Dr. Yannik Schreckenberger
PROMoting Quality is a collaborative research project bringing together leading German healthcare organisations, insurers, health economists and a technology provider. The goal of PROMoting Quality is to investigate the use of Patient-Reported Outcome Measures (PROMs) for cost-effectiveness and the early detection of post-surgical complications following a hip or knee replacement. 10.000 patients are currently being recruited at nine hospitals, costs and patient outcomes will be assessed throughout the care pathway in an intervention and control group.
With an ageing population, total hip and knee replacement surgery are now one of the most common in-patient surgeries in Germany. Between 2006 and 2016, the number of surgeries increased by 17% and 38% respectfully, and these numbers are expected to rise in line with life expectancy and implantations at earlier ages.
Recent guidelines from German public health agencies clearly state the need for a more cost-efficient, patient-centred care delivery; however, recommended criteria focus solely on clinical and administrative outcomes. Presently, the standardised quality control of treatment success from the patient’s vantage point is not in use. This results in the delayed detection of complications, impacting on patients’ quality of life (QoL). If real-time patient feedback is incorporated before and after surgical intervention, additional costs associated with complications may be avoided.
The goal of PROMoting Quality is to investigate the use of Patient-Reported Outcome Measures (PROMs) for cost-effectiveness and the early detection of post-surgical complications. The study is a multi-centre, randomised intervention and economic evaluation. 10,000 adult patients (ASA grade 1-3) with elective hip or knee replacements will be recruited over one year in 9 German hospitals and randomised into an intervention and control group.
The primary endpoint of the study is the cost-effectiveness (patient outcome vs costs ratio). The secondary endpoints are outcomes measured in the ICHOM Hip & Knee Osteoarthritis Standard Set: functional status (HOOS-PS / KOOS-PS Scores), quality of life (EQ-5D-3L Score); pain; working status; treatment satisfaction and clinical indicators (postoperative mortality, readmission and reoperation rates).
In the control group, PROMs are collected upon patient admission and one-year post-surgery. While, in the intervention group, PROMs are collected upon patient admission, discharge and at regular intervals (1, 3, 6 and 12 months after surgery). The regular capture of PROMs in the intervention group aims to facilitate the detection of complications and prompt early intervention. Patient outcomes are monitored by a study nurse who will notify the broader care team with unexpected results. Care teams will then decide if further investigation or intervention is required. The working hypothesis is that the cost-effectiveness ratio will be higher in the intervention group due to early detection of complications and subsequent management. The cost of care delivery for each patient over the study will be estimated using the associated statutory health insurance routine data.
PROMoting Quality began in April 2019 with a six-month implementation phase. Participating healthcare providers integrated the PROMs-collection software into their respective IT-infrastructures, while concurrently aligning with clinical routines and patient journeys, adhering to the requirements of high-quality data collection. Patient enrollment commenced on the 1st of October. As of the 10th February 2020, 2,500 patients were enrolled and had completed the baseline questionnaire to assess their quality of life before undergoing their respective surgeries. Since the project’s commencement, 650 post-surgical patients have responded to their first and/or second follow-up PROMs questionnaires (1 and 3 months after clinical admission respectively). Based on estimated complication trigger thresholds, 50 patients thus far have received an interventional treatment due to postoperative complications.
PROMoting Quality is a collaborative research project bringing together multidisciplinary teams of leading German healthcare providers, insurers, academics and a technology provider.