Clinical trial NCT03962595: Patient Satisfaction Survey (PSS) In Breast Clinic
Official title: Assessment Of Patient Satisfaction Of Outpatient Care In The Multi-Disciplinary Breast Clinic- Linguistic Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Tata Memorial Centre
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients attending both Private and General out-patient clinic for consultation will constitute the target population of the study.

Brief summary: Patient satisfaction is the primary means of assessing the effectiveness of primary health care delivery. It helps in improving the quality of care by identifying and help resolving the potential problem areas. It assesses the effectiveness of the care provided and document the quality to accrediting organisations.In our institute, we have developed a patient satisfaction survey (PSS) questionnaire and have conducted a pilot study (Institutional review board approved) with fifty English speaking breast cancer patients receiving active cancer directed treatment in outpatient clinic, to evaluate the level of patient satisfaction in them. Therefore, we are now conducting a linguistic validation study using Hindi and Marathi PSS questionnaire to assess the overall level of patient satisfaction in a larger cohort of patients with diverse linguistic and economic background attending both general and private Outpatient Clinic.

The aim of the study is to evaluate the overall level of patient satisfaction and their satisfaction at various encounters in the multi-disciplinary Breast Clinic which can be helpful to improve various aspects of patient care delivery.

Methods:

All patients who have already sort primary consultation in surgical, medical and radiation oncology outpatient clinics for their treatment plan and have had their last consultation within the last one month will be screened for the study. The Patient Satisfaction Survey (PSS) questionnaire (in preferred language) will be administered independently by a clinical research student who is not directly involved in patient care. The PSS will be anonymous. It will be administered to patients in the out-patient clinics waiting area. Patients will be asked to complete 3 surveys: one each for surgical, medical and radiation oncology professionals. It will take approximately 12 months to enroll the required number of patients.

Sample size: Previous studies conducted in India and the pilot study conducted at Tata Memorial Hospital (TMH) with the PSS questionnaire have shown that approximately 70% of the patients are satisfied with the health care services. Assuming that the proportion of patients satisfied with the health services, when assessed by Hindi and Marathi PSS questionnaire will be ± 5% of 70%, i.e. between 65% to 75%, a sample size of 340 will be needed to produces a two-sided 95% confidence interval, which is determined by using Confidence Intervals Formula- Clopper-Pearson method.

Potential Impact of the Study

1. Knowledge of patient satisfaction in breast cancer patients belonging to diverse linguistic and socio-economic background will help in improving the quality of life of patients using appropriate resources and measures relevant to Indian context.
2. Awareness of patient dissatisfaction will help improve doctor patient relationship.
3. Awareness of patient dissatisfaction will help to identify problem areas and improve the care delivery.


Eligibility criteria: Inclusion Criteria:

1. Women with histological confirmation of breast cancer.
2. Planned to receive multi-disciplinary curative active cancer directed treatment.
3. Aware of their diagnosis and treatment plan.
4. Willingness to participate in study.
5. Patient able to read and comprehend Hindi and Marathi. -

Exclusion Criteria:

1. Eastern Cooperative Oncology Group 4
2. Unable to read and fill the questionnaire -

Primary outcomes:
measure: Linguistic validation of patient satisfaction survey (PSS) questionnaires in Hindi and Marathi.
timeFrame: 1 Year
Secondary outcomes:
measure: Proportion of patients having mean overall satisfaction score <70
timeFrame: 1 Year
measure: To compare the level of overall patient satisfaction between paid and service patients: percentage of patients having overall score below 75 of the maximum 125
timeFrame: 1Year
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Tata Memorial Centre
state: Maharashtra
Study officials:
affiliation: Associate Professor, Breast Services
name: Dr. Tabassum Wadasadawala, MBBS,MD,DNB
role: PRINCIPAL_INVESTIGATOR
References: