Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2020
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
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)

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT05203146 - PIMPmyHospital: a Mobile App to Improve Emergency Care Efficiency and Communication N/A
Completed NCT04105751 - Testing a Novel Manual Communication System for Mechanically Ventilated ICU Patients N/A
Completed NCT04595695 - The Effect of Clear Masks in Improving Patient Relationships N/A
Completed NCT05540444 - RadConnect Communication Application
Recruiting NCT04317664 - Intervention to Improve Driving Practices Among High-Risk Teen Drivers Phase 3
Completed NCT05812599 - Understanding COVID-19 Testing Knowledge and Practices Among 2-1-1 Helpline Callers N/A
Completed NCT03221985 - ESM Pilot: Mobile Phones and Psychology N/A
Completed NCT03203018 - Health Literacy and Cardiovascular Knowledge Workshop in Women From Disadvantaged Communities N/A
Completed NCT02619474 - The Effect of Whiteboards on Patient Satisfaction N/A
Completed NCT02695316 - Barrier-free Communication in Maternity Care of Allophone Migrants N/A
Completed NCT02267265 - Pilot Study of Novel Postpartum Educational Video Intervention N/A
Completed NCT01933789 - Improving Communication About Serious Illness N/A
Completed NCT01697137 - Patient and Physician Intervention to Increase Organ Donation N/A
Completed NCT01459744 - An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations N/A
Recruiting NCT01170000 - Timely End-of-Life Communication to Parents of Children With Brain Tumors N/A
Completed NCT01040975 - Teen CHAT: Improving Physician Communication With Adolescents About Healthy Weight N/A
Completed NCT03044145 - The Cultural Formulation Interview-Engagement Aid N/A
Recruiting NCT04533126 - Channels of Communication & Brain Functioning: Pilot fMRI Study
Withdrawn NCT03901547 - Emotion Regulation and Burnout Impact on Communication Documentation N/A
Completed NCT06081660 - Advance Care Planning for Older Latinos With Chronic Illness N/A