Colorectal CancerGIVERNCT00310362
Use of Telehealth In-home Messaging to Improve GI (Gastrointestinal) Endoscopy Completion Rates
A study testing Use of Interactive Voice Response (IVR) system to improve adherence to GI appointments and prep procedures in people with Colorectal Cancer, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Use of Interactive Voice Response (IVR) system to improve adherence to GI appointments and prep procedures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,610 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Feb 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
About this study
Official title: Use of Telehealth In-Home Messaging to Improve GI Endoscopy Completion Rates
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.
Read the 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
- Conditions
- Colorectal Cancer
- Being tested
- Use of Interactive Voice Response (IVR) system to improve adherence to GI appointments and prep procedures
- Keywords
- telephone, telemedicine, mass screening, patient education, Patient compliance
- Medical subject headings
- Colorectal Neoplasms, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Interactive Voice Response (IVR) system to improve adherence to GI appointments and prep proceduresBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care with nurse phone call | Experimental | Usual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions. Receives: Behavioral: Use of Interactive Voice Response (IVR) system to improve adherence to GI appointments and prep procedures |
| interactive voice response 3 days prior | Experimental | Interactive voice response system was used to remind patients 3 days before a scheduled appointment and to educate them about preparation procedures for the appointment (IVR3) Receives: Behavioral: Use of Interactive Voice Response (IVR) system to improve adherence to GI appointments and prep procedures |
| interactive voice response 7 days prior | Experimental | Interactive voice response system was used to remind patients 7 days before a scheduled appointment and to educate them about preparation procedures for the appointment (IVR7) Receives: Behavioral: Use of Interactive Voice Response (IVR) system to improve adherence to GI appointments and prep procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appointment Nonadherence-colonoscopy
Nonattendance was defined as canceling the colonoscopy appointment or not attending the appointment
Measured: 3 months
Secondary outcomes (3)
Nonattendance-flexible Sigmoidoscopy
Nonattendance was defined as canceling the flexible sigmoidoscopy appointment or not attending the appointment
Measured: 3 months
Preparation Nonadherence-colonoscopy
Preparation nonadherence assessed whether patients had adequately prepared their bowels to complete the colonoscopy procedure.
Measured: 3 months
Preparation Non-adherence-flexible Sigmoidoscopy
Preparation nonadherence assessed whether patients had adequately prepared their bowels to complete the flexible sigmoidoscopy procedure.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study startJul 2007
- Primary completionJan 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,610 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joan M. Griffin, PhD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310362
- Sponsor's protocol ID
- IIR 03-295
- Acronym
- GIVER
- Status last verified
- Jun 2020
- First submitted
- 30 Mar 2006
- Last updated
- 30 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Griffin JM, Hulbert EM, Vernon SW, Nelson D, Hagel EM, Nugent S, Baines Simon A, Bangerter A, van Ryn M. Improving endoscopy completion: effectiveness of an interactive voice response system. Am J Manag Care. 2011 Mar;17(3):199-208.
PubMed 21504256
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Telehealth In-Home Messaging to Improve GI Endoscopy Completion Rates
- ClinicalTrials.gov ID
- NCT00310362
- Acronym / sponsor ID
- GIVER / IIR 03-295
- Conditions
- Colorectal Cancer
- Keywords
- telephone, telemedicine, mass screening, patient education, Patient compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,610 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jul 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 3 Apr 2006 (estimated)
- Results
- Posted 25 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care with nurse phone call | Experimental | Behavioral: Use of Interactive Voice Response (IVR) system to improve adherence to GI appointments and prep proceduresUsual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions. |
| interactive voice response 3 days prior | Experimental | Behavioral: Use of Interactive Voice Response (IVR) system to improve adherence to GI appointments and prep proceduresInteractive voice response system was used to remind patients 3 days before a scheduled appointment and to educate them about preparation procedures for the appointment (IVR3) |
| interactive voice response 7 days prior | Experimental | Behavioral: Use of Interactive Voice Response (IVR) system to improve adherence to GI appointments and prep proceduresInteractive voice response system was used to remind patients 7 days before a scheduled appointment and to educate them about preparation procedures for the appointment (IVR7) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Interactive Voice Response (IVR) system to improve adherence to GI appointments and prep proceduresInteractive 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. | Behavioural | Usual Care with nurse phone call, interactive voice response 3 days prior, interactive voice response 7 days prior |
Primary outcome
Appointment Nonadherence-colonoscopy
Time frame: 3 months
Nonattendance was defined as canceling the colonoscopy appointment or not attending the appointment
3 secondary outcomes
Nonattendance-flexible Sigmoidoscopy
Time frame: 3 months
Preparation Nonadherence-colonoscopy
Time frame: 3 months
Preparation Non-adherence-flexible Sigmoidoscopy
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21504256Griffin JM, Hulbert EM, Vernon SW, Nelson D, Hagel EM, Nugent S, Baines Simon A, Bangerter A, van Ryn M. Improving endoscopy completion: effectiveness of an interactive voice response system. Am J Manag Care. 2011 Mar;17(3):199-208.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan M. Griffin, PhD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Interactive Voice Response (IVR) system to improve adherence to GI appointments and prep procedures in people with Colorectal Cancer, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appointment Nonadherence-colonoscopy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00310362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.