Clinical trial NCT05232474: Using KomPas+ in the Treatment of Patients With Intermittent Claudication
Official title: Implementation and Evaluation of a Guideline-based Clinical Decision Support System (KomPas+) Used by Therapists and Patients in the Treatment of Intermittent Claudication: a Cluster Randomized Trial With a Parallel Process Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intermittent Claudication
Peripheral Arterial Disease
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Chronisch ZorgNet
name: Koninklijk Nederlands Genootschap voor Fysiotherapie
name: Vereniging van Oefentherapeuten Cesar en Mensendieck
name: Harteraad
First posted: 2022-02-09
Enrollment: 904
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intermittent claudication is the most common symptom of peripheral arterial disease (PAD). The recommended therapy is supervised exercise therapy combined with lifestyle counselling, provided by a physiotherapist. Ideally, during the treatment process patients' values and preferences are incorporated with evidence-based knowledge; shared decision making (SDM). Evidence shows the use of SDM in daily practice is scarce. Therefore, personalized outcome forecasts which provide insight into an individual's personal prognosis (called KomPas) were implemented in 2020. Now, as a next step, KomPas is further developed into a guideline-based clinical decision support system. The result is called KomPas+, a tool which integrates the person-centered approach of KomPas with the guideline recommendations for the conservative treatment of people with intermittent claudication.The primary objective of this study is to evaluate the impact of implementing KomPas+ in the physiotherapeutic treatment of patients with intermittent claudication on functional walking distance and health-related quality of life. Secondary, the level of SDM and person-centeredness of physiotherapists using KomPas or KomPas+ will be assessed. Third, the implementation process will be evaluated.


Eligibility criteria: Inclusion Criteria Primary objective:

- All therapists affiliated with Chronisch Zorgnet and specialized in the treatment of people with intermittent claudication are eligible to participate. Besides, all patients referred to a Chronisch Zorgnet therapist with intermittent claudication specialty are eligible to participate.

Inclusion Criteria Secondary objective:

* Provides written informed consent (both therapist and patients)
* Therapists should have finished two KomPas (control group) or KomPas+ (experimental group) e-learnings
* Therapists should have applied KomPas (control group) or KomPas+ (experimental group) to at least one patient with intermittent claudication

Inclusion Criteria Third objective:

- All therapists affiliated with Chronisch Zorgnet and specialized in the treatment of people with intermittent claudication who are included in the experimental group are eligible to participate.

Exclusion Criteria:

* Not applicable due to the "real world" setting of the study.

Primary outcomes:
measure: Mean Change from Baseline in Functional walking distance (FWD) using a standardized treadmill test at 3 months, 6 months, 9 months and 12 months.
timeFrame: Change from baseline at 3 months and 6 months
measure: Mean Change from Baseline in Health-Related Quality of Life using the Vascular Quality of Life Questionnaire-6 (VascuQol-6) at 3 months, 6 months, 9 months and 12 months.
timeFrame: Change from baseline at 3 months and 6 months
Secondary outcomes:
measure: Level of Person-Centredness assessed by using a Patient-Administered Questionnaire at the initial consult with the patient with intermittent claudication in which treatment goals and treatment plan are discussed.
timeFrame: During the initial consult with the patient with intermittent claudication in which treatment goals and treatment plan are discussed. This moment varies between the date of inclusion to three weeks after the date of inclusion.
measure: Level of Shared Decision Making (SDM) assessed by scoring video-records of clinical consultations with the Observer Patient Involvement (OPTION) 5 scale at the initial consult with the patient in which treatment goals and treatment plan are discussed.
timeFrame: During the initial consult with the patient with intermittent claudication in which treatment goals and treatment plan are discussed. This moment varies between the date of inclusion to three weeks after the date of inclusion.
Other outcomes:
measure: Perceived barriers and facilitators to (not) use KomPas+ in the physiotherapeutic treatment of patients with intermittent claudication using a qualitative assessment.
timeFrame: Between six and twelve months after the start of the implementation of KomPas+
measure: The degree of implementation of KomPas+ in terms of reach and demand measured by website logs (demand) and the use of KomPas+ (reach).
timeFrame: After the 4-month inclusion period
Locations:
city: Nijmegen
country: Netherlands
facility: IQ healthcare, Radboudumc
Study officials:
affiliation: Radboud university medical center, IQ healthcare
name: Thomas Hoogeboom, PhD
role: PRINCIPAL_INVESTIGATOR
References: