Trial Outcomes & Findings for The SAFE Study: Satisfaction and Adherence to Follow-Up With Colposcopy Exams (NCT NCT03296566)
NCT ID: NCT03296566
Last Updated: 2020-04-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
297 participants
Primary outcome timeframe
To be collected by questionnaire in 4-6 weeks following colposcopy visit
Results posted on
2020-04-24
Participant Flow
297 participants were recruited and subsequently randomized. Post-randomization, 3 participants withdrew from the control arm. 294 patients were analyzed in the statistical analysis.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
145
|
152
|
|
Overall Study
COMPLETED
|
126
|
103
|
|
Overall Study
NOT COMPLETED
|
19
|
49
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
19
|
46
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
The SAFE Study: Satisfaction and Adherence to Follow-Up With Colposcopy Exams
Baseline characteristics by cohort
| Measure |
Patient Liaison Intervention
n=145 Participants
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.
|
Control
n=149 Participants
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.
|
Total
n=294 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33 years
n=99 Participants
|
31 years
n=107 Participants
|
33 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=99 Participants
|
149 Participants
n=107 Participants
|
294 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
111 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
201 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
29 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: To be collected by questionnaire in 4-6 weeks following colposcopy visitMean 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.
Outcome measures
| Measure |
Patient Liaison Intervention
n=126 Participants
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.
|
Control
n=103 Participants
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.
|
|---|---|---|
|
Anxiety
|
37.3 score on a scale
Standard Deviation 12.8
|
40.7 score on a scale
Standard Deviation 11.2
|
PRIMARY outcome
Timeframe: To be collected by questionnaire in 4-6 weeks following colposcopy visitPatient 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.
Outcome measures
| Measure |
Patient Liaison Intervention
n=126 Participants
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.
|
Control
n=103 Participants
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.
|
|---|---|---|
|
Quantitative Satisfaction With Colposcopy Visit Experience Including Interactions With Colposcopy Professionals
|
68.3 score on a scale
Standard Deviation 19.2
|
66.6 score on a scale
Standard Deviation 18.2
|
PRIMARY outcome
Timeframe: To be collected by questionnaire in 4-6 weeks following colposcopy visitSatisfaction 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.
Outcome measures
| Measure |
Patient Liaison Intervention
n=126 Participants
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.
|
Control
n=103 Participants
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.
|
|---|---|---|
|
Satisfaction With Colposcopy Information and Diagnosis Education
|
65.6 score on a scale
Standard Deviation 11.4
|
65.1 score on a scale
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: To be collected by questionnaire in 4-6 weeks following colposcopy visitThe percent of patients who correctly report their colposcopy pathologic diagnosis
Outcome measures
| Measure |
Patient Liaison Intervention
n=126 Participants
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.
|
Control
n=103 Participants
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.
|
|---|---|---|
|
Patient Knowledge of Own Colposcopy Diagnosis
|
66.3 percentage of participants
|
84 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPercentage of patients who attended follow-up at the colposcopy clinic
Outcome measures
| Measure |
Patient Liaison Intervention
n=126 Participants
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.
|
Control
n=103 Participants
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.
|
|---|---|---|
|
Adherence to Colposcopy Treatment and Follow-up Instructions
|
61.4 percentage of participants
|
52.3 percentage of participants
|
Adverse Events
Patient Liaison Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place