Communication Clinical Trial
Official title:
Life Stories for Opioid Risk Reduction in the ED
NCT number | NCT03134092 |
Other study ID # | 826673 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 28, 2017 |
Est. completion date | November 19, 2019 |
Verified date | July 2020 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare the effectiveness of 3 strategies to inform patients of their risks associated with misuse of opioid prescriptions after treatment in the ED from renal colic or musculoskeletal back pain. Randomization will be to 3 arms for the Randomized Practical Control Trial across 3 sites (A) standardized general risk information sheet only (B) standardized general risk information sheet plus a visual probabilistic risk tool (C) standardized sheet plus narrative enhanced probabilistic risk tool.
Status | Completed |
Enrollment | 1302 |
Est. completion date | November 19, 2019 |
Est. primary completion date | August 7, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Age 18 years to 70 years old - Experiencing back pain or renal colic - Text messaging and internet access including email capabilities or access to a smartphone - Anticipated discharge within 24 hours Exclusion Criteria: - Patients who take opioids for chronic pain or cancer treatments - Patients who have taken opioids in the past month with the exception of patients who have taken opioids in the previous 48 hours before arriving at the ED for their presenting condition based on provider assessment - Patients who are pregnant, in police custody, intoxicated, cognitively impaired, or otherwise unable to fully consent and participate - Patients who are hemodynamically compromised, in respiratory distress, or in severe emotional or physical distress. - Patients older than 70 or younger than 18 - Patients who will be admitted to hospital or deemed to have a critical illness based on provider assessment - Patients who are cognitively impaired - Patients who are suicidal or homicidal ideation by chart review and clinician assessment. - Patients with evidence of aberrant behavior based on clinical assessment - Patients who do not have a phone, text messaging OR email address - Patients under police arrest at ED visit - Patients who are non-English or Spanish speaking - Patients previously enrolled - Patient with any current contraindications for NSAIDs or opioid medications including allergies, chronic kidney disease (GFR60, if measured) |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama- Birmingham | Birmingham | Alabama |
United States | Northwell Health | Manhasset | New York |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | Patient-Centered Outcomes Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Risk Awareness and Recall | The primary outcome of this study is for patients to gain an understanding of individual risk using the Opioid Risk Tool (ORT). The ORT is a brief screening tool allowing patients to confidentially enter their own history to determine the probability opioid dependency and addiction. High concordance between measured risk and patient recall might indicate sustained effectiveness (or stickiness) of the risk communication tool. Discordance might indicate a failure of risk communication and knowledge of individualized risk. This outcome is dichotomous, categorized as "Yes" the person correctly recalled their risk category or "No", either they did not correctly recall their risk category or they did not remember their risk category at all. The count of participants is the amount categorized as "Yes", they correctly recalled their risk category. | Day 14 | |
Primary | Patient Reported Use of Opioid Medication | Taking opioid medication at Day 14. This outcome is dichotomous. "Yes" if they were taking opioids at Day 14, or "No" if they were not taking opioids at Day 14. | Day 14 | |
Secondary | Patient Reported Use of Opioid Medication | A second outcome is measuring patient reported opioid medication use by Total morphine equivalents. | Days 1-2, 4-6 | |
Secondary | Patient Reported Use of Opioid Medication | Patient reported total pills taken | Days 1-2, 4-6 | |
Secondary | Patient Reported Use of Opioid Medication | Frequency of use | Day 14, 3 Months | |
Secondary | Patient Reported Use of Opioid Medication | Patient reported days to no longer taking opioids | Days 1-2, 4-6, day 14, 3 Months | |
Secondary | Reported Use of Non Opioid Pain Medication | Patient reported use and dose of NSAIDs and acetaminophen | Days 1-2, 4-6, day 14, 3 Months | |
Secondary | Functional Ability/Return to Usual Activities | The RAND health- 20 questionnaire will be used to measure functional ability. | At Baseline and 3 Months | |
Secondary | Functional Ability/Return to Usual Activities | The American Pain Outcome questionnaire will be used to measure functional ability. | Days 1 and 7, Day 14, 3 Months | |
Secondary | Functional Ability/Return to Usual Activities for Back Pain Patients | Back Pain Functional scale will be used to measure functional ability for back pain patients. | Days 1 and 7, Day 14, 3 Months | |
Secondary | Patient Reported Shared Decision Making | The CollaboRATE93 scale- a brief, patient reported measure of shared decision making after a clinical encounter will be used. The scale will be adapted to reflect the context of an acute pain clinical encounter in the emergency department. There are three questions scored 0-9 with higher values meaning more collaboration. The average score of the three questions was calculated. | Day 1 | |
Secondary | Satisfaction With Pain Treatment | Participants are asked "How satisfied were you with the results of your pain treatment while in the hospital?" with 0 = extremely dissatisfied and 10 = extremely satisfied. | Days 1 and 7, Day 14, 3 Months | |
Secondary | Trust in Provider | The Trust in Physician scale, will be used to measure the patient's their trust in their provider. Allows Patient to report their perception of their provider. Patients are more likely to be adherent to medical care when they trust their physicians. | Day 7 | |
Secondary | Patient Preference for Treatment Plan | Patients will be provided options paint treatment for discharge treatment plan. | At Baseline | |
Secondary | Treatment Plan Agreement Between Patient Preference and Provider Decision | Patient preference will be linked to electronic medical record data. Discordance between risk informed patient preferences and provider selection may indicate failure to achieve an optimized patient centered outcome. | At Baseline | |
Secondary | Self-Report Additional Provider Visits | Self-Report additional provider visits to measure follow-up visits for pain | Day 14 and 3 Month | |
Secondary | Current Opioid Misuse Measure (COMM) | The Current Opioid Misuse measure (COMM) will be used to measure misuse of opioids. | 3 months |
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