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Post-op Crowd Sourcing Health Data Via Text-messaging

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ClinicalTrials.gov Identifier: NCT03532256
Recruitment Status : Enrolling by invitation
First Posted : May 22, 2018
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
The Center for Disease Control has labeled the opioid prescription drug crisis an "epidemic" in the United States and recently this epidemic has been named a public health emergency. Various medical and surgical societies have begun to release general opioid prescribing guidelines for providers addressing acute pain, but these do not highlight the patient perspective or experience. Identifying an acceptable opioid dose and duration has remained a challenge and is a nuanced process. Though policy and provider driven changes may begin to augment practice, these avenues may miss a crucial perspective; the patient's.

Condition or disease Intervention/treatment
Orthopedic Surgery Opioid Use Acute Injuries Knee Neurosurgery Surgery Behavioral: Observation Behavioral: Text to online survey Behavioral: Bi-directional text script

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Using Text-messaging to Engage Patients and Crowdsource Data: an Opioid Pilot Study
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : April 30, 2022

Group/Cohort Intervention/treatment
Treated Patients
This prospective, observational study includes adult patients (age ≥18) undergoing elective surgical procedures within the departments of orthopedics, sports medicine, and neurosurgery, as well as patients treated for an acute injury and prescribed an opioid from the ED who own a mobile phone and can receive SMS text messaging at the University of Pennsylvania or Penn Presbyterian Medical Center.
Behavioral: Observation
Patients will be contacted postoperatively via an automated text-message to assess pain, functional status, and opioid consumption.

Treated patients randomized to receive survey
A subset of patients (described above) will receive an automated SMS text message with a link to an online survey. This survey contains the script questions about pain management and opioid use.
Behavioral: Observation
Patients will be contacted postoperatively via an automated text-message to assess pain, functional status, and opioid consumption.

Behavioral: Text to online survey
Subset of surgical patients will receive an automated text message with a link to a secure online survey with questions that assess pain, functional status, and opioid consumption.

Treated patients randomized to receive text script
A subset of patients (described above) will receive an automated questionnaire conducted via text message. Questions will be about pain management and opioid use.
Behavioral: Observation
Patients will be contacted postoperatively via an automated text-message to assess pain, functional status, and opioid consumption.

Behavioral: Bi-directional text script
Subset of surgical patients will receive an automated bi-directional text message script with questions that assess pain, functional status, and opioid consumption.




Primary Outcome Measures :
  1. Number of opioid tablets taken at 7 days [ Time Frame: 28 days ]
    We will tally number of pills taken at 7 days for each patient. We enroll patients for 12 months.


Secondary Outcome Measures :
  1. Number of opioid tablets prescribed [ Time Frame: 7 days ]
    Tally of opioid tablets prescribed per procedure before and after EMR defaults are implemented.

  2. Perceived ability to manage pain [ Time Frame: 28 days ]
    Patient's perceived ability to manage pain on a 10 point scale (10=highest, 1=lowest)

  3. Number of opioid pills remaining [ Time Frame: 28 days ]
    Tally of opioid pills left after a patient reports discontinued use.


Other Outcome Measures:
  1. Response rate [ Time Frame: 28 days ]
    Number of patients who respond to automated text with a survey or bi-directional text script

  2. Completion rate [ Time Frame: 7 days ]
    Number of patients who complete the automated text survey or bi-directional text script



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients (age ≥18) undergoing elective surgical procedures within the departments of orthopedics, sports medicine, and neurosurgery, as well as patients undergoing procedures in general surgery and the ED who own a mobile phone and can receive SMS text messaging at the University of Pennsylvania or Penn Presbyterian Medical Center.
Criteria

Inclusion Criteria:

  • Adults 18 or older
  • Undergoing elective surgical procedures within the departments of orthopedics, sports medicine, and neurosurgery, as well as patients undergoing procedures in general surgery and the ED at University of Pennsylvania Hospital or Penn Presbyterian Medical Center
  • Own a mobile phone and can receive SMS text messaging

Exclusion Criteria

  • Under 18
  • Does not own mobile phone
  • Owns mobile phone but cannot reliably receive SMS text messages

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532256


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: M. Kit Delgado, MD, MS University of Pennsylvania
Principal Investigator: Zarina Ali, MD University of Pennsylvania
Principal Investigator: Anish Agarwal, MD University of Pennsylvania
Publications:
Understanding the Epidemic | Drug Overdose | CDC Injury Center [Internet]. 2017 [cited 2017 Nov 2];Available from: https://www.cdc.gov/drugoverdose/epidemic/index.html
Compressed Mortality, 1999-2015 Request Form [Internet]. [cited 2017 Nov 2];Available from: https://wonder.cdc.gov/controller/datarequest/D132
Manchikanti L, Abdi S, Atluri S, Balog CC, Benyamin RM, Boswell MV, Brown KR, Bruel BM, Bryce DA, Burks PA, Burton AW, Calodney AK, Caraway DL, Cash KA, Christo PJ, Damron KS, Datta S, Deer TR, Diwan S, Eriator I, Falco FJ, Fellows B, Geffert S, Gharibo CG, Glaser SE, Grider JS, Hameed H, Hameed M, Hansen H, Harned ME, Hayek SM, Helm S 2nd, Hirsch JA, Janata JW, Kaye AD, Kaye AM, Kloth DS, Koyyalagunta D, Lee M, Malla Y, Manchikanti KN, McManus CD, Pampati V, Parr AT, Pasupuleti R, Patel VB, Sehgal N, Silverman SM, Singh V, Smith HS, Snook LT, Solanki DR, Tracy DH, Vallejo R, Wargo BW; American Society of Interventional Pain Physicians. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2--guidance. Pain Physician. 2012 Jul;15(3 Suppl):S67-116.
American Academy of Pain Medicine - State Legislative Updates [Internet]. [cited 2017 Nov 2];Available from: http://www.painmed.org/advocacy/state-updates/
Preventing Opioid Misuse: Legislative Trends and Predictions > National Conference of State Legislatures [Internet]. [cited 2017 Nov 2];Available from: http://www.ncsl.org/blog/2017/01/31/preventing-opioid-misuse-legislative-trends-and-predictions.aspx

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03532256    
Other Study ID Numbers: 827461
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
Quality Improvement
Prescription Use
Patient Experience
SMS Messaging
Crowd Sourcing
Additional relevant MeSH terms:
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Knee Injuries
Leg Injuries
Wounds and Injuries