Effectiveness of oral surgeon-led post-operative telephonic follow-up on the patient satisfaction among the patients undergoing minor oral surgical procedures in a tertiary care dental hospital in a coastal district of Karnataka- A randomised controlled study

Title: Effectiveness of oral surgeon-led post-operative telephonic follow-up on the patient satisfaction among the patients undergoing minor oral surgical procedures in a tertiary care dental hospital in a coastal district of Karnataka – A randomised controlled trial

Introduction:

A non-adherence to clinical recommendation is challenging issue in out-patient follow up during post op period. This issue is not limited to certain medical specialities or medical cohort. Poor patient compliance towards following post operative instructions and medications may result in poor health outcome. Follow up visits are essential for surgical patients to monitor wound healing.

Patients who have undergone minor surgical procedures and return home the same day have multiple queries regarding pain, bleeding from surgical site, doubts regarding medication etc.

A study conducted by Sarah et al aimed to assess the effect of post procedure personalised telephone call that showed a better compliance in subsequent post-discharge appointments.[ss1] (1) Presently,  standard of care is to contact the department clinic landline telephone or visit the OPD clinic by the patient during working hours and visit emergency department after working hours in case of need. Currently, it is not mandatory to share contact number between patient and doctors for clearing the patient queries peri-operatively. Hence most often we cannot resolve the queries regarding post operative instructions and medications which can negatively affect patient compliance and may also compromise desired healing outcome.

This study is designed to assess the patient satisfaction and treatment outcome with and without post operative oral surgeon led telephonic follow up. Patient compliance and addressing patient queries during post op period by sharing telephone numbers between patient and the treating doctors and this will be compared with patients being given standard of care.

 Aim:

To assess Effectiveness of oral surgeon-led post-telephonic follow-up on the patient satisfaction among the patients undergoing any minor oral surgical procedures in a tertiary care dental hospital in a coastal district of Karnataka.

 Objectives:

PRIMARY: To assess effectiveness of oral surgeon-led post-telephonic follow-up on the patient satisfaction among the patients undergoing any minor oral surgical procedure in a tertiary care dental hospital

SECONDARY: To determine the improvement in patient compliance among healthcare professional-led post operative telephonic follow up group as compared to patients receiving current post-op standard of care

METHODOLOGY:

·       STUDY DESIGN: A randomised controlled trial

·       STUDY DURATION: The study period will be 18 months.

·       STUDY SETTING: The study will be conducted in the Department of Oral and Maxillofacial Surgery, Manipal College of Dental Sciences, Lighthouse outpatient department.

·       STUDY POPULATION: The study is conducted among the patients who are undergoing any minor oral surgical procedures.

INCLUSION CRITERIA:

1.    All Surgical out-patients of 18 years and above undergoing any minor oral surgical procedure under local anaesthesia

2.    Patients giving written informed consent to participate in the study

3.    Minor surgical procedures under local anaesthesia that does not require hospitalisation or day care facility

EXCLUSION CRITERIA:

1.    Patients who are not willing to share their telephone number with the treating doctor or don’t have a telephone number

2.    Admitted patients undergoing minor surgical procedures for any reasons

 Â·       SAMPLE SIZE AND SAMPLING:

According to Tokedde.B et al (2023),the mean (SD) patient satisfaction score at the end of 7 days after a dental procedure with pain management in the group which received telephonic calls was 8.9(2.0) and in the control group was 8.6(2.2). Considering, a mean difference of at least 1 unit in the patient satisfaction score between two groups, we need a minimum sample of 70 patients in each group that is a total of 140 patients to achieve the outcome with a pooled standard deviation of 2.1 units, a power of 80% and 95% confidence intervals. The sample size is calculated using an online sample size calculator for two independent means “statulator” (2)

SAMPLING METHOD:

A total of 140 patients will be recruited for the study . A random number sequence will be generated using an an online software (sealed envelope) and the patients will be randomised into interventional group and control group with a block size of 4 and 6 (block randomisation technique).A sealed envelope technique for allocation concealment will be adopted.The random number sequence will be generated by a person who is not a part of the study.The randomisation and allocation concealement will be done by a junior resident of dept of omfs who is not the part of the study. the control group  will receive the basic care (STANDARD OF CARE) and the Intervention group  will receive the telephonic follow up by the treating oral surgeon.

 STUDY PROCEDURE:

In the present study, patients undergoing minor surgical procedures over a 18-month period of time in the Department of oral surgery of the MCODS Mangalore were included. Patients will be randomly assigned to intervention and control groups. Intervention group will be monitored by telephone follow-up, whereas the control group will be taken care as per standard of care in the department. Minor oral surgical procedure , post telephonic follow up will be done by the principal investigator. Patients of both groups will be examined for post extraction wound healing and patient satisfaction at the time of suture removal (8 to 10 days following surgery) at the outpatient clinic by the blinded co principal investigator.

On the first visit the patients will be explained about the procedure, alternative treatments if any and follow-up visits. Patients that fulfil the inclusion criteria and are willing to participate in the study will be included. A detailed case history of the patient will be recorded followed by taking informed written consent for the procedure. All case group patients will be provided with treating doctor’s phone number and their phone number will be collected.  Control group patients will be given hospital number to contact and asked to come to the OPD/Casualty in case of need. All minor surgical procedures will be performed under local anesthesia according to standard protocol in oral surgery department. All patients will receive the appropriate post-operative instructions. Case group patients will be contacted by phone on the day of surgery and third day after surgery by the treating doctor. The treating doctor will again give the appropriate post op instructions and clarify any queries by the patient during the telephonic conversation. All patients in both groups will be recalled between day 7 to 10 postoperatively. All patients will be asked to fill in a questionnaire that will include questions regarding patient satisfaction and will be checked for healing of the surgical site assessed by the healing criteria given in Annexure -III

A questionnaire will be filled out to report any possible wound problems or any other information during the week after surgery which could indicate the presence of post-operative complications or problems prior to examination.

STUDY TOOL AND VARIABLES:

Pre-designed, structured study tool will be made. Section A will include demographic data of the patient like name, age, profession of the patient etc. There are no questions about the subject’s personal details to maintain their anonymity**.** Section B contains clinical details of the patient like medical history, post procedure complications if any, etc. Section C will contain patient satisfaction assessment. Section D will contain questions related to patient compliance.

STASTICAL ANALYSIS:

Data collected will be entered in MS excel and analysis will be done in SPSS v.22. Descriptive analysis will be carried out. Variables like age, duration of hospital stay, patient satisfaction score will be expressed as mean (SD)/Median (IQR). The baseline and post follow-up improvement in the patient satisfaction score and across the two groups will be assessed by repeated measure ANOVA.

The compliance rate across two groups will be expressed as proportions and percentages. The difference in proportion across two groups will be assessed by chi-square test of association. All statistical significance will be attributed to p<0.05.

ENDPOINT AND OUTCOME:

Endpoint:

The primary endpoint for the RCT is between post surgical  day 7 to 10

Outcome:

Primary outcome : patient satisfaction across both groups

Secondary outcome : 1. perception of pain across both groups

2. post op healing across both groups

3. patient compliance across both groups