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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01649934
Other study ID # 01634
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2013
Est. completion date December 31, 2017

Study information

Verified date April 2018
Source VA Connecticut Healthcare System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years to 50 Years
Eligibility Inclusion Criteria:

- Completed appointment for secondary TBI screen

- English speaker

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Implementation Intention
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 Clinic
Participants will be asked to sign a form indicating their need to contact the recommended clinics to make their appointments.

Locations

Country Name City State
United States VA Connecticut Healthcare System West Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
VA Connecticut Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (9)

Brown 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. — View Citation

Collins 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. — View Citation

Guy 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. Review. — View Citation

Milkman 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. — View Citation

O'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. — View Citation

Sheeran 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. — View Citation

Sheeran P, Orbell S. Using implementation intentions to increase attendance for cervical cancer screening. Health Psychol. 2000 May;19(3):283-9. — View Citation

Stiggelbout AM, Van der Weijden T, De Wit MP, Frosch D, Légaré 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. — View Citation

Thornton R, Ballard K. Why military personnel fail to keep medical appointments. J R Army Med Corps. 2008 Mar;154(1):26-30. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Attendance at Scheduled Appointments The attendance of the participants at their scheduled appointments will be measured. Over a 60 Day Period
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