Colorectal Cancer
Conditions
Keywords
telephone, telemedicine, mass screening, patient education, Patient compliance
Brief summary
Low endoscopy completion rates are a major problem in the VA, causing delay or failure to receive essential care, increased clinic wait times, lost capacity, increased costs, thus limiting endoscopic screening for colorectal cancer. This study tests whether an Interactive Voice Response (IVR) messaging system is equally effective in promoting the completion of flexible sigmoidoscopy and colonoscopy as usual clinical care practices that include phone calls from nurses to patients prior to preparation and procedures. Previous studies have examined the role of scheduling facilitation or patient adherence on endoscopy completion and the use of IVR technology to enhance patient adherence in other medical contexts. This is the first study, however, to evaluate the use of IVR for endoscopy completion and the first to compare it to the effectiveness of phone calls from nurses prior to an endoscopy appointment.
Detailed description
Background: Low endoscopy completion rates are a major problem nationwide and in the VA. For clinics, delays or failure to complete exams can cause clinic inefficiencies, such as increased wait times for needed procedures, lost capacity, and increased costs. For patients, delays reduce the chance for recommended timely screening consistent with practice guidelines and for diagnostic tests, can cause significant anxiety, delayed treatment and possibly poorer prognosis. This study tests whether an Interactive Voice Response (IVR) messaging system is equally effective in motivating patients to complete a flexible sigmoidoscopy or colonoscopy as usual clinical care practices, which include reminder phone calls from clinic nurses. This is the first study to evaluate the use of IVR for endoscopy completion and the first to compare it to the effectiveness of phone calls from nurses prior to an endoscopy appointment. Objectives: The primary set of objectives was to test whether IVR messaging was equivalent to clinic usual care (UC) practices in motivating patients to attend a scheduled flexible sigmoidoscopy or colonoscopy appointment and to adequately prepare for the exam. Secondary objectives included comparing patient satisfaction with UC and IVR phone calls and assessing if IVR or UC was more effective for sub-groups that may have more difficulty with preparation, including those with poor physical and mental functioning, health literacy, social support and trust in physicians and those with spinal cord injury, paraplegia, PTSD, or with little intention to be tested for colorectal cancer in the future. Methods: This was a stratified 3-arm randomized controlled trial among patients with upcoming flexible sigmoidoscopy or colonoscopy appointments. All patients who had a colonoscopy or flexible sigmoidoscopy appointment scheduled from August 20, 2007 through October 31, 2008 were assessed for inclusion in this study. Patients were not considered eligible if, based on a medical record review prior to randomization, they had unreliable means of receiving the intervention or the intervention would have provided inappropriate or inaccurate information. The three study arms included: 1) UC (nurse phone call 7 days prior to the procedure); 2) IVR7 (call from IVR system 7 days prior to procedure); and, 3) IVR3 (call from IVR system 3 days prior to procedure). One week after the initial appointment self-administered surveys were sent to all participants to assess satisfaction with reminder/motivation calls. Appointment and gastrointestinal (GI) procedure data were extracted from medical record files to assess study outcomes. The principal outcome measures were (1) attendance at the scheduled endoscopy appointment; (2) adequate preparation for the exam; (3) patient satisfaction with reminder/motivation telephone calls. Status: Complete
Interventions
Interactive voice response system (IVR) calls patients 7 or 3 days prior to their appointment. Information available in the IVR system is based on the same template nurses use in usual care and includes an appointment reminder, preparation instructions, basic information about the procedure, and answers to commonly asked questions.
Sponsors
Study design
Eligibility
Inclusion criteria
All patients with either flexible sigmoidoscopy or colonoscopy appointments scheduled greater than 7 days before their appointment in the GI endoscopy clinic from August 20, 2007 through October 31, 2008.
Exclusion criteria
Patients were not considered eligible for inclusion in the study if, based on a medical record review prior to randomization, they had unreliable means of receiving the intervention or the intervention would have provided inappropriate or inaccurate information. These patients included those who lived in a nursing or group home or homeless shelter; had no listed telephone number; scheduled the appointment less than 8 days in advance; or, had Type 1 diabetes, dementia or Alzheimer's or multiple GI procedures on the same day (such as those with both upper and lower GI procedures). All patients excluded from the study were assigned to usual care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Appointment Nonadherence-colonoscopy | 3 months | Nonattendance was defined as canceling the colonoscopy appointment or not attending the appointment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nonattendance-flexible Sigmoidoscopy | 3 months | Nonattendance was defined as canceling the flexible sigmoidoscopy appointment or not attending the appointment |
| Preparation Nonadherence-colonoscopy | 3 months | Preparation nonadherence assessed whether patients had adequately prepared their bowels to complete the colonoscopy procedure. |
| Preparation Non-adherence-flexible Sigmoidoscopy | 3 months | Preparation nonadherence assessed whether patients had adequately prepared their bowels to complete the flexible sigmoidoscopy procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions. | 1,199 |
| IVR3 Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.. | 1,205 |
| IVR7 Arm 3 (IVR7) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures. | 1,206 |
| Total | 3,610 |
Baseline characteristics
| Characteristic | Usual Care | IVR3 | IVR7 | Total |
|---|---|---|---|---|
| Age, Continuous | 62.6 years STANDARD_DEVIATION 9.9 | 62.8 years STANDARD_DEVIATION 10.2 | 62.5 years STANDARD_DEVIATION 10.2 | 62.6 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment United States | 1199 participants | 1205 participants | 1206 participants | 3610 participants |
| Sex: Female, Male Female | 50 Participants | 54 Participants | 50 Participants | 154 Participants |
| Sex: Female, Male Male | 1149 Participants | 1151 Participants | 1156 Participants | 3456 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Appointment Nonadherence-colonoscopy
Nonattendance was defined as canceling the colonoscopy appointment or not attending the appointment
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Appointment Nonadherence-colonoscopy | 348 Participants |
| IVR3 | Appointment Nonadherence-colonoscopy | 333 Participants |
| IVR7 | Appointment Nonadherence-colonoscopy | 303 Participants |
Nonattendance-flexible Sigmoidoscopy
Nonattendance was defined as canceling the flexible sigmoidoscopy appointment or not attending the appointment
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Nonattendance-flexible Sigmoidoscopy | 155 Participants |
| IVR3 | Nonattendance-flexible Sigmoidoscopy | 169 Participants |
| IVR7 | Nonattendance-flexible Sigmoidoscopy | 164 Participants |
Preparation Nonadherence-colonoscopy
Preparation nonadherence assessed whether patients had adequately prepared their bowels to complete the colonoscopy procedure.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Preparation Nonadherence-colonoscopy | 348 Participants |
| IVR3 | Preparation Nonadherence-colonoscopy | 349 Participants |
| IVR7 | Preparation Nonadherence-colonoscopy | 319 Participants |
Preparation Non-adherence-flexible Sigmoidoscopy
Preparation nonadherence assessed whether patients had adequately prepared their bowels to complete the flexible sigmoidoscopy procedure.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Preparation Non-adherence-flexible Sigmoidoscopy | 164 Participants |
| IVR3 | Preparation Non-adherence-flexible Sigmoidoscopy | 173 Participants |
| IVR7 | Preparation Non-adherence-flexible Sigmoidoscopy | 168 Participants |