Telehealth Postop Follow up RCT

NCT03791697 | Unknown DMC

• 1 other identifier: Telehealth Study
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled trial that will evaluate whether telephone two-week postoperative follow up visits are an acceptable and safe alternative to traditional face-to-face-clinic two-week postoperative visits.

Conditions

Patient Satisfaction

Keywords

Postoperative patient satisfaction

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction (questionnaire)

  Comparison of patient satisfaction as determined by completion of a non-validated, treatment non-specific satisfaction questionnaire between the two groups.

  Survey will be provided at the six-week follow up visit.

Secondary Outcomes (2)

• Patient safety (adverse events)

  Postoperative period up to 6 weeks

• Time Spent (post op telephone follow up compared to clinic follow up [minutes])

  Calculated from time spent at the two week follow up visit

Study Arms (2)

Telephone Group

ACTIVE COMPARATOR

The patient randomized into the telephone follow up group, will be contacted, at the pre-scheduled date and time, by the urogynecology clinic nurse. The nurse will utilize a scripted series of postoperative questions, which are consistent with questions asked during our standard postoperative clinic visits. Vital signs and physical examination will be deferred for the patients in the telephone follow up group. Any patient responses that are not consistent with a usual postoperative course will be escalated to an in person visit. However, these patients will remain in the group, to which they were originally randomized, for research analysis purposes.

Other: Telehealth 2 week postoperative visit

In Person Clinic Visit Group

NO INTERVENTION

For the patient randomized into the clinic group, the clinic visit will entail questions about common postoperative complications (including fever, nausea/vomiting, pain, urinary symptoms, constipation, etc.). As per usual, vital signs and a focused physical examination will be completed at the clinic visit. All clinic visits will be performed by an FPRMS fellow and/or attending physician

Interventions

Telehealth 2 week postoperative visit OTHER

The patient randomized into the telephone follow up group, will be contacted, at the pre-scheduled date and time, by the urogynecology clinic nurse. The nurse will utilize a scripted series of postoperative questions, which are consistent with questions asked during our standard postoperative clinic visits. Vital signs and physical examination will be deferred for the patients in the telephone follow up group. Any patient responses that are not consistent with a usual postoperative course will be escalated to an in person visit. However, these patients will remain in the group, to which they were originally randomized, for research analysis purposes. (Intent to treat)

Telephone Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women \>18 desiring surgical management of prolapse or incontinence
• English speaking
• Willing and able to provide written and informed consent without assistance from medical surrogate or interpreter
• Immediate access to telephone services (landline, mobile phone, office phone)

You may not qualify if:

• Women \<18
• Non-English speaking
• Unwilling and unable to provide written and informed consent without assistance from surrogate or interpreter
• Hearing impairment
• No access to telephone services (landline, mobile phone, office phone)
• Grade 3 complication- a complication requiring surgical, endoscopic, or radiological intervention. \[3\]
• Patient who did not attend any postoperative follow up visit

Sponsors & Collaborators

• Jackson, Elisha: lead
• University of South Florida: collaborator

Study Sites (1)

University of Florida Health

Tampa, Florida, 33606, United States

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Elisha J Jackson, MD

  University of South Florida Morsani School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisha J Jackson, MD

CONTACT

8166860222; elisha.jackson815@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician-Fellow

Model Details: Eligible patients will be randomized to Arm1 or Arm2 (Telephone follow up or clinic follow up). Permuted block randomization with randomly varying block sizes will be used. Generation of allocation sequences will be performed using a random-number table. The allocation sequence will be generated by our statistician who is neither responsible for patient recruitment or outcome assessment. Sequentially numbered opaque sealed envelopes will be used for concealment of treatment allocation. It is not possible to mask clinical staff or participants, as they will be aware of the follow-up care that is being delivered over the telephone or in clinic. As such this is not a blinded study.

Study Record Dates

• First Submitted: December 30, 2018
• First Posted: January 3, 2019
• Study Start: July 9, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 31, 2019
• Last Updated: January 3, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)