Voices in Pain Care
Status: | Recruiting |
---|---|
Conditions: | Chronic Pain, Chronic Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/7/2018 |
Start Date: | November 13, 2017 |
End Date: | March 13, 2020 |
Contact: | Mayra L Lopez, MSW, MPH |
Email: | mayra.lopez@cshs.org |
Phone: | 310-423-8943 |
Integrating the Patient Voice Into Comparative Effectiveness Trial of Communication Strategies in the Management of Chronic Pain
Investigators will compare Clinical Decision Support (CDS) versus Patient Education and
Activation Tools (PEATs) in patients prescribed long-term or multiple opioids to measure
outcomes that are important to patients. Primary outcomes are pain interference, physical
function, and satisfaction with patient-physician communication. Secondary outcomes are
overall Health-Related Quality of Life and high-risk prescribing, including prescriptions
over 90 morphine milligram equivalents per day and co-prescribing of benzodiazepines and
opioids.
Patients in the PEAT arm will receive patient materials during the intervention, developed to
engage patients in chronic pain treatment, prior to Primary Care Physician office visits. In
the provider-facing CDS arm, PCPs will receive computerized reminders about appropriate
opioid use during office visits for enrolled patients. Patients in both groups will receive
questionnaires about pain interference, quality of life, and physician-patient communication
through the patient portal one month after each visit to their Primary Care Physician.
Investigators will use multi-level regression models to compare the effectiveness of these
two communication strategies.
Activation Tools (PEATs) in patients prescribed long-term or multiple opioids to measure
outcomes that are important to patients. Primary outcomes are pain interference, physical
function, and satisfaction with patient-physician communication. Secondary outcomes are
overall Health-Related Quality of Life and high-risk prescribing, including prescriptions
over 90 morphine milligram equivalents per day and co-prescribing of benzodiazepines and
opioids.
Patients in the PEAT arm will receive patient materials during the intervention, developed to
engage patients in chronic pain treatment, prior to Primary Care Physician office visits. In
the provider-facing CDS arm, PCPs will receive computerized reminders about appropriate
opioid use during office visits for enrolled patients. Patients in both groups will receive
questionnaires about pain interference, quality of life, and physician-patient communication
through the patient portal one month after each visit to their Primary Care Physician.
Investigators will use multi-level regression models to compare the effectiveness of these
two communication strategies.
Investigators will compare two strategies: (1) Engage PCPs with Clinical Decision Support at
the point of care, raising active alerts through the Electronic Health Record (EHR) when
there is risk of inappropriate opioid prescribing, thus leading to informed decision-making
with the patient about alternative treatments; versus (2) Engage patients prior to their PCP
visit using Patient Education and Activation Tools (PEATs) administered via REDCap, helping
patients to prepare for their visit and encouraging discussion about treatment preferences,
values and treatment goals at the time of the visit, thus leading to shared decision-making
with the provider. Our CDS intervention will use "Choosing Wisely" and CDC guidelines, and
our Patient Education and Activation Tool intervention will use widely disseminated material
developed by Consumer Reports and the ACPA. Investigators will assess whether improved
communication and patient activation through these strategies improve patient-reported
outcomes related to pain interference and HRQOL. To assess these outcomes, investigators will
use NIH Patient Reported Outcome Measurement Information System (PROMIS®) questionnaires to
capture health domains identified by our patient partners as most important. Using PROs will
also help capture whether the use of either of these strategies leads to unintended
consequences for patients when opioids are reduced and other pain management strategies are
not substituted.
Recruitment procedures: The study team mails study materials including an introductory
brochure, information sheet, and initial contact letter to eligible participants. Eligible
participants are then called and asked if they would like to enroll in the study, at which
point the study team obtains consent over the phone. Non-responders, eligible participants
who the study team has not been able to reach by phone and for whom a voicemail was left, are
automatically enrolled in an abbreviated arm of the study after two weeks of non-response.
Those enrolled in both the full study PEATs group and abbreviated PEATs group will be sent
the PEATs materials two days before an appointment with their primary care clinician.
Participants may choose to opt out of any arm of the study.
Data collection: Upon enrollment in the fully study, investigators will send patients an
enrollment questionnaire, which includes questions on education, language proficiency, and
health literacy. At this point, investigators will also send the two PROMIS questionnaires
(pain interference and physical function) via REDCap. The study team has programmed the
surveys to be sent via automatic email in REDCap. The email will contain a link where
participants can access the questionnaire and redeem their Amazon gift card instantly. The
total time to take this questionnaire is 2 minutes.
All enrolled participants will receive monthly PROMIS questionnaires during the 12-month
intervention period. Enrolled patients who have any follow-up visits during this intervention
period in both full study arms will be sent the Communication Questionnaire (COMRADE) via
REDCap one day after each office visit with their PCP.
For participants enrolled in the abbreviated arm of the study, the study team will have
access to medical records that will allow for a retrospective pull of relevant
patient-reported outcome measures and PCP satisfaction data collected by the health system.
the point of care, raising active alerts through the Electronic Health Record (EHR) when
there is risk of inappropriate opioid prescribing, thus leading to informed decision-making
with the patient about alternative treatments; versus (2) Engage patients prior to their PCP
visit using Patient Education and Activation Tools (PEATs) administered via REDCap, helping
patients to prepare for their visit and encouraging discussion about treatment preferences,
values and treatment goals at the time of the visit, thus leading to shared decision-making
with the provider. Our CDS intervention will use "Choosing Wisely" and CDC guidelines, and
our Patient Education and Activation Tool intervention will use widely disseminated material
developed by Consumer Reports and the ACPA. Investigators will assess whether improved
communication and patient activation through these strategies improve patient-reported
outcomes related to pain interference and HRQOL. To assess these outcomes, investigators will
use NIH Patient Reported Outcome Measurement Information System (PROMIS®) questionnaires to
capture health domains identified by our patient partners as most important. Using PROs will
also help capture whether the use of either of these strategies leads to unintended
consequences for patients when opioids are reduced and other pain management strategies are
not substituted.
Recruitment procedures: The study team mails study materials including an introductory
brochure, information sheet, and initial contact letter to eligible participants. Eligible
participants are then called and asked if they would like to enroll in the study, at which
point the study team obtains consent over the phone. Non-responders, eligible participants
who the study team has not been able to reach by phone and for whom a voicemail was left, are
automatically enrolled in an abbreviated arm of the study after two weeks of non-response.
Those enrolled in both the full study PEATs group and abbreviated PEATs group will be sent
the PEATs materials two days before an appointment with their primary care clinician.
Participants may choose to opt out of any arm of the study.
Data collection: Upon enrollment in the fully study, investigators will send patients an
enrollment questionnaire, which includes questions on education, language proficiency, and
health literacy. At this point, investigators will also send the two PROMIS questionnaires
(pain interference and physical function) via REDCap. The study team has programmed the
surveys to be sent via automatic email in REDCap. The email will contain a link where
participants can access the questionnaire and redeem their Amazon gift card instantly. The
total time to take this questionnaire is 2 minutes.
All enrolled participants will receive monthly PROMIS questionnaires during the 12-month
intervention period. Enrolled patients who have any follow-up visits during this intervention
period in both full study arms will be sent the Communication Questionnaire (COMRADE) via
REDCap one day after each office visit with their PCP.
For participants enrolled in the abbreviated arm of the study, the study team will have
access to medical records that will allow for a retrospective pull of relevant
patient-reported outcome measures and PCP satisfaction data collected by the health system.
Inclusion Criteria:
Within a 90-day period prior to the patient recruitment date:
- ≥30 days of prescriptions for opioid medications; or
- 2 or more opioid prescriptions; or
- a total amount of ≥700 MME in a single opioid prescription;
and
- Patients who have had 1 or more Cedars-Sinai Medical Group primary care physician in
the year prior to the study start date; and
- At least 1 visit during the follow-up year (the follow-up year will start after they
consent to be in the study).
Prescriptions in the inpatient setting will not make a patient eligible for this study.
Exclusion Criteria:
- Individuals less than 18 years of age; or
- Individuals with any cancer treatment (chemotherapy or radiotherapy) administered 180
days or less prior to patient recruitment; or
- Individuals with a cancer diagnosis in the Problem List 180 days or less prior to
patient recruitment (patients with cancer surveillance only will be included in the
study); or
- Individuals with palliative care treatment administered 180 days or less prior to
patient recruitment; or
- Individuals with any end-of-life treatment (comfort care) prior to patient
recruitment; or
- Patients currently taking prescription medications (e.g. Suboxone, subutex, Buprenex,
Butrans, Probuphine, Belbuca, buprenorphine/naloxone, Zubsolv, and Bunavail) for
Opioid Use or other Substance Use Disorder treatment.
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