ProlapseTIPPSNCT03890471
Telephone Intervention to Increase Patient Preparedness and Satisfaction Trial (TIPPS): A Randomized Control Trial
A study testing Preoperative telephone call three days before surgery in people with Prolapse and Stress Urinary Incontinence, run by University of Texas at Austin at 2 sites in United States.
Trial summary
Surgical preparedness improves patient satisfaction and perioperative outcomes. In urogynecology, interventions to increase preoperative patient preparedness have not been adequately studied. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prolapse, Stress Urinary Incontinence
- What is being tested?
- Preoperative telephone call three days before surgery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jun 2019to 11 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Speak and read English: Only English-speaking women will be allowed to participate because the questionnaires used in the study are validated only in English and Swedish; they are not validated in other languages.
- Planned surgery for pelvic organ prolapse and/or stress urinary incontinence
Who cannot join
- Less than 18 years of age
- Do not read or speak English
- Unable to participate in a telephone call (dementia, hard of hearing, deaf)
- Scheduled for surgery in 3 days or less
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Seton Midtown Medical Tower
Austin, Texas, 78705
Pelvic Floor Integrated Practice Unit at the University of Texas Health Austin
Austin, Texas, 78712
About this study
Official title: Telephone Intervention to Increase Patient Preparedness and Satisfaction Trial (TIPPS): A Randomized Control Trial Evaluating the Effect of Preoperative Telephone Calls on Patient Preparedness and Satisfaction in Urogynecologic Surgery
Surgical preparedness improves patient satisfaction and perioperative outcomes. In urogynecology, interventions to increase preoperative patient preparedness have not been adequately studied. Our objective is to evaluate the ability of preoperative provider-initiated telephone calls to increase patient preparedness for surgery. The investigators will conduct a randomized control trial comparing surgical preparedness between provider-initiated telephone call three days before surgery plus usual preoperative counseling versus usual preoperative counseling alone among women planning to undergo pelvic reconstructive surgery as measured by the Preoperative Patient Questionnaire (PPQ) and the Modified Preparedness for Colorectal Cancer Surgery Questionnaire (Modified PCSQ). Surgical satisfaction, perioperative outcomes, and medical costs will be also be compared between the two groups. Our hypothesis is that preoperative telephone calls will result in improved surgical preparedness. This novel approach in preoperative counseling has the potential to positively impact perioperative patient care.
The investigators will also conduct an ancillary qualitative study of sexually active women undergoing pelvic reconstructive surgery who are enrolled in the randomized control trial. This work will aim to describe the patient experience, concerns, and the quality of the first sexual encounter following surgery. This ancillary study will lay the foundation for future investigations into how to better counsel patients and discuss sexual activity after surgical repair.
Read the detailed description
Increased surgical preparedness is linked to improved surgical satisfaction and patient-reported outcomes. Interventions that increase preparedness for surgery are needed. The impact of a provider-initiated preoperative telephone call on surgical preparedness is unknown. The objectives of this study are to compare patient preparedness between women who receive a preoperative provider-initiated telephone call plus the usual preoperative counseling in the clinic versus usual preoperative counseling alone. The investigators hypothesize that a provider initiated preoperative telephone call will increase surgical preparedness and satisfaction, as well as improve perioperative outcomes. The investigators will test our working hypothesis by using the approach of randomizing patients undergoing surgery for SUI and/or POP to either a provider-initiated telephone call three days before surgery plus usual preoperative counseling or usual preoperative counseling alone. The rationale for this aim is that successful completion of the proposed research will contribute a missing, fundamental element to our understanding of preoperative counseling. It is our expectation that a preoperative telephone call three days before surgery will result in improved surgical preparedness. Such a finding would be of importance because it would provide evidence to support a novel method in preoperative counseling that positively impacts patient care.
Patients enrolled in the ancillary sexual function study will be scheduled for one-on-one telephone interview 2-4 months after surgery. Major themes of the interviews will be used to better describe the patient experience of return to sexual activity after surgery.
The investigators are also planning on performing a cost analysis. A provider-initiated telephone call before surgery requires the allocation of new resources that may result in additional perioperative costs. However, if telephone calls improve perioperative outcomes, an overall decrease in perioperative costs may be observed due to a decrease in direct and non-direct costs. Direct costs are attributable to the use of a health care intervention or illness and can be further classified in medical and non-medical costs. Medical care costs include emergency room visits, hospital admissions, unplanned clinic visits, clinic telephone calls. Non-medical costs include transportation, gas, and parking. Indirect costs include lost wages for the patient or caregiver. The objective of aspect of the study is to determine the difference in cost-effectiveness between women who receive a provider-initiated telephone call 3 days before surgery plus the usual preoperative counseling in the clinic versus the usual preoperative counseling alone from the patient and societal perspectives. The investigators hypothesize that preoperative telephone calls will be more cost-effective for both patients and society. The investigators will test our working hypothesis by using the approach of resource costing method. It is our expectation that preoperative telephone calls will improve perioperative outcomes resulting in overall cost to both the patient and society that will compensate for the additional perioperative costs associated with a telephone call before surgery.
- Conditions
- Prolapse, Stress Urinary Incontinence
- Being tested
- Preoperative telephone call three days before surgery
- Medical subject headings
- Prolapse, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative telephone call three days before surgeryBehavioural
Patients will receive a provider-initiated telephone call three days before surgery. In order to standardize counseling across providers, each provider will use a telephone script addressing the following components: Purpose of the surgery, alternatives to the surgery, surgical benefits, surgical risk (such as infection, bleeding, injury to other organ systems), potential surgical complications (such as mesh erosion, voiding dysfunction, urinary retention requiring indwelling catheter), bowel complaints (such as nausea, vomiting, constipation, diarrhea), and postoperative expectations (such as Foley management, pain management, activity restrictions, and diet. The following ERAS-specific components will be incorporated into the counseling: management of chronic medical conditions, cessation of alcohol and tobacco, and daily exercise until surgery. Questions from patients and total counseling time will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative telephone call | Experimental | Patients will receive routine preoperative counseling in the clinic plus a provider initiated telephone call 3 days before surgery. Receives: Behavioral: Preoperative telephone call three days before surgery |
| No preoperative telephone call | No intervention | Patients will receive routine preoperative counseling in the clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical preparedness
Patient Preparedness Questionnaire, Modified Preparedness for Colorectal Cancer Surgery Questionnaire
Measured: Baseline
Secondary outcomes (3)
Surgical satisfaction
Decision Regret Scale and Satisfaction with Decision Scale, Scale of 1-5, Scoring consists of reversing the scores of the 2 negatively phrased items, then taking the mean of the 5 items (range, 1-5).
Measured: Will be measured at postoperative visit 4-8 weeks after surgery.
Patient-reported outcomes
Pelvic Floor Distress Inventory - 20
Measured: Will be measured at baseline and at the postoperative visit 4-8 weeks after surgery.
Cost-effectiveness
The European Quality of Life-5 Dimensions
Measured: Will be measured at baseline and at the postoperative visit 4-8 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start5 Jun 2019
- Primary completion11 May 2020
- Study completion11 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ProlapseStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will conduct a randomized controlled trial comparing a provider-initiated preoperative telephone call plus usual clinic counseling to usual clinic counseling alone in women planning pelvic reconstructive surgery for SUI and/or POP.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Halder, University of Texas at Austin
- Investigators
- Rebecca Rogers, MD, Principal investigator, Tenured Processor, Department of Women's Health at UT Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890471
- Sponsor's protocol ID
- 2018120057
- Acronym
- TIPPS
- Status last verified
- Oct 2020
- First submitted
- 11 Mar 2019
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Halder GE, Guo F, Harvie H, White AB, Caldwell L, Giles DL, Bilagi D, Rogers RG. Cost Effectiveness of Additional Preoperative Telephone Call to Increase Surgical Preparedness: Analysis of a Randomized Clinical Trial. Int Urogynecol J. 2024 Mar;35(3):527-536. doi: 10.1007/s00192-023-05719-7. Epub 2024 Jan 8.
PubMed 38189853
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Intervention to Increase Patient Preparedness and Satisfaction Trial (TIPPS): A Randomized Control Trial Evaluating the Effect of Preoperative Telephone Calls on Patient Preparedness and Satisfaction in Urogynecologic Surgery
- ClinicalTrials.gov ID
- NCT03890471
- Acronym / sponsor ID
- TIPPS / 2018120057
- Conditions
- Prolapse, Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 11 May 2020 (actual)
- Study completion
- 11 May 2020 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Surgical preparedness improves patient satisfaction and perioperative outcomes. In urogynecology, interventions to increase preoperative patient preparedness have not been adequately studied. Our objective is to evaluate the ability of preoperative provider-initiated telephone calls to increase patient preparedness for surgery. The investigators will conduct a randomized control trial comparing surgical preparedness between provider-initiated telephone call three days before surgery plus usual preoperative counseling versus usual preoperative counseling alone among women planning to undergo pelvic reconstructive surgery as measured by the Preoperative Patient Questionnaire (PPQ) and the Modified Preparedness for Colorectal Cancer Surgery Questionnaire (Modified PCSQ). Surgical satisfaction, perioperative outcomes, and medical costs will be also be compared between the two groups. Our hypothesis is that preoperative telephone calls will result in improved surgical preparedness. This novel approach in preoperative counseling has the potential to positively impact perioperative patient care.
The investigators will also conduct an ancillary qualitative study of sexually active women undergoing pelvic reconstructive surgery who are enrolled in the randomized control trial. This work will aim to describe the patient experience, concerns, and the quality of the first sexual encounter following surgery. This ancillary study will lay the foundation for future investigations into how to better counsel patients and discuss sexual activity after surgical repair.
Detailed description
Increased surgical preparedness is linked to improved surgical satisfaction and patient-reported outcomes. Interventions that increase preparedness for surgery are needed. The impact of a provider-initiated preoperative telephone call on surgical preparedness is unknown. The objectives of this study are to compare patient preparedness between women who receive a preoperative provider-initiated telephone call plus the usual preoperative counseling in the clinic versus usual preoperative counseling alone. The investigators hypothesize that a provider initiated preoperative telephone call will increase surgical preparedness and satisfaction, as well as improve perioperative outcomes. The investigators will test our working hypothesis by using the approach of randomizing patients undergoing surgery for SUI and/or POP to either a provider-initiated telephone call three days before surgery plus usual preoperative counseling or usual preoperative counseling alone. The rationale for this aim is that successful completion of the proposed research will contribute a missing, fundamental element to our understanding of preoperative counseling. It is our expectation that a preoperative telephone call three days before surgery will result in improved surgical preparedness. Such a finding would be of importance because it would provide evidence to support a novel method in preoperative counseling that positively impacts patient care.
Patients enrolled in the ancillary sexual function study will be scheduled for one-on-one telephone interview 2-4 months after surgery. Major themes of the interviews will be used to better describe the patient experience of return to sexual activity after surgery.
The investigators are also planning on performing a cost analysis. A provider-initiated telephone call before surgery requires the allocation of new resources that may result in additional perioperative costs. However, if telephone calls improve perioperative outcomes, an overall decrease in perioperative costs may be observed due to a decrease in direct and non-direct costs. Direct costs are attributable to the use of a health care intervention or illness and can be further classified in medical and non-medical costs. Medical care costs include emergency room visits, hospital admissions, unplanned clinic visits, clinic telephone calls. Non-medical costs include transportation, gas, and parking. Indirect costs include lost wages for the patient or caregiver. The objective of aspect of the study is to determine the difference in cost-effectiveness between women who receive a provider-initiated telephone call 3 days before surgery plus the usual preoperative counseling in the clinic versus the usual preoperative counseling alone from the patient and societal perspectives. The investigators hypothesize that preoperative telephone calls will be more cost-effective for both patients and society. The investigators will test our working hypothesis by using the approach of resource costing method. It is our expectation that preoperative telephone calls will improve perioperative outcomes resulting in overall cost to both the patient and society that will compensate for the additional perioperative costs associated with a telephone call before surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will conduct a randomized controlled trial comparing a provider-initiated preoperative telephone call plus usual clinic counseling to usual clinic counseling alone in women planning pelvic reconstructive surgery for SUI and/or POP.
| Arm | Type | Receives |
|---|---|---|
| Preoperative telephone call | Experimental | Behavioral: Preoperative telephone call three days before surgeryPatients will receive routine preoperative counseling in the clinic plus a provider initiated telephone call 3 days before surgery. |
| No preoperative telephone call | No intervention | –Patients will receive routine preoperative counseling in the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- Speak and read English: Only English-speaking women will be allowed to participate because the questionnaires used in the study are validated only in English and Swedish; they are not validated in other languages.
- Planned surgery for pelvic organ prolapse and/or stress urinary incontinence
Key exclusion criteria (4 listed)
- Less than 18 years of age
- Do not read or speak English
- Unable to participate in a telephone call (dementia, hard of hearing, deaf)
- Scheduled for surgery in 3 days or less
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative telephone call three days before surgeryPatients will receive a provider-initiated telephone call three days before surgery. In order to standardize counseling across providers, each provider will use a telephone script addressing the following components: Purpose of the surgery, alternatives to the surgery, surgical benefits, surgical risk (such as infection, bleeding, injury to other organ systems), potential surgical complications (such as mesh erosion, voiding dysfunction, urinary retention requiring indwelling catheter), bowel complaints (such as nausea, vomiting, constipation, diarrhea), and postoperative expectations (such as Foley management, pain management, activity restrictions, and diet. The following ERAS-specific components will be incorporated into the counseling: management of chronic medical conditions, cessation of alcohol and tobacco, and daily exercise until surgery. Questions from patients and total counseling time will be recorded. | Behavioural | Preoperative telephone call |
Primary outcome
Surgical preparedness
Time frame: Baseline
Patient Preparedness Questionnaire, Modified Preparedness for Colorectal Cancer Surgery Questionnaire
3 secondary outcomes
Surgical satisfaction
Time frame: Will be measured at postoperative visit 4-8 weeks after surgery.
Patient-reported outcomes
Time frame: Will be measured at baseline and at the postoperative visit 4-8 weeks after surgery.
Cost-effectiveness
Time frame: Will be measured at baseline and at the postoperative visit 4-8 weeks after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Derived from this study: PubMed 38189853Halder GE, Guo F, Harvie H, White AB, Caldwell L, Giles DL, Bilagi D, Rogers RG. Cost Effectiveness of Additional Preoperative Telephone Call to Increase Surgical Preparedness: Analysis of a Randomized Clinical Trial. Int Urogynecol J. 2024 Mar;35(3):527-536. doi: 10.1007/s00192-023-05719-7. Epub 2024 Jan 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Rogers, MD principal investigator
Tenured Processor, Department of Women's Health at UT Austin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative telephone call three days before surgery in people with Prolapse and Stress Urinary Incontinence, run by University of Texas at Austin at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical preparedness (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03890471, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.