Condition category
Not Applicable
Date applied
16/09/2015
Date assigned
07/10/2015
Last edited
13/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Care coordination in the day-to-day running of a health care provider, such as a hospital or community health centre, is an effective approach to ensure that patients receive the best possible care. A vital part of care coordination is that information is shared among everyone who plays a role in patient care. It has been found that many primary healthcare services (the first contact and point of continuing care for a patient) are poorly coordinated, which can lead to frustration in both patients and staff. The aim of this study is to try to improve the coordination of primary healthcare teams, so that better patient care is given.

Who can participate?
Primary healthcare teams at U.S. Department of Veterans Affairs (VA) Medical Centres.

What does the study involve?
The study consists of three phases. In the first phase, a small group of health care professionals attend focus groups in order to find ways to improve coordination of healthcare services. In the second phase, the same group attend a second set of focus groups to find the best ways of to implement the strategies from phase one into a primary healthcare setting. In the third phase of the study, the participating healthcare teams are randomly allocated into two groups. Both groups implement the strategies from the first phases of the study in their workplaces. The first group (intervention group) receives monthly feedback about how well the coordination is working and hold monthly meetings to discuss and improve their performance. The second group (control group) do not receive any feedback. Every month for the yearlong study period, the performance of both groups is observed, to find out how effective the strategies are.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Clement J. Zablocki Medical Center (USA)

When is the study starting and how long is it expected to run for?
April 2014 to March 2017

Who is funding the study?
United States Department of Veterans Affairs Health Services Research & Development (USA)

Who is the main contact?
1. Dr Sylvia Hysong (Scientific)
2. Ms Terry Fisher (Public)
terry.fisher@bcm.edu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sylvia Hysong

ORCID ID

http://orcid.org/0000-0002-9063-5207

Contact details

2450 Holcombe Blvd
Ste.01Y
Houston
77021
United States of America

Type

Public

Additional contact

Ms Terry Fisher

ORCID ID

Contact details

2450 Holcombe Blvd
Ste.01Y
Houston
77021
United States of America
+1 (0)713 794 8601
terry.fisher@bcm.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

H-36145

Study information

Scientific title

Delivering point-of-care information to improve care coordination in VA pact

Acronym

Study hypothesis

The aims are:
1. Develop measurable criteria for and indicators of effective coordination in PACTs, prioritized and weighted by contribution to overall quality of care
2. Using the measurable criteria developed in Aim 1, determine the specific information needed at the point of care to improve coordination and recommend point-of-care aids for delivering the needed information
3. Assess the effect of adopting the aforementioned coordination criteria on PACT clinicians' coordination behaviors

Ethics approval

Baylor College of Medicine institutional review board, 31/12/2014, ref: H-36145

Study design

Single-centre multi-phase mixed-methods partnership research study consisting of two observational cross-sectional focus group phases (phase 1 & 2) and an interventional non-randomized study phase (phase 3)

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Coordination by care providers at the point of care

Intervention

Phase 1: The first phase aims to develop measurable, prioritized point-of-care criteria for and indicators of effective PACT coordination. We will assemble a design team of 8-10 health care professionals representing a diversity of roles in the primary care team, and employ the Productivity Measurement and Enhancement System (ProMES) methodology to (a) develop objectives for coordination in primary care, (b), develop indicators to monitor the extent to which coordination objectives are being met, and (c) develop “contingencies” for each indicator, which are functions that show how much a given score on the indicator (e.g., 50% vs. 75%) contributes to overall effectiveness. ProMES is structured focus group style methodology firmly grounded in motivational theory and performance measurement; it utilizes diagnostic measurement to optimize the effectiveness and performance of people in complex organizations. An advisory team similar to the design team in size and composition will provide feedback to the design team at each step of the process (a-c above), to ensure validity and feasibility. By the end of Phase 1, we expect to have a set of valid, feasible, measures of coordination, which will have received the approval of the participating sites’ leadership.

Phase 2: The second phase aims to identify the specific information needed at the point of care to improve coordination and recommend point-of-care aids for delivering the needed information. The participants for this aim will again be the members of the design and advisory teams described in Aim 1. A new round of 2-4 focus group meetings will be held to generate a list of specific needs at the point of care and proposed recommendations for addressing these needs. We will rely on the teams’ expertise as clinicians and their experience having completed Phase 1 to generate our Phase 2 product: a list of evidence-based point-of-care aids for delivering the necessary point-of-care information that will facilitate coordination .

Phase 3: The final phase aims to assess the effect of adopting the aforementioned coordination criteria on PACT clinicians' coordination behaviors. This phase is a non-randomized trial with 2 arms: an intervention arm consisting of up to 50 PACTs , and concurrent control arm of similar size and configuration, which will only be monitored passively. The intervention arm will receive periodic feedback reports on their coordination performance consisting of their scores on the measures created in Phase 1, and will have monthly group meetings to reflect on the feedback received. We will monitor scores on the newly developed coordination measures for up to one year after the end of baseline, and compare the intervention arm's performance to that of the control arm. All the data for creating the measures will be extracted from exisiting VA clinical databases, thus making passive monitoring of the control arm possible. We will provide periodic audit and feedback reports on the PACTs’ coordination performance (as measured by the indicators developed in Aim 1) to all PACTs in the intervention arm. These reports will be utilized in monthly feedback meetings between the PACT Teams and the PACT Team Leader to identify barriers and facilitators to productivity, and discuss strategies to implement needed change. PACT Team Leaders will be trained on how to run these feedback meetings; training will include interpretation of the feedback report, as well as instruction on delivering feedback in a team setting and discussing the results with the PACTs.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Coordination will be assessed using the measures developed in Phase 1 of this study every month for a total period of one year.

Secondary outcome measures

Care coordination will be assessed every month for a total period of one year using measures currently used by the VA system, such as ER/Urgent Care Utilization Rates by primary care patients, and the Team 2-day post-discharge contact ratio.

Overall trial start date

01/04/2013

Overall trial end date

31/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Participants must hold one of the four central roles in a Patient Aligned Care Team (PACT), also known as the “teamlet”: provider (physician or physician extender), Care Manager (RN), Clinical Associate (LVN/LVN), or Patient Services Assistant (Clerk).

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

254

Participant exclusion criteria

Extended members of the Patient Aligned Care Team, such as social workers, pharmacists, and nutritionists.

Recruitment start date

01/10/2015

Recruitment end date

31/12/2015

Locations

Countries of recruitment

United States of America

Trial participating centre

Clement J. Zablocki Medical Center
5000 W National Ave
Milwaukee
53295
United States of America

Sponsor information

Organisation

U.S. Department of Veterans Affairs Health Services Research & Development (USA)

Sponsor details

810 Vermont AVE
Washington
DC
20420
United States of America

Sponsor type

Government

Website

http://www.hsrd.research.va.gov

Funders

Funder type

Government

Funder name

United States Department of Veterans Affairs Health Services Research & Development

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to publish the protocol for this study in Implementation Science as soon as we receive our trial registration number (the journal requires trial registration for publication of protocols). We have already published one paper, based generally on this study, about publication of partnered research protocols:

Intention to publish date

01/01/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes