Outpatient Visits Versus Telephone Interviews for Postoperative Care: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Patient Satisfaction
研究概览
简要总结
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.
详细描述
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:
- 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.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects ≥ 18 years of age
- •Women undergoing surgery for a pelvic floor disorder
- •Able to give informed consent
- •Has a reliable phone number for contact postoperatively
- •Able to speak and understand English or Spanish. Spanish forms will be submitted after initial review of English materials.
排除标准
- •Any patient whose physician decides medical necessity for the patient to have postoperative follow-up in the clinic
- •Unable to give written informed consent
- •Does not have a reliable phone number
- •Inability to speak and understand either English or Spanish. As noted above, Spanish forms will be submitted after initial review of English materials.
- •Those who specifically request postoperative clinic visits
- •Pregnant patients
研究组 & 干预措施
Outpatient Clinic Visits
Outpatient clinic visits for postoperative care is currently the standard of care. Patients who undergo surgery for a pelvic floor disorder will be scheduled appointments in the outpatient clinic at 1-2 weeks, 6 weeks, and 3 months where they will be evaluated by a physician.
干预措施: Outpatient Clinic Visits (Behavioral)
Telephone Follow-up
Patients will be called instead of returning to clinic for postoperative care at 1-2 weeks, 6 weeks, and 3 months.
干预措施: Telephone follow-up (Behavioral)
结局指标
主要结局
Patient Satisfaction
时间窗: Preoperative until 3 months postoperative
The objective is to compare patient satisfaction between women who present for clinic postoperative visits versus telephone follow-up. The investigators hypothesize that telephone calls will show non-inferior patient satisfaction when compared to clinic postoperative visits. The investigators will test the working hypothesis by using the approach of randomizing patients undergoing surgery for PFDs to either telephone follow-up or routine outpatient visits for their postoperative care and utilizing the S-CAHPS questionnaire preoperatively and 3 months postoperatively.
次要结局
- Adverse Events(3 months postoperative)