Clinical Course and Prognostic Factors of Patients Receiving Physiotherapy Services in Primary Health Care in Norway (FYSIOPRIM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,985
- 试验地点
- 2
- 主要终点
- Change in Health-Related Quality of LIfe - assessed by EuroQual 5 Dimensions questionnaire (EQ-5D)
研究概览
简要总结
Background: Physiotherapists (PTs) in primary health care manage patients with a large variation in medical diagnosis, age, functional status, disability and prognosis. Lack of knowledge and systematically collected data about patients treated by PTs in primary health care has prompted this longitudinal observational physiotherapy project in Norway. This paper aims to describe a method for developing a database of patients managed by PTs in primary health care to study patients' characteristics, treatment courses and prognostic factors.
The study is a longitudinal observational project, following patients through physiotherapy treatment periods in primary health care in Norway and until one year after inclusion. The project involves both private practice and municipally employed PTs working in primary health care in eight municipalities in Norway. The participants are recruited to three different parts of the project depending on age and whether they are referred to a private practice or a municipally employed PT. All data are recorded electronically, transferred and stored securely. All patients complete extensive questionnaires providing information about demographics, disability and function, pain related variables, treatment and evaluation of treatment as well as clinical tests. The PTs have access to their own patients' data. The investigators have also prepared for linkage to national patient registers and population-based studies to be able to gather further important data.
This project will have important implications for physiotherapy services in primary health care. The database already contains almost 3000 patients, and data collection is ongoing. Preliminary analyses suggest that the patients included so far are representative of the larger population of patients treated by private practice or municipally employed PTs in Norway. This large scale prospective physiotherapy project will provide knowledge about the patient groups treated, treatment given as well as short and long term outcome of the patients.
详细描述
The primary aim of the FYSIOPRIM project is to build a database by systematically collecting data from baseline throughout the intervention period and beyond, including both patient-reported outcome measures, the patients' and PTs' goals and plans for intervention, and their evaluation thereof. This will enable description of patients receiving physiotherapy services, of goal-setting and type of interventions and how general health, physical function and relevant clinical factors change throughout and after a treatment period. Secondly, the investigators want to study associations and interaction effects between and among clinical characteristics, interventions and change as well as perform health-economic evaluations. The investigators will also examine how physiotherapy practice is affected by using the system for systematic registration of clinical data and effects of such registration. Moreover, the investigators will be able to compare patients receiving physiotherapy services with information from national patient registries. In addition, elderly participants' physical fitness, balance and walking ability will be examined to study associations between these aspects of physical functioning and health-related quality of life, self-reported physical and psychological functioning as well as response to physical fitness tests. The investigators will compare data from this group of elderly with data from other patients with musculoskeletal complaints who receive physiotherapy treatment, and with similar data from large population-based studies in Norway. Finally, this project enables methodological studies to validate clinical tests and questionnaires.
Design and setting This is a longitudinal observational project following patients through physiotherapy treatment periods in primary health care in Norway and until one year after baseline. The project involves both private practice and municipally employed PTs working in primary health care in eight municipalities of Norway; Lørenskog, Ski, Nedre Eiker, Lillehammer, Stavanger, Bergen, Trondheim and Alta. All five health regions of Norway are represented. The Norwegian Health care system is publicly funded. PTs working as private practitioners have an agreement with the municipality. Hence, they are partly paid by the municipality (as a financial support for practice) and partly paid per visit by the Norwegian Health Economics Administration (HELFO) and the patient's charge (maximum around 200 Euro per patient per calendar year). Patients seeking physiotherapy services in private practice will normally meet at the PT's clinic.
Municipally employed PTs are on fixed salary. They work in an out-patient setting, and their patients receive physiotherapy services in their usual daily environment, i.e. for children at home, in kindergarten or in school, and for elderly patients often in their own home. There are no clear guidelines for which patients that should receive physiotherapy from a private practice or a municipally employed PT. The choice can be based on previous personal experiences with physiotherapy, the possibility to visit a clinic, evaluation of need and/or benefit of treating the patients in their own setting.
Characteristics of participants
The participants are recruited to three different parts of the project depending on age and whether they are referred to a private practice PT or to a municipally employed PT (in this project, these PTs are from Trondheim). The three parts of the project are:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 125 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •any patient seeking or receiving physiotherapy services in primary health care
排除标准
- •Not understanding Norwegian or English language
结局指标
主要结局
Change in Health-Related Quality of LIfe - assessed by EuroQual 5 Dimensions questionnaire (EQ-5D)
时间窗: Baseline, 3, 6 and 12 months
Utility measure of Health related quality of life. Range -0.59 (worst) to 1 (best)
Change in Pain intensity
时间窗: Baseline, 1, 3, 6 and 12 months
Pain intensity assessed by a numeric rating scale. Range 0 (no pain) to 10 (worst imaginable)
General Perceived Effect
时间窗: 3, 6 and 12 months
A global assessment of change- 7 level scale. Score range 1 (very much better) to 5 (very much worse)
Change in Patient-Specific Functional Scale (PSFS)
时间窗: Baseline, 1, 3, 6 and 12 months
Participants identify activities that are difficult to perform and scores them from 0 (cannot perform) to 10 (perform without problems)
次要结局
- Change in Work participation(Baseline, 3, 6 and 12 months)
- Change in Pain Self-efficacy(Baseline, 3, 6 and 12 months)
- Change in 6 min walk(Baseline, 3, 6 and 12 months)
- Change in Oswestry Disability Index (ODI)(Baseline, 3, 6 and 12 months)
- Change in use of analgesics containing acetylsalicylacid(Baseline, 3, 6 and 12 months)
- Change in catastrophising thoughts assessed by Pain Catastrophizing Scale(Baseline, 3, 6 and 12 months)
- Change in Neck disability Index (NDI)(Baseline, 3, 6 and 12 months)
- Change in Disability of the Arm, Shoulder and Hand score (Quick-DASH)(Baseline, 3, 6 and 12 months)
- Change in work ability(Baseline, 3, 6 and 12 months)
- Change in pain distribution(Baseline, 3, 6 and 12 months)
- Change in use of analgesics containing paracetamol(Baseline, 3, 6 and 12 months)
- Change in use of analgesics containing ibuprofen(Baseline, 3, 6 and 12 months)
- Change in emotional distress assessed by Hopkins Symptoms Check List (HSCL)(Baseline, 3, 6 and 12 months)
- Change in health related quality of life assessed by 15D(Baseline, 3, 6 and 12 months)
- Change in knee disability - assessed by the Knee Disability and Osteoarthritis Outcome Score (KOOS)(Baseline, 3, 6 and 12 months)
- Benefit of treatment(3, 6 and 12 months)
- Change in Shoulder Pain and Disability Index (SPADI)(Baseline, 3, 6 and 12 months)
- Change in temporal aspects of pain(Baseline, 3, 6 and 12 months)
- Change in pelvic girdle pain and disability assessed by the Pelvic Girdle Questionnaire(Baseline, 3, 6 and 12 months)
- Change in stair climb capacity(Baseline, 3, 6 and 12 months)
- Fulfilment of expectations(3, 6 and 12 months)
- Change in hip disability - assessed by the Hip Disability and Osteoarthritis Outcome Score (HOOS)(Baseline, 3, 6 and 12 months)
- Change in physical functioning assessed by the Physcal function domain of Short Form 36 - (SF-36)(Baseline, 3, 6 and 12 months)
- Fulfillment of treatment goals(3 months)
- Change in insomnia problems assessed by the Insomnia Severity Index(Baseline, 3, 6 and 12 months)
- Change in physical capacity assessed by 30 s sit to stand(Baseline, 3, 6 and 12 months)
- Short Physical Performance Battery(Baseline, 3, 6 and 12 months)
研究者
Nina K. Vollestad
Professor
University of Oslo