Brain InjuriesNCT01649934
The Use of Implementation Intentions to Increase the Appointment Attendance of OEF/OIF Veterans
A study testing Implementation Intention and Contact Clinic in people with Brain Injuries, run by VA Connecticut Healthcare System at 1 site in United States.
Trial summary
The purpose of the current pilot study will be to utilize implementation intentions to increase patient compliance with appointment attendance. Participants in the current study will be individuals referred for evaluation of their treatment needs. Read more about this study
- Who is it for?
- Ages 22 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Implementation Intention and Contact Clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Completed appointment for secondary TBI screen
- English speaker
Who cannot join
- Neurological injury leading to dementia
- In ability to consent owing to cognitive barriers
- Non-English speaker
- Unable to schedule appointments the next working day after their secondary screen
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
Official title: The Use of Implementation Intentions to Increase the Appointment Attendance of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans
The purpose of the current pilot study will be to utilize implementation intentions to increase patient compliance with appointment attendance. Participants in the current study will be individuals referred for evaluation of their treatment needs. Experimental groups will create a simple induction consisting of "what/when/where" statements (implementation intentions) with the intention of increasing their rate of calling to schedule and subsequently attend appointments associated with their care. It is anticipated that participants who take an active role in their plan and utilize the implementation intention procedures will be more likely to make and attend the appointments suggested by their treating clinician. This pilot project will provide valuable initial data as to the potential effectiveness of a simple, cost-effective means of increasing appointment attendance. If successful, it could lead to cost savings and a decrease in the appointment wait time for people by increasing the utilization of available appointments.
Read the detailed description
The purpose of the current pilot study will be to utilize implementation intentions to increase patient compliance with appointment attendance. It is anticipated that participants who take an active role in their plan and utilize the implementation intention procedures will be more likely to make and attend the appointments suggested by their treating clinician. Sixty participants will be recruited to participate in the research project. Participants in the current study will be individuals referred for a secondary Traumatic Brain Injury (TBI) screen. This appointment serves to develop the plan of care that will be used for determination of the treatments that would be beneficial to the Veteran and as such the appointments necessary for further assessment or treatment in affiliated clinics (i.e. mental health, physical therapy, neuropsychology). Twenty participants will serve as controls who will receive treatment planning as usual. Twenty participants will receive treatment as usual but will be asked to contact the clinics directly to make their appointments. Twenty participants will be provided with a simple implementation intention induction. The simple induction will consist of the creation of "what/when/where" statements surrounding their intention to call to schedule and to attend medical appointments associated with their care. Research staff will then monitor the participants' appointment schedule daily to determine if they made the appropriate appointments and subsequently attended those appointments. Primary data for the examination will be these yes/no data points as to whether the participant successfully adhered to their initial intention to schedule the prescribed appointments. Additionally, for those who schedule the prescribed appointments, the latency in days from the time they indicated they intended to make their appointments will serve as a measure of their compliance. Across all groups, attendance at those appointments will be recorded to determine if the procedures lead to an increase in their attendance at their appointments compared to the treatment as usual group. This pilot project will provide valuable initial data as to the potential effectiveness of a simple, cost-effective means of increasing appointment attendance. If successful, it could lead to cost savings to the VA system and a decrease in the appointment wait time for Veterans by increasing the utilization of available appointments.
- Conditions
- Brain Injuries
- Being tested
- Implementation Intention, Contact Clinic
- Keywords
- Appointments and Schedules
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation IntentionBehavioural
Implementation Intentions are a series of what/when/where statements that a participant will make to create automatic cues to complete a behaviorally advantageous action.
Contact ClinicBehavioural
Participants will be asked to sign a form indicating their need to contact the recommended clinics to make their appointments.
| Study group | Role | What they receive |
|---|---|---|
| Scheduling as Usual | No intervention | Participants will be subject to the current appointment scheduling procedures. |
| Contact Clinic | Experimental | This group will be required to contact the clinic themselves to make appointments. Receives: Behavioral: Contact Clinic |
| Implementation Intentions | Experimental | This group will create Implementation Intentions to contact the clinic to make their appointments and to attend those appointments. Receives: Behavioral: Implementation Intention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance at Scheduled Appointments
The attendance of the participants at their scheduled appointments will be measured.
Measured: Over a 60 Day Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startJun 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joseph F Kulas, Ph.D., Principal investigator, VA Connecticut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649934
- Sponsor's protocol ID
- 01634
- Status last verified
- Apr 2018
- First submitted
- 22 Jul 2012
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sheeran P, Orbell S. Using implementation intentions to increase attendance for cervical cancer screening. Health Psychol. 2000 May;19(3):283-9. doi: 10.1037//0278-6133.19.3.283.
PubMed 10868773Collins J, Santamaria N, Clayton L. Why outpatients fail to attend their scheduled appointments: a prospective comparison of differences between attenders and non-attenders. Aust Health Rev. 2003;26(1):52-63. doi: 10.1071/ah030052.
PubMed 15485374Thornton R, Ballard K. Why military personnel fail to keep medical appointments. J R Army Med Corps. 2008 Mar;154(1):26-30. doi: 10.1136/jramc-154-01-08.
PubMed 19090383Stiggelbout AM, Van der Weijden T, De Wit MP, Frosch D, Legare F, Montori VM, Trevena L, Elwyn G. Shared decision making: really putting patients at the centre of healthcare. BMJ. 2012 Jan 27;344:e256. doi: 10.1136/bmj.e256.
PubMed 22286508Guy R, Hocking J, Wand H, Stott S, Ali H, Kaldor J. How effective are short message service reminders at increasing clinic attendance? A meta-analysis and systematic review. Health Serv Res. 2012 Apr;47(2):614-32. doi: 10.1111/j.1475-6773.2011.01342.x. Epub 2011 Nov 8.
PubMed 22091980O'Carroll R, Dennis M, Johnston M, Sudlow C. Improving adherence to medication in stroke survivors (IAMSS): a randomised controlled trial: study protocol. BMC Neurol. 2010 Feb 24;10:15. doi: 10.1186/1471-2377-10-15.
PubMed 20181255Sheeran P, Aubrey R, Kellett S. Increasing attendance for psychotherapy: implementation intentions and the self-regulation of attendance-related negative affect. J Consult Clin Psychol. 2007 Dec;75(6):853-63. doi: 10.1037/0022-006X.75.6.853.
PubMed 18085903Brown I, Sheeran P, Reuber M. Enhancing antiepileptic drug adherence: a randomized controlled trial. Epilepsy Behav. 2009 Dec;16(4):634-9. doi: 10.1016/j.yebeh.2009.09.014. Epub 2009 Oct 27.
PubMed 19864187Milkman KL, Beshears J, Choi JJ, Laibson D, Madrian BC. Using implementation intentions prompts to enhance influenza vaccination rates. Proc Natl Acad Sci U S A. 2011 Jun 28;108(26):10415-20. doi: 10.1073/pnas.1103170108. Epub 2011 Jun 13.
PubMed 21670283
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Implementation Intentions to Increase the Appointment Attendance of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans
- ClinicalTrials.gov ID
- NCT01649934
- Acronym / sponsor ID
- 01634
- Conditions
- Brain Injuries
- Keywords
- Appointments and Schedules
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Study start
- Jun 2013
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 25 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the current pilot study will be to utilize implementation intentions to increase patient compliance with appointment attendance. Participants in the current study will be individuals referred for evaluation of their treatment needs. Experimental groups will create a simple induction consisting of "what/when/where" statements (implementation intentions) with the intention of increasing their rate of calling to schedule and subsequently attend appointments associated with their care. It is anticipated that participants who take an active role in their plan and utilize the implementation intention procedures will be more likely to make and attend the appointments suggested by their treating clinician. This pilot project will provide valuable initial data as to the potential effectiveness of a simple, cost-effective means of increasing appointment attendance. If successful, it could lead to cost savings and a decrease in the appointment wait time for people by increasing the utilization of available appointments.
Detailed description
The purpose of the current pilot study will be to utilize implementation intentions to increase patient compliance with appointment attendance. It is anticipated that participants who take an active role in their plan and utilize the implementation intention procedures will be more likely to make and attend the appointments suggested by their treating clinician. Sixty participants will be recruited to participate in the research project. Participants in the current study will be individuals referred for a secondary Traumatic Brain Injury (TBI) screen. This appointment serves to develop the plan of care that will be used for determination of the treatments that would be beneficial to the Veteran and as such the appointments necessary for further assessment or treatment in affiliated clinics (i.e. mental health, physical therapy, neuropsychology). Twenty participants will serve as controls who will receive treatment planning as usual. Twenty participants will receive treatment as usual but will be asked to contact the clinics directly to make their appointments. Twenty participants will be provided with a simple implementation intention induction. The simple induction will consist of the creation of "what/when/where" statements surrounding their intention to call to schedule and to attend medical appointments associated with their care. Research staff will then monitor the participants' appointment schedule daily to determine if they made the appropriate appointments and subsequently attended those appointments. Primary data for the examination will be these yes/no data points as to whether the participant successfully adhered to their initial intention to schedule the prescribed appointments. Additionally, for those who schedule the prescribed appointments, the latency in days from the time they indicated they intended to make their appointments will serve as a measure of their compliance. Across all groups, attendance at those appointments will be recorded to determine if the procedures lead to an increase in their attendance at their appointments compared to the treatment as usual group. This pilot project will provide valuable initial data as to the potential effectiveness of a simple, cost-effective means of increasing appointment attendance. If successful, it could lead to cost savings to the VA system and a decrease in the appointment wait time for Veterans by increasing the utilization of available appointments.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Scheduling as Usual | No intervention | –Participants will be subject to the current appointment scheduling procedures. |
| Contact Clinic | Experimental | Behavioral: Contact ClinicThis group will be required to contact the clinic themselves to make appointments. |
| Implementation Intentions | Experimental | Behavioral: Implementation IntentionThis group will create Implementation Intentions to contact the clinic to make their appointments and to attend those appointments. |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Completed appointment for secondary TBI screen
- English speaker
Key exclusion criteria (4 listed)
- Neurological injury leading to dementia
- In ability to consent owing to cognitive barriers
- Non-English speaker
- Unable to schedule appointments the next working day after their secondary screen
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 |
|---|---|---|
| Implementation IntentionImplementation Intentions are a series of what/when/where statements that a participant will make to create automatic cues to complete a behaviorally advantageous action. | Behavioural | Implementation Intentions |
| Contact ClinicParticipants will be asked to sign a form indicating their need to contact the recommended clinics to make their appointments. | Behavioural | Contact Clinic |
Primary outcome
Attendance at Scheduled Appointments
Time frame: Over a 60 Day Period
The attendance of the participants at their scheduled appointments will be measured.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Background: PubMed 10868773Sheeran P, Orbell S. Using implementation intentions to increase attendance for cervical cancer screening. Health Psychol. 2000 May;19(3):283-9. doi: 10.1037//0278-6133.19.3.283.
- Background: PubMed 15485374Collins J, Santamaria N, Clayton L. Why outpatients fail to attend their scheduled appointments: a prospective comparison of differences between attenders and non-attenders. Aust Health Rev. 2003;26(1):52-63. doi: 10.1071/ah030052.
- Background: PubMed 19090383Thornton R, Ballard K. Why military personnel fail to keep medical appointments. J R Army Med Corps. 2008 Mar;154(1):26-30. doi: 10.1136/jramc-154-01-08.
- Background: PubMed 22286508Stiggelbout AM, Van der Weijden T, De Wit MP, Frosch D, Legare F, Montori VM, Trevena L, Elwyn G. Shared decision making: really putting patients at the centre of healthcare. BMJ. 2012 Jan 27;344:e256. doi: 10.1136/bmj.e256.
- Background: PubMed 22091980Guy R, Hocking J, Wand H, Stott S, Ali H, Kaldor J. How effective are short message service reminders at increasing clinic attendance? A meta-analysis and systematic review. Health Serv Res. 2012 Apr;47(2):614-32. doi: 10.1111/j.1475-6773.2011.01342.x. Epub 2011 Nov 8.
- Background: PubMed 20181255O'Carroll R, Dennis M, Johnston M, Sudlow C. Improving adherence to medication in stroke survivors (IAMSS): a randomised controlled trial: study protocol. BMC Neurol. 2010 Feb 24;10:15. doi: 10.1186/1471-2377-10-15.
- Background: PubMed 18085903Sheeran P, Aubrey R, Kellett S. Increasing attendance for psychotherapy: implementation intentions and the self-regulation of attendance-related negative affect. J Consult Clin Psychol. 2007 Dec;75(6):853-63. doi: 10.1037/0022-006X.75.6.853.
- Background: PubMed 19864187Brown I, Sheeran P, Reuber M. Enhancing antiepileptic drug adherence: a randomized controlled trial. Epilepsy Behav. 2009 Dec;16(4):634-9. doi: 10.1016/j.yebeh.2009.09.014. Epub 2009 Oct 27.
- Background: PubMed 21670283Milkman KL, Beshears J, Choi JJ, Laibson D, Madrian BC. Using implementation intentions prompts to enhance influenza vaccination rates. Proc Natl Acad Sci U S A. 2011 Jun 28;108(26):10415-20. doi: 10.1073/pnas.1103170108. Epub 2011 Jun 13.
- Individual participant dataSharing planned: No
Related trials for Brain Injuries
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
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.
Joseph F Kulas, Ph.D. principal investigator
VA Connecticut Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Intention and Contact Clinic in people with Brain Injuries, run by VA Connecticut Healthcare System 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 2 inclusion and 4 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 3 May 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Attendance at Scheduled Appointments (time frame: Over a 60 Day Period). 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 NCT01649934, which also lists 9 linked publications.
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 3 May 2018.