Uterine Cervical Dysplasia, Uterine Cervix Cancer
Conditions
Brief summary
This study is intended to improve the patient experience of communication of colposcopy results and follow-up recommendations to patients. Current practice involves results being forwarded from the colposcopy clinic to the family or referring physician who then informs the patient. We are testing an intervention informed by focus groups in which a trained colposcopy nurse (patient liaison) directly contacts patients with their results and follow-up recommendations while providing education and support. We will examine whether this intervention improves patient satisfaction, reduces anxiety, and improves rates of adherence to follow-up and treatment appointments compared to the current practice.
Detailed description
Cervical cancer is the second most commonly diagnosed cancer and third leading cause of cancer death in women worldwide. Pre-cancerous cells can be detected with regular Pap smear screening and diagnosed and treated with colposcopy. This process is limited by patient adherence to the follow-up and treatment recommendations. Currently at Vancouver General Hospital (VGH), the largest colposcopy clinic in the province, results are forwarded from the colposcopy clinic to the family or referring physician who informs patients of results and recommendations. Inefficiencies or errors in this step may cause patient dissatisfaction, missed appointments, increased costs, and compromise patient outcomes. The primary objective of this study is to examine whether having a trained colposcopy nurse directly contact patients with their results and follow-up recommendations while providing education and support will improve patient satisfaction and reduce anxiety, with the secondary aim being to assess the clinical effectiveness of this intervention in improving rates of adherence to follow-up and treatment appointments and potentially long-term clinical outcomes. The first phase of the study involves patient focus groups that will be interviewed about what elements of a patient liaison interaction are most important (separate Ethics submission). This information will inform the development of the patient liaison role and approaches to patient interaction to be utilized in the intervention in the second phase. The second phase will entail a randomized controlled trial comparing patient anxiety, satisfaction and adherence to follow-up between a control group (current practice) versus the intervention group exposed to the patient liaison at the VGH Colposcopy Clinic. For the primary aim, a questionnaire containing items pertaining to patient anxiety and satisfaction with their experience of receiving their colposcopy results will be administered both to the intervention and control groups and the mean scores pertaining to anxiety and satisfaction will be compared using two-tailed t-tests. For the secondary aim, a chart review at 6-12 months following the initial colposcopy visit will examine the rates of compliance with the recommended follow-up or treatment visits and histologic diagnoses, and comparisons will be sought between the intervention and control groups using z-score test.
Interventions
BEHAVIORALPatient Liaison
An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy report will inform the referring provider that these patients will be informed of the results. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients. She will forward any patient questions beyond her scope to the patient's colposcopist who may then provide answers to the patient liaison or to the patient directly depending on the complexity and nature of the question.
Sponsors
British Columbia Cancer Agency
Women's Health Research Institute of British Columbia
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must be 19 years of age or older 2. Must be patients presenting for an initial visit at the VGH Colposcopy Clinic
Exclusion criteria
1. Inability to speak conversational English- required to complete the questionnaire as well as provide informed consent to participate 2. Inability or refusal to provide consent 3. Pregnant - pregnant women do not usually have biopsies and their subsequent care may be much different than non-pregnant patients 4. Do not have a family physician or referring physician who will provide continuity of care following colposcopy - these patients do not have the option of getting results from a family or referring physician, so they would bias results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | To be collected by questionnaire in 4-6 weeks following colposcopy visit | Mean state anxiety scores as measured by the State Trait Anxiety Inventory (STAI) State Subscale. The STAI has 40 items with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings from 1-4 at this moment: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Item scores are added to obtain subtest total scores and for anxiety-present items, a higher score suggests higher anxiety. Scoring is reversed for anxiety-absent items (items in which a higher score suggests lower anxiety). Range of scores for the subscale is 20-80 with a higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale. |
| Quantitative Satisfaction With Colposcopy Visit Experience Including Interactions With Colposcopy Professionals | To be collected by questionnaire in 4-6 weeks following colposcopy visit | Patient satisfaction scores as measured by items in the questionnaire drawn from the Visit Specific Satisfaction Instrument (VSQ-9) Inventory. The VSQ-9 is a 9 item survey that measures patient satisfaction with access to primary care, with the direct interaction with the physician, and with the visit overall on a scale ranging from 1 (poor) to 5 (excellent). To score the VSQ-9, responses from each individual are transformed linearly to a 0 to 100 scale, with 100 corresponding to excellent and 0 corresponding to poor (0= Poor, 25= Fair, 50= Good, 75= Very Good, 100= Excellent). The 9 responses are then averaged together to create a VSQ-9 overall score for each person, again with 100 being the best evaluation and 0 the poorest. |
| Satisfaction With Colposcopy Information and Diagnosis Education | To be collected by questionnaire in 4-6 weeks following colposcopy visit | Satisfaction with information and education received regarding colposcopy, patient diagnosis and follow-up recommendations measured by questionnaire items that measure these factors (PSQ-18 Inventory). This inventory contains 18 items assessing each of the 7 dimensions of satisfaction with medical care (general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, accessibility and convenience). Each item is scored from 1-5. Some PSQ-18 items are worded so that agreement reflects satisfaction with medical care, whereas other items are worded so that agreement reflects dissatisfaction with medical care. All items all scored so that high scores reflect satisfaction with medical care. All items are then summed; sum score of all items may range from 18 to 90 points, where 18 points is the poorest evaluation and 90 points the best. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Knowledge of Own Colposcopy Diagnosis | To be collected by questionnaire in 4-6 weeks following colposcopy visit | The percent of patients who correctly report their colposcopy pathologic diagnosis |
| Adherence to Colposcopy Treatment and Follow-up Instructions | 6 months | Percentage of patients who attended follow-up at the colposcopy clinic |
Countries
Canada
Participant flow
Pre-assignment details
297 participants were recruited and subsequently randomized. Post-randomization, 3 participants withdrew from the control arm. 294 patients were analyzed in the statistical analysis.
Participants by arm
| Arm | Count |
|---|---|
| Patient Liaison Intervention The participants randomized to the intervention group will be exposed to the patient liaison in receiving their colposcopy report results and recommendations. Rather than receive results from their referring physician, an experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report.
Patient Liaison: An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy report will inform the referring provider that these patients will be informed of the results. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients. She will forward any patient questions beyond her scope to the patient's colposcopist. | 145 |
| Control The control group will receive the standard of care for colposcopy results reporting via their referring physician. Following their colposcopy visit, control patients are given a slip of paper reminding them to call their family/referring physician for their colposcopy results in three weeks if they have not yet been contacted. Upon receipt of the final pathology, colposcopy reports are prepared by the colposcopists and forwarded to family/referring physicians typically within 2-3 weeks of the visit. Patients then receive the results of their colposcopy report from their family/referring physician by whatever method of communication preferred by that provider. | 149 |
| Total | 294 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 19 | 46 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Patient Liaison Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 33 years | 31 years | 33 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 111 Participants | 90 Participants | 201 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 29 Participants | 55 Participants | 84 Participants |
| Sex: Female, Male Female | 145 Participants | 149 Participants | 294 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 145 | 0 / 149 |
| other Total, other adverse events | 0 / 145 | 0 / 149 |
| serious Total, serious adverse events | 0 / 145 | 0 / 149 |
Outcome results
Primary
Anxiety
Mean state anxiety scores as measured by the State Trait Anxiety Inventory (STAI) State Subscale. The STAI has 40 items with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings from 1-4 at this moment: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Item scores are added to obtain subtest total scores and for anxiety-present items, a higher score suggests higher anxiety. Scoring is reversed for anxiety-absent items (items in which a higher score suggests lower anxiety). Range of scores for the subscale is 20-80 with a higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale.
Time frame: To be collected by questionnaire in 4-6 weeks following colposcopy visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Liaison Intervention | Anxiety | 37.3 score on a scale | Standard Deviation 12.8 |
| Control | Anxiety | 40.7 score on a scale | Standard Deviation 11.2 |
Primary
Quantitative Satisfaction With Colposcopy Visit Experience Including Interactions With Colposcopy Professionals
Patient satisfaction scores as measured by items in the questionnaire drawn from the Visit Specific Satisfaction Instrument (VSQ-9) Inventory. The VSQ-9 is a 9 item survey that measures patient satisfaction with access to primary care, with the direct interaction with the physician, and with the visit overall on a scale ranging from 1 (poor) to 5 (excellent). To score the VSQ-9, responses from each individual are transformed linearly to a 0 to 100 scale, with 100 corresponding to excellent and 0 corresponding to poor (0= Poor, 25= Fair, 50= Good, 75= Very Good, 100= Excellent). The 9 responses are then averaged together to create a VSQ-9 overall score for each person, again with 100 being the best evaluation and 0 the poorest.
Time frame: To be collected by questionnaire in 4-6 weeks following colposcopy visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Liaison Intervention | Quantitative Satisfaction With Colposcopy Visit Experience Including Interactions With Colposcopy Professionals | 68.3 score on a scale | Standard Deviation 19.2 |
| Control | Quantitative Satisfaction With Colposcopy Visit Experience Including Interactions With Colposcopy Professionals | 66.6 score on a scale | Standard Deviation 18.2 |
Primary
Satisfaction With Colposcopy Information and Diagnosis Education
Satisfaction with information and education received regarding colposcopy, patient diagnosis and follow-up recommendations measured by questionnaire items that measure these factors (PSQ-18 Inventory). This inventory contains 18 items assessing each of the 7 dimensions of satisfaction with medical care (general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, accessibility and convenience). Each item is scored from 1-5. Some PSQ-18 items are worded so that agreement reflects satisfaction with medical care, whereas other items are worded so that agreement reflects dissatisfaction with medical care. All items all scored so that high scores reflect satisfaction with medical care. All items are then summed; sum score of all items may range from 18 to 90 points, where 18 points is the poorest evaluation and 90 points the best.
Time frame: To be collected by questionnaire in 4-6 weeks following colposcopy visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Liaison Intervention | Satisfaction With Colposcopy Information and Diagnosis Education | 65.6 score on a scale | Standard Deviation 11.4 |
| Control | Satisfaction With Colposcopy Information and Diagnosis Education | 65.1 score on a scale | Standard Deviation 11.1 |
Secondary
Adherence to Colposcopy Treatment and Follow-up Instructions
Percentage of patients who attended follow-up at the colposcopy clinic
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patient Liaison Intervention | Adherence to Colposcopy Treatment and Follow-up Instructions | 61.4 percentage of participants |
| Control | Adherence to Colposcopy Treatment and Follow-up Instructions | 52.3 percentage of participants |
Secondary
Patient Knowledge of Own Colposcopy Diagnosis
The percent of patients who correctly report their colposcopy pathologic diagnosis
Time frame: To be collected by questionnaire in 4-6 weeks following colposcopy visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patient Liaison Intervention | Patient Knowledge of Own Colposcopy Diagnosis | 66.3 percentage of participants |
| Control | Patient Knowledge of Own Colposcopy Diagnosis | 84 percentage of participants |