Testing an implementation strategy to help primary care providers provide mental health medications for veterans with PTSD (PROMPT trial)
| ISRCTN | ISRCTN16140131 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16140131 |
| Secondary identifying numbers | CRE 12-020 |
- Submission date
- 25/02/2019
- Registration date
- 06/03/2019
- Last edited
- 20/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Some veterans with PTSD are reluctant to see mental health providers, and so do not receive mental health care. Others have reduced access to medication treatments for PTSD because of the distance they live from VA medical centers where more mental health prescribers are available. To provide more rural veterans and those reluctant to see mental health providers with an additional pathway to receive medications for PTSD, we developed an intervention to help primary care providers at VA community clinics become more competent in and comfortable with prescribing medications recommended by clinical practice guidelines for their patients with PTSD.
Who can participate?
VA community clinics
What does the study involve?
We developed a clinic-based intervention to increase primary care providers' prescribing rates for their patients with PTSD. The intervention included tools to help providers learn about medication treatments for PTSD in greater depth, an electronic medical record-based tool to provide prescribing information and help providers make decisions about medication treatments, and a one-time help with problem solving local changes to patient flow that might result from primary care providers taking on this added responsibility. Control sites did not receive these tools or assistance.
What are the possible benefits and risks of participating?
Not applicable
Where is the study run from?
Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System
When is the study starting and how long is it expected to run for?
March 2012 to March 2017
Who is funding the study?
This study was funded by VA Health Services Research & Development grant CRE-12-020.
Who is the main contact?
Michele Spoont, PhD
michele.spoont@va.gov
Contact information
Scientific
Center for Care Delivery Outcomes Research
Minneapolis VA Health Care System (152/9)
One Veterans Drive
Minneapolis
55417
United States of America
| Phone | +1 612-467-1428 |
|---|---|
| michele.spoont@va.gov |
Study information
| Study design | Clustered randomized pre-post pragmatic implementation trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | None available |
| Scientific title | Promoting Evidence-Based Pharmacotherapy for PTSD in Community Based Outpatient Clinics |
| Study acronym | PROMPT |
| Study objectives | Can the implementation intervention (i.e., training and decision support tools) encourage primary care providers to increase the proportion of veterans with PTSD in their panels to whom they prescribe an evidence based medication for PTSD? |
| Ethics approval(s) | Approved 04/02/2013, VA Central Institutional Review Board (vacentralirb@va.gov; 1-877-254-3130; no postal address available), ref: 12-36 |
| Health condition(s) or problem(s) studied | Prescribing medications for Posttraumatic Stress Disorder (PTSD) |
| Intervention | We tested whether an implementation intervention (i.e., optional free CME training in guideline-recommended PTSD pharmacotherapy, point-of-care provider decision support tool availability, and external facilitation) would encourage primary care providers to expand their scope of practice to prescribe PTSD pharmacotherapy for the relevant patients in their panels. Clinic clusters were randomized to receive or not receive these tools. All primary outcomes from VA prescribing databases. This study recruited paired clusters of VA community clinics and randomized one of the site clusters to an implementation intervention. Quantitative Outcomes were from VA administrative databases. Also conducted a formative evaluation of implementation strategy. It was difficult to fit this study into the format of a traditional RCT despite the use of randomization because the “participants” were community clinics, not individuals. This was, effectively, an organizational intervention in which organizational leaders consented to have their community clinics participate in the study. That is, facility organizational leaders gave us permission to randomize their facility and attendant community clinics to either the project control arm or intervention arm. Community clinics in the intervention arm were provided with resources that primary care providers could choose (or not choose) to make use of – online training module, provider decision support tool in the electronic medical record, and facilitated negotiation of roles between primary care providers and mental health providers in the clinic regarding the care of patients with PTSD. Although provider behavior (i.e., prescribing rates of specific medication classes) was the target of the intervention, providers were not enrolled. Instead, study resources were simply made available to primary care providers in the control arm, whereas providers in control arm clinics were not given access to these resources. |
| Intervention type | Other |
| Primary outcome measure | Change in the proportion of patients in providers' panels who received a PTSD guideline-recommended medication (either a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)) from the year pre-intervention relative to the year post-intervention, measured using patient notes. |
| Secondary outcome measures | Subgroup analyses comparing prescribing behavior between training participants and non-participants at the intervention sites. |
| Overall study start date | 07/12/2011 |
| Completion date | 01/05/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 8 sites, 4 in each arm, approx. 33,500 patient records |
| Key inclusion criteria | sites where leadership agreed to study participation |
| Key exclusion criteria | not applicable |
| Date of first enrolment | 01/03/2012 |
| Date of final enrolment | 22/09/2015 |
Locations
Countries of recruitment
- United States of America
Study participating centres
55417
United States of America
60141
United States of America
02132
United States of America
West Haven, CT
06516
United States of America
85012
United States of America
Sponsor information
Government
Center for Care Delivery and Outcomes Research
Minneapolis VA Health Care System
Minneapolis
55417
United States of America
| Phone | +1 612-467-1428 |
|---|---|
| michele.spoont@va.gov | |
| Website | http://www.minneapolis.va.gov/ |
"ROR" |
https://ror.org/02ry60714 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- VA Health Services Research and Development Service, VA HSR&D, Veterans Health Administration HSR and D, HSR&D
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | We intend to publish the primary paper later this year, in a high-impact peer-reviewed journal, using an implementation evaluation framework. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to: The outcome data consists of medication prescriptions ordered by individual providers and received by individual patients. The prescribing database, which includes identifying information of providers and patients, is too large to obtain informed consents and HIPAA authorizations. Public disclosure of the final study data containing PII and/or PHI would be inconsistent with the IRB approved waiver of informed consent and HIPAA authorization that was obtained. |
Editorial Notes
20/12/2021: The intention to publish date was changed from 31/12/2021 to 31/12/2022.
18/02/2021: The intention to publish date was changed from 30/08/2020 to 31/12/2021.
15/01/2020: The intention to publish date has been changed from 30/07/2019 to 30/08/2020.
10/01/2020: Internal review.
08/03/2019: Internal review.
06/03/2019: Trial’s existence confirmed by IRB
