ComorbidityTipping PointsNCT04176510
Preventing Tipping Points in High Comorbidity Patients: A Lifeline From Health Coaches
A study testing Health Coach Intervention in people with Comorbidity and Self-Management, run by Clinical Directors Network at 4 sites in United States.
Trial summary
This pragmatic cluster randomized clinical trial (cRCT) aims to evaluate the comparative effectiveness (CER) of two approaches to preventing destabilization ("tipping points") that lead to unplanned hospitalization and increased disability. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Comorbidity, Self-Management
- What is being tested?
- Health Coach Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,920 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Nov 2019to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Established patients of the participating Federally Qualified Health Centers (FHQCs)
- Charlson comorbidity index ≥4
Who cannot join
- Metastatic cancer,
- End stage renal disease on dialysis
- Post-transplant
- Severe mental illness
- Drug/alcohol abuse
- Cannot communicate in English or Spanish.
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Family Health Centers at NYU Langone
Brooklyn, New York, 11220
Radhika Gore, PhD, Radhika.Gore@nyulangone.org
- Recruiting
Friend Health, Inc.
Chicago, Illinois, 60615
Biswas Pradhan, bpradhan@bsd.uchicago.edu
- Recruiting
Erie Family Health Centers
Chicago, Illinois, 60622
Paula Rusca, prusca@eriefamilyhealth.org
- Recruiting
Community Healthcare Network
New York, New York, 10010
Christine Rutkoski, CRutkoski@chnnyc.org
About this study
This pragmatic cluster randomized clinical trial (cRCT) aims to evaluate the comparative effectiveness (CER) of two approaches to preventing destabilization ("tipping points") that lead to unplanned hospitalization and increased disability. The cRCT compares the outcomes of patients randomized in clusters by site within four Federally Qualified Health Center (FQHC) networks in New York City (NYC) and Chicago to either: 1) the Patient Centered Medical Home (PCMH); or 2) the Patient Centered Home plus a health coaching intervention that employs a positive affect/self-affirmation intervention to help motivate patients to succeed at implementing self-management by setting life goals (experimental).
This RCT embeds novel effective interventions within large FQHC networks, namely, Community Healthcare Network and the Family Health Centers of New York University (NYU) Langone in NYC and Erie Family Health Centers and Friend Family Health Center in Chicago, serving patients with multiple chronic diseases or high comorbidity. This CER study compares two PCMH-based strategies and will provide a manualized training system that can be disseminated and implemented across the national FQHC networks, with over 9,000 delivery sites that serve nearly 25 million low-income and minority patients, and can be implemented in a wider range of practice settings, organization types and population characteristics.
Read more
Among 1920 adult patients with a Charlson Comorbidity Index ≥4 who are established primary care patients of 16 Federally Qualified Health Centers (FQHCs) in NYC (8 FQHCs) and Chicago (8 FQHCs) this pragmatic cRCT aims to evaluate the effectiveness of two approaches to preventing destabilization that leads to unplanned hospitalization and increased disability.
This Patient-Centered Outcomes Research Institute (PCORI) study builds on the National Patient-Centered Clinical Research Network (PCORnet) Clinical Data Research Networks (CDRNs) in NYC and Chicago. Patients will be identified via electronic health records (EHRs) and their outcomes assessed through comprehensive, longitudinal, electronic health records that are aggregated by these PCORnet CDRNs.
- Conditions
- Comorbidity, Self-Management
- Being tested
- Health Coach Intervention
- Keywords
- Comorbidity, Self-Management, Charlson Comorbidity Index, Health Coach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Coach InterventionBehavioural
A structured, manualized coaching intervention by a lay Health Coach that employs a standardized positive affect/self-affirmation intervention, not tied to specific chronic diseases, to help motivate patients to learn to implement self-management by setting life goals.
| Study group | Role | What they receive |
|---|---|---|
| Patient Centered Medical Home (PCMH) plus Health Coach | Experimental | A health coaching intervention that employs a positive affect/self-affirmation intervention to help motivate patients to succeed at implementing self-management by setting life goals, in addition to the usual care provided for patients with multiple chronic diseases by the The Patient-Centered Medical Home (PCMH). Receives: Behavioral: Health Coach Intervention |
| Patient Centered Medical Home (PCMH) | No intervention | Usual care provided for patients with multiple chronic diseases by the Patient-Centered Medical Home (PCMH). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Unplanned Hospitalizations
Unplanned hospitalizations are hospitalizations for any reason other than elective procedures. This specifically excludes admissions for a planned procedure (i.e. elective surgery, chemotherapy, childbirth, etc.). Admissions not accompanied by an acute diagnosis are not counted. Circumstances surrounding hospitalization will be recorded through a vignette, classified by two independent blinded reviewers.
Measured: 24 months
World Health Organization Disability Assessment Scale (WHODAS) Scale
The WHODAS 2.0 (36 items) assesses individual level of function in six major life domains: cognition (understanding and communication) mobility (move and get around), self-care (attend to personal hygiene, dress, eat and live alone), getting along (interact with other people); life activities (carry out responsibility of home, work, school), and participation in society (engage in community, civil and recreational activities).Chronbach's α was >0.79 for each of the domains. The test-retest reliability ranged from 0.93 to 0.96 at the domain level. WHODAS 2.0 generates one global score and six domain-specific scores, validated against the Short Form 36 (SF-36) Health Survey and other scales and is responsive to change.
Measured: 24 months
Secondary outcomes (3)
Number of Emergency Department Visits
This includes visits to emergency departments as captured by Encounter Type, Provider and Facility Location in Electronic Health Records.
Measured: 24 months
Health Education Impact Questionnaire
The Health Education Impact Questionnaire evaluates eight domains: positive and active engagement in life, health directed behavior, skill and technique acquisition, constructive attitudes and approaches, self-monitoring and insight, health services navigation, social integration and support, and emotional wellbeing. Each domain is scored separately and domain scores range between 1 and 4. For the domain of emotional wellbeing, lower score represents better outcome. For all other domains, higher scores represent better outcomes.
Measured: 24 months
Patient Activation Measure
The Patient Activation Measure (PAM-13) assesses skill and confidence for self-management of chronic conditions. It is a 13 item scale with a 5-point Likert response scale (disagree strongly, disagree, agree, agree strongly, or N/A). Raw scores are transformed to a scale of 0-100 with 100 being the highest activation and 0 the lowest activation in self-management.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start20 Nov 2019
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ComorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,920 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Directors Network
- Sponsor type
- Research network
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Jonathan N Tobin, PhD, Principal investigator, Clinical Directors NetworkMary Charlson, MD, Principal investigator, Weill Medical College of Cornell UniversityAndrea Cassells, MPH, Study director, Clinical Directors NetworkAnisa Mian, MPH, Study director, Clinical Directors Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176510
- Sponsor's protocol ID
- IHS-2017C3-8923
- Other IDs
- 8923
- Acronym
- Tipping Points
- Status last verified
- Feb 2023
- First submitted
- 28 Jun 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Charlson ME, Mittleman I, Ramos R, Cassells A, Lin TJ, Eggleston A, Wells MT, Hollenberg J, Pirraglia P, Winston G, Tobin JN. Preventing "tipping points" in high comorbidity patients: A lifeline from health coaches - rationale, design and methods. Contemp Clin Trials. 2025 May;152:107865. doi: 10.1016/j.cct.2025.107865. Epub 2025 Feb 28.
PubMed 40024364
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Tipping Points in High Comorbidity Patients: A Lifeline From Health Coaches
- ClinicalTrials.gov ID
- NCT04176510
- Acronym / sponsor ID
- Tipping Points / IHS-2017C3-8923
- Conditions
- Comorbidity, Self-Management
- Keywords
- Comorbidity, Self-Management, Charlson Comorbidity Index, Health Coach
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,920 participants (estimated)
- Lead sponsor
- Clinical Directors NetworkResearch network
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pragmatic cluster randomized clinical trial (cRCT) aims to evaluate the comparative effectiveness (CER) of two approaches to preventing destabilization ("tipping points") that lead to unplanned hospitalization and increased disability. The cRCT compares the outcomes of patients randomized in clusters by site within four Federally Qualified Health Center (FQHC) networks in New York City (NYC) and Chicago to either: 1) the Patient Centered Medical Home (PCMH); or 2) the Patient Centered Home plus a health coaching intervention that employs a positive affect/self-affirmation intervention to help motivate patients to succeed at implementing self-management by setting life goals (experimental).
This RCT embeds novel effective interventions within large FQHC networks, namely, Community Healthcare Network and the Family Health Centers of New York University (NYU) Langone in NYC and Erie Family Health Centers and Friend Family Health Center in Chicago, serving patients with multiple chronic diseases or high comorbidity. This CER study compares two PCMH-based strategies and will provide a manualized training system that can be disseminated and implemented across the national FQHC networks, with over 9,000 delivery sites that serve nearly 25 million low-income and minority patients, and can be implemented in a wider range of practice settings, organization types and population characteristics.
Among 1920 adult patients with a Charlson Comorbidity Index ≥4 who are established primary care patients of 16 Federally Qualified Health Centers (FQHCs) in NYC (8 FQHCs) and Chicago (8 FQHCs) this pragmatic cRCT aims to evaluate the effectiveness of two approaches to preventing destabilization that leads to unplanned hospitalization and increased disability.
This Patient-Centered Outcomes Research Institute (PCORI) study builds on the National Patient-Centered Clinical Research Network (PCORnet) Clinical Data Research Networks (CDRNs) in NYC and Chicago. Patients will be identified via electronic health records (EHRs) and their outcomes assessed through comprehensive, longitudinal, electronic health records that are aggregated by these PCORnet CDRNs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Centered Medical Home (PCMH) plus Health Coach | Experimental | Behavioral: Health Coach InterventionA health coaching intervention that employs a positive affect/self-affirmation intervention to help motivate patients to succeed at implementing self-management by setting life goals, in addition to the usual care provided for patients with multiple chronic diseases by the The Patient-Centered Medical Home (PCMH). |
| Patient Centered Medical Home (PCMH) | No intervention | –Usual care provided for patients with multiple chronic diseases by the Patient-Centered Medical Home (PCMH). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Established patients of the participating Federally Qualified Health Centers (FHQCs)
- Charlson comorbidity index ≥4
Key exclusion criteria (6 listed)
- Metastatic cancer,
- End stage renal disease on dialysis
- Post-transplant
- Severe mental illness
- Drug/alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Coach InterventionA structured, manualized coaching intervention by a lay Health Coach that employs a standardized positive affect/self-affirmation intervention, not tied to specific chronic diseases, to help motivate patients to learn to implement self-management by setting life goals. | Behavioural | Patient Centered Medical Home (PCMH) plus Health Coach |
Primary outcome
Number of Unplanned Hospitalizations
Time frame: 24 months
Unplanned hospitalizations are hospitalizations for any reason other than elective procedures. This specifically excludes admissions for a planned procedure (i.e. elective surgery, chemotherapy, childbirth, etc.). Admissions not accompanied by an acute diagnosis are not counted. Circumstances surrounding hospitalization will be recorded through a vignette, classified by two independent blinded reviewers.
World Health Organization Disability Assessment Scale (WHODAS) Scale
Time frame: 24 months
The WHODAS 2.0 (36 items) assesses individual level of function in six major life domains: cognition (understanding and communication) mobility (move and get around), self-care (attend to personal hygiene, dress, eat and live alone), getting along (interact with other people); life activities (carry out responsibility of home, work, school), and participation in society (engage in community, civil and recreational activities).Chronbach's α was >0.79 for each of the domains. The test-retest reliability ranged from 0.93 to 0.96 at the domain level. WHODAS 2.0 generates one global score and six domain-specific scores, validated against the Short Form 36 (SF-36) Health Survey and other scales and is responsive to change.
3 secondary outcomes
Number of Emergency Department Visits
Time frame: 24 months
Health Education Impact Questionnaire
Time frame: 24 months
Patient Activation Measure
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 40024364Charlson ME, Mittleman I, Ramos R, Cassells A, Lin TJ, Eggleston A, Wells MT, Hollenberg J, Pirraglia P, Winston G, Tobin JN. Preventing "tipping points" in high comorbidity patients: A lifeline from health coaches - rationale, design and methods. Contemp Clin Trials. 2025 May;152:107865. doi: 10.1016/j.cct.2025.107865. Epub 2025 Feb 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan N Tobin, PhD principal investigator
Clinical Directors Network
Mary Charlson, MD principal investigator
Weill Medical College of Cornell University
Andrea Cassells, MPH study director
Clinical Directors Network
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coach Intervention in people with Comorbidity and Self-Management, run by Clinical Directors Network at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anisa Mian, MPH (2123820699 ext. 254, tp@cdnetwork.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Unplanned Hospitalizations (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04176510, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.