The Life STORRIED Study

Communication Clinical Trial

Official title:

Life Stories for Opioid Risk Reduction in the ED

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134092
• Other study ID #: 826673
• Status: Completed
• Phase: N/A
• Start date: June 28, 2017
• Est. completion date: November 19, 2019

Study information

• Verified date: July 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Amid a devastating public health crisis, in which 19,000 overdose deaths per year in the United States are due to prescription opioids, the investigators ask the following questions: Can risk-informed communication (with or without a narrative-enhanced tool) improve patient-centered outcomes in the domains of knowledge, opioid use, functional outcomes, and patient provider therapeutic alignment? This question has implications for over 17 million patients who present to acute care settings with acute pain from common conditions. Can these goals be accomplished in a real-world setting, for a diverse patient population? The investigators approach to this project includes a practical randomized controlled trial, conducted in nine acute care settings, at three geographically distinct hospital centers, with broad inclusion criteria and a diverse population. Aims: This project aims to compare the effectiveness of 1) a standardized general risk information sheet only; 2 a standardized general risk information sheet plus a probabilistic risk tool; and 3) a standardized sheet plus narrative-enhanced probabilistic risk tool on the following outcomes: * Knowledge as measured by risk awareness and treatment preferences for fewer opioids, particularly among those at higher risk for addiction * Reduced use of opioids as measured by quantity of opioids taken, functional improvement, and repeat use of unscheduled visits for pain at 14 days * Patient provider alignment as measured by concordance between patient preference and finalized prescription plan, and the presence of shared decision making. These aims will be achieved in a multicenter randomized practical clinical trial of 1,300 patients who are planned for discharge from acute care settings after being treated for acute back or acute kidney stone pain. The investigators hypothesize that, compared with patients receiving a generalized risk information sheet or a probabilistic risk communication tool alone, patients with acute renal colic and musculoskeletal back pain randomized to receive narrative-enhanced risk communication, will do the following: (H1) demonstrate greater knowledge, as determined by awareness of risk for opioid dependency; (H2a) select a treatment plan with fewer opioids; (H2b) take fewer opioids for fewer days, while achieving the same degree of pain relief and improved functional status; (H3a) enjoy greater levels of concordance between the patient-preferred and provider-selected treatment plans; and (H3b) engage in greater shared decision making with their providers. How these aims are important to patients: The research question is important to patients because 1) patients are frequently exposed to the potential for either under- or over-treatment of pain; 2) patients have different risk factors for dependency, which may impact the appropriateness of certain medications for pain relief; and 3) opioid dependence and misuse which often begin with prescriptions for acute pain are costly and common, and affect families, communities, and society as a whole.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Communication
• Narrative Medicine
• Opioid Dependence
• Opioid-Related Disorders
• Risk Behavior

Intervention

Other:
• Probabilistic Risk Communication Tool (PRT)
The probabilistic risk communication tool (PRT) is a visual tool that communicates risk using the previously validated Opioid Risk Tool (ORT). The ORT is designed to assess risk of opioid dependency for patients for whom an opioid pain relief prescription is being considered in outpatient settings. Patients in this arm will be given an iPad which will prompt them to take a short survey that automatically communicates their risk score. After which the iPad will show them a color coded visual thermometer that informs them of their risk of having issues related to opioids.
• Narrative Enhanced Risk Tool (NERT)
Participants assigned to this arm will receive the PRT described above but will also be instructed to watch one or more narrative videos. This video intervention will include a brief narrative video of an individuals' cautionary tale around prolonged opioid uses. Narrative videos are developed from actual patients sharing their stories - put into a in a structured format of ~ 2-minute length and recorded.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

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