Integration of Musculoskeletal Physical Therapy Care in the Patient Centered Medical Home
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Total patient costs accrued for musculoskeletal care during the 3 month study period
研究概览
简要总结
Purpose and Objective: To determine the effectiveness of a physical therapist first versus a primary care physician first for patients entering a primary care setting with a musculoskeletal complaint on the outcomes of costs/charges, utilization and healthcare satisfaction.
Study activities and population group: This will be a randomized clinical trial enrolling patients who are seeking care to the Duke Outpatient Clinic with a musculoskeletal complaint. Patients, adults aged 18 years or greater, that agree to be part of the study will be randomized to see a physical therapist first or primary care physician first. All aspects of the evaluation and treatment by both providers will be standard care for musculoskeletal conditions.
Data analysis and risk/safety issues: Descriptive data including means and standard deviations and counts and proportions of baseline scores will be conducted. Differences in total costs/charges, opioid prescriptions, emergency department visits will be calculated and tested across groups. Participants may not personally be helped by taking part in this study. Participants may experience improvements in pain, function, or other symptoms from physical therapy program in this study. There is a minimal risk of loss of confidentiality. If a patient chooses not to participate, there will be no effect on their medical treatment and the study team will cease contact.
详细描述
The purpose of this study is to conduct a randomized clinical trial to examine the effectiveness an initial evaluation by a physical therapist compared to a primary care provider for patients with a musculoskeletal (MSK) complaint entering a primary care setting.
Background & Significance: MSK Conditions in Primary Care are Prevalent: More than 50% of the US population reported MSK conditions in 2011. The increase number of people over the age of 65 years will continue to increase the number of people with MSK conditions and increase demands on the health care system. The US healthcare system is already facing numerous challenges and care inefficiencies. Care for MSK conditions in primary care is an important area for care redesign to reduce inefficiencies. About 85% of people with MSK conditions have at least one visit with a primary care provider (PCP) and average six visits a year. Although, clinical guidelines recommend physical therapy as front-line care for MSK conditions, referrals to physical therapy for evaluation and management are disproportionate to the number in need. Uptake of these clinical guidelines is slow; yet advanced imaging and prescriptions for opioids for MSK pain is common. There was a 142% increase in the number of prescription medications filled by people with MSK conditions from 2009-2011. Overuse of opioids and advanced imaging and underuse of physical therapy can be deviated with novel care models that include physical therapists (PT) as frontline providers to where downstream healthcare utilization and costs are reduced and patients' needs are more directly met.
Coordinated care models can impact outcomes for prevalent conditions in primary care but data on MSK conditions is lacking: The high prevalence of depression among patients seeking primary care led to new models of integrated care. Co-location, for example, has proven successful for PCP and mental-health services, where it has almost doubled the rate of guideline based care, facilitating collaboration and referral due to proximity of specialized services. The current standard for primary care and patient-centered medical homes (PCMH) is for patients with MSK-related pain or complaints to be seen and evaluated by a PCP and then be recommended for advanced diagnostic imaging, opioids, or referral to PT at an offsite location (sometimes considered the medical neighborhood). Referral to an offsite location may negatively impact care continuity, provider communication and collaboration, and result in lower patient satisfaction from de-fragmented care and overuse of unnecessary services and prescription medication. Our approach to integrated and co-located PT could significantly decrease healthcare costs, improve patient satisfaction with care, decrease "no-show" PT rates and decrease physician burnout (by improving collaboration and satisfaction). In turn, changing mainstream MSK care.
Design & Procedures: This is a one-year randomized clinical trial of a novel health system redesign to study the immediate effect of a physical therapist first versus a primary care provider first for MSK conditions within a single primary care setting, the Duke Outpatient Clinic (DOC), at Duke University.
Randomization: This study will have two levels of randomization. Our biostatistician will generate the randomization schedule using a computerized random number generator with equal allocation to both groups for both levels of randomization. The investigators will use Redcap's Randomization Module to implement randomization scheme after consent to randomize appointments via phone. The first level consists of randomization to a Physical Therapist or Primary Care Physician as front line provider, both are considered standard of care approaches. The research coordinator will coordinate all randomization who will be blinded to the primary outcomes data collection. The second level of randomization will occur in the Primary Care Physician arm of the study. In this arm, if the Primary Care Physician decides physical therapy is medically necessary then the participant will be randomized to either be evaluated by an onsite Physical Therapist or receive a referral to be evaluated by an offsite Physical Therapist at a location of their choosing which is the current model of care at the DOC. This second level of randomization is so that the investigators can determine if physical therapy outcomes provided onsite are better when compared to offsite.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients seeking care to the Duke Outpatient Clinic for a musculoskeletal complaint
- •Patients speak English
排除标准
- •Physical Therapist determines inappropriate for study due to medical reasons
- •Patient does not speak English
研究组 & 干预措施
Physical Therapist Evaluation
Patients are randomized to have an initial appointment with a physical therapist for a musculoskeletal complaint. The intervention is an initial evaluation and treatment recommendations by a physical therapist.
干预措施: Physical Therapist Evaluation (Procedure)
Primary Care Physician Evaluation
Patients are randomized to have an initial appointment with a primary care physician for a musculoskeletal complaint. The intervention is an initial evaluation and treatment recommendations by a primary care physician.
干预措施: Primary Care Physician (Procedure)
结局指标
主要结局
Total patient costs accrued for musculoskeletal care during the 3 month study period
时间窗: 3 months
Total costs accrued for musculoskeletal care will be aggregated and abstracted by revenue code by the Duke University Health System Department of Finance
Total patient charges submitted for musculoskeletal care during the 3 month study period
时间窗: 3 months
Total charges submitted for musculoskeletal care will be aggregated and abstracted by revenue code by the Duke University Health System Department of Finance
次要结局
- Patient Satisfaction with Healthcare(3 months)
- Physical Therapy Missed Appointments(3 months)
- Provider Satisfaction(3 months)
- Opioid prescriptions(3 months)
- Emergency Room Visits(3 months)
- Imaging received(3 months)
- Imaging Type(3 months)
