Clinical trial NCT02891187: Visits Versus Telephone Calls for Postoperative Care
Official title: Outpatient Visits Versus Telephone Interviews for Postoperative Care: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satisfaction
Postoperative Complications
Pelvic Floor Disorder
Keywords: Postoperative Care
Telephone follow-up
Healthcare Value
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The OPTIONs study is a randomized controlled, non-inferiority study to evaluate postoperative care using outpatient clinic visits versus telephone calls for women undergoing surgery for pelvic floor disorders. The primary outcome is patient satisfaction using the Surgical-Consumer Assessment of Healthcare Providers and Systems (S-CAHPS) questionnaire provided by the Agency for Healthcare Research and Quality (AHRQ). Secondary outcomes include safety and cost analysis for patients' direct and indirect medical costs. Women who speak and understand either English or Spanish and planning to undergo an elective surgery for a pelvic disorder will be recruited. Baseline demographics, satisfaction, and cost analysis questionnaires will be acquired pre-operatively. Randomization will be assigned at the time of discharge from the hospital. Patients will either have scheduled clinic visits at 1-2 weeks, 6 weeks, and 3 months or telephone calls by a registered nurse at these same intervals. Questionnaires will be completed at 3 months for satisfaction and cost analysis.

Detailed description: A. Objectives Healthcare in the United States is costly, does not result in high patient satisfaction and is in need of reform. It is well known that the current state of healthcare delivery is trapped in a paradox with higher spending and poorer outcomes compared to other countries. To bring American healthcare back on course, the focus must shift to value. Health care value relies on quality and cost with the following equation: value = quality ÷ cost. Quality incorporates clinical outcomes, safety, and patient satisfaction. Routinely, hospitals and providers are rated on their postoperative care using the Consumer Assessment of Healthcare Providers and Systems (S-CAHPS) endorsed by the Agency for Healthcare Research and Quality (AHRQ). (https://cahps.ahrq.gov) In this equation, value increases by improving quality with increasing patient satisfaction and/or lowering costs without negatively impacting outcomes and maintaining safety. All healthcare stakeholders including patients, payers, providers, and suppliers benefit from working towards improving value.

The value of routine, interval post-operative visits is unknown. Post-operative clinical visits are considered a "gold standard" based solely on tradition. Postoperative care of patients over the telephone has been utilized in place of traditional outpatient postoperative visits in the pediatric and adult surgery literature. Retrospectively, this form of postoperative care has proven to be safe, effective, and reduces patients' nonmedical costs with improvements in patient satisfaction as measured on non-validated global scales. However, a prospective trial evaluating patient satisfaction and the safety of phone call postoperative visits has not been undertaken. A key gap in assessing the value of Urogynecologic care is assessing the value of routine postoperative visits.

The specific aims for this study include the following:

1. Compare patient satisfaction with their postoperative care among women randomized to telephone calls versus routine outpatient visits at 3 months as measured by the postoperative domain of the S-CAHPS. Hypothesis: The investigators hypothesize that patients receiving postoperative care with telephone calls will report non-inferior satisfaction on the S-CAHPS as women who have in-person postoperative clinic visits.
2. Compare adverse events at 3 months between patients randomized to telephone calls versus postoperative visits. Hypothesis: The investigators hypothesize that adverse events will not differ between the two groups.
3. Determine the cost-effectiveness of postoperative care with telephone calls versus visits at 3 months using patient and societal perspectives. Hypothesis: The investigators hypothesize that postoperative care with phone calls is more cost-effective than in-person visits from both the patient and societal perspectives.

Ultimately, the long-term goal is to institute novel approaches to postoperative care that adds value to healthcare delivery. The overall objective is to replace routine postoperative visits with telephone follow-up in a non-inferiority randomized controlled trial of postoperative patients after surgery for a pelvic floor disorders. The central hypothesis is this novel use of telephone follow-up calls versus clinic visits in uncomplicated post-operative patients after surgery for pelvic floor disorders will result in non- inferior satisfaction for their care as well as significantly reduce patients' direct and indirect nonmedical costs for postoperative care. The hypothesis has been formulated on the basis of other retrospective, observational studies in the pediatric and adult surgery literature. The rationale for the proposed research is that, once it is established that postoperative care with telephone calls offers similar rates of satisfaction among patients for their postoperative care, that this new approach for healthcare will offer an alternative to routine postoperative care.

B. Study Design The investigators will conduct a randomized non-inferiority trial to compare patient satisfaction between outpatient visits and telephone calls for post-operative care. The investigators will recruit women pre-operatively at the UNM Urogynecology clinic who are undergoing surgery for pelvic floor disorders including urinary and/or anal incontinence and/or pelvic organ prolapse and/or pelvic pain, and/or mesh exposure/complications. All women will give written informed consent. Patients will be randomized at the time of discharge to either telephone follow-up or outpatient visits. Computer generated randomization will be assigned by research staff uninvolved with recruitment and will be stored in opaque, sequentially numbered envelops. Follow-up for both randomization arms will be scheduled at 1-2 weeks, 6 weeks, and 3 months post-operatively, as these are common timeframes for routine postoperative visits in our practice.

C. Number of Subjects The recruitment goal for this study is 120 patients to allocate 60 patients in the clinic visit group and 60 patients in the telephone follow-up group.

The sample size for this study is determined by our primary objective, patient satisfaction measured by the Consumer Assessment of Healthcare Providers and Systems (S-CAHPS) survey. The investigators will conduct a non-inferiority patient satisfaction study comparing postoperative care with clinic visits versus telephone calls.

The investigators have been able to identify two publications that have used the S-CAHPS; both of these reported scores for individual items, as well as composites of "top box" responses for individual items. For example, responses for the question, "After your surgery did the surgeon listen carefully to you?" has three responses: 1. Yes, definitely, 2. Yes, somewhat, and 3. No. A top box response is "Yes, definitely". The global satisfaction with their surgeon is a single item, ranging from 0 (worst surgeon possible) to 100 (best surgeon possible), with "top" box responses of 100. "Top" box responses in prior studies ranged from 56-100% with the majority of responses about 90%. Assuming both the control and experimental groups are equivalent in patient satisfaction, a non-inferiority calculation can be applied using 90% as the percentage "success" in the control group and experimental groups with 80% power, an alpha of 0.05, and 15% non-inferiority limit. In this equation, if there is truly no difference between the control and experimental groups, then 100 patients for total sample size are required to be 80% sure that the upper limit of a 90% two-sided confidence interval will exclude a difference in favor of the control group of more than 15%. The primary outcome measure is the global composite for the surgeon rating, which has been used in the previous studies. This sample size will provide similar power for comparison of other items and scale of the S-CAHPS between groups. The investigators anticipate that up to 10% of women who are recruited will have complications that preclude them from participation after consent and prior to randomization, such as poorly controlled pain, complications or surgeon concerns. In addition, the investigators anticipate that 10% of women will be lost to follow-up. Therefore the plan is to recruit a total of 120 women, 60 per group.

Eligibility criteria: Inclusion Criteria:

1. Subjects ≥ 18 years of age
2. Women undergoing surgery for a pelvic floor disorder
3. Able to give informed consent
4. Has a reliable phone number for contact postoperatively
5. Able to speak and understand English or Spanish. Spanish forms will be submitted after initial review of English materials.

Exclusion Criteria:

1. Any patient whose physician decides medical necessity for the patient to have postoperative follow-up in the clinic
2. Unable to give written informed consent
3. Does not have a reliable phone number
4. Inability to speak and understand either English or Spanish. As noted above, Spanish forms will be submitted after initial review of English materials.
5. Those who specifically request postoperative clinic visits
6. Pregnant patients

Primary outcomes:
measure: Patient Satisfaction
timeFrame: Preoperative until 3 months postoperative
Secondary outcomes:
measure: Adverse Events
timeFrame: 3 months postoperative
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Rebecca G Rogers, MD
role: PRINCIPAL_INVESTIGATOR
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