Health PromotionNCT03891368
Study of a Learning Collaborative to Implement Health Promotion in Mental Health
A study testing Virtual Learning Collaborative and Technical Assistance in people with Health Promotion and Obesity, run by Massachusetts General Hospital.
Trial summary
Healthcare organizations have increasingly formed quality-improvement Learning Collaboratives to improve care for specific populations; however, there are few data on the effectiveness of this strategy compared to conventional training approaches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Promotion, Obesity, Organizational Innovation
- What is being tested?
- Virtual Learning Collaborative and Technical Assistance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 26 Nov 2014to 31 Jan 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- None
About this study
Official title: Randomized Controlled Trial of a Learning Collaborative to Implement Health Promotion in Mental Health
Healthcare organizations have increasingly formed quality-improvement Learning Collaboratives to improve care for specific populations; however, there are few data on the effectiveness of this strategy compared to conventional training approaches. The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervention for persons with serious mental illness (SMI) in routine mental health settings, compared to typical implementation consisting of site training and one-on-one individual technical assistance (TA). The investigators hypothesize that VLC compared to TA will be associated with greater Program Participation, Program Fidelity, and a greater proportion of participants achieving clinically significant weight loss.
Read the detailed description
Despite the existence of a variety of evidence-based health promotion practices, it is not well documented how to effectively transform community mental health organizations to embrace wellness as central to their mission and services. Healthcare organizations have increasingly formed quality-improvement Learning Collaboratives to improve care for specific populations; however, there are few data on the effectiveness of this strategy compared to conventional training approaches. The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervention for persons with serious mental illness (SMI) in routine mental health settings, compared to typical implementation consisting of site training and one-on-one individual technical assistance (TA). Forty-eight mental health provider organizations from across the United States providing behavioral health services to people with SMI will be recruited to participate in collaboration with the National Council for Behavioral Health. The evidence-based practice to be implemented is the InSHAPE health coaching intervention for persons with SMI. Sites will be stratified by size and randomized to receive an 18-month intensive group-based VLC with monthly learning sessions or individual technical assistance with four scheduled conference calls over 18 months. Sites will be enrolled in three blocks of 16 sites each. The investigators will compare implementation VLC to TA with respect to service outcomes, implementation outcomes, and participant outcomes:
Aim 1 (Service Outcomes): Compare the effectiveness of VLC to TA with respect to Program Participation as measured by the proportion of enrolled individuals who received an adequate exposure to the evidence-based practice, as defined by attending at least 50% of the InSHAPE Health Mentor sessions over 6 months.
(H1) Hypothesis: VLC compared to TA will be associated with greater Program Participation.
Aim 2 (Implementation Outcomes): Compare VLC to TA with respect to Program Fidelity as measured by the InSHAPE Fidelity Scale.
(H2) Hypothesis: VLC compared to TA will be associated with greater Program Fidelity.
Aim 3 (Participant Outcomes): Compare VLC to TA with respect to adult participants with SMI enrolled in the InSHAPE program achieving clinically significant weight loss (≥5% weight loss).
(H3) Hypothesis: VLC compared to TA will be associated with a greater proportion of InSHAPE participants achieving clinically significant weight loss.
Secondary aims:
The investigators will also examine the following exploratory hypotheses: VLC compared to TA will result in (E1) more rapid Full Program Operation; (E2) greater Program Uptake; (E3) significantly improved participant health behaviors of physical activity and nutrition; and (E4) greater likelihood of Program Sustainability at 24 months. The investigators will also explore (E5) the effect of Organizational Change and VLC fidelity on Program Participation, and (E6) agency participation and adherence to the core elements of a Learning Collaborative as a predictor of InSHAPE program participation, InSHAPE program fidelity, and participant weight outcomes.
- Being tested
- Virtual Learning Collaborative, Technical Assistance
- Keywords
- Learning collaborative, Technical assistance, Serious mental illness, Organizational change, InSHAPE
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Learning CollaborativeOther
InSHAPE teams consisting of health mentors, supervisors, and senior leaders from each mental health agency randomized to the VLC will be invited to attend an in-person initial kick-off meeting followed by once per month 90-minute VLC sessions. The VLC is organized into three stages: Prework, Action, and Continuous Improvement. VLC faculty, including interventionists with expertise in implementation science, quality improvement, and subject matter (i.e., InSHAPE) experts, will facilitate VLC sessions following a structured protocol to standardize the planning and execution of the VLC across three cohorts enrolled in the study.
Technical AssistanceOther
Scheduled calls will occur at 1 month, 2 months, 8 months, and 14 months following their participation in initial InSHAPE training following randomization and follow a structured protocol. At the end of each scheduled conference call, the coach will schedule the next call with the site.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Learning Collaborative | Experimental | The virtual learning collaborative (VLC) is an 18-month intensive training, skill building, and structured implementation process focused on reinforcing fidelity to the InSHAPE model. Receives: Other: Virtual Learning Collaborative |
| Technical Assistance | Active comparator | The technical assistance (TA) condition includes four scheduled conference calls between an InSHAPE expert TA "coach" and the agency's InSHAPE team, with the option for sites to request additional calls as needed through 18-months post-randomization. Receives: Other: Technical Assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Program Participation
Program Participation will be measured as the proportion of InHAPE participants who have been enrolled and have received adequate exposure to the intervention, defined by attending at least 50% of health mentor sessions over 6 months.
Measured: 6, 12, 18, and 24 months
Change in Program Fidelity
Program Fidelity will be measured using the 22-item InSHAPE Fidelity Scale which assesses structural elements of program implementation in the domains of staffing, organization, and services. Items are rated on a 5-point behaviorally-anchored scale ranging from 1 (not implemented) to 5 (fully implemented) (e.g., weekly review of exercise objectives is scored 5 if 90-100% of required exercise logs are completed, a score of 1 represents 0-24%). The 22 items give a total score ranging from 22 to 110, with a higher score indicating stronger fidelity to the InSHAPE model.
Measured: 6, 12, and 24 months
Change in Participant Weight
Participant Weight will be defined as clinically significant weight loss of ≥5% body weight since baseline, and weight will be measured to the tenth of a pound on a digital bathroom scale.
Measured: Baseline, quarterly through 24 months
Secondary outcomes (8)
Change in Full Program Operation defined as a 1.0 FTE Health Mentor with a caseload of 20 participants
Full Program Operation will be measured by time to having 1.0 FTE Health Mentor with a caseload of 20 participants.
Measured: 12 and 24 months
Change in Program Uptake defined as the number of 1.0 FTE Health Mentors
Program Uptake will be measured by the number of 1.0 FTE Health Mentors and participants served at 12 and 24 months.
Measured: 12 and 24 months
Change in Participant Cardiorespiratory Fitness
Participant Cardiorespiratory Fitness will be assessed using the 6-Minute Walk Test, which measures the distance an individual can walk in six minutes. An increase in distance of >50 meters on the 6-MWT is associated with clinically significant reduction in risk for cardiovascular disease.
Measured: Baseline, quarterly through 24 months
Change in Participant Dietary Behavior
Participant Dietary Behavior will be assessed using Weight Loss Behavior Stages of Change Scale. Higher scores indicate greater readiness to change dietary behaviors. An overall dietary behavior score consisting of the mean for the items related to three domains: portion control, consumption of dietary fat, and intake of fruits and vegetables will be calculated.
Measured: Baseline, quarterly through 24 months
Change in Participant Physical Activity
Participant Physical Activity will be assessed using the short-form International Physical Activity Questionnaire. Summary scores will be calculated for vigorous activities obtaining an estimate of weekly metabolic equivalent expenditure (MET) minutes of vigorous physical activity.
Measured: Baseline, quarterly through 24 months
Change in Program Sustainability defined as having a Health Mentor who meets with at least one InSHAPE participant
Program Sustainability at 24-month follow-up will be measured by the number of sites still implementing InSHAPE, as defined by having a Health Mentor who has a personal trainer certification and who meets with at least one InSHAPE participant.
Measured: 24 months
Change in Organizational Change that supports an organization's capacity to implement and sustain the InSHAPE program
Organizational Change will be measured using the Dartmouth Organizational Structure Scale (DOSS), an 11-item interviewer-rated scale developed by the investigators. It measures a set of practices and procedures aimed at supporting the organization's capacity to implement and sustain the InSHAPE program. The content dimensions include leadership, financing, policies, agency commitment to the evidence-based practice, process and outcome monitoring for quality improvement, and other organizational factors found in prior implementation studies to be associated with successful implementation of evidence-based practices. Each DOSS item is scored on a 5-point behavioral-anchored continuum. The interviewer assesses five objective criteria for each item, giving one point for each criterion met for a maximum score of 5. The 11 items are summed, yielding a total DOSS score with possible values ranging from 11 to 55, with a higher score indicating greater organizational change.
Measured: 3, 12, and 24 months
Change in VLC Adherence
VLC Adherence will be measured using an 11-item VLC Adherence Tool. The tool was developed by the investigators for the study based on a review of the literature, feedback from experts and the research team, and feasibility testing. Key domains include the extent to which a team engages in verbal participation, chat box participation, implementation progress, use of quality improvement tools or approaches, use of data collection to drive improvement, collaborative learning and sharing, and planning for program sustainment. VLC faculty score each team on every domain by consensus at the conclusion of each learning session based on a review of submitted homework, participation, and group interaction. Total score ranges from 0 (poor VLC adherence) to 41 (strong VLC adherence).
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start26 Nov 2014
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Jan 2022 (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 Health PromotionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Dartmouth-Hitchcock Medical Center, Dartmouth College
- Responsible party
- Principal investigator, Stephen Bartels, Massachusetts General Hospital
- Investigators
- Stephen Bartels, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891368
- Sponsor's protocol ID
- R01MH102325
- Other IDs
- R01MH102325, STUDY00028067
- Status last verified
- Aug 2021
- First submitted
- 16 Mar 2019
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aschbrenner KA, Pratt SI, Bond GR, Zubkoff L, Naslund JA, Jue K, Williams G, Kinney A, Cohen MJ, Godfrey MM, Bartels SJ. A virtual learning collaborative to implement health promotion in routine mental health settings: Protocol for a cluster randomized trial. Contemp Clin Trials. 2019 Sep;84:105816. doi: 10.1016/j.cct.2019.105816. Epub 2019 Jul 22.
PubMed 31344520
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Learning Collaborative to Implement Health Promotion in Mental Health
- ClinicalTrials.gov ID
- NCT03891368
- Acronym / sponsor ID
- R01MH102325
- Keywords
- Learning collaborative, Technical assistance, Serious mental illness, Organizational change, InSHAPE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Dartmouth-Hitchcock Medical Center, Dartmouth College
- Study start
- 26 Nov 2014 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 27 Mar 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.
Healthcare organizations have increasingly formed quality-improvement Learning Collaboratives to improve care for specific populations; however, there are few data on the effectiveness of this strategy compared to conventional training approaches. The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervention for persons with serious mental illness (SMI) in routine mental health settings, compared to typical implementation consisting of site training and one-on-one individual technical assistance (TA). The investigators hypothesize that VLC compared to TA will be associated with greater Program Participation, Program Fidelity, and a greater proportion of participants achieving clinically significant weight loss.
Detailed description
Despite the existence of a variety of evidence-based health promotion practices, it is not well documented how to effectively transform community mental health organizations to embrace wellness as central to their mission and services. Healthcare organizations have increasingly formed quality-improvement Learning Collaboratives to improve care for specific populations; however, there are few data on the effectiveness of this strategy compared to conventional training approaches. The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervention for persons with serious mental illness (SMI) in routine mental health settings, compared to typical implementation consisting of site training and one-on-one individual technical assistance (TA). Forty-eight mental health provider organizations from across the United States providing behavioral health services to people with SMI will be recruited to participate in collaboration with the National Council for Behavioral Health. The evidence-based practice to be implemented is the InSHAPE health coaching intervention for persons with SMI. Sites will be stratified by size and randomized to receive an 18-month intensive group-based VLC with monthly learning sessions or individual technical assistance with four scheduled conference calls over 18 months. Sites will be enrolled in three blocks of 16 sites each. The investigators will compare implementation VLC to TA with respect to service outcomes, implementation outcomes, and participant outcomes:
Aim 1 (Service Outcomes): Compare the effectiveness of VLC to TA with respect to Program Participation as measured by the proportion of enrolled individuals who received an adequate exposure to the evidence-based practice, as defined by attending at least 50% of the InSHAPE Health Mentor sessions over 6 months.
(H1) Hypothesis: VLC compared to TA will be associated with greater Program Participation.
Aim 2 (Implementation Outcomes): Compare VLC to TA with respect to Program Fidelity as measured by the InSHAPE Fidelity Scale.
(H2) Hypothesis: VLC compared to TA will be associated with greater Program Fidelity.
Aim 3 (Participant Outcomes): Compare VLC to TA with respect to adult participants with SMI enrolled in the InSHAPE program achieving clinically significant weight loss (≥5% weight loss).
(H3) Hypothesis: VLC compared to TA will be associated with a greater proportion of InSHAPE participants achieving clinically significant weight loss.
Secondary aims:
The investigators will also examine the following exploratory hypotheses: VLC compared to TA will result in (E1) more rapid Full Program Operation; (E2) greater Program Uptake; (E3) significantly improved participant health behaviors of physical activity and nutrition; and (E4) greater likelihood of Program Sustainability at 24 months. The investigators will also explore (E5) the effect of Organizational Change and VLC fidelity on Program Participation, and (E6) agency participation and adherence to the core elements of a Learning Collaborative as a predictor of InSHAPE program participation, InSHAPE program fidelity, and participant weight outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Learning Collaborative | Experimental | Other: Virtual Learning CollaborativeThe virtual learning collaborative (VLC) is an 18-month intensive training, skill building, and structured implementation process focused on reinforcing fidelity to the InSHAPE model. |
| Technical Assistance | Active comparator | Other: Technical AssistanceThe technical assistance (TA) condition includes four scheduled conference calls between an InSHAPE expert TA "coach" and the agency's InSHAPE team, with the option for sites to request additional calls as needed through 18-months post-randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Virtual Learning CollaborativeInSHAPE teams consisting of health mentors, supervisors, and senior leaders from each mental health agency randomized to the VLC will be invited to attend an in-person initial kick-off meeting followed by once per month 90-minute VLC sessions. The VLC is organized into three stages: Prework, Action, and Continuous Improvement. VLC faculty, including interventionists with expertise in implementation science, quality improvement, and subject matter (i.e., InSHAPE) experts, will facilitate VLC sessions following a structured protocol to standardize the planning and execution of the VLC across three cohorts enrolled in the study. | Other | Virtual Learning Collaborative |
| Technical AssistanceScheduled calls will occur at 1 month, 2 months, 8 months, and 14 months following their participation in initial InSHAPE training following randomization and follow a structured protocol. At the end of each scheduled conference call, the coach will schedule the next call with the site. | Other | Technical Assistance |
Primary outcome
Change in Program Participation
Time frame: 6, 12, 18, and 24 months
Program Participation will be measured as the proportion of InHAPE participants who have been enrolled and have received adequate exposure to the intervention, defined by attending at least 50% of health mentor sessions over 6 months.
Change in Program Fidelity
Time frame: 6, 12, and 24 months
Program Fidelity will be measured using the 22-item InSHAPE Fidelity Scale which assesses structural elements of program implementation in the domains of staffing, organization, and services. Items are rated on a 5-point behaviorally-anchored scale ranging from 1 (not implemented) to 5 (fully implemented) (e.g., weekly review of exercise objectives is scored 5 if 90-100% of required exercise logs are completed, a score of 1 represents 0-24%). The 22 items give a total score ranging from 22 to 110, with a higher score indicating stronger fidelity to the InSHAPE model.
Change in Participant Weight
Time frame: Baseline, quarterly through 24 months
Participant Weight will be defined as clinically significant weight loss of ≥5% body weight since baseline, and weight will be measured to the tenth of a pound on a digital bathroom scale.
8 secondary outcomes
Change in Full Program Operation defined as a 1.0 FTE Health Mentor with a caseload of 20 participants
Time frame: 12 and 24 months
Change in Program Uptake defined as the number of 1.0 FTE Health Mentors
Time frame: 12 and 24 months
Change in Participant Cardiorespiratory Fitness
Time frame: Baseline, quarterly through 24 months
Change in Participant Dietary Behavior
Time frame: Baseline, quarterly through 24 months
Change in Participant Physical Activity
Time frame: Baseline, quarterly through 24 months
Change in Program Sustainability defined as having a Health Mentor who meets with at least one InSHAPE participant
Time frame: 24 months
Change in Organizational Change that supports an organization's capacity to implement and sustain the InSHAPE program
Time frame: 3, 12, and 24 months
Change in VLC Adherence
Time frame: Up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Derived from this study: PubMed 31344520Aschbrenner KA, Pratt SI, Bond GR, Zubkoff L, Naslund JA, Jue K, Williams G, Kinney A, Cohen MJ, Godfrey MM, Bartels SJ. A virtual learning collaborative to implement health promotion in routine mental health settings: Protocol for a cluster randomized trial. Contemp Clin Trials. 2019 Sep;84:105816. doi: 10.1016/j.cct.2019.105816. Epub 2019 Jul 22.
Related trials for Health Promotion
Recruiting
DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
Diabetic Foot Ulcer (DFU), Diabetes Mellitus
Enrolling by invitationObservational study
Developing a Gynecologic Cancer Health Promotion Community Engagement Program
Gynecologic Cancer Survivors
Active, not recruiting
MEST : A School- Based Health Literacy Intervention Trial
Health Literacy, Adolescent Health
Not yet recruiting
Short, Wordless Animated Storytelling to Promote Mental Health Help-Seeking in Young Adults: A U.S. Online Randomized Controlled Trial
Mental Health Help-Seeking
Active, not recruitingPhase 3
PREVENT HPV -Related Cancers Trial
HPV Vaccination, Uptake Vaccination
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.
Stephen Bartels, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Learning Collaborative and Technical Assistance in people with Health Promotion and Obesity, run by Massachusetts General Hospital.
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 0 inclusion and 1 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 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Program Participation (time frame: 6, 12, 18, and 24 months). The study lists 3 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 NCT03891368, 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 18 Oct 2021.