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OBJECTIVE

The aim is to evaluate effectiveness and costs of allied healthcare in patients recovering from COVID-19. Since there is no control group it will not be possible to directly assess effectiveness. We will therefore obtain estimates of effectiveness through several research questions using different data sources.

Research questions focus on outcomes in physical, nutritional, cognitive, mental and daily functioning of patients with COVID-19 who received allied healthcare during recovery; costs of different mono- and multidisciplinary allied healthcare trajectories; and experiences of patients, allied health professionals (AHPs) and referring physicians.

 

HYPOTHESIS

The health status of patients with COVID-19 will improve relevantly after an allied healthcare treatment episode on participation, quality of life, fatigue, and profession-specific outcomes related to functioning.

 

STUDY DESIGN

An ambispective observational cohort study in which existing real world data will be combined with prospective data collection for describing differences in characteristics of patients, subgrouping of associated variables, and the cost analyses.

A process evaluation will be included to evaluate the experiences of patients, AHPs and referring physicians with the provided allied healthcare treatment. Text-mining will be used to obtain additional information about functional outcomes and components of allied healthcare using open text fields in electronic health records of AHPs. Finally, we will use a consensus process to develop recommendations for updating or creating new guidance for AHPs.

 

STUDY POPULATION(S)/DATASETS

All adult patients diagnosed or suspected with COVID-19 with severe symptoms and activity limitations and/or participation restrictions, who are referred to an AHP by a general practitioner or medical specialist will be eligible.

For the retrospective data collection, we will use four outcome registries and one claims data registry. In addition, we will collaborate with networks and practices of AHPs to obtain data via their electronic health records.

For the prospective cohort we will use two different mechanisms for data collection. First, we will continue using the data from the registries. Second, we will set up a prospective registration via the Castor electronic data capture system. We will develop a case report form for each of the AHPs.

 

INTERVENTION

No specific intervention will be developed for this observational study. The interventions used by the AHPs will be based on recommendations published by the professional bodies of AHPs, and Long Alliantie Nederland.

To enable evaluation of the outcomes of different types of allied health interventions we will distinguish: Monodisciplinary care (i.e., dietitian, exercise therapist, occupational therapist, physical therapist, or speech and language therapist) and Multidisciplinary care (i.e., combined care by of two or more AHPs).

 

OUTCOME MEASURES

Primary outcomes for allied healthcare in patients with COVID-19 are participation (measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P)); quality of life (measured with the EQ-5D-5L); and fatigue (measured with the Fatigue Severity Scale (FSS)).

 

The following professional-specific outcomes will be used:

 

Physical therapy and exercise therapy:

*Patient Specific Complaints

*PROMIS Physical Functioning

 

Dietary care:

*BMI (weight and height)

*PG-SGA short form

 

Speech and language therapy:

*Voice Handicap Index

*Dysphagia Handicap Index

 

Occupational therapy:

*Canadian Occupational Performance Measure

*Cognitive Complaints – Participation

 

SAMPLE SIZE CALCULATION/DATA ANALYSIS

With 715 expected new patients in the prospective cohort we have sufficient power to detect clinically relevant changes on the primary outcome measure. The sample size is also sufficient for subgroup analyses of outcomes per profession for the profession-specific and secondary outcomes. Estimations of recovery will be modeled using mixed linear and logistic regression analysis for continuous outcomes and dichotomous outcomes, respectively. Analyses will be based on statistically significant differences estimating mean differences and odds ratios with 95%-confidence intervals in recovery for the different comparisons, and on clinically relevant changes of the outcomes.

 

COST-EFFECTIVENESS ANALYSIS

A cost description will be performed to estimate the cost of providing allied healthcare to patients recovering from COVID-19; a cost-consequence analysis to provide an overview of the total costs and consequences of the different types of allied health interventions; and a cost-outcome description to compare the costs of the various interventions to their associated health gains. For these analyses, the patients’ EQ-5D-5L health states will be converted to utility values and costs will be assessed with cost questionnaires.

 

TIME SCHEDULE

The project has a three year time frame comprising six work packages.

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