Allied Health Professionals, Covid19, National Dutch Program, Performance Measures, Primary Care, PROMs, Prospective Cohort, Retrospective Cohort
Conditions
Keywords
Covid19, Allied health professionals, primary care, PROMs
Brief summary
SUMMARY Rationale: Allied health professionals (i.e., dietitians, exercise therapists, physical therapists, occupational therapists and speech and language therapists) might play an important role in the recovery of patients with COVID-19 who experience limitations in daily physical functioning and participation. However, the evidence base for allied healthcare in patients with COVID-19 has yet to be established. To facilitate care for people recovering from COVID-19 and to establish this evidence base, the Dutch ministry has created a temporary regulation for primary care allied healthcare specifically for patients with COVID-19. Objective: This study is setup alongside the temporary regulation and aims to evaluate the longitudinal recovery trajectories and related costs of patients who visited a primary care allied healthcare professional for the management of severe symptoms and activity limitations and/or participation restrictions related to COVID-19. Study design: Prospective cohort study. Study population: 1,315 adult patients recovering from COVID-19 with severe symptoms and activity limitations and/or participation restrictions, and who are referred to a primary care allied health professional by a general practitioner or medical specialist within four months of the start of the disease will be eligible for this study. Intervention (if applicable): Although the nature of this study is non-experimental, the allied healthcare intervention can be considered experimental due to the novelty of the disease. Main study parameters/endpoints: The primary outcome domain of this study is participation measured with the Utrechtse Schaal voor Revalidatie - Participatie (USER-P). The primary endpoint is set at 6 months. A 5 point difference will be considered clinically relevant for patients with COVID-19. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no specific risks involved with participation in this study, as it entails the completion of questionnaires over the timeframe of one year (at the start of the treatment, the end of the treatment, 3 months, 6 months, 9 months and 12 months). The load of the survey will be highest at months 3, 6 and 12 with a total of 74 survey items. Input from patient representatives suggested that this number of items was feasible, especially because participants are allowed to complete the survey over a number of days. Finally, none of the items in the survey are considered emotionally distressing. The prescribed interventions are conform the recommendations of the best available evidence and are in line with usual allied healthcare interventions. Therefore, risks are likely to be negligible conform usual allied healthcare.
Interventions
We will not develop specific interventions for this prospective observational cohort study. The care provided by allied health professionals in daily practice are based on recommendations published by the professional bodies of allied health professionals and on the interdisciplinary guidance developed by the LAN. All allied health professionals are working according to these recommendations. Dissemination of these recommendations is done by the professional bodies of the allied health professionals. Given the observational nature of our study, no additional implementation strategies will be employed to stimulate this care by the research group.
Sponsors
Study design
Eligibility
Inclusion criteria
Adult patients * recovering from COVID-19 with severe symptoms and activity limitations and/or participation restrictions, and; * who are referred to a primary care allied health professional by a general practitioner or medical specialist within four months of the start of the disease; will be eligible for this study. The need for referring the patient to an allied health professional will be judged by the primary care physician or medical specialist. Criteria for referral are described in guidance published by the Long Alliantie Nederland (LAN) with recommendations for treatment of post-COVID-19-patients: the COVID-19 Associated Syndrome (CAS) (Chapters 3.3 and 4). http://www.longalliantie.nl/files/2515/9359/4621/Handreiking\_voor\_de\_zorg.pdf
Exclusion criteria
Adult patients: \- receiving palliative care; are excluded from this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | Baseline (T0) | Measured with the Fatigue Severity Scale (FSS) |
| Physical functioning | Baseline (T0) | PROMIS Physical Functioning Short Form 10b (10 items). |
| Quality of life measured with EQ-5D-5L | Baseline (T0) | Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items) |
| Participation | Baseline (T0) | Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items) |
| Costs | Baseline (T0) | will be measured using a cost questionnaire (18 items) |
| Patient Specific Activities | baseline (T0) as part of usual care | measured with the Patient Specific Complaints (PSC) |
| Nutritional Status | baseline (T0) as part of usual care | measured with the BMI (weight and height) |
| Global Assessment | baseline (T0) as part of usual care | measured with the PG-SGA short form weight history, food intake, symptoms, activities and function). |
| Voice Problems | baseline (T0) as part of usual care | measured with Voice Handicap Index (VHI) |
| Swallowing Problems | baseline (T0) as part of usual care | Dysphagia Handicap Index (DHI). |
| Activities | baseline (T0) as part of usual care | measured with the PRO-ergo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Swallowing Problems | baseline (T0) as part of usual care | measured with Maximum Swallowing Speed (MSP) |
| Physical Functioning | baseline (T0) as part of usual care | measured with the Assessment of Motor and Process Skills (AMPS) |
| Cognitive Functioning | baseline (T0) as part of usual care | measured with the Cognitive Complaints - Participation (CoCo-P) |
| Exercise capacity | baseline (T0) as part of usual care | 6 Minute Walk Test (6MWT) |
| Quadriceps strength | baseline (T0) as part of usual care | with a hand dynamometer. |
| Hand grip strength | baseline (T0) as part of usual care | with a hand dynamometer. |
| Bioimpedance (BIA | baseline (T0) as part of usual care | — |
| VAS-appetite, taste and smell | baseline (T0) as part of usual care | — |
| Dietary goal attainment | baseline (T0) as part of usual care | — |
| Liquid medical nutrition | baseline (T0) as part of usual care | — |
| Sarcopenia | baseline (T0) as part of usual care | measured with the SARC-F |
| Types of Stool | baseline (T0) as part of usual care | measured with the Bristol Stool Chart (BCS) |
| Voice Problems | baseline (T0) as part of usual care | measured with Maximum Phonation Time (MPT) |
Countries
Netherlands