Patient Satisfaction
Conditions
Keywords
Postoperative patient satisfaction
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.
Detailed description
This is a two group, parallel randomized non-inferiority clinical trial at one institution evaluating telephone postoperative visits as non-inferior in patient satisfaction, patient preference, and patient safety, when compared with clinic postoperative visits. This protocol was written in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines 2011.
Interventions
OTHERTelehealth 2 week postoperative visit
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)
Sponsors
University of South Florida
Jackson, Elisha
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction (questionnaire) | Survey will be provided at the six-week follow up visit. | Comparison of patient satisfaction as determined by completion of a non-validated, treatment non-specific satisfaction questionnaire between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient safety (adverse events) | Postoperative period up to 6 weeks | • Comparison of adverse events and Emergency Department (ED) visits between the two groups. Will be determined by reviewing the patient's record to identify adverse events as defined below |
| Time Spent (post op telephone follow up compared to clinic follow up [minutes]) | Calculated from time spent at the two week follow up visit | • Actual time spent on phone call during postoperative telephone follow up compared to time spent in clinic follow up measured in minutes. |
Countries
United States
Contacts
Primary ContactElisha J Jackson, MD
Outcome results
None listed