Standardization of written informed consent forms to improve patient care, a quality improvement project

Standardization of written informed consent forms to improve patient care, a quality improvement project
Jaweria Akram, Madeha Khalid, Rawand Abdelnaser Jebril, Isra Saleh Alsheikh, Amina Bougaila, Esha Subhash, Muhammed Zahid
BMJ Open Quality, 23 April 2025
Open Access
Abstract
Background
Informed consent taken by inadequately explaining the procedure to the patient or patient representative, along with incomplete documentation of the process, can have ethical, legal and administrative implications. We conducted a baseline survey from the patient’s representative admitted to the Acute Medical Assessment Unit (AMAU), Hamad General Hospital (HGH) [Doha, Qatar], and their representatives to assess the level of satisfaction and understanding with the current informed consent taking process for thoracocentesis, ascitic tapping, lumbar puncture, blood, and blood product transfusion. It showed only 64% were satisfied. We conducted a Quality Improvement project to standardize the process of taking informed consent for the above-mentioned procedures in order to improve patient satisfaction from 64% to 80% by December 2021 by providing them with individualized informed consent forms along with patient information template in their preferred language.
Methods
A thorough process mapping showed different factors that can lead to inadequate informed consent. We introduced the use of individualized informed consent forms for each above-mentioned procedure with the already printed complications along with patient information template in their preferred language with pictorial presentation of the procedure. Ten Plan/Do/Study/Act (PDSA) cycles were conducted with each cycle lasting four weeks. Before each cycle, the quality team conducted extensive training sessions for the residents and nurses. Different reinforcements were provided with each cycle to ensure the utilization of the interventions.
Results
After 10 PDSA cycles, the level of satisfaction with the process of taking informed consent improved from 64% to 94%.
Conclusion
A standardized informed consent form, along with a patient information template written in their preferred language, improves patients’ understanding to make a well-informed decision and therefore improves their satisfaction with the process, acting as a marker of quality improvement.