain Association (ACPA) named "A Car with Four Flat Tires," which helps to give patients a better understanding of how multi-modal treatment can be more effective than relying on one source of treatment (e.g., pain medication).
Number of Opioid Co-prescription of Opioids and Benzodiazepines Written by Physicians Co-Prescription	196 prescriptions	264 prescriptions
Number of Opioid Co-prescription of Opioids and Benzodiazepines Written by Physicians Not Co-Prescription	139 prescriptions	168 prescriptions

SECONDARY outcome

Timeframe: 1-year pre-intervention vs. 1-year post-intervention at all appointments (i.e. repeated measures).

Population: Includes all subjects who had at least one PHQ-9 score in the medical record during the study period.

The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The raw score was categorized by severity according to the scoring guide and analyzed as such. Raw scores were assigned the following categories: 0-4, None; 5-9, Mild; 10-14, Moderate; 15-19, Moderately severe; and 20 or greater, Severe. We report the count of categorized PHQ-9 responses in the pre- (baseline characteristics) and post-intervention periods by group. Analysis featured a mixed effects ordered logistic regression model for repeated measures where the term of interest was an interaction describing the change in the odds of a "top box" score in the PEAT group during the post-intervention period. Analysis did not require balanced data (i.e. any scores in any time period meant patient was included).

Outcome measures

Outcome measures
Measure	Clinical Decision Support n=445 Participants Patients within the physicians randomized to the IDM arm will receive the Clinical Decision Support alerts via the EHR when certain order criteria are triggered appropriately. Clinical Decision Support: The CDS intervention will test the use of existing guideline-based EHR alerts related to the prescription of opioids. CDS alerts employ computer algorithms that account for patient characteristics and diagnoses to deliver reminders of appropriate use when a provider enters an order for a medication.	Patient Education and Activation Tools n=506 Participants Patients within the physicians randomized to SDM will receive the PEAT materials via REDCap two days prior to their PCP office visit. They will receive these materials every time they have an office visit with their PCP. Patient Education and Activation Tools: The patient education materials selected for this study: "Pain Management: Which Treatment is Right for You," "Preparing for Your Health Care Visit," and a video from the American Chronic Pain Association (ACPA) named "A Car with Four Flat Tires," which helps to give patients a better understanding of how multi-modal treatment can be more effective than relying on one source of treatment (e.g., pain medication).
Patient Health Questionnaire-9 (PHQ-9) Mild	9 participants	16 participants
Patient Health Questionnaire-9 (PHQ-9) None	220 participants	270 participants
Patient Health Questionnaire-9 (PHQ-9) Moderate	17 participants	23 participants
Patient Health Questionnaire-9 (PHQ-9) Moderately Severe	14 participants	15 participants
Patient Health Questionnaire-9 (PHQ-9) Severe	4 participants	11 participants

Adverse Events

Clinical Decision Support

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Patient Education and Activation Tools

Serious events: 3 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Clinical Decision Support n=445 participants at risk Patients within the physicians randomized to the IDM arm will receive the Clinical Decision Support alerts via the EHR when certain order criteria are triggered appropriately. Clinical Decision Support: The CDS intervention will test the use of existing guideline-based EHR alerts related to the prescription of opioids. CDS alerts employ computer algorithms that account for patient characteristics and diagnoses to deliver reminders of appropriate use when a provider enters an order for a medication.	Patient Education and Activation Tools n=506 participants at risk Patients within the physicians randomized to SDM will receive the PEAT materials via REDCap two days prior to their PCP office visit. They will receive these materials every time they have an office visit with their PCP. Patient Education and Activation Tools: The patient education materials selected for this study: "Pain Management: Which Treatment is Right for You," "Preparing for Your Health Care Visit," and a video from the American Chronic Pain Association (ACPA) named "A Car with Four Flat Tires," which helps to give patients a better understanding of how multi-modal treatment can be more effective than relying on one source of treatment (e.g., pain medication).
General disorders Death	0.22% 1/445 • Number of events 1 • 1 year As the interventions in this trial are not greater than minimal risk, our study was monitored by the Cedars-Sinai Medical Center's Institutional Review Board (IRB), which operates under a Federal-wide Assurance (FWA) approved by the Office of Human Research Protections of the U.S. Department of Health and Human Services. All adverse events were required to be reported to the IRB within 48 hours. Throughout the study period, we did not receive any reports of adverse events.	0.59% 3/506 • Number of events 3 • 1 year As the interventions in this trial are not greater than minimal risk, our study was monitored by the Cedars-Sinai Medical Center's Institutional Review Board (IRB), which operates under a Federal-wide Assurance (FWA) approved by the Office of Human Research Protections of the U.S. Department of Health and Human Services. All adverse events were required to be reported to the IRB within 48 hours. Throughout the study period, we did not receive any reports of adverse events.

Other adverse events

Adverse event data not reported

Additional Information

Brennan Spiegel

Cedars-Sinai Medical Center

Phone: 310-423-6467

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place