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The Life STORRIED Study

Primary Purpose

Opioid Dependence, Communication, Risk Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Probabilistic Risk Communication Tool (PRT)
Narrative Enhanced Risk Tool (NERT)
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid Dependence

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Alabama- Birmingham
  • Mayo Clinic
  • Northwell Health
  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Generalized Risk Communication (GRC)

Probabilistic Risk Communication (PRT)

Narrative Enhanced Risk Tool (NERT)

Arm Description

Generalized Risk Communication (GRC): Participants in this arm will receive standard discharge instructions similar to instructions they would receive during usual care. This arm represents a standardized way of communicating post-discharge risk-benefit information about treatment options for patients with back pain and renal colic. The GRC, includes a standardized discharge information sheet about the clinical condition of interest and a written overview of population based evidence describing comparative benefits and side effects of alternative classes of medication acute pain.

Probabilistic Risk Communication (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 related to prolonged opioid use. Narrative videos are developed from actual patient stories - put into a in a structured format of ~ 2-minute length and recorded.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Patient Reported Use of Opioid Medication
A second outcome is measuring patient reported opioid medication use by Total morphine equivalents.
Patient Reported Use of Opioid Medication
Patient reported total pills taken
Patient Reported Use of Opioid Medication
Frequency of use
Patient Reported Use of Opioid Medication
Patient reported days to no longer taking opioids
Reported Use of Non Opioid Pain Medication
Patient reported use and dose of NSAIDs and acetaminophen
Functional Ability/Return to Usual Activities
The RAND health- 20 questionnaire will be used to measure functional ability.
Functional Ability/Return to Usual Activities
The American Pain Outcome questionnaire will be used to measure functional ability.
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.
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.
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.
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.
Patient Preference for Treatment Plan
Patients will be provided options paint treatment for discharge treatment plan.
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.
Self-Report Additional Provider Visits
Self-Report additional provider visits to measure follow-up visits for pain
Current Opioid Misuse Measure (COMM)
The Current Opioid Misuse measure (COMM) will be used to measure misuse of opioids.

Full Information

First Posted
March 21, 2017
Last Updated
July 31, 2020
Sponsor
University of Pennsylvania
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03134092
Brief Title
The Life STORRIED Study
Official Title
Life Stories for Opioid Risk Reduction in the ED
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 28, 2017 (Actual)
Primary Completion Date
August 7, 2019 (Actual)
Study Completion Date
November 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence, Communication, Risk Behavior, Narrative Medicine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Generalized Risk Communication (GRC)
Arm Type
No Intervention
Arm Description
Generalized Risk Communication (GRC): Participants in this arm will receive standard discharge instructions similar to instructions they would receive during usual care. This arm represents a standardized way of communicating post-discharge risk-benefit information about treatment options for patients with back pain and renal colic. The GRC, includes a standardized discharge information sheet about the clinical condition of interest and a written overview of population based evidence describing comparative benefits and side effects of alternative classes of medication acute pain.
Arm Title
Probabilistic Risk Communication (PRT)
Arm Type
Active Comparator
Arm Description
Probabilistic Risk Communication (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.
Arm Title
Narrative Enhanced Risk Tool (NERT)
Arm Type
Active Comparator
Arm Description
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 related to prolonged opioid use. Narrative videos are developed from actual patient stories - put into a in a structured format of ~ 2-minute length and recorded.
Intervention Type
Other
Intervention Name(s)
Probabilistic Risk Communication Tool (PRT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Narrative Enhanced Risk Tool (NERT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Risk Awareness and Recall
Description
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.
Time Frame
Day 14
Title
Patient Reported Use of Opioid Medication
Description
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.
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Patient Reported Use of Opioid Medication
Description
A second outcome is measuring patient reported opioid medication use by Total morphine equivalents.
Time Frame
Days 1-2, 4-6
Title
Patient Reported Use of Opioid Medication
Description
Patient reported total pills taken
Time Frame
Days 1-2, 4-6
Title
Patient Reported Use of Opioid Medication
Description
Frequency of use
Time Frame
Day 14, 3 Months
Title
Patient Reported Use of Opioid Medication
Description
Patient reported days to no longer taking opioids
Time Frame
Days 1-2, 4-6, day 14, 3 Months
Title
Reported Use of Non Opioid Pain Medication
Description
Patient reported use and dose of NSAIDs and acetaminophen
Time Frame
Days 1-2, 4-6, day 14, 3 Months
Title
Functional Ability/Return to Usual Activities
Description
The RAND health- 20 questionnaire will be used to measure functional ability.
Time Frame
At Baseline and 3 Months
Title
Functional Ability/Return to Usual Activities
Description
The American Pain Outcome questionnaire will be used to measure functional ability.
Time Frame
Days 1 and 7, Day 14, 3 Months
Title
Functional Ability/Return to Usual Activities for Back Pain Patients
Description
Back Pain Functional scale will be used to measure functional ability for back pain patients.
Time Frame
Days 1 and 7, Day 14, 3 Months
Title
Patient Reported Shared Decision Making
Description
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.
Time Frame
Day 1
Title
Satisfaction With Pain Treatment
Description
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.
Time Frame
Days 1 and 7, Day 14, 3 Months
Title
Trust in Provider
Description
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.
Time Frame
Day 7
Title
Patient Preference for Treatment Plan
Description
Patients will be provided options paint treatment for discharge treatment plan.
Time Frame
At Baseline
Title
Treatment Plan Agreement Between Patient Preference and Provider Decision
Description
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.
Time Frame
At Baseline
Title
Self-Report Additional Provider Visits
Description
Self-Report additional provider visits to measure follow-up visits for pain
Time Frame
Day 14 and 3 Month
Title
Current Opioid Misuse Measure (COMM)
Description
The Current Opioid Misuse measure (COMM) will be used to measure misuse of opioids.
Time Frame
3 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
If the patient identifies as male or female, we will enter that as such for the study.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zachary F Meisel, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama- Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Northwell Health
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35143273
Citation
Meisel ZF, Shofer F, Dolan A, Goldberg EB, Rhodes KV, Hess EP, Bellamkonda VR, Perrone J, Cannuscio CC, Becker L, Rodgers MA, Zyla MM, Bell JJ, McCollum S, Engel-Rebitzer E, Tiako MJN, Ridgeway G, Schapira MM. A Multicentered Randomized Controlled Trial Comparing the Effectiveness of Pain Treatment Communication Tools in Emergency Department Patients With Back or Kidney Stone Pain. Am J Public Health. 2022 Feb;112(S1):S45-S55. doi: 10.2105/AJPH.2021.306511.
Results Reference
derived
PubMed Identifier
34323984
Citation
Engel-Rebitzer E, Dolan AR, Aronowitz SV, Shofer FS, Nguemeni Tiako MJ, Schapira MM, Perrone J, Hess EP, Rhodes KV, Bellamkonda VR, Cannuscio CC, Goldberg E, Bell J, Rodgers MA, Zyla M, Becker LB, McCollum S, Meisel ZF. Patient Preference and Risk Assessment in Opioid Prescribing Disparities: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2118801. doi: 10.1001/jamanetworkopen.2021.18801.
Results Reference
derived
PubMed Identifier
32969832
Citation
Meisel ZF, Goldberg EB, Dolan AR, Bansal E, Rhodes KV, Hess EP, Cannuscio CC, Schapira MM, Perrone J, Rodgers MA, Zyla MM, Bell JJ, McCollum S, Shofer FS. Stories to Communicate Individual Risk for Opioid Prescriptions for Back and Kidney Stone Pain: Protocol for the Life STORRIED Multicenter Randomized Clinical Trial. JMIR Res Protoc. 2020 Sep 24;9(9):e19496. doi: 10.2196/19496.
Results Reference
derived

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The Life STORRIED Study

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