Evaluating the implementation of personalised outcomes forecasts to optimise supervised exercise therapy in patients with intermittent claudication in the Netherlands: a multimethods study.

BACKGROUND: To support the optimisation of supervised exercise therapy (SET) in patients with intermittent claudication, we developed personalised outcomes forecasts (POFs), which visualise estimated walking distance and quality of life for individual patients. The POFs may enable healthcare professionals, such as physical and exercise therapists, to improve shared decision-making and patient outcomes. OBJECTIVES: To assess differences in patient outcomes (functional walking distance, maximal walking distance and health-related quality of life) and the level of shared decision-making before and after the implementation of POFs in the conservative treatment of patients with intermittent claudication. METHODS: An interrupted time series design was used to compare preimplementation and postimplementation differences on patient outcomes. Using routinely collected data, differences from baseline to 6 months were compared between patients before and patients after the implementation. To compare levels of shared decision-making, we conducted observations of initial consults within a sample of physical or exercise therapists both before and after the implementation. Audiorecords of observations were scored on shared decision-making using the OPTION-5 instrument. RESULTS: Differences in improvements between patients with whom POFs were discussed (n=317) and patients before the implementation of POFs (n=721) did not reach statistical significance for both functional walking distance (experimental vs. control=+23%, p=0.11) and maximal walking distance (experimental vs. control=+21%, p=0.08). For health-related quality of life, the POFs-informed patients showed a statistically significant greater improvement of 4% (p=0.04). Increased levels of shared decision-making were observed in postimplementation consults (n=20) when compared with preimplementation consults (n=36), as the median OPTION-5 total score showed a statistically significant increase from 45 to 55 points (p=0.01). CONCLUSIONS: Integrating POFs into daily practice of SET for patients with intermittent claudication could assist in improving health-related quality of life and enhancing patient involvement. Using POFs did not result in statistically significant different improvements between groups on walking distances. TRIAL REGISTRATION NUMBER: NL8838.

Nationwide implementation of personalized outcomes forecasts to support physical therapists in treating patients with intermittent claudication: Protocol for an interrupted time series study.

INTRODUCTION: Shared decision-making is the cornerstone of patient-centered care. However, evidence suggests that the application of shared decision-making in physical therapy practice is limited. To elicit shared decision-making and thereby potentially improve patient outcomes for patients with intermittent claudication, we developed a decision support system. This decision support system provides personalized outcomes forecasts that visualize the estimated walking distance of an individual patient. We hypothesize that personalized outcomes forecasts can support physical therapists in personalizing care to the needs and priorities of the individual patient to improve therapy outcomes. RESEARCH OBJECTIVES: The primary aim is to evaluate the impact of personalized outcomes forecasts for patients with intermittent claudication to optimize personalized treatment. Second, this study aims to evaluate the process of implementation. METHODS: This study uses a prospective interrupted time series (ITS) design. Participating physical therapists are divided into four clusters. Every month of the study period, a new cluster will be invited to begin using the decision support system. We aim to include data of 11,250 newly referred patients for physical therapy treatment. All therapists associated with a network of specialized therapists (Chronic CareNet) and patients treated by these therapists are eligible to participate. The decision support system, called the KomPas, makes use of personalized outcomes forecasts, which visualize the estimated outcome of supervised exercise therapy for an individual patient with intermittent claudication. Personalized outcomes forecasts are developed using a neighbors-based approach that selects patients similar to the index patient (a.k.a. neighbors) from a large database. Outcomes to evaluate impact of implementation are patients' functional and maximal walking distance, quality of life and shared decision-making. Process evaluation will be measured in terms of utilization efficacy, including the outcomes dropout rate and reasons to (not) use the personalized outcomes forecasts. Data will be routinely collected through two online systems: the Chronic CareNet Quality system, and the website logs of the decision support system. Additionally, observations and semi-structured interviews will be conducted with a small subset of therapists. ETHICS: Formal medical ethical approval by the Medical Research Ethics Committees United 'MEC-U' was not required for this study under Dutch law (reference number 2020-6250).

Impact of Personalized Outcomes Forecasts on Clinical Reasoning of Physical Therapists in Intermittent Claudication: A Vignette Study.

OBJECTIVE: Guidelines recommend supervised exercise therapy and lifestyle counseling by a physical therapist as initial treatment for patients with intermittent claudication. However, guidelines provide only a crude estimate of the outcomes that therapists and patients might expect from treatment. The purpose of this study was to explore the impact of personalized outcomes forecasts (POFs) on the decision-making process of physical therapists and to learn lessons on facilitating the use of forecasts in daily practice. METHODS: A vignette-based, think-aloud interview study design was used. The participants were physical therapists trained in treating patients with intermittent claudication. Vignettes described fictitious patients diagnosed with intermittent claudication and included POFs. A directed approach was used to code, organize, and describe the data. Transcripts were analyzed using a thematic approach. RESULTS: Sixteen therapists participated in the study. Three themes were identified: (1) setting and contextualizing treatment expectations, (2) setting (shared) goals and (de)motivating the patient, and (3) establishing and monitoring the treatment plan. Therapists mentioned that POFs could be useful for setting expectations and realistic treatment goals, contextualizing expected treatment response, stimulating patients to achieve their goals, and deciding on treatment frequency and treatment timing. Therapists thought POFs would be of less use for changing treatment goals during follow-up visits or for establishing intensity or type of training. CONCLUSION: To overcome challenges that may arise when adopting POFs in daily practice, adequate training of physical therapists should be conducted. Potential areas to address with training include statistical and data literacy as well as guidance on integrating POFs with existing treatment protocols. IMPACT: The use of POFs by physical therapists might contribute to a more person-centered care approach. The insights provided by this study on the first use of POFs by physical therapists can serve as an example and lesson on how to optimally implement such supporting tools into daily practice.

Personalised Outcomes Forecasts of Supervised Exercise Therapy in Intermittent Claudication: An Application of Neighbours Based Prediction Methods with Routinely Collected Clinical Data.

OBJECTIVE: Insights regarding individual patient prognosis may improve exercise therapy by informing patient expectations, promoting exercise adherence, and facilitating tailored care. Therefore, the aim was to develop and evaluate personalised outcomes forecasts for functional claudication distance over six months of supervised exercise therapy for patients with intermittent claudication. METHODS: Data of 5 940 patients were eligible for analysis. Neighbours based predictions were generated via an adaptation of predictive mean matching. Data from the nearest 223 matches (a.k.a. neighbours) for an index patient were modelled via Generalised Additive Model for Location Scale and Shape (GAMLSS). The realised outcome measures were then evaluated against the GAMLSS model, and the average bias, coverage, and precision were calculated. Model calibration was analysed via within sample and of sample analyses. RESULTS: Neighbours based predictions demonstrated small average bias (- 0.04 standard deviations; ideal = 0) and accurate average coverage (48.7% of realised data within 50% prediction interval; ideal = 50%). Moreover, neighbours based predictions improved prediction precision by 24%, compared with estimates derived from the whole sample. Both within sample and of sample testing showed predictions to be well calibrated. CONCLUSION: Neighbours based prediction is a method for generating accurate personalised outcomes forecasts for patients with intermittent claudication undertaking supervised exercise therapy. Future work should examine the influence of personalised outcomes forecasts on clinical decisions and patient outcomes.

Using a Learning Health System to Improve Physical Therapy Care for Patients With Intermittent Claudication: Lessons Learned From the ClaudicatioNet Quality System.

Routinely collected outcomes data can be used to improve physical therapy care through benchmarking, personalization, continued education, and treatment optimization. This article describes how a nationwide infrastructure to routinely collect data from daily practice was created and how these data were used through a support system (called the ClaudicatioNet Quality system) to improve physical therapy care for patients with intermittent claudication in the Netherlands. ClaudicatioNet is a nationwide network of 2100 specialized physical therapists, providing high-quality supervised exercise therapy in combination with lifestyle counseling. The ClaudicatioNet Quality system uses a large national registry in which specific relevant health outcomes have been routinely collected since 2015. These data have then been used in turn to assess quality of care and provide transparency to therapists and other stakeholders. The Quality system is intended to serve as a learning health system, to support continuous learning at the therapist, practice, and network level. In this approach, individual patients and physical therapists are provided with opportunities to personalize, benchmark, and evaluate (and possibly alter) a treatment plan using routinely collected data from historical patients. The Quality system is described based on the essential elements of a learning health system. The challenges and lessons learned in developing the Quality system also are described. IMPACT: The use of routinely collected health outcomes can, if implemented correctly, facilitate continuous learning among physical therapists and contribute to person-centered care. This example of a learning health system might serve as a blueprint for physical therapists on how to optimally implement and distill meaning from routinely collected clinical data.

A Nationwide Network to Provide Supervised Exercise Therapy and Lifestyle Counseling for All Patients with Non-Communicable Diseases: Chronic CareNet.

Non-communicable diseases (NCDs) are a major cause of disability and mortality worldwide. Physical inactivity is an important contributor to the development of NCDs. Increasing physical activity through supervised exercise therapy (SET) is proven to be effective, and is a key component in both the prevention and treatment of most NCDs. However, only a minority of patients with NCDs receive this treatment, mainly due to an insufficient number and poor accessibility of specialized physical therapists. The aim of this article is to describe a solution that, if indicated, enables all patients with NCDs in the Netherlands to receive SET by a specialized physical therapist: Chronic CareNet. Chronic CareNet is a nationwide network of specialized physical therapists, providing high quality SET and lifestyle counselling to patients with NCDs, initially focusing on peripheral arterial disease, chronic obstructive pulmonary disease and coronary heart disease. The network evolved from ClaudicatioNet. In order to monitor quality of care, therapists enroll in a continuous educational program, and process and outcome indicators are collected by all therapists, which can be compared with a nationwide benchmark (quality system). A robust infrastructure of information and communication technology provides an online care finder and referral system to locate and refer to nearby therapists. All elements of Chronic CareNet are essential, to ensure that all patients in the Netherlands have access to a nearby specialized therapist.

Protocol for a prospective, longitudinal cohort study on the effect of arterial disease level on the outcomes of supervised exercise in intermittent claudication: the ELECT Registry.

INTRODUCTION: Despite guideline recommendations advocating conservative management before invasive treatment in intermittent claudication, early revascularisation remains widespread in patients with favourable anatomy. The aim of the Effect of Disease Level on Outcomes of Supervised Exercise in Intermittent Claudication Registry is to determine the effect of the location of stenosis on the outcomes of supervised exercise in patients with intermittent claudication due to peripheral arterial disease. METHODS AND ANALYSIS: This multicentre prospective cohort study aims to enrol 320 patients in 10 vascular centres across the Netherlands. All patients diagnosed with intermittent claudication (peripheral arterial disease: Fontaine II/Rutherford 1-3), who are considered candidates for supervised exercise therapy by their own physicians are appropriate to participate. Participants will receive standard care, meaning supervised exercise therapy first, with endovascular or open revascularisation in case of insufficient effect (at the discretion of patient and vascular surgeon). For the primary objectives, patients are grouped according to anatomical characteristics of disease (aortoiliac, femoropopliteal or multilevel disease) as apparent on the preferred imaging modality in the participating centre (either duplex, CT angiography or magnetic resonance angiography). Changes in walking performance (treadmill tests, 6 min walk test) and quality of life (QoL; Vascular QoL Questionnaire-6, WHO QoL Questionnaire-Bref) will be compared between groups, after multivariate adjustment for possible confounders. Freedom from revascularisation and major adverse cardiovascular disease events, and attainment of the treatment goal between anatomical groups will be compared using Kaplan-Meier survival curves. ETHICS AND DISSEMINATION: This study has been exempted from formal medical ethical approval by the Medical Research Ethics Committees United 'MEC-U' (W17.071). Results are intended for publication in peer-reviewed journals and for presentation to stakeholders nationally and internationally. TRIAL REGISTRATION NUMBER: NTR7332; Pre-results.