Condition category
Mental and Behavioural Disorders
Date applied
25/02/2019
Date assigned
06/03/2019
Last edited
08/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michele Spoont

ORCID ID

Contact details

Center for Care Delivery Outcomes Research
Minneapolis VA Health Care System (152/9)
One Veterans Drive
Minneapolis
55417
United States of America
+1 612-467-1428
michele.spoont@va.gov

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CRE 12-020

Study information

Scientific title

Promoting Evidence-Based Pharmacotherapy for PTSD in Community Based Outpatient Clinics

Acronym

PROMPT

Study hypothesis

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

Approved 04/02/2013, VA Central Institutional Review Board (vacentralirb@va.gov; 1-877-254-3130; no postal address available), ref: 12-36

Study design

Clustered randomized pre-post pragmatic implementation trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

None available

Condition

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

Phase

Drug names

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 trial start date

07/12/2011

Overall trial end date

01/05/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

sites where leadership agreed to study participation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

8 sites, 4 in each arm, approx. 33,500 patient records

Participant exclusion criteria

not applicable

Recruitment start date

01/03/2012

Recruitment end date

22/09/2015

Locations

Countries of recruitment

United States of America

Trial participating centre

Minneapolis VA Health Care System
Minneapolis, MN
55417
United States of America

Trial participating centre

Edward Hines Jr. VA Hospital
Hines, IL
60141
United States of America

Trial participating centre

VA Boston Healthcare System
Boston, MA
02132
United States of America

Trial participating centre

VA Connecticut Healthcare System
West Haven Campus
West Haven, CT
06516
United States of America

Trial participating centre

Phoenix VA Health Care System
Phoenix, AZ
85012
United States of America

Sponsor information

Organisation

Michele Spoont, PhD (Sponsor-investigator)

Sponsor details

Center for Care Delivery and Outcomes Research
Minneapolis VA Health Care System
Minneapolis
55417
United States of America
+1 612-467-1428
michele.spoont@va.gov

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Health Services Research and Development

Alternative name(s)

VA Health Services Research and Development Service, VA HSR&D, Veterans Health Administration HSR and D, HSR&D

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Results and Publications

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 statement:
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.

Intention to publish date

30/07/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/03/2019: Internal review. 06/03/2019: Trial’s existence confirmed by IRB