The study design that will be used for this project is an evidence-based practice change design. This design involves identifying a problem in practice and coming up with a proposed change based on the evidence from research. The proposed intervention is then implemented and evaluated for effectiveness in producing the expected outcomes within a particular population or context. From the clinical question, the current intervention involves using text messages to provide diabetes education and support, and providing the patients with clinical support through phone calls. The expected outcomes of the practice change include a reduction in the HbA1c levels and improvement in patient satisfaction of Hispanic diabetes patients. Various studies have shown that the intervention is likely to achieve these outcomes among the target population (Philis-Timikas et al., 2016; Arora, Peters, Burner, Lam, and Menchine, 2014; Capozza et al., 2015; Levy et al., 2015).
Setting and Sample
The setting for the intervention will be a health care center that provides clinical services to diabetes patients. The health care center is preferred in this case as it provides a central location where participants can be recruited as well as clinical nurses who will provide the telemedicine support. The health professionals at the selected locations will be responsible for implementing the intervention. Minimal training will be required on the side of the health professionals as the intervention does not include technical information or practices outside the scope of the nurse or physician. However, the participants will be trained on how to monitor blood glucose and how to utilize the messaging system. The participants of the study will be Hispanic patients who have been diagnosed with diabetes mellitus and have a HbA1c value of >7.5%. The participants should also be in possession of a mobile telephone that receives and sends text messages. They will be recruited by the clinical staff who will assess their eligibility.
Confidentiality of Participants
Confidentiality of the participants will be maintained at all levels of the intervention. Practices that will be employed to ensure confidentiality include:
- Encrypting identifiable data.
- Assigning security codes and passwords to computerized data.
- Restricting access to participant information to only the investigators.
- Properly disposing, destroying or deleting any information relating to the intervention.
- Securely storing documents within locked locations.
- Maintaining anonymity by avoiding data that can identify a participant.
Intervention and Procedures
The participants will be enrolled in a text messaging platform where they will receive daily text messages requesting a blood glucose measurement value and other messages providing information on diabetes and the ways of self-management. A participant may call the participating nurse at any time during the intervention if they need any form of clinical support or information. A nurse at the health center will be assigned to each group and will record the blood glucose measurements received from the participants. In case they receive an alarm value, the nurses will call the patients and follow-up on the problem. HbA1c values of all the participants will be collected at baseline and three more times in three-month intervals. The participants will also complete a medication adherence questionnaire at the beginning and end of the intervention, and a patient satisfaction questionnaire at the end of the intervention.
The measurement instruments will include both quantitative and qualitative types. Quantitative data includes the HbA1c values while the qualitative data includes patient satisfaction and adherence to clinical guidelines. The primary outcome, HbA1c levels, will be measured at the health center and analyzed progressively to identify any changes. Alarm values will be addressed by the nurses participating in the intervention by calling the patient and inquiring more on the reasons for the abnormal blood glucose levels. The secondary outcomes, adherence to clinical guidelines and patient satisfaction, will be measured using a self-administered questionnaire. The questionnaire will be used to collect the data on the patient’s rate of adherence to clinical guidelines of diabetes self-management and will incorporate the elements of the diabetes treatment satisfaction questionnaire (DTSQ).provider data that will be collected includes the nurses and physicians satisfaction with the program, and will be measured using a questionnaire containing both open-ended and closed-ended questions.
Data will be collected using both quantitative and qualitative methods. HbA1c values will be logged into the computer when the participants will be tested at the health center as a routine procedure. Blood glucose values will also be logged into the computer as they are received from the participants. Comparisons will then be made during analysis to identify the trends in relation to the expected values. The secondary outcomes will be assessed using a self-administered questionnaire, after which the data will be analyzed to identify the degree of participant compliance to diabetes self-management best practices and the extent of satisfaction with the treatment.
Different types of data will be collected at various intervals throughout the intervention period. HbA1c values will be collected four times: at baseline, three months into the intervention, at the end of the intervention, and three months after completion of the intervention. These values will be compared progressively to identify extreme values and take action depending on the group to which the participant has been assigned. The data on patient adherence to diabetes self-management best practices will be collected twice, at the beginning and end of the intervention. Patient satisfaction information will be obtained once at the end of the intervention using the self-administered questionnaire.