Development and Feasibility Testing of an Advanced Practice Physiotherapy Role in Chronic Pain Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Participant recruitment
研究概览
简要总结
The current study is intended to evaluate the feasibility of conducting a future trial to evaluate the effects of implementing an advanced practice physiotherapist (APP) role within a chronic pain clinic setting.
详细描述
This line of research ultimately seeks to assess the impact of integrating an APP as the first point of contact within interprofessional chronic pain clinics on patient health outcomes, care provided to patients, chronic pain clinic flow, and cost-utility in comparison to usual physician or nurse practitioner-led care.
The primary objectives of the feasibility study are:
- To determine the feasibility of implementing the trial methods by evaluating participant recruitment rates, retention, and assessment completion at each of four follow-up time-points over a 12-month period.
- To determine the feasibility of implementing the new APP model of care by monitoring the care provided and treatment fidelity.
- To explore the perspectives of participants and health care providers related to the acceptability of the APP role; barriers, facilitators, and strategies for refining implementation; and perceived impact on clinic processes and outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Participants will be invited to participate in the study with an understanding that they will be assigned to either a model of care in which they see the physician or nurse practitioner first or a model of care in which they see a physiotherapist first, even though this is a single arm feasibility study and all participants will be assigned to the APP model of care. This partial masking at the time of consent and initial assessment was determined to be important to provide accurate estimates of feasibility (e.g. consent rate, percentage of consenting participants who see the physiotherapist first who also request to see the physician or nurse practitioner). Due to the nature of the intervention, participants and healthcare providers will not be blinded to the intervention received in this or the fully powered trial. Since the primary outcome measures are self-report measures (ie. the participant is the assessor), the outcome assessor is similarly not planned to be blinded.
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
- •Chronic musculoskeletal pain (pain > 3 months in duration) (e.g., neck pain, thoracic pain, limb pain, low back pain) -OR-
- •Chronic widespread pain (e.g., fibromyalgia, myofascial syndrome) -AND-
- •18 years of age or older -AND-
- •Must be able to read, write, and speak English
- •Exclusion Criteria (as identified in referral package):
- •Primary reason for referral stated as medication change or interventional pain management (e.g., injections, nerve block)
- •Primary reason for referral is stated as headache or migraine.
- •Reason for referral is chronic pelvic pain
- •Referral includes information that patient has an untreated addiction, mental health disorder, or substance use disorder
- •Referral indicates cancer-related pain
- •Referral indicates medical "red flags" suggestive of non-musculoskeletal etiology of symptoms (e.g., unexplained symptoms, sudden weight loss, urinary retention, saddle anesthesia, evidence of upper motor neuron lesion, or fever)
- •Referral states visceral pain or abdominal pain.
排除标准
- 未提供
研究组 & 干预措施
APP-led model of care for chronic pain management
The APP-led model of care involves integrating an APP as the first point of contact within an interprofessional chronic pain clinic setting. This is in contrast to the usual physician- or nurse practitioner-led model of care.
干预措施: APP-led model of care for chronic pain management (Behavioral)
结局指标
主要结局
Participant recruitment
时间窗: Baseline to 8 weeks
Recruitment rate (participants/week) over 8 weeks.
Assessment completion
时间窗: 12 months
Proportion of all assessment items completed over the study duration (includes assessment items from baseline and 3, 6, 9, and 12 months follow-up)
Duration of baseline survey completion
时间窗: Baseline
Mean time to complete the baseline survey
Participant attrition
时间窗: 12 months
Attrition of participants expressed as a percentage lost to follow-up at 12 months.
Transfer of care
时间窗: Baseline to 8 weeks
Percentage of cases where the APP can successfully fulfill the role without having to transfer care to a physician or nurse practitioner as the most responsible provider.
Duration of follow-up survey completion
时间窗: 12 months
Mean time to complete follow-up surveys (includes surveys at 3, 6, 9, and 12 months)
Treatment fidelity
时间窗: Baseline to 8 weeks
Fidelity checklist for the APP intervention. Percentage of red flags screened for and percentage completion of all other assessment items.
Participant perspectives
时间窗: 1-2 months after visit with APP
Semi-structured interviews with participants involved in the study to explore acceptability of and satisfaction with the APP model of care.
Health care provider perspectives
时间窗: 1-2 months after visit with APP
Semi-structured interviews with health care providers involved in the study to explore acceptability of and satisfaction with the APP model of care.
次要结局
- Pain Catastrophizing Scale(Baseline and 3, 6, 9, and 12 months follow-up)
- Tampa Scale of Kinesiophobia(Baseline and 3, 6, 9, and 12 months follow-up)
- Self-reported rating of change(3, 6, 9, and 12 months follow-up)
- Brief Pain Inventory - pain severity subscale(Baseline and 3, 6, 9, and 12 months follow-up)
- Brief Pain Inventory - pain interference subscale(Baseline and 3, 6, 9, and 12 months follow-up)
- Health-related quality of life(Baseline and 3, 6, 9, and 12 months follow-up)
- Pain Self-Efficacy Questionnaire(Baseline and 3, 6, 9, and 12 months follow-up)
- Satisfaction with health care(3, 6, 9, and 12 months follow-up)
- Adverse events(3, 6, 9, and 12 months follow-up)
- Care provided(12 months)
- Health utilization(12 months)
- Health costs(12 months)
- Indirect costs(12 months)
研究者
Jordan Miller, PT, PhD
Assistant Professor, School of Rehabilitation Therapy, Queen's University
Queen's University