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Improving Primary Care Follow-up for Patients With Pelvic Inflammatory Disease

Primary Purpose

Pelvic Inflammatory Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Message Reminders
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Inflammatory Disease focused on measuring Text message reminders, Pelvic inflammatory disease, PID, Primary care follow-up, Emergency department care, Discharge instructions

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Females aged 15 years and older
  • New diagnosis of PID, as defined by the 2006 CDC minimum criteria for diagnosis of PID, on current ED encounter
  • Determined by attending physician to be appropriate for outpatient treatment

Exclusion Criteria:

  • Patient does not have a cell phone that is capable of receiving text messages
  • Developmental disability
  • Non-English speaking
  • Pregnancy
  • Patient who was enrolled in this study on a prior ED visit

Sites / Locations

  • The Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Text Message Reminders

Control Group

Arm Description

Subjects randomized to the the intervention group will receive a total of 4 text messages on days 2 through 5 to remind them to schedule and attend a PCP follow-up appointment

The control group will not receive any additional reminders to follow-up with PCP.

Outcomes

Primary Outcome Measures

PCP follow-up rates will be used to evaluate the efficacy of text message reminders.

Secondary Outcome Measures

Number of adolescents who accept text message reminders as an measure of feasibility and acceptability.
The acceptability among adolescents of using text message reminders after ED discharge in adolescents treated in a pediatric ED.
Number of adolescents satisfied with ED care between the control group and intervention group as a measure of patient satisfaction.
Patient satisfaction of ED care when receiving text message reminders.
Type of participant characteristics associated with PCP follow-up as a measure of behavior change, compliance and rate of follow-up care
Patient characteristics associated with PCP follow-up
Barriers to PCP follow-up from an ED visit to measure use of text message technology and rate of change in follow-up care between groups
Types of barriers encountered to PCP follow-up from an ED visit for PID care to measure rate of change in follow-up care between groups

Full Information

First Posted
November 30, 2010
Last Updated
October 27, 2014
Sponsor
Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT01299259
Brief Title
Improving Primary Care Follow-up for Patients With Pelvic Inflammatory Disease
Official Title
Improving Primary Care Follow-up for Adolescents With PID: A Randomized Controlled Trial Using Text Message Reminders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators hypothesize that text message reminders to girls diagnosed with pelvic inflammatory disease (PID) in the emergency department (ED) will improve follow-up to their primary care provider (PCP) after being discharged from the ED.
Detailed Description
The Centers for Disease Control (CDC) recommends that patients diagnosed with pelvic inflammatory disease (PID) receive follow-up care within 72 hours of diagnosis. However, recent studies show that the majority of teenage girls diagnosed with PID do not receive this follow-up care within 72 hours. We hypothesize that text message reminders to girls diagnosed with PID in the emergency department (ED) will improve follow-up to their primary care provider (PCP) after being discharged from the ED.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Inflammatory Disease
Keywords
Text message reminders, Pelvic inflammatory disease, PID, Primary care follow-up, Emergency department care, Discharge instructions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text Message Reminders
Arm Type
Experimental
Arm Description
Subjects randomized to the the intervention group will receive a total of 4 text messages on days 2 through 5 to remind them to schedule and attend a PCP follow-up appointment
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will not receive any additional reminders to follow-up with PCP.
Intervention Type
Behavioral
Intervention Name(s)
Text Message Reminders
Intervention Description
Patients in the intervention group will receive text messages on their cell phones following discharge from the emergency department reminding them to make an appointment with their primary care provider. Text messages will be sent daily for 4 days after discharge from the ED.
Primary Outcome Measure Information:
Title
PCP follow-up rates will be used to evaluate the efficacy of text message reminders.
Time Frame
PCP follow-up rates will be assessed 7-14 days after discharge from the ED.
Secondary Outcome Measure Information:
Title
Number of adolescents who accept text message reminders as an measure of feasibility and acceptability.
Description
The acceptability among adolescents of using text message reminders after ED discharge in adolescents treated in a pediatric ED.
Time Frame
7-14 days after discharge from the ED
Title
Number of adolescents satisfied with ED care between the control group and intervention group as a measure of patient satisfaction.
Description
Patient satisfaction of ED care when receiving text message reminders.
Time Frame
7-14 days after ED discharge
Title
Type of participant characteristics associated with PCP follow-up as a measure of behavior change, compliance and rate of follow-up care
Description
Patient characteristics associated with PCP follow-up
Time Frame
7-14 days after ED discharge
Title
Barriers to PCP follow-up from an ED visit to measure use of text message technology and rate of change in follow-up care between groups
Description
Types of barriers encountered to PCP follow-up from an ED visit for PID care to measure rate of change in follow-up care between groups
Time Frame
7-14 days after ED visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females aged 15 years and older New diagnosis of PID, as defined by the 2006 CDC minimum criteria for diagnosis of PID, on current ED encounter Determined by attending physician to be appropriate for outpatient treatment Exclusion Criteria: Patient does not have a cell phone that is capable of receiving text messages Developmental disability Non-English speaking Pregnancy Patient who was enrolled in this study on a prior ED visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Mollen, MD, MSCE
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frances Balamuth, MD, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Study Director
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16888612
Citation
Centers for Disease Control and Prevention; Workowski KA, Berman SM. Sexually transmitted diseases treatment guidelines, 2006. MMWR Recomm Rep. 2006 Aug 4;55(RR-11):1-94. Erratum In: MMWR Recomm Rep. 2006 Sep 15;55(36):997.
Results Reference
background
PubMed Identifier
16027575
Citation
Trent M, Ellen JM, Walker A. Pelvic inflammatory disease in adolescents: care delivery in pediatric ambulatory settings. Pediatr Emerg Care. 2005 Jul;21(7):431-6. doi: 10.1097/01.pec.0000169432.14067.eb.
Results Reference
background
PubMed Identifier
16781961
Citation
Trent M, Judy SL, Ellen JM, Walker A. Use of an institutional intervention to improve quality of care for adolescents treated in pediatric ambulatory settings for pelvic inflammatory disease. J Adolesc Health. 2006 Jul;39(1):50-6. doi: 10.1016/j.jadohealth.2005.08.008.
Results Reference
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PubMed Identifier
18619710
Citation
Engel KG, Heisler M, Smith DM, Robinson CH, Forman JH, Ubel PA. Patient comprehension of emergency department care and instructions: are patients aware of when they do not understand? Ann Emerg Med. 2009 Apr;53(4):454-461.e15. doi: 10.1016/j.annemergmed.2008.05.016. Epub 2008 Jul 10.
Results Reference
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PubMed Identifier
19917951
Citation
Armstrong AW, Watson AJ, Makredes M, Frangos JE, Kimball AB, Kvedar JC. Text-message reminders to improve sunscreen use: a randomized, controlled trial using electronic monitoring. Arch Dermatol. 2009 Nov;145(11):1230-6. doi: 10.1001/archdermatol.2009.269.
Results Reference
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PubMed Identifier
18653444
Citation
Franklin VL, Greene A, Waller A, Greene SA, Pagliari C. Patients' engagement with "Sweet Talk" - a text messaging support system for young people with diabetes. J Med Internet Res. 2008 Jun 30;10(2):e20. doi: 10.2196/jmir.962.
Results Reference
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PubMed Identifier
19822583
Citation
Miloh T, Annunziato R, Arnon R, Warshaw J, Parkar S, Suchy FJ, Iyer K, Kerkar N. Improved adherence and outcomes for pediatric liver transplant recipients by using text messaging. Pediatrics. 2009 Nov;124(5):e844-50. doi: 10.1542/peds.2009-0415. Epub 2009 Oct 12.
Results Reference
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PubMed Identifier
18809542
Citation
Riley W, Obermayer J, Jean-Mary J. Internet and mobile phone text messaging intervention for college smokers. J Am Coll Health. 2008 Sep-Oct;57(2):245-8. doi: 10.3200/JACH.57.2.245-248.
Results Reference
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PubMed Identifier
26686262
Citation
Wolff M, Balamuth F, Sampayo E, Mollen C. Improving Adolescent Pelvic Inflammatory Disease Follow-up From the Emergency Department: Randomized Controlled Trial With Text Messages. Ann Emerg Med. 2016 May;67(5):602-609.e3. doi: 10.1016/j.annemergmed.2015.10.022. Epub 2015 Dec 11.
Results Reference
derived

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Improving Primary Care Follow-up for Patients With Pelvic Inflammatory Disease

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