The Use of Implementation Intentions to Increase the Appointment Attendance of OEF/OIF Veterans

April 30, 2018 updated by: VA Connecticut Healthcare System

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Scheduling as Usual
Participants will be subject to the current appointment scheduling procedures.
Experimental: Contact Clinic
This group will be required to contact the clinic themselves to make appointments.
Behavioral: Contact Clinic
Participants will be asked to sign a form indicating their need to contact the recommended clinics to make their appointments.
Experimental: Implementation Intentions
This group will create Implementation Intentions to contact the clinic to make their appointments and to attend those appointments.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Attendance at Scheduled Appointments
Time Frame: Over a 60 Day Period
The attendance of the participants at their scheduled appointments will be measured.
Over a 60 Day Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Connecticut Healthcare System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joseph F Kulas, Ph.D., VA Connecticut Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01634

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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