Condition category
Signs and Symptoms
Date applied
15/03/2017
Date assigned
27/03/2017
Last edited
20/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many people suffer from long-term medical conditions, such as hypertension (high blood pressure), diabetes (disorder of blood sugar control) or depression (low mood). These conditions require monitoring and effective management on the part of health providers, especially in primary care (GP). New models of primary care to manage long-term conditions have shown promising results; however, these models are not widely adopted in community practice for several reasons. These include concerns about reimbursement and uncertainty regarding fees. The Palo Alto Medical Foundation designed and implemented a program called “Champion,” a new model of care that includes new standard work (such as proactive patient outreach, pre-visit schedule grooming, depression screening, care planning) to support patients’ self-management of hypertension and diabetes. The aim of this study is to collect data from providers, patients, and other staff to evaluate the various effect of the Champion program on patient outcomes, provider satisfaction, service utilization, and organisational costs.

Who can participate?
Adults who have been diagnosed with high blood pressure, diabetes or depression in any combination.

What does the study involve?
The study is looking at two health clinics, one which is following the Champion program and one which is not. At the start of the study and then six and twelve months later, a selection of patients complete interviews and surveys about their experiences with the care they are being offered, and have their scheduled appointments with their primary care physician observed by members of the research team. At the same timepoints, health providers and other members of the health care team, such as the medical assistants and health coaches, also complete interviews in order to allow the research team to evaluate the success of the program.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.

Where is the study run from?
1. Mountain View Clinic- Palo Alto Medical Foundation (USA)
2. Fremont Clinic- Palo Alto Medical Foundation (USA)

When is the study starting and how long is it expected to run for?
December 2010 to June 2015

Who is funding the study?
Gordon and Betty Moore Foundation (USA)

Who is the main contact?
1. Dr Ming Tai-Seale (scientific)
tai-sealem@pamfri.org
2. Dr Ellis Dillon (public)
dillone@pamfri.org

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ming Tai-Seale

ORCID ID

Contact details

Sutter Health Palo Alto Medical Foundation
2350 W. El Camino Real
4th floor
Mountain View
94040
United States of America
+1 (0)650 853 4779
tai-sealem@pamfri.org

Type

Public

Additional contact

Dr Ellis Dillon

ORCID ID

Contact details

Sutter Health Palo Alto Medical Foundation
2350 W. El Camino Real
4th floor
Mountain View
94041
United States of America
+1 (0)650 625 3876
dillone@pamfri.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

769702

Study information

Scientific title

A quasi-experimental prospective evaluation of the CHAMPION chronic care model in a pilot clinic at PAMF

Acronym

Study hypothesis

The aim of this study is to evaluate to what degree Champion helps patients who suffer from diabetes and/or hypertension meet clinical targets more quickly, provide more effective coordination of their care, and improve both patient and provider satisfaction with the experience.

Ethics approval

Sutter Health Institutional Review Board (SHIRB), 09/12/2013, ref: 769702

Study design

Multi-centre epidemiological study

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

GP practices

Trial type

Other

Patient information sheet

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

Condition

Hypertension and diabetes

Intervention

This mixed-methods study incorporate direct observation of patient appointments, patient and health care team interviews, patient and physician surveys, and EHR data at baseline and then 6 months and 12 months after implementation.

Physician surveys: A 5-10 minute survey delivered to all primary care physicians in both the clinic implementing Champion and the control clinic at baseline, 6 months and 12 months.

Physician interviews: A 30-60 minute interview with a member of the research team completed by the enough physicians to reach saturation at baseline, 6 months and 12 months. Some physicians were interviewed at each of the 3 stages, while others were interviewed only once or twice.

Appointment observations: A member of the research team recorded and physically observed enough regularly scheduled Champion appointments to reach saturation at baseline, 6 months and 12 months. Some primary care physicians, health coaches, medical assistants and patients had their appointments observed at all 3 stages, while others were only observed once or twice. Champion patients with upcoming appointments were identified and approached in the waiting room prior to their appointment to ask if they would like to participate by having their appointment observed.

Health care team interviews: A 30-60 minute interview with a member of the research team completed by the enough members of the health care team, such as medical assistants and health coaches, to reach saturation at baseline, 6 months and 12 months. Some members of the health care team were interviewed at each of the 3 stages, while others were interviewed only once or twice.

Patient surveys: A 5-10 minutes delivered to all Champion patients in both the clinic implementing Champion and the control clinic at baseline, 6 months and 12 months.

Patients interviews: A 30-60 minute interview with a member of the research team completed by the enough patients to reach saturation at baseline, 6 months and 12 months. Some patients were interviewed at each of the 3 stages, while others were interviewed only once or twice.

Intervention type

Other

Phase

Drug names

Primary outcome measures

PCP experience with providing chronic care management using appointment observations, interviews, surveys and EHR data at baseline, 6 months and 12 months.

Secondary outcome measures

Patient experience with receiving chronic care management using appointment observations, interviews, surveys and EHR data at baseline, 6 months and 12 months.

Overall trial start date

01/12/2010

Overall trial end date

30/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 years or older
2. Male and female
3. Diagnoses: hypertension only; diabetes only; hypertension & diabetes; hypertension & depression; diabetes & depression; hypertension & diabetes & depression

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Accounting for the multiple types of interviewees there are plans to recruit, 30-35 participants (patients, physicians, and clinic staff) may be required per site, per wave (interviews are repeated at intervention sites at baseline, 6 months, and 12 months; at comparison site only once). However, saturation may be reached before conducting 30 interviews, in which case data collection for that wave would cease. The study team intends to interview the same participants in each wave, resulting in a tentative maximum of 70 (30-35 at intervention site; 30-35 at comparison site) participants in the qualitative component of this study. In 2016, there will be 15-20 interviews conducted at Dublin and Danville. For the quantitative portion of this research, the estimated total number of subjects we planned to include is 1,008 (that is, 504 per arm).

Participant exclusion criteria

1. Terminal illness
2. Residence in a long-term care facility
3. Severe hearing loss
4. Ongoing psychiatric care for bipolar or schizophrenia, or dementia

Recruitment start date

13/09/2013

Recruitment end date

23/12/2014

Locations

Countries of recruitment

United States of America

Trial participating centre

Mountain View Clinic- Palo Alto Medical Foundation
701 E El Camino Real
Mountain View
94040
United States of America

Trial participating centre

Fremont Clinic- Palo Alto Medical Foundation
3200 Kearney Street
Fremont
94538
United States of America

Sponsor information

Organisation

Palo Alto Medical Foundation Research Institute

Sponsor details

795 El Camino Real
Palo Alto
94301
United States of America

Sponsor type

Research organisation

Website

http://www.pamf.org/research/

Funders

Funder type

Charity

Funder name

Gordon and Betty Moore Foundation

Alternative name(s)

Gordon E. and Betty I. Moore Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

A manuscript titled “Workflow Standardization of a Novel Team Care Model to Improve Chronic Care: a Quasi-Experimental Study” is currently under review by BMC Health Services Research.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study is not expected to be made available due to the protocol that was approved by the Institutional Review Board.

Intention to publish date

31/12/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26674597
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28420376

Publication citations

Additional files

Editorial Notes

20/04/2017: Publication reference added.