Clinical Trials Logo

Clinical Trial Summary

Background: To diagnose osteoarthritis (OA), Swedish guidelines recommend an overall assessment including patient history, symptoms, and clinical findings. However, diagnostic radiography is not recommended when assessing OA. Assessing and giving core treatments of patients with knee OA (KOA) is included in physiotherapists' area of expertise. Former studies show that there is no statistically significant difference in health-related quality of life for patients with KOA assessed by physiotherapists compared to being assessed by a physician in primary care. There is also research showing that costs can be reduced with a physiotherapist as first assessor. A task-shifting care model with physiotherapists as the primary assessor, can result in a reduced waiting time to recommended treatment for patients with KOA, as well as increase the accessibility to physicians in primary care for patients with more severe health conditions. Previous studies have explored expectations in patients with KOA and how they have experienced the health care when the first assessment and treatment has been performed by a physician. It has been described how referred patients with KOA have experienced physiotherapy treatment, and the physiotherapists' impact on exercise adherence. To the best of our knowledge, there are no studies describing how patients with KOA have experienced health care, when being referred directly to a physiotherapist for assessment and treatment. The main purpose is to explore expectations, perceptions, and experiences among patients with KOA in primary care who have been assessed and treated by a physiotherapist. The second purpose is to explore the possible meaning of the first meeting when it comes to future self-care and experienced health status. Methods: Estimated 12-15 patients with KOA will be recruited from rehabilitation centers in Region Västra Götaland, Sweden, from October 2022 to February 2023. Semi-structured interviews will be conducted and will be analyzed with qualitative content analysis. Expected results: This study is expected to contribute to a deeper understanding of what expectations patients with KOA have before they seek health care, how they experience physiotherapists as primary assessor in KOA and possible influences of the physiotherapy assessment and treatment on patients' perceived health after the rehabilitation period. This knowledge could be valuable when implementing new care models for patients with KOA.


Clinical Trial Description

Background: To diagnose osteoarthritis (OA), Swedish guidelines recommend an overall assessment with patient history, symptoms, and clinical findings, and diagnostic radiography is not recommended when assessing OA. The recommended core treatment should consist patient education, exercising, self-care and if necessary, weight loss, whereas assessing and giving core treatments of knee OA (KOA) is included in physiotherapists area of expertise. Former study show that there is no statistic significant difference in health-related quality of life for patients with KOA assessed by physiotherapists compared to being assessed by a physician in primary care. Furthermore, costs can be reduced with the model "physiotherapists first". A task-shifting care model with physiotherapists as the primary assessor can result in a faster track to recommended treatment for patients with KOA and increase the accessibility to physicians in primary care for patients with more severe health conditions. Qualitative studies show that patients generally are skeptical to physiotherapists competence compared to physicians regarding assessing musculoskeletal disorders, and a physician assessment could be experienced as an assurance before being assessed and treated by physiotherapist. At the same time, one of these studies shows that there is an acceptance that advanced physiotherapy practitioner can be primary assessor for patients with musculoskeletal disorders. Previous patient experiences of physician assessment could affect patient's expectation of a physician to assess and diagnose their musculoskeletal disorder again, and a belief in need of further examinations with radiography could be another cause to consult a physician first. Overall, patients with OA have had a negative view on conservative OA treatment and experienced that health care have trivialized their symptoms. Patients with KOA could feel hesitant to seek help due to beliefs of physicians' attitude regarding joint pain as a normal ageing symptom. This patient group have reported that their complaints were not taken seriously, and want more focus on the individual rather than the joint. Many patients assessed and treated by physicians report lack of understanding of OA and experience pain avoidance. Patients want other treatment options than drugs, and urge for more time for counselling and information about OA. Physicians experience difficulties in OA management due to time constraints, priorities, and in presenting and choosing treatments. Exercise was reported as an important factor in the management of OA. Referred patients with KOA treated with physiotherapy reported receiving treatments that was recommended for this patient group and the relationship between physiotherapists and patients are important for exercise adherence. To the best of our knowledge, there are no studies of how patients with KOA, have experienced the health care, when being referred directly to a physiotherapist for assessment and treatment. To offer person-centred care for patients with suspected KOA, it is of value to get a deeper understanding of what expectations patients have and what possible meaning a primary assessment by physiotherapists have on patient's future self-care and experienced health status. Purpose: Firstly, the purpose is to explore expectations, perceptions, and experiences among patients with KOA who have sought primary care and being assessed and treated by a physiotherapist first. The second purpose is to explore the possible meaning of the first meeting when it comes to future self-care and experienced health status. Question areas: 1. What expectations did patients with KOA have when they sought primary care for their knee pain? What was important before the first meeting with the health care? 2. How did patients with KOA experience their meetings with the health care? 3. Did the first meeting with health care influence the continued experience of health status for patients with KOA? If so, how? Study design Qualitative research study with an inductive approach. The consolidated criteria for reporting qualitative research' (COREQ) checklist will be used in the planning and reporting results of the study. Patient recruitment and sample size An estimation of 12-15 patients with diagnosed KOA will be recruited from rehabilitations centers in Region Västra Götaland, in southwestern Sweden, from October 2022 to February 2023. Patients will be recruited either by the physiotherapist who treated them, or through a search in a medical record database where patients with KOA will be contacted if they have been patients the last year on the rehabilitation centers. All participants will approve their participation through informed consent. The Swedish Ethical Review Authority have approved the study, reference number 2022-03479-01. Data collection Semi-structured interviews will be conducted by project leader CMHH. An interview guide will be designed and approved by the research group to ensure it answering to the purpose of the study. The interview guide will be pilot tested and approximately 1-2 interviews will be conducted. These interviews might be included in the analysis. The interviews are expected to last about 45-60 minutes and will be recorded with MP3-player or via the secure video conference call system. The interviewer will make a strategic selection of informants, to get a rich variation of the interview data. Data collection will end when no new information that corresponds to the purpose is added. Participants will be strategically selected based on patient characteristics: gender, age, origin (born in Sweden or not), living alone or together with someone, educational level, pain duration, pain intensity, comorbidities, health care process. These data will be collected via questionnaires. Data management All data will be coded and managed according to the General Data Protection Regulation. All data will be confidential and only authorized will have access to the patient registry. No individual information can be identified since the results will be presented at group level. Data will be saved for at least 10 years to enable audit. Analysis plan Patient characteristics will be de-identified and presented on an individual level. The interview data will be listened through, and transcribed verbatim. A qualitative content analysis with inductive approach will be performed according to Graneheim and Lundman: Initial phase: All interviews will be read thoroughly several times to get an overall feeling for the data. Data will be prepared in Microsoft Excel, Office 365 and thereafter transferred to the analytic data program NVivo Pro for Windows. Analyzing the manifest content First phase: Extracting meaning units based on the purpose. i.e., choosing contents that correspond to the purpose of the study. Second phase: Condensing meaning units by shortening the texts without losing its context. Third phase: Coding condensed meaning units. Labeling the content without losing the understanding or the relation to the context. Analyzing the latent content Fourth phase: Creating sub-/categories where codes with similar content will be sorted in as homogeneous internal and heterogeneous external categories as possible. Fifth phase: If possible, the categories will be abstracted further to themes. The project leader/first author (CMHH) will be responsible for transcribing, preparing and coding themes for all interviews. Preliminary categorizing and suggesting themes will also be conducted by CMHH. Every co-author (LN, LZ and CT) will read interviews and all authors will approve the analysis and its results. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05566925
Study type Observational
Source Vastra Gotaland Region
Contact
Status Active, not recruiting
Phase
Start date November 22, 2022
Completion date April 30, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT03895489 - Effectiveness of the Journey Total Knee Arthroplasty Versus Two Standard of Care Total Knee Arthroplasty Prostheses N/A
Completed NCT03660943 - A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain Phase 3
Completed NCT04531969 - Comparison of Outpatient and Inpatient Spa Therapy N/A
Completed NCT02848027 - Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment Phase 3
Completed NCT05160246 - The Instant Effect of Kinesiology Taping in Patients With Knee OA N/A
Recruiting NCT06080763 - Biomechanics and Clinical Outcomes in Responders and Non-Responders
Completed NCT03643588 - The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain N/A
Active, not recruiting NCT05100225 - Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis Phase 2
Active, not recruiting NCT04061733 - New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis N/A
Completed NCT04051489 - A Novel Smartphone Application for "Smart" Knee Osteoarthritis Trials
Recruiting NCT05546541 - Epidemiology and Nutrition
Recruiting NCT05447767 - Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg Phase 2
Not yet recruiting NCT04448106 - Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis Phase 2
Not yet recruiting NCT03225911 - Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis N/A
Completed NCT05070871 - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women N/A
Completed NCT05703087 - Positive Cueing in Knee Arthroplasty. N/A
Not yet recruiting NCT06042426 - Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population Phase 4
Not yet recruiting NCT02854176 - Somatosensory Stimulation in Knee Osteoarthritis Phase 2
Not yet recruiting NCT02865174 - Topical Tranexamic Acid and Floseal® in Total Knee Arthroplasty Phase 4
Terminated NCT02615522 - Prospective Post Market Clinical Follow-Up of the Primary Knee Endoprosthesis BPK-S Integration